key: cord-252691-757mh2mh authors: Pratt, R. J.; Pellowe, C. M.; Wilson, J. A.; Loveday, H. P.; Harper, P. J.; Jones, S.R.L.J.; McDougall, C.; Wilcox, M. H. title: epic2: National Evidence-Based Guidelines for Preventing Healthcare-Associated Infections in NHS Hospitals in England date: 2007-02-28 journal: Journal of Hospital Infection DOI: 10.1016/s0195-6701(07)60002-4 sha: doc_id: 252691 cord_uid: 757mh2mh Executive Summary National evidence-based guidelines for preventing healthcare-associated infections (HCAI) in National Health Service (NHS) hospitals in England were commissioned by the Department of Health (DH) and developed during 1998-2000 by a nurse-led multi-professional team of researchers and specialist clinicians. Following extensive consultation, they were published in January 2001.1 These guidelines describe the precautions healthcare workers should take in three areas: standard principles for preventing HCAI, which include hospital environmental hygiene, hand hygiene, the use of personal protective equipment, and the safe use and disposal of sharps; preventing infections associated with the use of short-term indwelling urethral catheters; and preventing infections associated with central venous catheters. The evidence for these guidelines was identified by multiple systematic reviews of experimental and non-experimental research and expert opinion as reflected in systematically identified professional, national and international guidelines, which were formally assessed by a validated appraisal process. In 2003, we developed complementary national guidelines for preventing HCAI in primary and community care on behalf of the National Collaborating Centre for Nursing and Supportive Care (National Institute for Healthand Clinical Excellence).2 A cardinal feature of evidence-based guidelines is that they are subject to timely review in order that new research evidence and technological advances can be identified, appraised and, if shown to be effective in preventing HCAI, incorporated into amended guidelines. Periodically updating the evidence base and guideline recommendations is essential in order to maintain their validity and authority. Consequently, the DH commissioned a review of new evidence published following the last systematic reviews. We have now updated the evidence base for making infection prevention and control recommendations. A critical assessment of the updated evidence indicated that the original epic guidelines published in 2001 remain robust, relevant and appropriate but that adjustments need to be made to some guideline recommendations following a synopsis of the evidence underpinning the guidelines. These updated national guidelines (epic2) provide comprehensive recommendations for preventing HCAI in hospitals and other acute care settings based on the best currently available evidence. Because this is not always the best possible evidence, we have included a suggested agenda for further research in each section of the guidelines. National evidence-based guidelines are broad principles of best practice which need to be integrated into local practice guidelines. To monitor implementation, we have suggested key audit criteria for each section of recommendations. Clinically effective infection prevention and control practice is an essential feature of protecting patients. By incorporating these guidelines into routine daily clinical practice, patient safety can be enhanced and the risk of patients acquiring an infection during episodes of healthcare in NHS hospitals in England can be minimised. We would like to acknowledge the assistance we received from The Liverpool Reviews and Implementation Group (University of Liverpool) who shared with us data from their Health Technology Assessment focused on the clinical and cost effectiveness of central venous catheters treated with antimicrobial agents in preventing bloodstream infections. We are also indebted to the Infection Control Nurses Association and the Hospital Infection Society for their input into the S2 R.J. Pratt et al. made to some guideline recommendations following a synopsis of the evidence underpinning the guidelines. These updated national guidelines (epic2) provide comprehensive recommendations for preventing HCAI in hospitals and other acute care settings based on the best currently available evidence. Because this is not always the best possible evidence, we have included a suggested agenda for further research in each section of the guidelines. National evidence-based guidelines are broad principles of best practice which need to be integrated into local practice guidelines. To monitor implementation, we have suggested key audit criteria for each section of recommendations. Clinically effective infection prevention and control practice is an essential feature of protecting patients. By incorporating these guidelines into routine daily clinical practice, patient safety can be enhanced and the risk of patients acquiring an infection during episodes of healthcare in NHS hospitals in England can be minimised. Standard Principles for preventing healthcareassociated infections in hospital and other acute care settings This guidance is based on the best critically appraised evidence currently available. The type and class of supporting evidence explicitly linked to each recommendation is described. All recommendations are endorsed equally and none is regarded as optional. These recommendations are not detailed procedural protocols and need to be incorporated into local guidelines. This guidance on infection control precautions should be applied by all healthcare practitioners to the care of every patient. Job descriptions should reflect this and annual appraisal evidence should be available to support continuing engagement of each member of staff. The recommendations are divided into four distinct interventions: 1. Hospital environmental hygiene; 2. Hand hygiene; 3. The use of personal protective equipment; and 4. The safe use and disposal of sharps. These guidelines do not address the additional infection control requirements of specialist settings, such as the operating department. Hospital environmental hygiene SP1 The hospital environment must be visibly Class C clean, free from dust and soilage and acceptable to patients, their visitors and staff. Guidelines for preventing infections associated with the use of short-term indwelling urethral catheters This guidance is based on the best critically appraised evidence currently available. The type and class of supporting evidence explicitly linked to each recommendation is described. All recommendations are endorsed equally and none is regarded as optional. These recommendations are not detailed procedural protocols and need to be incorporated into local guidelines. These guidelines apply to adults and children aged 1 year and older and should be read in conjunction with the guidance on Standard Principles. The recommendations are divided into five distinct interventions: This guidance is based on the best critically appraised evidence currently available. The type and class of supporting evidence explicitly linked to each recommendation is described. All recommendations are endorsed equally and none is regarded as optional. These recommendations are not detailed procedural protocols and need to be incorporated into local guidelines. These guidelines apply to adults and children aged one year and older and should be read in conjunction with the guidance on Standard Principles. The recommendations are divided into 9 distinct interventions: 1. Education of healthcare workers and patients; 2. General asepsis; 3. Selection of catheter type; 4. Selection of catheter insertion site; 5. Maximal sterile barrier precautions during catheter insertion; 6. Cutaneous antisepsis; 7. Catheter and catheter site care; 8. Catheter replacement strategies; and 9. General principles for catheter management. 2 An evidence review in 2004 indicated the necessity to amend and update some of the original epic guideline recommendations to ensure that they continue to reflect new and emerging evidence, remain relevant to infection control and prevention practice and enjoy the confidence of practitioners and patients. 3, 4 Additional updating systematic reviews were conducted in 2005 and the original epic guidelines have now been revised. They are referred to in this publication as the epic2 infection prevention guidelines, which now replace the original 2001 guidelines. What are national evidence-based guidelines? These are systematically developed broad statements (principles) of good practice. They are driven by practice need, based on evidence and subject to multi-professional debate, timely and frequent review, and modification. National guidelines are intended to inform the development of detailed operational protocols at local level and can be used to ensure that these incorporate the most important principles for preventing HCAI in NHS hospitals and other acute care health services. Why do we need national guidelines for preventing healthcare-associated infections? During the past two decades, HCAI have become a significant threat to patient safety. The technological advances made in the treatment of many diseases and disorders are often undermined by the transmission of infections within healthcare settings, particularly those caused by antimicrobial-resistant strains of disease-causing microorganisms that are now endemic in many healthcare environments. The financial and personal cost of these infections, in terms of the economic consequences to the NHS and the physical, social and psychological costs to patients and their relatives, have increased both government and public awareness of the risks associated with healthcare interventions, especially that of acquiring a new infection. Although not all HCAI can be prevented, many can. Clinical effectiveness, i.e., using prevention measures that are based on reliable evidence of efficacy, is a core component of an effective strategy designed to protect patients from the risk of infection. What is the purpose of the guidelines? These guidelines describe clinically effective measures that are used by healthcare workers for preventing infections in hospital and other acute care health services. What is the scope of the guidelines? Three sets of guidelines were originally developed and have now been updated. They include: • Standard infection control principles include best practice recommendations for hospital environmental hygiene, effective hand hygiene, the appropriate use of personal protective equipment, and the safe use and disposal of sharps; • Guidelines for preventing infections associated with the use of short-term indwelling urethral catheters; and • Guidelines for preventing infections associated with the use of central venous access devices. What is the evidence for these guidelines? The evidence for these guidelines was identified by multiple systematic reviews of experimental and non-experimental research. In addition, evidence from expert opinion as reflected in systematically identified professional, national and international guidelines was considered following formal assessment using a validated appraisal process. 5, 6 All evidence was critically appraised for its methodological rigour and clinical practice applicability and the best available evidence influenced the guideline recommendations. Who developed these guidelines? The epic2 guidelines were developed by a nurseled team of researchers, senior infection control nurses and a Director of Microbiology and Infection Prevention and Control in a large NHS Teaching Hospital Trust (see 1.1). Who are these guidelines for? These guidelines can be appropriately adapted and used by all hospital practitioners. They will inform the development of more detailed local protocols and ensure that important standard principles for infection prevention are incorporated. Consequently, they are aimed at hospital managers, members of hospital infection control teams, and individual health care practitioners. At an individual level, they are intended to influence the quality and clinical effectiveness of infection prevention decision-making. The dissemination of these guidelines also help patients understand the standard infection prevention precautions recommended to protect them from HCAI. How are these guidelines structured? Each set of guidelines follows an identical format, which consists of: • a resume of the systematic review process; • the intervention heading; • a headline statement describing the key issues being addressed; • a synthesis of the related evidence; • an economic opinion, where appropriate; • guideline recommendation(s) classified according to the strength of the underpinning evidence. Finally, at the end of each section there is a description of areas for further research and suggested audit criteria. All evidence is referenced in section 5. How frequently are the guidelines reviewed and updated? A cardinal feature of evidence-based guidelines is that they are subject to timely review in order that new research evidence and technological advances can be identified, appraised and, if shown to be effective in preventing HCAI, incorporated into amended guidelines. The evidence base for these guidelines will be reviewed in two years (2009) and the guidelines will be updated approximately four years after publication (2011). How can these guidelines be used to improve your clinical effectiveness? In addition to informing the development of detailed local operational protocols, these guidelines can be used as a benchmark for determining appropriate infection prevention decisions and, as part of reflective practice, to assess clinical effectiveness. They also provide a baseline for clinical audit, evaluation and education, and facilitate ongoing quality improvements. How much will it cost to implement these guidelines? Significant additional costs are not anticipated in implementing these guidelines. However, where current equipment or resources do not facilitate the implementation of the guidelines, or where staff levels of adherence to current guidance are poor, there may be an associated increase in costs. Given the social and economic costs of HCAI, the consequences associated with not implementing these guidelines would be unacceptable to both patients and health care professionals. These guidelines have been subject to extensive external consultation with key stakeholders, including Royal Colleges, professional societies and organisations, including patients, and trades unions (Appendix A.1). The guidelines were developed using a systematic review process (Appendix A.2). In each set of guidelines a resume of the relevant guideline development methodology is provided. Electronic databases were searched for national and international guidelines and research studies published during the period 01 January 1999 to 31 August 2005. A two-stage search process was used. For each set of epic guidelines, an electronic search was conducted for systematic reviews of randomised controlled trials and current national and international guidelines. The following data bases were searched: • Cochrane Library; • National Guideline Clearinghouse; • National Electronic Library of Health; • National Institute for Health and Clinical Excellence. Guidelines were retrieved and subjected to critical appraisal using the AGREE Instrument, 6 an evaluation method used in Europe for assessing the methodological quality of clinical practice guidelines. Following appraisal, accepted guidelines were included as part of the evidence base supporting guideline development. They were also used to verify professional consensus and in some instances, as the primary source of evidence. Stage 2: Systematic search for additional evidence Review questions for the systematic reviews of the literature were then developed for each set of epic guidelines following recommendations from expert advisors. Searches were constructed using relevant MeSH (medical subject headings) and free-text terms. On completion of the main search, an economic filter was applied. The following databases were searched: • Cumulated Index of Nursing and Allied Health Literature; • Embase; • The Cochrane Library. Abstract review -identifying studies for appraisal Search results were downloaded into a Reference Manager™ database and titles and abstracts printed for preliminary review. Reviewers identified and retrieved all studies where the title or abstract: addressed one or more of the review questions; identified primary research or systematically conducted secondary research; indicated a theoretical/clinical/ in use study. No research designs were specifically excluded but wherever possible, in use rather than in vitro studies were retrieved. Where no abstract was available and the title indicated one or more of the above criteria, the study was retrieved. Due to the limited resources available for this review, foreign language studies were not reviewed. All full-text studies retrieved were independently assessed by two experienced reviewers who identified those studies meeting the above inclusion criteria for critical appraisal. Included studies were appraised using an adapted data extraction process based on systems developed by the Scottish Intercollegiate Guideline Network for study quality assessment. 7 Due to the limited resources available for this review, studies were not double-blind appraised. However, all studies were appraised and data extracted by one experienced reviewer and then checked by a second experienced reviewer. Any disagreement between reviewers was resolved through discussion. Evidence tables were constructed from the quality assessments and the studies summarised in the evidence reports. The evidence was classified using methods adopted by the National Institute for Health and Clinical Excellence (NICE) from The Scottish Intercollegiate Guideline Network (SIGN) ( Table 1) . 8, 9 This system differs from that used in the previous epic and NICE infection prevention guidelines. 1, 2 The evidence tables and reports were presented to the advisors for discussion. At this stage, expert advice derived from seminal works and appraised national and international guidelines were considered. Following extensive discussion the guidelines were drafted. Factors influencing the guideline recommendations included: • the nature of the evidence; • the applicability of the evidence to practice; • costs and knowledge of healthcare systems. The classification scheme adapted by NICE from SIGN was used to define the strength of recommendation (Table 2 ). 8, 9 The complete series of evidence tables are posted on the epic website at: [http://www.epic. tvu.ac.uk]. Type of evidence 1 ++ High-quality meta-analyses, systematic reviews of randomised controlled trials (RCT), or RCT with a very low risk of bias 1 + Well-conducted meta-analyses, systematic reviews of RCT, or RCT with a low risk of bias 1 -Meta-analyses, systematic reviews of RCT, or RCT with a high risk of bias* 2 ++ High-quality systematic reviews of case-control or cohort studies High-quality case-control or cohort studies with a very low risk of confounding, bias or chance and a high probability that the relationship is causal 2 + Well-conducted case-control or cohort studies with a low risk of confounding, bias or chance and a moderate probability that the relationship is causal 2 -Case-control or cohort studies with a high risk of confounding bias, or chance and a significant risk that the relationship is not causal* 3 Non-analytic studies (for example, case reports, case series) 4 Expert opinion, formal consensus *Studies with a level of evidence ' -' should not be used as a basis for making a recommendation These guidelines do not address the additional infection control requirements of specialist settings, such as the operating department or for outbreak situations. We have previously described the systematic review process in Section 1.10. For detailed descriptions of previous systematic reviews which have contributed to the evidence base underpinning these guidelines, readers should consult the original guidelines, 1 the guidelines for the prevention of health-care associated infections in primary and community care 2 and our interim report in 2004 on changes in the evidence base. 3 Search questions were developed from advice received from our specialist advisors and the results of the searches are found in Section 2.10. The process outlined in Section 2.10 refers only to the most recent systematic review of the literature undertaken in 2005. Following our reviews, guidelines were drafted which described 38 recommendations within the below intervention categories: 1. Hospital environmental hygiene; 2. Hand hygiene; 3. Personal protective equipment; and 4. Safe use and disposal of sharps. Good hospital hygiene is an integral and important component of a strategy for preventing healthcare-associated infections in hospitals This section discusses the evidence upon which recommendations for hospital environmental hygiene are based. Hospital environmental hygiene encompasses a wide range of routine activities including: cleaning and decontamination; laundry and housekeeping; safe collection and disposal of general and clinical waste; and kitchen and food hygiene. Guidelines are provided here for: • cleaning the general hospital environment; • cleaning items of shared equipment; and • education and training of staff. Our initial systematic review concluded that there was little research evidence of an acceptable quality upon which to base guidance related to the maintenance of hospital environmental hygiene. 1 However, there was a body of clinical evidence, derived from case reports and outbreak investigations, which suggested an association between poor environmental hygiene and the transmission of microorganisms causing healthcare-associated infections in hospital. 10, 11 Attention had been drawn to perceived falling standards in the cleanliness of hospitals since the introduction of compulsory comprehensive tendering and the internal market. This concern was addressed by the Infection Control Nurses Association and the Association of Domestic Managers, resulting in the adoption and publication by the Department of Health of quality standards for hospital cleanliness 12, 13 and more recently the NHS Healthcare Cleaning Manual. 14 In addition, existing regulations, 15-17 specialist advice, 18, 19 and clinical governance guidance, 20 all provide a framework within which hospital environmental hygiene can be improved and monitored. The NHS Code of Practice on the Prevention and Control of Healthcare Associated infection came into effect in October 2006. 21 The purpose of this Code of Practice is to help NHS bodies plan and implement strategies for the prevention and control of HCAI. It sets out criteria by which managers of NHS organisations and other healthcare providers should ensure that patients are cared for in a clean environment, where the risk of HCAI is kept as low as possible. Failure to comply with the Code may result in an Improvement Notice being issued or other measures. There is new evidence highlighting that the hospital environment can become contaminated with microorganisms responsible for HCAI. [22] [23] [24] [25] [26] [27] Transmission of microorganisms from the environment to patients may occur through direct contact with contaminated equipment, or indirectly as a result of touching by hands. Meticillin epic2: Guidelines for Preventing Healthcare-Associated Infections in NHS Hospitals S13 30, 31 and sink taps, 22, 26, 30 and sites where dust is allowed to accumulate. 24, 32 However, whilst the presence of the same strain of microorganism in the environment as those infecting/colonising patients demonstrates that the environment becomes contaminated with microorganisms from patients, it does not provide confirmation that the environment is responsible for contamination of patients. Evidence suggesting that contamination of the environment is responsible for the transmission of HCAI is therefore not conclusive. Nevertheless, the evidence that pathogens responsible for HCAI can be widely found in the hospital environment and hence readily acquired on hands by touching surfaces, does demonstrate the importance of decontaminating hands before every patient contact. Many microorganisms recovered from the hospital environment do not cause HCAI. Cleaning will not completely eliminate microorganisms from environmental surfaces and reductions in their numbers will be transient. 24 There is some evidence that improved cleaning regimens are associated with the control of outbreaks of HCAI. In one study, the control of an outbreak of an epidemic strain of MRSA was linked with increased cleaning hours and an emphasis on the removal of dust. 32 However, often a range of interventions are introduced in order to control an outbreak and it is difficult to clearly distinguish the effect of a single component such as cleaning. Some evidence suggests that routine cleaning methods may not be sufficient to eliminate surface contamination with MRSA. 26, 32 Disinfectants have been recommended for cleaning of the hospital environment but a systematic review failed to confirm a link between disinfection and the prevention of HCAI, though contamination of detergent and inadequate disinfection strength could have been an important confounder. 33 The use of hypochlorite for cleaning has been associated with a reduction in incidence of Clostridium difficile infection in one study but this was in the absence of a detectable change in environmental contamination when either detergent or hypochlorite was used. 25 In laboratory tests a combination of cleaning with detergent followed by hypochlorite was required to consistently eliminate norovirus from surfaces and prevent cross contamination. 23 Dusting and cleaning using detergent was reported to have no effect on the number of MRSA isolated from the hospital environment, but the organism was virtually eliminated by exposure to hydrogen peroxide vapour. 26 Indicators of cleanliness based on levels of microbial or adenosine triphosphate (ATP) contamination have been proposed but are based on arbitrary standards of acceptable contamination and do not distinguish between normal environmental flora and pathogens responsible for HCAI. 22, 34 The relationship between these proposed standards and the risk of acquiring infection through contact with the environment have not been established. Since cleaning will only have a transient effect on the numbers of microorganisms, regular cleaning of hospital surfaces will not guarantee complete elimination. Hand decontamination before every patient contact is therefore required to ensure that pathogens acquired by touch are not transferred to patients. The hospital environment must be visibly Class C clean, free from dust and soilage and acceptable to patients, their visitors and staff. Shared equipment must be decontaminated after use There is some evidence demonstrating that shared clinical equipment becomes contaminated with pathogens. One study found that more than 50% of commodes tested were contaminated with Clostridium difficile. 25 A systematic review identified a number of studies demonstrating that pathogens can be recovered from a range of noninvasive clinical equipment, including stethoscopes, lifting equipment, and ultrasound probes. None of these studies demonstrated a link between the contamination and infection in a patient. 22 Shared clinical equipment used to deliver care in the clinical environment comes into contact with intact skin and is therefore unlikely to introduce infection. However it can act as a vehicle by which microorganisms are transferred between patients, which may result in infection. 35 This equipment should therefore be appropriately decontaminated after each use with detergent and water. In some outbreak situations hypochlorite and detergent should be considered. SP4 Shared equipment used in the clinical Class D environment must be decontaminated appropriately after each use. Hospital hygiene is everybody's business Three studies in a systematic review of healthcare workers' knowledge about MRSA and/or frequency of cleaning practices indicated that staff were not utilising appropriate cleaning practices with sufficient frequency to ensure minimisation of MRSA contamination of personal equipment. 22 Staff education was lacking on optimal cleaning practices in the clinical areas. Knowledge deficits may hinder the application of cleaning practices and monitoring and evaluation was indicated. This is further reinforced by an observational study which noted that lapses in adhering to the cleaning protocol were linked with an increase in environmental contamination with isolates of Acinetobacter baumannii. 24 A second systematic review of four cohort studies comparing the use of detergents and disinfectants on microbial contaminated hospital environmental surfaces suggested that a lack of effectiveness was, in many instances due inadequate strengths of disinfectants, probably resulting from a lack of knowledge. 33 The following section provides the evidence for recommendations concerning hand hygiene practice. The difficulty in designing and conducting robust, ethical, randomised controlled trials in the field of hand hygiene means that recommendations in these areas are based on evidence from non-randomised controlled trials (NRCT), quasiexperimental studies and expert opinion derived from systematically retrieved and appraised professional, national and international guidelines. The areas discussed include: • assessment of the need to decontaminate hands; • the efficacy of hand decontamination agents and preparations; • the rationale for choice of hand decontamination practice; • technique for hand decontamination; • care required to protect hands from the adverse effects of hand decontamination practice; • promoting adherence to hand hygiene guidelines. Why is hand decontamination crucial to the prevention of healthcare-associated infection? Cross-transmission, the transfer of microorganisms between humans, which occurs directly via hands, or indirectly via an environmental source, such as a commode or wash-bowl, occurs all the time in hospitals. It is the antecedent factor to crossinfection that can result in severe clinical outcomes. Overviews of epidemiological evidence conclude that hand-mediated cross-transmission is a major contributing factor in the current infection threats to hospital in-patients. 1 Crosstransmission via hands has been identified as contributing to hospitals outbreaks involving both meticillin-sensitive and meticillin-resistant Staphylococcus aureus (MRSA/MSSA), multiresistant Gram-negative microorganisms, such as Acinetobacter spp and vancomycin resistant enterococci (VRE). 1 Hand-mediated cross-transmission from resident flora (microorganisms that are present on the hands most of the time) and transient flora (microorganisms that are acquired during healthcare activity and without hand hygiene can be deposited directly on to vulnerable patients) presents a direct clinical threat to patients. When these microorganisms are cross transmitted onto susceptible sites, such as surgical wounds, endo-tracheal tubes during pulmonary ventilation, intravascular cannulation sites, enteral feeding systems or urinary catheter drainage systems, etc., serious lifethreatening infections can arise. Even the crosstransmission to non-vulnerable sites can still leave a patient colonised with more pathogenic and resistant hospital microorganisms which may, if opportunity arises, result in a healthcare associated infection at sometime in the future. epic2: Guidelines for Preventing Healthcare-Associated Infections in NHS Hospitals S15 Current evidence-based guidelines conclude that in both outbreak and non-outbreak situations contaminated hands are responsible for crosstransmission of microorganisms and that effective and effective hand decontamination can significantly reduce both cross-transmission and crossinfection rates for the majority of HCAI in all healthcare settings. 1 A recent case control study, conducted during an outbreak of Klebsiella pneumoniae in a neonatal intensive care unit, demonstrated an association between being cared for by a nurse with positive hand cultures for the outbreak strain and infants developing infection or colonisation. 37 Descriptive studies of the dynamics of bacterial hand contamination demonstrate an association between patient care activities that involve direct patient contact and hand contamination. 38, 39 In an observational study of hand contamination during routine patient care in a large teaching hospital, high levels of hand contamination were associated with direct patient contact, respiratory care and handling body fluids. 38 A further descriptive study of healthcare workers' hand contamination during routine neonatal care demonstrated that hands become increasingly contaminated and that gloves do not fully protect healthcare workers' hands from becoming contaminated. 39 The association between hand decontamination and reductions in infection have been confirmed by two additional clinically-based trials 40, 41 and two descriptive studies. 42, 43 A NRCT introducing the use of alcohol-based hand gel to a long term elderly care facility, demonstrated a reduction of 30% in HCAI over a period of 34 months when compared with the control unit. 40 A further NRCT, demonstrated a 45% reduction in respiratory illness in the post-intervention period following the introduction of a hand washing programme. 41 One descriptive study conducted over a four year period during which alcohol-based handrub was introduced for routine hand hygiene demonstrated a reduction in HCAI from 16.9% to 9.9%. 42 A second study that compared rates of HCAI caused by MRSA, vancomycin-resistant enterococci (VRE) and Clostridium difficile (C. difficile) in the three years prior to the introduction of alcohol-based handrub showed reductions of 21% in MRSA and 41% decrease in VRE. Rates of C. difficile remained unchanged throughout the intervention period. 43 Current national and international guidance consistently identify that effective hand decontamination results in significant reductions in the carriage of potential pathogens on the hands and logically decreases the incidence of preventable HCAI leading to a reduction in patient morbidity and mortality. 1, 44 When must you decontaminate your hands in relation to patient care? Decontamination refers to a process for the physical removal of blood, body fluids, and the removal or destruction of microorganisms from the hands, 44 Current national and international guidance suggests that in deciding when it is necessary to decontaminate hands prior to patient contact, four key factors need to be considered: 1, 44 • the level of the anticipated contact with patients or objects; • the extent of the contamination that may occur with that contact; • the patient care activities being performed; • the susceptibility of the patient. Patients are put at risk of developing a HCAI when informal carers or healthcare workers caring for them have contaminated hands. Hands must be decontaminated before every episode of care that involves direct contact with patients' skin, their food, invasive devices or dressings. Current expert opinion recommends that hands need to be decontaminated after completing an episode of patient care and following the removal of gloves to minimise cross contamination of the environment. 1, 44 Hands must be decontaminated Class C immediately before each and every episode of direct patient contact/care and after any activity or contact that potentially results in hands becoming contaminated. Is any one hand cleaning preparation better than another? Current national and international guidelines 1,44 consider the effectiveness of various preparations for the decontamination of hands using liquid soap and water, antiseptic handwash agents, and alcohol-based handrubs. Overall there is no compelling evidence to favour the general use of antiseptic handwashing agents over soap, or one antiseptic agent over another. 1, 44 Systematic reviews conducted to underpin guidelines for community and primary care and update the 2001 epic guidance 2,3 identified nineteen studies comparing hand hygiene preparations including alcohol-based handrubs and gels, antiseptic hand washes and liquid soap. Five randomised controlled trials (RCT) were conducted in clinical settings and compared the use of alcohol-based preparations with other agents. [45] [46] [47] [48] [49] Four RCTs demonstrated alcohol-based preparations to be a more effective hand hygiene agent than non-medicated soap and antiseptic handwashing agents, [45] [46] [47] [48] while a fifth study found no statistical difference between the use of alcoholbased preparations and antiseptic soap. 49 A clinical crossover trial conducted over 11 months within a neonatal intensive care unit demonstrated no statistical difference between infection rates during the hand washing and handrub phases of the trial. 50 Three clinically based, quasi-experimental studies [51] [52] [53] and nine controlled laboratory experiments 54-62 also demonstrated an association between reductions in microbiological flora and the use of alcohol-based preparations. These studies underpin a growing trend to adopt the use of alcohol-based handrubs and gels in clinical practice. However, two of the above laboratory studies highlight the need for continued evaluation of the use of alcohol-based handrubs within the clinical environment to ensure staff adherence to guidelines and effective hand decontamination. 61, 62 The first study, using European Union (EU) reference standards raises the possibility that alcohol-based gels may not be as effective as handrubs for short durations of use. 61 The second laboratory study, comparing 14 different hand hygiene agents used for a 'clinically realistic' 10 second hand hygiene episode, suggests that some alcohol-based handrubs may lose efficacy after 10 consecutive uses. 62 One clinically-based quasiexperimental study compared the use of 4% chlorhexidine gluconate and 1% triclosan antiseptic handwash preparations in reducing MRSA hand carriage in a specialist surgical ward. 63 Both preparations effectively reduced total hand bacterial counts but 1% triclosan was more effective at eliminating MRSA. Choice of decontamination: is it always necessary to wash hands to achieve decontamination? Choosing the method of decontaminating hands will depend upon the assessment of what is appropriate for the episode of care, the available resources, what is practically possible and, to some degree, personal preferences based on the acceptability of preparations or materials. In general, effective handwashing with a liquid soap will remove transient microorganisms and render the hands socially clean. This level of decontamination is sufficient for general social contact and most clinical care activities. 1, 3, 44 The use of a liquid soap preparation that contains an antiseptic will reduce both transient micro-organisms and resident flora. 1, 44 The effective use of alcohol-based handrubs will also successfully remove transient microorganisms and substantially reduce resident microorganisms. However, alcohol is not effective against some microorganisms such as C. difficile, will not remove dirt and organic material and may not be effective in some outbreak situations. 43, 63 When deciding which hand decontamination preparation to use, the practitioner must consider the need to remove transient and/or resident hand flora. Preparations containing certain antiseptics that exert a residual effect on skin flora can be useful in situations where prolonged reduction in microbial flora on the skin is required e.g. surgery and some invasive procedures. They are not normally necessary for everyday clinical practice but may be used in outbreak situations. National and international guidelines suggest that the acceptability of agents and techniques is an essential criterion for the selection of preparations for hand hygiene. 1,44 Acceptability of preparations is dependent upon the ease with which the preparation can be used in terms of time and access together with their dermatological effects. Due to their efficacy and ease of use, alcohol-based handrubs are recommended for routine use and offer a practical and acceptable alternative to handwashing when hands are not grossly soiled. 44 There are no robust economic evaluations of the comparative costs associated with different hand hygiene agents and rates of HCAI. In an unpublished study of the potential cost savings associated with a national hand hygiene campaign the cost of a single HCAI is estimated at over £3,000. The authors hypothesise that even a small reduction in infections through the use of alcoholbased handrubs, would result in a cost saving. 64 Hands 37, 65 The first study proposes that there is an association between effective hand decontamination and the wearing of rings by healthcare staff for clinical care. 65 It suggests that the removal of rings should result in decreased frequency of hand carriage of pathogens before and after the performance of hand hygiene. In a case control study, conducted during an outbreak of Klebsiella pneumoniae in a neonatal intensive care unit, investigators suggest an association between being cared for by a nurse who wore false nails and had positive hand cultures for the outbreak strain, and infants developing infection or colonisation. 37 Systematic reviews conducted to underpin guidelines for community and primary care and update the 2001 epic guidance 2,3 identified one RCT comparing different durations of handwashing and handrubbing on bacterial reduction that found no significant differences between the two study groups. 45 In addition a laboratory study conducted following a period of clinical observation of hand hygiene technique identified that practitioners on average applied a product for 11.6 seconds and concluded that some alcohol-based handrubs become less effective following 10 consecutive hand hygiene episodes. The authors suggest that periodic decontamination of hands, using liquid soap and water, is advisable throughout a shift. 62 Two small-scale laboratory studies investigating methods of hand drying were identified. One found no statistically significant differences between the four methods studied 66 and the other suggests that warm air drying, when the hands are not rubbed simultaneously, may be more effective at reducing the numbers of bacteria on the hands following hand washing than the use of paper towels. 67 Due to the methodological limitations of the above studies, recommendations continue to be based on existing expert opinion that the duration of hand decontamination, the exposure of all aspects of the hands and wrists to the preparation being used, the use of vigorous rubbing to create friction, thorough rinsing in the case of handwashing, and ensuring that hands are completely dry are key factors in effective hand hygiene and the maintenance of skin integrity. 1 Does hand decontamination damage skin? Expert opinion concludes that skin damage is generally associated with the detergent base of the preparation and/or poor handwashing technique. 1 However, the frequent use of hand hygiene agents may cause damage to the skin and alter normal hand flora. Excoriated hands are associated with increased colonisation of potentially pathogenic microorganisms and increase the risk of infection. 1, 44 In addition, the irritant and drying effects of hand preparations have been identified as one of the reasons why healthcare practitioners fail to adhere to hand hygiene guidelines. 1, 44 Systematic reviews conducted to underpin guidelines for community and primary care and update the 2001 epic guidance 2,3 identified ten studies of which four were RCT conducted in clinical settings. 46, 47, 50, 68 They compared the use of alcohol-based preparations with liquid soap and water using self-assessment of skin condition by nurses. In these studies a greater level of irritation was associated with the use of soap. Three further studies, one clinically-based quasi-experimental study, one descriptive clinical study and one nonclinical experimental study concluded that S18 R.J. Pratt et al. alcohol-based handrubs caused less skin irritation. 53, 69, 70 In addition, one longitudinal study of the introduction and subsequent use of alcoholbased handrub over a seven year period observed no reports of irritant and contact dermatitis associated with the use of alcohol-based handrubs. 42 A laboratory study demonstrated a strong relationship between the frequency of handwashing with a chlorhexidine preparation and dermatitis. 71 Current national and international guidance suggests that skin care, through the appropriate use of hand lotion or moisturizers added to hand hygiene preparations, is an important factor in maintaining skin integrity, encouraging adherence to hand decontamination practices and assuring the health and safety of healthcare practitioners. 1 How can adherence to hand hygiene guidance be promoted? National and international guidelines emphasise the importance of adherence with hand hygiene guidance and provide an overview of the barriers and factors that impact on hand hygiene compliance. 1, 44 In a systematic review of 21 studies of interventions to improve hand hygiene compliance reviewers concluded that: • Single interventions have a short-term influence on hand hygiene; • Reminders have a modest but sustained effect; • Feedback increases rates of hand hygiene but must be regular; • Near patient alcohol-based preparations improve the frequency with which healthcare workers clean their hands; • Multi-faceted approaches have a more marked effect on hand hygiene and rates of HCAI. 72 Recent observational studies of multimodal interventions involving the introduction of alcohol-based handrubs support findings that the use of near patient alcohol-based handrub is consistently associated with greater compliance by healthcare staff. 42, [73] [74] [75] [76] [77] However, observational studies identify that staff fail to assess risk appropriately and therefore make inappropriate choices in relation to hand hygiene and glove use. [78] [79] [80] [81] [82] One study suggests that the use of motivational strategies, for example feedback may be beneficial. 81 There is some evidence from small-scale observational studies that providing patient information and actively involving patients in hand hygiene improvement programmes has a positive effect on hand hygiene compliance. 73 This section discusses the evidence and associated recommendations for the use of personal protective equipment (PPE) by healthcare workers in general care settings and includes the use of aprons, gowns, gloves, eye protection and face masks. Where appropriate, in addition to the classification of the evidence underpinning the recommendations, there is an indication of a Health and Safety (H&S) requirement. Infection control dress code -protect your patients and yourself! Expert opinion suggests that the primary uses of PPE are to protect staff and reduce opportunities for transmission of microorganisms in hospitals. 1, 18, 85 A trend to eliminate the inappropriate wearing of aprons, gowns and masks in general care settings has evolved over the past twenty years due to the absence of evidence that they are effective in preventing HCAI. 1, 85 The decision to use or wear personal protective equipment must be based upon an assessment of epic2: Guidelines for Preventing Healthcare-Associated Infections in NHS Hospitals S19 the level of risk associated with a specific patient care activity or intervention and take account of current health and safety legislation. 18 Since the mid-1980s the use of gloves as an element of PPE has become an every-day part of clinical practice for healthcare workers. 1 Expert opinion agrees that there are two main indications for the use of gloves in preventing HCAI: 1,85 1. to protect hands from contamination with organic matter and microorganisms; and 2. to reduce the risks of transmission of microorganisms to both patients and staff. To glove or not to glove? Gloves should not be worn unnecessarily as their prolonged and indiscriminate use may cause adverse reactions and skin sensitivity. 1, 85 As with all items of PPE the need for gloves and the selection of appropriate materials must be subject to careful assessment of the task to be carried out and its related risks to patients and health care workers. 1, 85 Risk assessment should include consideration of: • who is at risk (whether it is the patient or the healthcare worker) and whether sterile or nonsterile gloves are required; • the potential for exposure to blood, body fluids, secretions and excretions; • contact with non-intact skin or mucous membranes during general care and invasive procedures. Gloves must be discarded after each care activity for which they were worn in order to prevent the transmission of microorganisms to other sites in that individual or to other patients. Washing gloves rather than changing them is not safe. 1 Gloves leak! Our previous systematic review provided evidence that gloves used for clinical practice may leak when apparently undamaged. 1, 85 In terms of leakage, gloves made from natural rubber latex (NRL) performed better than vinyl gloves in laboratory test conditions. Revised standards (BSI 2000) relating to the manufacture of medical gloves for single use have been devised and implemented. [92] [93] [94] These standards require gloves regardless of material to perform to the same standard. Expert opinion supports the view that the integrity of gloves cannot be taken for granted and additionally, hands may become contaminated during the removal of gloves. 1, 85 An additional study provided evidence that vancomycin resistant enterococcus remained on the hands of healthcare workers after the removal of gloves. 95 Therefore, the use of gloves as a method of barrier protection reduces the risk of contamination but does not eliminate it and hands are not necessarily clean because gloves have been worn. Expert opinion is quite clear about when gloves must be used by healthcare workers in general clinical practice. 1, 85 Having decided that gloves should be used for a healthcare activity, the healthcare worker must make a choice between the use of: • sterile or non-sterile gloves, based on contact with susceptible sites or clinical devices; • surgical or examination gloves, based on the aspect of care or treatment to be undertaken. NHS Trusts need to provide gloves that conform to European Standard, and which are acceptable to health care practitioners. 1, 85 Gloves are available in a variety of materials, the most common being natural rubber latex (NRL) and synthetic materials. NRL remains the material of choice due to its efficacy in protecting against bloodborne viruses and properties that enable the wearer to maintain dexterity. 1, 85 The problem of patient or health care practitioner sensitivity to NRL proteins must be considered when deciding on glove materials. Synthetic materials are generally more expensive than NRL and due to certain properties may not be suitable for all purposes. 1 Nitrile gloves have the same chemical range as NRL and may also lead to sensitivity problems. Vinyl gloves made to European Standards provide the same level of protection as NRL. 1 Polythene gloves are not suitable for clinical use due to their permeability and tendency to damage easily. 1 A study comparing the performance of nitrile, latex, copolymer and vinyl gloves under stressed and unstressed conditions found that nitrile gloves had the lowest failure rate, adding further evidence that nitrile gloves are a suitable alternative to latex, providing there are no sensitivity issues. Importantly, the study noted variation in performance of the same type of glove produced by different manufacturers and propose a test and rating system to assist healthcare workers. We identified four small scale observational studies that investigated the potential for uniforms to become contaminated during clinical care. However none of these studies established an association between contaminated uniforms and HCAI. [97] [98] [99] A further study demonstrated high levels of contamination of gowns, gloves and stethoscopes with vancomycin-resistant enterococci (VRE) following examination of patients known to be infected. 100 A systematic review of eight studies reporting outcomes of 3,811 babies to assess the effects of wearing and gowning by attendants and visitors in newborn nurseries found no evidence to suggest that over gowns are effective in reducing mortality, clinical infection or bacterial colonisation in infants admitted to newborn nurseries. 101 One quasi-experimental study investigated the use of gowns and gloves as opposed to gloves only in preventing the acquisition of VRE in a medical intensive care unit setting. 102 A further prospective observational study investigated the use of a similar intervention in a medical intensive care unit. 103 These studies suggest that the use of gloves and gowns may minimise the transmission of VRE when colonisation pressure is high. National and international guidelines recommend that protective clothing should be worn by all healthcare workers when close contact with the patient, materials or equipment may lead to contamination of uniforms or other clothing with microorganisms or, when there is a risk of contamination with blood, body fluids, secretions, or excretions (with the exception of perspiration). 1, 85, 104 Disposable plastic aprons are recommended for general clinical use. 1, 85, 104 However, unused aprons need to be stored in an appropriate area away from potential contamination. 97 Full body gowns need only be used where there is the possibility of extensive splashing of blood, body fluids, secretions or excretions and should be fluid repellent. 1, 85, 104 waste. Non-disposable protective clothing should be sent for laundering. When is a facemask, respiratory protection and eye protection necessary? Healthcare workers (and sometimes patients) may use standard surgical facemasks to prevent respiratory droplets from the mouth and nose being expelled into the environment. Facemasks are also used, often in conjunction with eye protection, to protect the mucous membranes of the wearer from exposure to blood and/or body fluids when splashing may occur. Our previous systematic review failed to reveal any robust experimental studies that demonstrated that healthcare workers wearing surgical facemasks protected patients from HCAI during routine ward procedures, such as wound dressing or invasive medical procedures. 1 Facemasks are also used to protect the wearer from inhaling minute airborne respiratory particles. As surgical facemasks are not effective in filtering out such small respiratory particles, specialised respiratory protective equipment is recommended for the care of patients with certain respiratory diseases, e.g. active multiple drugresistant pulmonary tuberculosis, 105 Severe Acute Respiratory Syndrome (SARS), pandemic influenza. The filtration efficiency of these masks (sometimes called 'respirators') will protect the wearer from inhaling small respiratory particles but to be effective, they must fit closely to the face to minimise leakage around the mask. 1, 106, 107 Although the advice to use particulate filter masks is based on expert opinion, there is evidence from one study that staff exposed to patients with SARS acquired the infection when they did not use particulate filter masks. 108 Another study demonstrated a lack of knowledge about guidance on using particulate respirator masks among staff caring for patients with SARS and suggests that focused training on the use of personal protective equipment and the transmission risk of SARS is required. 109 Our previous systematic review indicated that different protective eyewear offered protection against physical splashing of infected substances into the eyes (although not on all occasions) but that compliance was poor. 1 Expert opinion recommends that face and eye protection reduce the risk of occupational exposure of healthcare workers to splashes of blood, body fluids, secretion or excretions. 1 This section discusses the evidence and associated recommendations for the safe use and disposal of sharps in general care settings and include minimising the risks associated with sharps use and disposal, and the use of needle protection devices. Where appropriate, in addition to the classification of evidence underpinning the recommendations, there is an indication of a Health and Safety (H&S) legislation requirement. The safe handling and disposal of needles and other sharp instruments forms part of an overall strategy of clinical waste disposal to protect staff, patients and visitors from exposure to bloodborne pathogens. 110 113 The report draws attention to the need for NHS Trusts to provide local protocols and information on the risk of bloodborne viruses in the work place and to ensure that healthcare workers are adequately trained on how to prevent injuries. The average risk of transmission of bloodborne viruses following a single percutaneous exposure from an infected person, in the absence of appropriate post exposure prophylaxis has been estimated to be: 113, 114 • hepatitis B virus (HBV) 33 .3% (1 in 3) National and international guidelines, are consistent in their recommendations for the safe use and disposal of sharp instruments and needles. 18, [115] [116] [117] As with many infection prevention and control policies, the assessment and management of the risks associated with the use of sharps is paramount and safe systems of work and engineering controls must be in place to minimise any identified risks, e.g., positioning the sharps bin as close as possible to the site of the intended clinical procedure. 88 Any healthcare worker experiencing an occupational exposure to blood or body fluids needs to be assessed for the potential risk of infection by a specialist practitioner, e.g., physician, occupational health nurse and offered testing, immunisation and postexposure prophylaxis if appropriate. 118 Avoiding sharps injuries is everybody's responsibility All healthcare workers must be aware of their responsibility in avoiding needlestick injuries. This should be a part of induction programmes for new staff and on-going in-service education. A national blended e-learning programme on preventing HCAI is available for all healthcare workers. 36 The incidence of sharps injuries has led to the development of needlestick-prevention devices in many different product groups. 121 They are designed to minimise the risk of operator injury during needle use as well as so-called "downstream" injuries that occur after disposal, often involving the housekeeping or portering staff responsible for the collection of sharps disposal units. Our previous systematic reviews 1,2 failed to identify any convincing evidence that needlestickprevention devices were responsible for any significant impact on injury rates. This was primarily due to the lack of well-designed, controlled intervention studies. More recent studies have shown significant reductions in injuries associated with the use of safety devices in cannulation, 122,123 phlebotomy 124-126 and injections. 127 It would seem to be logical that where needlefree or other protective devices are used, there should be a resulting reduction in sharps injuries. A review of needlestick injuries in Scotland suggested that 56% of injuries would 'probably' or 'definitely' have been prevented if a safety device had been used. 128 However, some studies identify a range of barriers to the expected reduction in injuries, including staff resistance to using new devices, complexity of device operation or improper use, and poor training. 1 A comprehensive report and product review conducted in the United States of America (USA) provides background information and guidance on the need for and use of needlestick-prevention devices but also gives advice on establishing and evaluating a epic2: Guidelines for Preventing Healthcare-Associated Infections in NHS Hospitals S23 sharps injury prevention program. 121 The report identifies that all devices have limitations in relation to cost, applicability and/or effectiveness. Some of the devices available are more expensive than standard devices, may not be compatible with existing equipment, and may be associated with an increase in bloodstream infection rates. 129 In the USA, the Occupational Safety Health Administration (OSHA) and the National Institute for Occupational Safety and Health (NIOSH) suggest that a thorough evaluation of any device is essential before purchasing decisions are made. 117, 130 Similarly in the United Kingdom, the National Health Service Purchasing and Supply Agency identifies that meaningful evaluations are paramount in assessing user acceptability and clinical applicability of any needle safety devices. 131 The evaluation should ensure that the safety feature works effectively and reliably, that the device is acceptable to health care practitioners and that it does not adversely affect patient care. Hazard analysis critical control points (HACCP) has been used for many years in the food industry to identify and control hazards in food production. It is a systems approach involving a seven stage process starting with the development of a flowchart describing the process, identifying areas (critical control points) where a hazard may occur and then establishing monitoring and control procedures. Clinical governance introduced audit and quality improvement into the NHS. Winning Ways recommended the use of HACCP in preventing HCAIs and the introduction of HACCP is particularly suitable for hospital environmental hygiene. 132 Within the catering industry there are several good examples of cleaning and disinfection HACCP flowcharts, which could be adapted for acute care settings. However all processes need to be defined locally in order to address the particular hazards within the organisation and the people responsible for monitoring them. 133 In adapting these guidelines into local protocols, one should also consider the use of HACCP. Total number of articles located = 7830 Abstract indicates that the article: relates to infections associated with hospital hygiene, is written in English, is primary research or a systematic review or a meta-analysis, and appears to inform one or more of the review questions. Total number of articles retrieved from sift 1 = 34 Full Text confirms that the article relates to infections associated with hospital hygiene is written in English, is primary research or a systematic review or a meta-analysis, and informs one or more of the review questions. Total number of articles selected for appraisal during sift 2 = 5 All articles which described primary research, a systematic review or, a meta-analysis and met the sift 2 criteria were independently critically appraised by two appraisers. Consensus and grading was achieved through discussion. Total number of articles accepted after critical appraisal = 5 Total number of articles rejected after critical appraisal = 0 Evidence tables for accepted and rejected studies were generated and used to create evidence summary reports. The summary reports were, in turn, used as the basis for guideline writing. Total number of articles located = 32,088 Abstract indicates that the article: relates to infections associated with hand hygiene, is written in English, is primary research or a systematic review or a meta-analysis, and appears to inform one or more of the review questions. Total number of articles retrieved from sift 1 = 194 Full Text confirms that the article relates to infections associated with hand hygiene is written in English, is primary research or a systematic review or a meta-analysis, and informs one or more of the review questions. Total number of articles selected for appraisal during sift 2 = 31 All articles which described primary research, a systematic review or, a meta-analysis and met the sift 2 criteria were independently critically appraised by two appraisers. Consensus and grading was achieved through discussion. Evidence tables for accepted and rejected studies were generated and used to create evidence summary reports. The summary reports were, in turn, used as the basis for guideline writing. Sharps -Systematic Review Process Abstract indicates that the article: relates to infections associated with protective clothing, is written in English, is primary research or a systematic review or a meta-analysis, and appears to inform one or more of the review questions. Total number of articles retrieved from sift 1 = 112 Full Text confirms that the article relates to infections associated with protective clothing is written in English, is primary research or a systematic review or a meta-analysis, and informs one or more of the review questions. Total number of articles selected for appraisal during sift 2 = 14 All articles which described primary research, a systematic review or, a meta-analysis and met the sift 2 criteria were independently critically appraised by two appraisers. Consensus and grading was achieved through discussion. Total number of articles accepted after critical appraisal = 10 Total number of articles rejected after critical appraisal = 4 Evidence tables for accepted and rejected studies were generated and used to create evidence summary reports. The summary reports were, in turn, used as the basis for guideline writing. 1. What is the evidence that recommended modes of use and disposal of sharps reduce the incidence of sharps injury in health care workers? 2. What is the evidence that education and training interventions improve health care workers adherence to recommended modes of practice? 3. What is the evidence that the use of needle-free devices reduce occupational exposure to bloodborne pathogens? 4. Is there any cost effectiveness evidence relating to the above? 5. What are the training and education implications for staff and patients? Abstract indicates that the article: relates to infections associated with sharps, is written in English, is primary research or a systematic review or a meta-analysis, and appears to inform one or more of the review questions. Total number of articles retrieved from sift 1 = 49 Full Text confirms that the article relates to infections associated with sharps is written in English, is primary research or a systematic review or a meta-analysis, and informs one or more of the review questions. All articles which described primary research, a systematic review or, a meta-analysis and met the sift 2 criteria were independently critically appraised by two appraisers. Consensus and grading was achieved through discussion. Total number of articles accepted after critical appraisal = 12 Total number of articles rejected after critical appraisal = 7 Evidence tables for accepted and rejected studies were generated and used to create evidence summary reports. The summary reports were, in turn, used as the basis for guideline writing. This guidance is based on the best critically appraised evidence currently available. The type and class of supporting evidence explicitly linked to each recommendation is described. All recommendations are endorsed equally and none is regarded as optional. These recommendations are not detailed procedural protocols and need to be incorporated into local guidelines. These guidelines apply to adults and children aged one year and older and should be read in conjunction with the guidance on Standard Principles. The recommendations are divided into five distinct interventions: 1. Assessing the need for catheterisation; 2. Selection of catheter type and system; 3. Catheter insertion; 4. Catheter maintenance; and 5. Education of patients, relatives and healthcare workers. Background and context of the Guidelines Catheter associated urinary tract infection (CAUTI) is the most common nosocomial infection in hospitals. Most bacteria causing infection associated with catheterisation gain access to the urinary tract either extraluminally or intraluminally. Extraluminal contamination may occur as the catheter is inserted, by contamination of the catheter from the health care worker's hands or from the patient's own colonic or perineal flora. Extraluminal contamination is also thought to occur by microorganisms ascending from the perineum. Intraluminal contamination occurs by reflux of bacteria from a contaminated urine drainage bag. Bacteria quickly develop into colonies known as biofilms which adhere to the catheter surface and drainage bag. A biofilm forms when bacteria attach to a surface and subsequently encase themselves in an exopolymeric material. Such bacteria are morphologically and physiologically different from free-living planktonic bacteria. Bacteria in biofilms have considerable survival advantages over free-living microorganisms, being extremely resistant to antibiotic therapy. These biofilms cause further problems if the bacteria produce the enzyme urease, such as Proteus mirabilis. The urine then becomes alkaline, causing the crystallisation of calcium and magnesium phosphate within the urine, which then is incorporated into the biofilm resulting in encrustation of the catheter over a period of time. Encrustation is generally associated with longterm catheterisation, since it has a direct relationship with the length of catheterisation. We have previously described the systematic review process in Section 1.10. For detailed descriptions of previous systematic reviews which have contributed to the evidence base underpinning these guidelines readers should consult the original guidelines, 1 the guidelines for the prevention of healthcare associated infections in primary and community care 2 and our interim report. 3 Search questions were developed from advice received from our specialist advisors and the results of the searches are found in Section 3.10. The process outlined in Section 3.10 refers only to the most recent systematic review of the literature undertaken in 2005. Catheterising patients places them in significant danger of acquiring a urinary tract infection. The longer a catheter is in place, the greater the danger There is consistent evidence that a significant number of healthcare-associated infections in hospital are related to urinary catheterisation. 115, [134] [135] [136] The risk of infection is associated with the method and duration of catheterisation, the quality of catheter care and host susceptibility. Urinary catheterisation is a frequent intervention during clinical care in hospital affecting a significant number of patients at any one time. The highest incidence of infection is associated with indwelling urethral catheterisation. 137 The per day risk of the development of bacteriuria appears comparable throughout catheterisation (3-6 percent) but the cumulative risk increases with duration of catheterisation. [137] [138] [139] Consequently, around 50 percent of hospitalised patients catheterised longer than 7-10 days contract bacteriuria. 137 Although frequently asymptomatic, 20-30 percent of patients with catheter-associated bacteriuria will develop symptoms of CAUTI. 137 Many of these infections are serious and lead to significant morbidity and mortality. Of patients with a CAUTI, 1-4 percent develops bacteraemia and, of these, 13-30 die. 137, 140 Duration of catheterisation is strongly associated with risk of infection, i.e., the longer the catheter is in place, the higher the incidence of urinary tract infection. 137, 140 Advice from best practice emphasises the importance of documenting all procedures involving the catheter or drainage system in the patient's records and providing patients with adequate information in relation to the need for catheterisation and details of the insertion, maintenance and removal of their catheter. 115, 141 There is some evidence to suggest that computer management systems improve documentation and in so doing reduce the length of time catheters are in situ. 142 Only Is one catheter better than another? Current evidence-based guidelines 1 identified three experimental studies that compared the use of latex with silicone catheters. [143] [144] [145] No significant difference in the incidence of bacteriuria was found. Four studies compared the use of silver coated (silver alloy or silver oxide) catheters with silicone, hydrogel or Teflon latex. [146] [147] [148] [149] A systematic review and meta-analysis of these and other studies found that silver alloy (but not silver oxide) catheters were associated with a lower incidence of bacteriuria. 140, 150 New evidence related to the efficacy of using urinary catheters coated or impregnated with antiseptic or antimicrobial agents has emerged since our original review in 2000. Two subsequent reviews, 2,3 together with the current update review undertaken by us, have identified four systematic reviews and one meta-analysis that have examined this issue. [150] [151] [152] [153] [154] In general, all of these five studies suggest antiseptic impregnated or antimicrobial-coated urinary catheters can significantly prevent or delay the onset of CAUTI when compared to standard untreated urinary catheters. The consensus in these five reviews of evidence however, is that the individual studies reviewed are generally of poor quality; for instance in one case only 8 studies out of 117 met the inclusion criteria and in another, of the six reports describing 7 trials included, only one scored 5 in the quality assessment the other five scored only 1. 150, 154 Studies investigating a wide range of coated or impregnated catheters are explored in the new evidence including: catheters coated or impregnated with: silver alloy 150,151,154-161 ; silver oxide 150 ; gendine 162 ; gentamicin 163 and silver-hydrogel [164] [165] [166] ; minocycline 167 ; rifampicin 167 ; chlorhexidine-silver sulfadiazine 166 ; chlorhexidine-sulfadiazine-triclosan 166 ; nitrofurazone 166 ; and nitrofuroxone. 168 New evidence suggests that catheters coated with silver alloy are clinically effective in reducing the incidence of CAUTI, but many studies are of poor methodological quality. Consequently there remains inconclusive evidence to recommend their use in preference to other types of catheter at this time. Despite their unit cost, there is a suggestion that these devices might be a cost-effective option if overall numbers of infections are significantly reduced through their use. The few studies that have explored the cost benefit/ effectiveness of using these devices have, however, also been inconclusive. 157, 159, 161, 165 Evidence from best practice indicates that the incidence of CAUTI in patients catheterised for a short time (up to one week) is not influenced by any particular type of catheter material. 136, 169 However, many practitioners have strong preferences for one type of catheter over another. This preference is often based on clinical experience, patient assessment, and which materials induce the least allergic response. Smaller gauge catheters with a 10 ml balloon minimise urethral trauma, mucosal irritation and residual urine in the bladder, all factors that predispose to CAUTI. 135, 170 However, in adults that have recently undergone urological surgery, larger gauge catheters may be indicated to allow for the passage of blood clots. Choice of catheter material will depend Class D on clinical experience, patient assessment and anticipated duration of catheterisation. Select the smallest gauge catheter that Class D will allow free urinary outflow. A catheter with a 10 ml balloon should be used in adults. Urological patients may require larger gauge sizes and balloons. epic2: Guidelines for Preventing Healthcare-Associated Infections in NHS Hospitals S29 Catheterisation is a skilled aseptic procedure Despite evidence from one systematic review 153 which suggests that the use of aseptic technique has not demonstrated a reduction in the rate of CAUTI, principles of good practice, clinical guidance 115, 134 and expert opinion [135] [136] [137] [171] [172] [173] [174] , together with findings from another systematic review 140 agree that urinary catheters must be inserted using sterile equipment and an aseptic technique. Expert opinion indicates that there is no advantage in using antiseptic preparations for cleansing the urethral meatus prior to catheter insertion. 153, 173 Urethral trauma and discomfort will be minimised by using an appropriate sterile, single-use lubricant or anaesthetic gel. Ensuring healthcare practitioners are trained and competent in the insertion of urinary catheters will minimise trauma, discomfort and the potential for CAUTI. 115, 135, 173, 174 UC6 Catheterisation is an aseptic procedure. Ensure that health care workers are trained and competent to carry out urethral catheterisation. Clean the urethral meatus with sterile normal Class D saline prior to the insertion of the catheter. Use an appropriate lubricant from a sterile Class D single use container to minimise urethral trauma and infection. Leave the closed system alone! Maintaining a sterile, continuously closed urinary drainage system is central to the prevention of CAUTI. 115, 134, 135, 173, 175, 176 The risk of infection reduces from 97 percent with an open system to 8-15 percent when a sterile closed system is employed. 136, 174, 177 Breaches in the closed system such as unnecessary emptying of the urinary drainage bag or taking a urine sample, will increase the risk of catheter-related infection and should be avoided. 115, 136, 178 Hands must be decontaminated and clean, non-sterile gloves worn before manipulation. A systematic review suggests that sealed (e.g., taped, pre-sealed) drainage systems contribute to preventing bacteriuria. 153 There is limited evidence as to how often catheter bags should be changed. One study showed higher rates of symptomatic and asymptomatic CAUTI were associated with a three day urinary drainage bag change regimen when compared to no routine change regimen. 179 Best practice suggests changing only when necessary, i.e., according to either the manufacturers' recommendations or the patient's clinical need. 115, 134 Reflux of urine is associated with infection and consequently, drainage bags should be positioned in a way that prevents back-flow of urine. 115, 135 It is also recommended that urinary drainage bags should be hung on an appropriate stand that prevents contact with the floor. 136 A number of studies have investigated the addition of disinfectants and antimicrobials to drainage bags as a way of preventing CAUTI. 140 Three acceptable studies from our original systematic review demonstrated no reduction in the incidence of bacteriuria following the addition of hydrogen peroxide or chlorhexidine to urinary drainage bags. 1, [180] [181] [182] A systematic review supports these findings in that it suggests that adding bacterial solutions to drainage bags has no effect on catheter associated infection. 153 Connect indwelling urethral catheters to Class A a sterile closed urinary drainage system. Meatal cleansing with antiseptic solutions is unnecessary Our original systematic review considered six acceptable studies that compared meatal cleansing with a variety of antiseptic/antimicrobial agents or soap and water. 1 No reduction was demonstrated in bacteriuria when using any of these preparations for meatal care compared with routine bathing or showering. [183] [184] [185] [186] [187] [188] Our subsequent reviews 2,3 revealed two studies 153,189 that support these findings in that the outcomes indicate that the use of antiseptics provides no benefit in respect of meatal/peri-urethral hygiene. Expert opinion [134] [135] [136] and another systematic review 140 support the view that vigorous meatal cleansing is not necessary and may increase the risk of infection and that daily routine bathing or showering is all that is needed to maintain meatal hygiene. Class A that is needed to maintain meatal hygiene. None of our systematic review evidence demonstrates any beneficial effect of bladder irrigation, instillation or washout with a variety of antiseptic or antimicrobial agents in preventing CAUTI. 1, 140, [190] [191] [192] [193] [194] [195] [196] [197] [198] [199] Three studies, however, suggest that an acid washout solution (Suby G) is effective in reducing catheter encrustation. 196, 198, 200 Evidence from best practice supports the findings in respect of bladder irrigation, instillation and washout and indicates that the introduction of such agents may have local toxic effects and contribute to the development of resistant microorganisms. However, continuous or intermittent bladder irrigation may be indicated during urological surgery or to manage catheter obstruction. 115, [134] [135] [136] 140 UC18 Bladder irrigation, instillation or washouts Class A should not be used to prevent catheterassociated infection. Given the frequency of urinary catheterisation in hospital patients and the associated risk of urinary tract infection, it is important that patients, their relatives and healthcare workers responsible for catheter insertion and management are educated about infection prevention. All those involved must be aware of the signs and symptoms of urinary tract infection and how to access expert help when difficulties arise. Healthcare professionals must be confident and proficient in procedures associated with preventing CAUTI. In developing the recommendations we identified several areas that were inadequately addressed in the literature. We recommend further research in the following areas. Epidemiological studies of the prevalence and incidence of bacteriuria/urinary tract infection during short-term catheterisation in different populations and different care settings. These should at least encompass the predominant populations, i.e. older people and those undergoing surgery. There needs to be clear definition of the 'cases' and the populations from which they are drawn. Randomised controlled trials of the efficacy of antiseptic/antimicrobial coated/impregnated urethral catheters for short-term use. These need to be high quality studies, using the hospital's actual catheter-associated UTI prevalence rather than national data, and appropriate follow-up. Randomised controlled trials of strategies to establish how often catheters and catheter bags need to be changed. This guidance is based on the best critically appraised evidence currently available. The type and class of supporting evidence explicitly linked to each recommendation is described. All recommendations are endorsed equally and none is regarded as optional. These recommendations are not detailed procedural protocols and need to be incorporated into local guidelines. Background and context to the Guidelines Bloodstream infections associated with the insertion and maintenance of central venous access devices (CVAD) are among the most dangerous complications of healthcare that can occur, worsening the severity of the patient's underlying ill health, prolonging the period of hospitalisation and increasing the cost of care. [201] [202] [203] [204] Approximately 3 in every 1000 patients admitted to hospital in the UK acquires a bloodstream infection, and nearly one third of these infections are related to central venous access devices. 205 Catheter related blood stream infection (CR-BSI) involves the presence of systemic infection and evidence implicating the CVAD as its source, i.e., the isolation of the same microorganism from blood cultures as that shown to be significantly colonising the CVAD of a patient with clinical features of bacteraemia. Catheter colonization refers to a significant growth of microorganisms on either the endoluminal or the external catheter surface beneath the skin in the absence of systemic infection. [206] [207] [208] The microorganisms that colonise catheter hubs and the skin adjacent to the insertion site are the source of most CR-BSI. Coagulase-negative staphylococci, particularly Staphylococcus epidermidis, are the most frequently implicated microorganisms associated with CR-BSI. Other microorganisms commonly involved include Staphylococcus aureus, Candida species and enterococci. 208 CR-BSI is generally caused either by skin microorganisms at the insertion site that contaminate the catheter during insertion and migrate along the cutaneous catheter track, or microorganisms from the hands of healthcare workers that contaminate and colonise the catheter hub during care interventions. 206 Infusate contamination or haematogenous seeding from site of infection elsewhere in the body is more rarely implicated as a cause of CR-BSI. Abstract indicates that the article: relates to infections associated with short-term indwelling urinary catheters, is written in English, is primary research or a systematic review or a meta-analysis, and appears to inform one or more of the review questions. Total number of articles retrieved from sift 1 = 46 Full Text confirms that the article relates to infections associated with short-term indwelling urinary catheters, is written in English, is primary research or a systematic review or a meta-analysis, and informs one or more of the review questions. Total number of articles selected for appraisal during sift 2 = 12 All articles which described primary research, a systematic review or, a meta-analysis and met the sift 2 criteria were independently critically appraised by two appraisers. Consensus and grading was achieved through discussion. Evidence tables for accepted and rejected studies were generated and used to create evidence summary reports. The summary reports were, in turn, used as the basis for guideline writing. What is the evidence for these guidelines? Evidence upon which practice can be based is derived from a range of sources and through varying processes. These guidelines are primarily based upon an expert review of evidence-based guidelines for preventing intravascular devicerelated infections developed at the Centers for Disease Control and Prevention (CDC) in the United States of America by the Healthcare Infection Control Practices Advisory Committee (HICPAC) 208 which were updated in 2002. 209 Using a validated guideline appraisal instrument developed by the AGREE collaboration, 6 three experienced appraisers independently reviewed the updated guidelines, taking into consideration supplementary information provided by HICPAC at our request. We concluded that the development processes were valid and that the guidelines were evidence-based, categorised to the strength of the evidence examined, reflective of current concepts of best practice, and acknowledged as the most authoritative reference guidelines currently available. They were subsequently used by us as the principal source of evidence for updating the first version of the epic guidelines. 1 In preparing the epic2 guidance, we conducted a final updating systematic review which is described in Section 4.14. This search was confined to elements of infection prevention where expert members of the Guideline Advisory Group indicated new developments or changes in technology had occurred, or where pertinent new experimental trials or systematic reviews had been published. Following our reviews, guidelines were drafted which described 47 recommendations within the 9 intervention categories listed below: 1. Education of healthcare workers and patients; 2. General asepsis; 3. Selection of catheter type; 4. Selection of catheter insertion site; 5. Maximal sterile barrier precautions during catheter insertion; 6. Cutaneous antisepsis; 7. Catheter and catheter site care; 8. Catheter replacement strategies; and 9. General principles for catheter management. These guidelines apply to caring for all adults and children over the age of 1 year in NHS acute care settings with a CVAD which is being used for the administration of fluids, medications, blood components and/or total parenteral nutrition (TPN). They should be used in conjunction with the recommendations on Standard Principles for Preventing HCAI previously described in these guidelines. Although these recommendations describe general principles of best practice that apply to all patients in hospital in which a CVAD is being used, they do not specifically address the more technical aspects of the care of infants under the age of 1 year or those children or adults receiving haemodialysis, who will generally have their CVAD managed in dialysis centres. Because these recommendations describe broad general statements of best practice, they need to be adapted and incorporated into local practice guidelines. To improve patient outcomes and reduce healthcare costs, it is essential that everyone involved in caring for patients with CVAD is educated about infection prevention. Healthcare workers in hospitals need to be confident and proficient in infection prevention practices and to be aware of the signs and symptoms of clinical infection. Wellorganised educational programmes that enable healthcare worker to provide, monitor, and evaluate care and to continually increase their competence are critical to the success of any strategy designed to reduce the risk of infection. Evidence reviewed by HICPAC consistently demonstrated that the risk of infection declines S34 R.J. Pratt et al. following the standardisation of aseptic care and increases when the maintenance of intravascular catheters is undertaken by inexperienced healthcare workers. 209 Additional evidence demonstrates that relatively simple education programmes focused on training healthcare workers to adhere to local evidence-based CVAD protocols may decrease the risk to patients of CR-BSI. 210 Good standards of hand hygiene and antiseptic technique can reduce the risk of infection Because the potential consequences of catheterrelated infections (CR-infections) are so serious, enhanced efforts are needed to reduce the risk of infection to the absolute minimum. For this reason, hand antisepsis and proper aseptic nontouch technique (ANTT) are required for changing catheter dressings and for accessing the system. 44, 209 Hand antisepsis can be achieved by washing hands with an antimicrobial liquid soap and water or by using an alcohol-based handrub. 44 When hands are visibly dirty or contaminated with organic material, such as blood and other body fluids or excretions, they must first be washed with liquid soap and water if alcohol-based handrubs are going to be used to achieve hand antisepsis. Appropriate ANTT does not necessarily require sterile gloves; a new pair of disposable non-sterile gloves can be used in conjunction with a nontouch technique, for example, in changing catheter site dressings. 209 The Standard Principles for Preventing HCAI previously described in these guidelines gives additional advice on hand decontamination, the use of gloves and other protective equipment. Selecting the right catheter for the right patient can minimise the risk of infection Different types of CVAD are available, i.e.: • made of different materials; • have one or more lumens; • coated or impregnated with antimicrobial or antiseptic agents or heparin-bonded; • cuffed and designed to be tunnelled; • having totally implantable ports. The selection of the most appropriate CVAD for each individual patient can reduce the risk of subsequent CR-related infection (CR-infection). Although catheter material may be an important determinant of CR-infection, evidence available to HICPAC when developing their guidelines was inconclusive and they were unable to draw any specific conclusions about the contribution of catheter material to CR-infections. 209, 215 Teflon ® and polyurethane catheters have been associated with fewer infections than catheters made of polyvinyl chloride or polyethylene. There is no additional evidence that demonstrates conclusively that CR-infection rates vary with different materials. 206 In England, short-term CVAD are almost always made of polyurethane and longterm tunnelled catheters are usually made of silicone. Number of catheter lumens Clinicians often prefer multi-lumen CVAD because they permit the concurrent administration of various fluids and medications, hyperalimentation, and haemodynamic monitoring among critically ill patients. HICPAC examined several randomised controlled trials and other studies which suggested that multi-lumen catheters were associated with a higher risk of infection than were single lumen catheters. 208, [216] [217] [218] [219] [220] However, other studies examined by HICPAC failed to demonstrate a difference in the rates of CR-BSI. 221, 222 HICPAC noted that multi-lumen catheter insertion sites may be particularly prone to infection because of increased trauma at the insertion site or because multiple ports increase the frequency of CVAD manipulation. 218,219 HICPAC also noted that although patients with multi-lumen catheters tend to be more ill than those without such catheters, the infection risk observed with these catheters may have been independent of the patient's underlying disease severity. 220 Two additional studies were identified from our systematic reviews. A systematic review and quantitative meta-analysis focused on determining the risk of CR-BSI and catheter colonisation in multilumen catheters compared with single-lumen catheters. 223 Reviewers reported that although CR-BSI was more common in patients with multilumen when compared with single-lumen catheters, when confined to high quality studies that control for patient differences, there is no significant difference in rates of CR-BSI. This analysis suggests that multilumen catheters are not a significant risk factor for increased CR-BSI or local catheter colonisation compared with single-lumen CVAD. Another systematic review and quantitative meta-analysis tested whether single versus multilumen CVAD had an impact on catheter colonisation and CR-BSI. 224 Study authors concluded that there is some evidence from 5 randomised controlled trials (RCTs) with data on 530 CVAD, that for every 20 single-lumen catheters inserted, one CR-BSI will be avoided which would have occurred had multi-lumen catheters been used. As authors were only able to analyze a limited number of trials, further large RCTs of adequate power and rigour are needed to confirm these findings. In the meantime, it may be reasonable for patients who need a CVAD to choose a singlelumen catheter whenever there is no indication for a multi-lumen catheter. Tunnelled and totally implantable ports Surgically implanted (tunnelled) CVAD, e.g., Hickman ® catheters, are commonly used to provide vascular access (and stable anchorage) to patients requiring long-term intravenous therapy. Alternatively, totally implantable intravascular devices, e.g., Port-A-Cath, ® are also tunnelled under the skin but have a subcutaneous port or reservoir with a self-sealing septum that is accessible by needle puncture through intact skin. In developing their 1996 guidelines, HICPAC examined multiple studies that compared the incidence of infection associated with long-term tunnelled CVAD and/or totally implantable intravascular devices with that from percutaneously (non-tunnelled) inserted CVAD. 208 Although in general most studies reported a lower rate of infection in patients with tunnelled CVAD, [225] [226] [227] [228] [229] [230] [231] [232] [233] some studies (including one randomised controlled trial) found no significant difference in the rate of infection between tunnelled and non-tunnelled catheters. 234, 235 However, most studies examined by HICPAC concluded that totally implantable devices had the lowest reported rates of CR-BSI compared to either tunnelled or non-tunnelled CVAD. [236] [237] [238] [239] [240] [241] [242] [243] [244] [245] [246] Additional evidence was obtained from studies of efficacy of tunnelling to reduce CR-infections in patients with short-term CVAD. One randomised controlled trial demonstrated that subcutaneous tunnelling of short-term CVAD inserted into the internal jugular vein reduced the risk for CR-BSI. 247 In a later randomised controlled trial, the same investigators failed to show a statistically significant difference in the risk for CR-BSI for subcutaneously tunnelled femoral vein catheters. 248 An additional meta-analysis of randomised controlled trials focused on the efficacy of tunnelling short-term CVAD to prevent CRinfections. 249 Data synthesis demonstrated that tunnelling decreased catheter colonisation by 39% and decreased CR-BSI by 44% in comparison with non-tunnelled placement. The majority of the benefit in the decreased rate of catheter-sepsis came from one trial of CVAD inserted at the internal jugular site. The reduction in risk was not significant when pooled with data from five subclavian catheter trials. Tunnelling was not associated with increased risk of mechanical complications from placement or technical difficulties during placement; these outcomes were not rigorously evaluated. This meta-analysis concluded that tunnelling decreased CRinfections. However, a synthesis of the evidence in this meta-analysis does not support routine subcutaneous tunnelling of short-term subclavian venous catheters and this cannot be recommended unless efficacy is evaluated at different placement sites and relative to other interventions. Neither we nor HICPAC identified any additional evidence in updating our systematic reviews. Some catheters and cuffs are marketed as antiinfective and are coated or impregnated with antimicrobial or antiseptic agents, e.g., chlorhexidine/ silver sulfadiazine, minocycline/rifampin, platinum/ silver, and ionic silver in subcutaneous collagen cuffs attached to CVAD. Evidence reviewed by HICPAC indicated that the use of antimicrobial or antiseptic-impregnated CVAD in adults whose catheter is expected to remain in place for more than 5 days can decrease the risk for CR-BSI. [250] [251] [252] [253] [254] [255] [256] [257] [258] [259] [260] This may be cost-effective in high risk patients (intensive care, burn and neutropenic patients) and in other patient populations in which the rate of CR-BSI exceeds 3.3 per 1,000 catheter days despite implementing a comprehensive strategy to reduce rates of CR-BSI. 250 A more recent meta-analysis analysed 23 RCTs published between 1988-1999 and which included data on 4,660 catheters (2,319 anti-infective and 2,341 control). 261 Eleven of the trials in this metaanalysis were conducted in Intensive Care Unit settings; 4 among oncologic patients, 2 among surgical patients; 2 among patients receiving TPN; 4 among other patient populations. Study authors concluded that antibiotic and chlorhexidine-silver sulfadiazine coatings are anti-infective for short (approximately 1 week) insertion time. For longer insertion times, there are no data on antibiotic coating, and there is evidence of lack of effect for first generation chlorhexidine-silver sulfadiazine coating. For silver-impregnated collagen cuffs, there is evidence of lack of effect for both shortand long-term insertion. Second generation chlorhexidine/silver sulfadiazine catheters with chlorhexidine coating both the internal and external luminal surfaces are now available. The external surface of these catheters has three times the amount of chlorhexidine and extended release of the surface bound antiseptics than that in the first generation catheters (which are coated with chlorhexidine/silver sulfadiazine only on the external luminal surface). Early studies indicated that the prolonged anti-infective activity associated with the second generation catheters improved efficacy in preventing infections. 262 The most recent appraisal of all of the evidence for the clinical and cost-effectiveness of CVAD treated with antimicrobial agents in preventing CR-BSI is a systematic review and economic evaluation recently conducted by the Liverpool Reviews and Implementation Group (LRiG). 263 Study authors conclude that rates of CR-BSI are statistically significantly reduced when an antimicrobial CVAD was used. Studies report the best effect when catheters were treated with minocycline/rifampin, or internally and externally treated with silver or chlorhexidine/silver sulfadiazine. A trend to statistical significance was seen in catheters only extraluminally coated. Investigation of other antibiotic treated catheters is limited to single studies with non-significant results. HICPAC guidelines recommend the use of an antimicrobial or antiseptic-impregnated CVAD in adults whose catheter is expected to remain in place for more than 5 days if, after implementing a comprehensive strategy to reduce rates of CR-BSI, the CR-BSI rate remains above the goal set by the individual institution based on benchmark rates and local factors. Selecting the best insertion site for the patient can minimise the risk of infection Several factors need to be assessed when determining the site of CVAD placement, including: • patient-specific factors (e.g., pre-existing CVAD, anatomic deformity, bleeding diathesis, some types of positive pressure ventilation); epic2: Guidelines for Preventing Healthcare-Associated Infections in NHS Hospitals S37 • relative risk of mechanical complications (e.g., bleeding, pneumothorax, thrombosis); • the risk of infection. HICPAC concluded that the site at which a CVAD is placed can influence the subsequent risk of CRinfection because of variation in both the density of local skin flora and risk of thrombophlebitis. CVAD are generally inserted in the subclavian, jugular or femoral veins, or peripherally inserted into the superior vena cava by way of the major veins of the upper arm, i.e., the cephalic and basilar veins of the antecubital space. Multiple studies examined by HICPAC concluded that CVAD inserted into subclavian veins had a lower risk for CR-infection than those inserted in either jugular or femoral veins, but none of these was a randomised controlled trial. HICPAC stated that internal jugular insertion sites may pose a greater risk for infection because of their proximity to oropharyngeal secretions and because CVAD at this site are difficult to immobilise. They noted, however, that mechanical complications associated with catheterisation might be less common with internal jugular than with subclavian vein insertion. HICPAC noted that no RCT satisfactorily has compared CR-infection rates for catheters placed in jugular, subclavian, and femoral sites. However, both previous and new evidence examined by HICPAC demonstrated that catheters inserted into an internal jugular vein have been associated with higher risks for CR-infection than those inserted into a subclavian or femoral vein. 252, 264, 265 Femoral catheters have been demonstrated to have relatively high colonization rates when used in adults and should be avoided because they are presumed to be associated with a higher risk of deep vein thrombosis (DVT) and CR-infection than are internal jugular or subclavian catheters. [266] [267] [268] [269] [270] [271] Thus, in adult patients, a subclavian site is preferred for infection control purposes, although other factors, e.g., the potential for mechanical complications, risk for subclavian vein stenosis, and catheter-operator skill, should be considered when deciding where to place the catheter. HICPAC cited a meta-analysis of 8 studies and guidelines from the National Institute for Health and Clinical Excellence (NICE) indicate that the use of bedside ultrasound for the placement of CVAD substantially reduced mechanical complications compared with the standard landmark placement technique. 272, 273 Consequently, the use of ultrasound may indirectly reduce the risk of infection by facilitating mechanically uncomplicated subclavian placement. Peripherally inserted CVAD (PICC) may be used as an alternative to subclavian or jugular vein catheterisation. These are inserted into the superior vena cava by way of the major veins of the upper arm. HICPAC stated that they are less expensive, associated with fewer mechanical complications, e.g., thrombosis, haemothorax, infiltration and phlebitis, and easier to maintain than short peripheral venous catheters, i.e., a reduced need for frequent site rotation. Additionally, previous evidence examined by HICPAC suggested that PICC are associated with a lower rate of infection than that associated with other non-tunnelled CVAD, perhaps because the skin at the antecubital fossa is less moist and oily and colonised by fewer microorganisms than the chest and neck. 234, 274, 275 HICPAC also noted that an antecubital placement removes the catheter away from endotracheal and nasal secretions. Finally, they noted that further studies were needed to adequately determine how long PICC could be safely left in place and to determine whether routine replacement influenced the risk of associated infection. We examined a prospective cohort study using data from two randomized trials and a systematic review published in 2005. 276 In the review the authors reported a rate of PICC-BSI of 2.1 per 1,000 PICC-days. This was comparable to the rates reported in their prospective cohort study (2.1 to 3.5 per 1,000 catheter-days) and similar to that reported with prospectively studied, short-term non-cuffed CVAD placed percutaneously in the internal jugular, subclavian or femoral veins in inpatients (approximately 2.3 per 1,000 days). Investigators concluded that PICC used in high-risk hospitalised patients are associated with a rate of CR-BSI similar to conventional CVAD placed in the internal jugular or subclavian veins (2 to 5 per 1,000 catheter-days). This rate is much higher than with PICC used exclusively in the outpatient setting (approximately 0.4 per 1,000 catheterdays). They question whether the growing trend in many hospital haematology and oncology services to switch from the use of cuffed and tunnelled CVAD to PICC is justified, particularly since PICC are more vulnerable to thrombosis and dislodgment, and are less useful for drawing blood specimens. Moreover, PICC are not advisable in patients with renal failure and impending need for dialysis, in whom preservation of upper-extremity veins is needed for fistula or graft implantation. Furthermore: '…the assumption that PICC are safer than conventional CVAD with regard to the risk of infection is in question and should be assessed by a larger, adequately powered randomized trial that assesses peripheral vein thrombo-phlebitis, PICC-related thrombosis, and premature dislodgment, as well as CR-BSI.' CVAD Using maximal sterile barrier precautions during CVAD placement will significantly reduce the risk of infection The primacy of strict adherence to hand decontamination and aseptic technique as the cornerstone for preventing CR-infection is widely accepted. Although this is considered adequate for preventing infections associated with the insertion of short peripheral venous catheters, it is recognised that central venous catheterisation carries a significantly greater risk of infection. However, the level of barrier precautions needed to prevent infection during CVAD insertion was controversial at the time of the development of the HICPAC guidelines. 208 Studies examined by HICPAC concluded that if maximal sterile barrier precautions (MSB) were used during CVAD insertion, catheter contamination and subsequent CR-infections could be significantly minimised. 264, [277] [278] [279] One of these studies was a prospective randomised trial that tested the efficacy of maximal sterile barriers to reduce infections associated with long-term nontunnelled subclavian silicone catheters. 279 When MSB were compared with routine procedures, they significantly decreased the risk of CR-BSI. 279 MSB involve wearing sterile gloves and gown, a cap, mask and using a large sterile drape during insertion of the catheter as opposed to routine infection prevention procedures that involve wearing only sterile gloves and the use of a small drape. However, there is no specific evidence that wearing a facemask or cap during catheter insertion is important in preventing CR-BSI. It has been generally assumed that CVAD inserted in the operating theatre posed a lower risk of infection than did those inserted on inpatient wards or other patient care areas. 208 Data examined by HICPAC from two prospective studies suggests that the difference in risk of infection depended largely on the magnitude of barrier protection used during catheter insertion, rather than the surrounding environment, i.e., ward versus operating room. 264, 279 Previous expert reviewers who have examined the above evidence agree that maximal sterile barrier precautions are essential during CVAD placement to reduce the risk of infection. 115, 207, [280] [281] [282] Systematic Review Evidence A systematic review published in 2004 aimed to determine the value of MSB to prevent CVADrelated infection. 283 MSB were defined as: person inserting the CVAD wear a head cap, facemask, sterile body gown, and sterile gloves and uses a full-size sterile drape. Their search identified 95 articles discussing the prevention of CVAD-related infections. The majority of these articles were review articles or consensus statements. Only three primary research studies comparing infection outcomes using MSB with less stringent barrier techniques were identified and included in the review. Authors identified no additional unpublished or ongoing primary studies. All three studies included in the review concluded that the use of MSB resulted in a reduction in catheterrelated infections. The studies differed notably in their patient populations, research designs, and healthcare settings. Study authors concluded that using MSB has been found to decrease transmission of microorganisms, to delay colonization, and to reduce the rate of hospital-acquired infections. They suggest that biological plausibility and the available evidence support using MSB during routine insertion of a CVAD to minimise the risk of infection. They recommend that given the lack of adverse patient reactions, the relatively low cost of MSB, and the high cost of CR-BSI, it is probable that MSB will prove to be a cost-effective or even a cost-saving intervention. Appropriate preparation of the insertion site will reduce the risk of catheter-related infection Microorganisms that colonise catheter hubs and the skin surrounding the CVAD insertion site are the cause of most CR-BSIs. 206, 260, 284 The risk of infection increases with the density of microorganisms around the insertion site. Skin cleansing/ antisepsis of the insertion site is therefore one of the most important measures for preventing CRinfection. 208 An important prospective randomised trial of agents used for cutaneous antisepsis demonstrated that 2% aqueous chlorhexidine was superior to either 10% povidone-iodine or 70% alcohol for preventing central venous and arterial CR-infections. 285 An additional study has since confirmed the superior efficacy of 2% aqueous chlorhexidine compared to povidone iodine in substantially reducing central venous catheter colonisation. 286 Direct comparisons of aqueous versus alcoholic solutions of chlorhexidine have not been undertaken in relation to cutaneous antisepsis for preventing CR-infections. However, an alcoholic solution of chlorhexidine combines the benefits of rapid action and excellent residual activity. 287 The application of organic solvents, such as acetone or ether, to 'defat' (remove skin lipids) the skin before catheter insertion and during routine dressing changes had been a standard component of many hyperalimentation protocols. However, there was no evidence available to HICPAC to show that the use of these agents provided any protection against CR-infection and their use could greatly increase local inflammation and patient discomfort. 208 Several studies were examined that focused on the application of antimicrobial ointments to the catheter site at the time of catheter insertion, or during routine dressing changes, to reduce microbial contamination of catheter insertion sites. 284 Reported efficacy in preventing CRinfections by this practice yielded contradictory findings. [288] [289] [290] [291] [292] [293] There was also concern that the use of polyantibiotic ointments that were not fungicidal could significantly increase the rate of colonisation of the catheter by Candida species. 292, 294 Systematic Review Evidence A meta-analysis published in 2004 assessed studies that compared the risk for CR-BSI following insertion-site skin care with either any type of chlorhexidine gluconate (CHG) solution versus povidone iodine (PI) solution. 295 This analysis indicated that the use of CHG rather than PI can reduce the risk for CR-BSI by approximately 49% (risk ratio, 0.51 [CI, 0.27 to 0.97]) in hospitalised patients who require short-term catheterisation, i.e., for every 1000 catheter sites disinfected with CHG rather than PI, 71 episodes of catheter colonization and 11 episodes of CR-BSI would be prevented. In this analysis, several types of CHG solutions were used in the individual trials, including 0.5 percent or 1 percent CHG alcohol solution and 0.5 percent or 2 percent CHG aqueous solution. All of these solutions provided a concentration of CHG that is higher than the minimal inhibitory concentration (MIC) for most nosocomial bacteria and yeasts. Subset analysis of aqueous and non-aqueous solutions showed similar effect sizes, but only the subset analysis of the five studies that used alcoholic CHG solution produced a statistically significant reduction in CR-BSI. Because few studies used CHG aqueous solution, the lack of a significant difference seen for this solution compared with PI solution may be a result of inadequate statistical power. A prospective randomised trial in Germany and published in 2004 investigated the optimal disinfection regimen at the time of catheter insertion to avoid catheter colonisation, comparing skin disinfection performed with either povidoneiodine 10% (PVP-iodine), chlorhexidine 0.5% propanol 70%, or chlorhexidine 0.5% propanol 70% followed by PVP-iodine 10%. 296 Investigators found that significantly fewer catheter tips were colonized following skin disinfection of the insertion site with propanol/chlorhexidine followed by PVP-iodine (p = 0.006). Study authors concluded that skin disinfection with sequential application of propanol/chlorhexidine followed by PVP-iodine was superior in the prevention of microbial CVAD colonisation compared to either of the regimens alone. A randomised prospective multiple unit crossover trial conducted in France and published in 2004 compared the effectiveness in preventing central venous catheter colonization and infection of two protocols for pre-insertion cutaneous antisepsis using aqueous 10% povidone-iodine (PVP-I) or a solution of 5% PVP-I in 70% ethanol. 297 Investigators found that the incidence of catheter colonization was significantly lower in the alcoholic PVP-I solution protocol than in the aqueous PVP-I solution protocol (relative risk, 0.38: 95% confidence interval, 0.22-0.65, p < 0.001), and so was the incidence of CR-infection (relative risk, 0.34: 95% confidence interval, 0.13-0.91, p < 0.04). Study authors concluded that the use of alcoholic PVP-I rather than aqueous PVP-I can significantly reduce the incidence of catheter-tip colonization and nosocomial catheter-related infection in intensive care units.This study was designed to demonstrate the superiority of alcoholic PVP-I over aqueous PVP-I in preventing CVAD colonization. However, the weight of evidence in the majority of studies appraised in our review favours alcoholic chlorhexidine for preinsertion cutaneous antisepsis. CVAD Infections can be minimised by good catheter and insertion site care The safe maintenance of a CVAD and relevant care of the insertion site are essential components of a comprehensive strategy for preventing CRinfections. This includes good practice in caring for the patient's catheter hub and connection port, the use of an appropriate CVAD site dressing regimen, and using flush solutions to maintain the patency of the CVAD. Choose the right dressing for insertion sites to minimise infection Following CVAD placement, a dressing is used to protect the insertion site. Because occlusive dressings trap moisture on the skin, and provide an ideal environment for the rapid growth of local microflora, dressings for insertion sites must be permeable to water vapour. 206 The two most common types of dressings used for insertion sites are sterile, transparent, semi-permeable polyurethane dressings coated with a layer of an acrylic adhesive ('transparent dressings'), and gauze and tape dressings. Transparent dressings, e.g., Opsite ® IV3000, Tegaderm IV ® , are permeable to water vapour and oxygen, and impermeable to microorganisms. HICPAC reviewed the evidence related to which type of dressing provided the greatest protection against infection and found little difference. 209 They concluded that the choice of dressing can be a matter of preference. If blood is oozing from the catheter insertion site, a gauze dressing might be preferred. Gauze dressings are not waterproof and require frequent changing in order to inspect the catheter site. They are rarely useful in patients with longterm CVAD. Sterile transparent, semi-permeable polyurethane dressings have become a popular means of dressing catheter insertion sites. They reliably secure the CVAD, permit continuous visual inspection of the catheter site, allow patients to bathe and shower without saturating the dressing, and require less frequent change than that required for standard gauze and tape dressings, thus saving personnel time. A Cochrane Review of gauze and tape versus transparent polyurethane dressings for CVAD concluded that there was no evidence demonstrating any difference in the incidence of CR-related infections between any of the dressing types compared in this review. 298 Each of these comparisons was based on no more than 2 studies and all of these studies reported data from a small patient sample. Therefore it is probable that the findings of no difference between dressing types is due to the lack of adequate data. They further concluded that because there is a high level of uncertainty regarding the risk of infection associated with the CVAD dressings included in this review, at this stage it appears that the choice of dressing for CVAD can be based on patient preference. CVAD Use an appropriate antiseptic agent for disinfecting the catheter insertion site during dressing changes HICPAC described compelling evidence that aqueous chlorhexidine 2% was superior to either 10% povidone iodine or 70% alcohol in lowering CR-BSI rates when used for skin antisepsis prior to CVAD insertion. 209, 285 They made no recommendation for the use of any disinfectant agent for cleaning the insertion site during dressing changes. Studies focused on the use of antimicrobial ointment applied under the dressing to the catheter insertion site to prevent CVAD-related infection do not clearly demonstrate efficacy. 289, 294 Systematic Review Evidence A recent meta-analysis assessed studies that compared the risk for CR-BSI following insertionsite skin care with either any type of chlorhexidine gluconate (CHG) solution versus povidone iodine (PI) solution. 295 This analysis indicated that the use of CHG rather than PI can reduce the risk for CR-BSI by approximately 49% (risk ratio, 0.51 [CI, 0.27 to 0.97]) in hospitalised patients who require short-term catheterisation, i.e., for every 1000 catheter sites disinfected with CHG rather than PI, 71 episodes of catheter colonization and 11 episodes of CR-BSI would be prevented. In this analysis, several types of CHG solutions were used in the individual trials, including 0.5 percent or 1 percent CHG alcohol solution and 0.5 percent or 2 percent CHG aqueous solution. All of these solutions provided a concentration of CHG that is higher than the minimal inhibitory concentration (MIC) for most nosocomial bacteria and yeasts. Subset analysis of aqueous and non-aqueous solutions showed similar effect sizes, but only the subset analysis of the five studies that used alcoholic CHG solution produced a statistically significant reduction in CR-BSI. Because few studies used CHG aqueous solution, the lack of a significant difference seen for this solution compared with PI solution may be a result of inadequate statistical power. Most modern CVAD and other catheter materials are generally alcohol-resistant, i.e., they are not damaged by contact with alcohol. However, alcohol and other organic solvents and oil-based ointments and creams may damage some types of polyurethane and silicon CVAD tubing, e.g., some catheters used in haemodialysis. The manufacturer's recommendations for only using disinfectants that are compatible with specific catheter materials must be followed. CVAD When and how catheters are replaced can influence the risk of infection A catheter replacement strategy is composed of two elements; the frequency and the method of catheter replacement. Frequency HICPAC noted that with short peripheral venous catheters, the risk of phlebitis and catheter colonisation, both associated with CR-infection, could be reduced by catheter replacement and site rotation every 48-72 hours. 208 However, decisions regarding the frequency of CVAD replacement were more complicated. They considered evidence that showed duration of catheterisation to be a risk factor for infection and which advocated routine replacement of CVAD at specified intervals as a measure to reduce infection. 222, 265, 299, 300 Other studies, however, suggested that the daily risk of infection remains constant and showed that routine replacement of CVAD, without a clinical indication, does not reduce the rate of catheter colonisation or the rate of CR-BSI. 301, 302 Conclusions from a systematic review agree that exchanging catheters by any method every three days was not beneficial in reducing infections, compared with catheter replacement on an as-needed basis. 303 Two methods are used for replacing CVAD; placing a new catheter over a guide wire at the existing site, or percutaneously inserting a new catheter at another site. Guide wire insertion has been the accepted technique for replacing a malfunctioning catheter (or exchanging a pulmonary artery catheter for a CVAD when invasive monitoring was no longer needed) as they are associated with less discomfort and a significantly lower rate of mechanical complications than those percutaneously inserted at a new site. Studies of the risks for infection associated with guide wire insertions examined by HICPAC yielded conflicting results. One prospective study showed a significantly higher rate of CR-BSI associated with catheters replaced over a guide wire compared with catheters inserted percutaneously. 301 However, three prospective studies (two randomised) showed no significant difference in infection rates between catheters inserted percutaneously and those inserted over a guide wire. 302, 304, 305 Since these studies suggest that the insertion of the new catheter at a new site does not alter the rate of infectious complications per day but does increase the incidence of mechanical complications, guide wire exchange is recommended. Most studies examined by HICPAC concluded that, in cases where the catheter being removed is known to be infected, guidewire exchange is contraindicated. 302, [304] [305] [306] [307] A systematic review concluded that, compared with new site replacement, guidewire exchange was associated with a trend toward a higher rate of subsequent catheter colonisation, regardless of whether patients had a suspected infection at the time of replacement. Guidewire exchange was also associated with trends toward a higher rate of catheter exit-site infection and CR-BSI. However, guidewire exchange was associated with fewer mechanical complications relative to new-site replacement. 303 Methods are available and techniques have been described which allow a diagnosis of CR-BSI to be made without the need for catheter removal. 308 Such approaches could be used prior to the replacement of a new catheter over a guide wire in order to reduce the subsequent risk of CRinfection. 308 Aseptic technique is important when accessing the system HICPAC considered evidence demonstrating that contamination of the catheter hub is an important contributor to intraluminal microbial colonisation of catheters, particularly long-term catheters. [310] [311] [312] [313] [314] [315] [316] In a relatively recent overview, additional evidence from a prospective cohort study suggested that frequent catheter hub manipulation increases the risk for microbial contamination. 260, 317 During prolonged catherisation, catheter hubs are accessed more frequently, increasing the likeli-epic2: Guidelines for Preventing Healthcare-Associated Infections in NHS Hospitals hood of a CR-BSI emanating from a colonised catheter hub rather than the insertion site. 316 Consequently, the reviewer commented that hubs and sampling ports should be disinfected before they are accessed and noted that both povidoneiodine and chlorhexidine are effective. 250, 318, 319 Systematic Review Evidence In a recent randomized prospective clinical trial conducted in England, the microbial contamination rate of luers of CVAD with either PosiFlow ® needleless connectors or standard caps attached was investigated. 320 The efficacy of: chlorhexidine gluconate 0.5% w/v in industrial methylated spirit (IMS) BP 70% w/w spray (Hydrex DS ® ); Sterile isopropyl alcohol (IPA) 70% w/w spray (Spiriclens ® ); and 10% (w/v) aqueous povidone-iodine (Betadine ® ) was assessed for the disinfection of intravenous connections. Patients were designated to receive chlorhexidine/alcohol, isopropyl alcohol or povidone-iodine for pre-CVAD insertion skin preparation and disinfection of the connections. After 72 h in situ the microbial contamination rate of 580 luers, 306 with standard caps and 274 with needleless connectors attached, was determined. The microbial contamination rate of the external compression seals of 274 needleless connectors was also assessed to compare the efficacy of the three disinfectants. The internal surfaces of 55 out of 306 (18%) luers with standard caps were contaminated with microorganisms, whilst only 18 out of 274 (6.6%) luers with needleless connectors were contaminated (p < 0.0001). Of those needleless connectors disinfected with isopropyl alcohol, 69.2% were externally contaminated with microorganisms compared with 30.8% disinfected with chlorhexidine/alcohol (p < 0.0001) and 41.6% with povidone-iodine (p < 0.0001). These results suggest that the use of needleless connectors may reduce the microbial contamination rate of CVAD luers compared with the standard cap. Furthermore, disinfection of needleless connectors with either chlorhexidine/alcohol or povidone-iodine significantly reduced external microbial contamination. Both these strategies may reduce the risk of catheter-related infections acquired via the intraluminal route. Although now generally alcohol-resistant, some CVAD and catheter hub materials may be chemically incompatible with alcohol or iodine and the manufacturer's recommendations must be complied with. Although in-line filters reduce the incidence of infusion-related phlebitis, HICPAC could find no reliable evidence to support their efficacy in preventing infections associated with intravascular catheters and infusion systems. Infusate-related BSI is rare and HICPAC concluded that filtration of medications or infusates in the pharmacy is a more practical and less costly way to remove the majority of particulates. Furthermore, in-line filters might become blocked, especially with certain solutions, e.g., dextran, lipids, mannitol, thereby increasing the number of line manipulations and decreasing the availability of administered drugs. 209 In our systematic review we found no additional good quality evidence to support their use for preventing infusate-related CR-BSI. However, there may be a role for the use of in-line filtration of parenteral nutrition solutions for reasons other than the prevention of infection but these are beyond the scope of these guidelines. CVAD Antibiotic lock prophylaxis, i.e., flushing and then filling the lumen of the CVAD with an antibiotic solution and leaving it to dwell in the lumen of the catheter, is sometimes used in special circumstances to prevent CR-BSI, e.g., in treating a patient with a long-term cuffed or tunnelled catheter or port who has a history of multiple CR-BSI despite optimal maximal adherence to aseptic technique. Evidence reviewed by HICPAC demonstrated the effectiveness of this type of prophylaxis in neutropenic patients with long-term CVAD. 209 However, they found no evidence that routinely using this procedure in all patients with CVAD reduced the risk of CR-BSI and may lead to an increase in antimicrobial resistant microorganisms. CVAD 321 Patients with cancer often need to be given drugs and other treatments intravenously, so are frequently fitted with long-term tunnelled CVAD. Infections sometimes occur. Clinical trial evidence shows it may be useful to give prophylactic antibiotics prior to inserting a tunnelled CVAD or to flush the catheter with combined vancomycin and heparin, but microbial resistance may occur unless this practice is limited to highrisk patients. CVAD Maintaining CVAD patency and preventing catheter thrombosis may help prevent infections Indwelling central venous and pulmonary artery catheters are thrombogenic. Thrombus forms on these catheters in the first few hours following placement and may serve as a nidus for microbial colonization of intravascular catheters. 322, 323 Thrombosis of large vessels occurs after long-term catheterisation in 35 to 65% of patients. [324] [325] [326] [327] [328] Prophylactic heparin and warfarin have been widely used to prevent catheter thrombus formation and catheter related complications, such as deep venous thrombosis (DVT). 209, 329 Two types of heparin can be used: unfractionated (standard) heparin and low molecular weight heparins. Although more expensive, low molecular weight heparins have a longer duration of action than unfractionated heparin and are generally administered by subcutaneous injection once daily. The standard prophylactic regimen of low molecular weight heparins are at least as effective and as safe as unfractionated heparin in preventing venous thrombo-embolism and does not require laboratory monitoring. 330 A meta-analysis of randomised controlled trials evaluating the benefit of infused prophylactic heparin through the catheter, given subcutaneously or bonded to the catheter in patients with CVAD found that prophylactic heparin: • was associated with a strong trend for reducing catheter thrombus (RR, 0. The authors of this meta-analysis concluded that heparin administration effectively reduces thrombus formation and may reduce catheterrelated infections in patients who have central venous and pulmonary artery catheters in place. They suggest that various doses of subcutaneous and intravenous unfractionated and low molecular weight heparins and new methods of heparin bonding need further comparison to determine the most cost-effective strategy for reducing catheter-related thrombus and thrombosis. There are many different preparations and routes of administration of heparin, and as yet there is no definite evidence that heparin reduces the incidence of CR-BSI, but this may reflect the heterogeneity of heparin and its administration. Warfarin has also been evaluated as a means for reducing catheter-related thrombosis. A controlled trial of 82 patients with solid tumours were randomised to receive or not to receive low-dose warfarin (1 mg a day) beginning 3 days prior to catheter insertion and continuing for 90 days. Warfarin was shown to be effective in reducing catheter-related thrombosis. 331 In this study, warfarin was discontinued in 10% of patients due to prolongation of the prothrombin time. Heparin versus Normal Saline Intermittent Flushes Although many clinicians use low dose intermittent heparin flushes to fill the lumens of CVAD locked between use in an attempt to prevent thrombus formation and to prolong the duration of catheter patency, the efficacy of this practice is unproven. Despite its beneficial antithrombotic effects, decreasing unnecessary exposure to heparin is important to minimise adverse effects associated with heparin use, e.g., autoimmunemediated heparin-induced thrombocytopenia, allergic reactions and the potential for bleeding complications following multiple, unmonitored heparin flushes. 332 The risks of these adverse effects can be avoided by using 0.9 percent sodium chloride injection instead of heparin flushes. A systematic review and meta-analysis of randomised controlled trials evaluating the effect of heparin on duration of catheter patency and on prevention of complications associated with the use of peripheral venous and arterial catheters concluded that heparin at doses of 10 U/ml for intermittent flushing is no more beneficial than flushing with normal saline alone. 333 This finding was in agreement with two other metaanalyses. 334, 335 Manufacturers of implanted ports or opened-ended catheter lumens may recommend heparin flushes for maintaining catheter patency and many clinicians feel that heparin flushes are appropriate for flushing CVAD that are infrequently accessed. HICPAC reviewed all of the evidence for intermittent heparin flushes and systemic heparin and warfarin prophylaxis and concluded that no data demonstrated that their use reduces the incidence of CR-BSI and did not recommend them for infection prevention purposes. 209, [322] [323] [324] [325] [326] [327] [328] [329] [331] [332] [333] [334] [335] Although their use for preventing CR-BSI remains controversial, patients who have CVAD may also have risk factors for DVT and systemic anticoagulants may be prescribed for DVT prophylaxis. In addition, heparin flush solutions may be useful in helping to maintain patency in catheter lumens that are infrequently accessed and may also be recommended by manufacturers of implantable ports and for CVAD used for blood processing, e.g., haemodialysis or apheresis. We did not identify and further new evidence when updating our systematic review. Needle-free devices require vigilance Needle-free infusion systems have been widely introduced into clinical practice to reduce the incidence of sharp injuries and the potential for the transmission of bloodborne pathogens to healthcare worker. HICPAC examined evidence that these devices may increase the risk for CR-BSI and concluded that when they are used according to the manufacturers' recommendations, they do not substantially affect the incidence of CR-BSI. 209 Some of the devices available are more expensive than standard devices, may not be compatible with existing equipment, and may be associated with an increase in bloodstream infection rates. 129 Class D/GPP The optimal interval for the routine replacement of intravenous (IV) solution administration sets has been examined in three well-controlled studies reviewed by HICPAC. Data from each of these studies reveal that replacing administration sets no more frequently than 72 hours after initiation of use is safe and cost-effective. When a fluid that enhances microbial growth is infused, e.g., lipid emulsions, blood products, more frequent changes of administration sets are indicated as these products have been identified as independent risk factors for CR-BSI. 209 CVAD This is a well researched area and few realistic research needs were identified in developing these guidelines. The following investigations, along with a health economic assessment, may inform future clinical practice. The effectiveness of subcutaneous low molecular weight heparins or low dose warfarin to prevent catheter thrombus, colonisation and CR-BSI. The infection risks associated with the use of peripherally inserted central catheters (PICC). The impact of nurse consultants (intravenous therapy) and/or intravenous therapy teams on hospital CR-BSI rates. The efficacy and cost-effectiveness of antimicrobial impregnated CVAD to provide sustained protection against CRBSI in hospital patients with long term catherisation. The efficacy and cost-effectiveness of antimicrobial impregnated catheter site dressings in preventing catheter colonisation and CR-BSI. Ensure that all healthcare workers are trained All healthcare worker involved in the care of people with CVAD to implement these guidelines and assessed receive training and updates in the management of CVAD. as competent. Standard 100% Support healthcare workers to consistently adhere to guideline recommendations. Data collection: Review of staff education records/direct observation/self-audit Assess the need for continuing venous access Evidence of regular and frequent assessment of the need for on a regular basis and remove a CVAD as soon CVAD and catheter discontinuation rates when the catheter is as clinically possible in order to reduce the no longer essential for medical management. risk for infection. Standard 100% Total number of articles located = 5273 Abstract indicates that the article: relates to infections associated with central venous access devices, is written in English, is primary research or a systematic review or a meta-analysis, and appears to inform one or more of the review questions. Total number of articles retrieved from sift 1 = 169 Full Text confirms that the article relates to infections associated with central venous access devices, is written in English, is primary research or a systematic review or a meta-analysis, and informs one or more of the review questions. Total number of articles selected for appraisal during sift = 25 All articles which described primary research, a systematic review or, a meta-analysis and met the sift 2 criteria were independently critically appraised by two appraisers. Consensus and grading was achieved through discussion. Total number of articles accepted after critical appraisal = 20 Total number of articles rejected after critical appraisal = 5 Evidence tables for accepted and rejected studies were generated and used to create evidence summary reports. The summary reports were, in turn, used as the basis for guideline writing. The epic Project: Developing National Evidence-based Guidelines for Preventing Healthcare associated Infections. 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National Institute for Health and Clinical Excellence A new system for grading recommendations in evidence based guidelines Mopping up hospital infection CDC Guideline for Handwashing and Hospital Environmental Control Working Party for Standards for Environmental Cleanliness in Hospitals. Standards for Environmental Cleanliness in Hospitals. Infection Control Nurses Association and the Association of Domestic Management Standards for environmental cleanliness in hospitals. London: The Stationery Office The NHS Healthcare Cleaning Manual. London: Department of Health Safe Disposal of Clinical Waste. London: HSE Hospital Laundry Arrangements for Used and Infected Linen Leeds: NHSE Guidance for clinical health care workers: Protection against infection with bloodborne viruses. London: Department of Health Decontamination of equipment, linen or other surfaces contaminated with Hepatitis B and/or human immunodeficiency viruses. HC(91) 33 London: Department of Health; 1991. 20. National Health Service Executive. A First Class Service: Quality in the new NHS. Leeds: Department of Health Department of Health. The Health Act 2006: Code of Practice for the Prevention and Control of Health Care Associated Infections. London: Department of Health Reservoirs of MRSA in the acute hospital setting: A systematic review Effects of cleaning and disinfection in reducing the spread of Norovirus contamination via environmental surfaces Role of environmental cleaning in controlling an outbreak of Acinetobacter baumannii on a neurosurgical unit Comparison of the effect of detergent versus hypochlorite on environmental contamination and incidence of Clostridium difficile infection Tackling contamination of the hospital environment by methicillin-resistant Staphylococcus aureus (MRSA): a comparison between conventional terminal cleaning and hydrogen peroxide vapour decontamination Environmental contamination due to methicillin-resistant Staphylococcus aureus: possible infection control implications Contamination of room door handles by methicillin -sensitive/methicillin-resistant Staphylococcus aureus Bacterial contamination of computer keyboards in a teaching hospital An evaluation of hospital cleaning regimes and standards Chlorhexidine resistance in antibiotic resistant bacteria isolated from the surfaces of dispensers of soap containing chlorhexidine Evidence that hospital hygiene is important in the control of methicillin-resistant Staphylococcus aureus Does disinfection of environmental surfaces influence nosocomial infection rates? A systematic review Use of audit tools to evaluate the efficacy of cleaning systems in hospitals Microbiological Advisory Committee to the Department of Health. Sterilisation, disinfection and cleaning of medical equipment. London: Department of Health Outbreak of extended beta lactamase-producing Klebsiella pneumoniae in a neonatal intensive care unit linked to artificial nails Bacterial contamination of the hands of hospital staff during routine patient care Dynamics of bacterial hand contamination during routine neonatal care The impact of alcohol hand sanitizer use on infection rates in an extended care facility Handwashing and respiratory illness among young adults in military training Effectiveness of a hospital wide programme to improve compliance with hand hygiene Reduction in nosocomial transmission of drug resistant bacteria after introduction of an alcohol-based hand rub Guidelines for hand hygiene in health-care settings. 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London: Infection Control Nurses Association Management of Health and Safety at Work Regulations. London: HSE Books Personal Protective Equipment at Work Regulations: Guidance on Regulations. London: HSE Books Control of Substances Hazardous to Health Regulations Knowledge of standard and isolation precautions in a large teaching hospital Healthcare workers' knowledge of inoculation injuries and glove use Critical incidents of nonadherence with standard precautions guidelines among community hospital-based health care workers Medical Gloves for Single Use Part 1: Specification for freedom from holes Medical Gloves for Single Use Part 2: Specification for physical properties Medical Gloves for Single Use Part 3: Requirements and testing for biological evaluation Effectiveness of gloves in the prevention of hand carriage of vancomycinresistant enterococcus species by health care workers after patient care To determine the effects of gloves stress, type of material (vinyl, nitrile, copolymer, latex) and manufacturer on the barrier effectiveness of medical examination gloves Bacterial contamination of nurses' uniforms: a study Bacterial contamination of uniforms Bacterial contamination of scrub jackets during dental hygiene procedures Contamination of gowns, gloves, and stethoscopes with vancomycin-resistant enterococci Gowning by attendants and visitors in newborn nurseries for prevention of neonatal morbidity and mortality (Review). The Cochrane Database of To gown or not to gown: The effect on acquisition of vancomycin-resistant enterococci A prospective study to determine whether cover gowns in addition to gloves decrease nosocomial transmission of vancomycin-resistant enterococci in an intensive care unit National Collaborating Centre for Chronic Conditions for the National Institute for Health and Clinical Excellence. Tuberculosis: Clinical diagnosis and management of tuberculosis, and measures for its prevention and control The Prevention and Control of Tuberculosis in the United Kingdom: UK Guidance on the prevention and control of transmission of 1. HIV-related tuberculosis 2. Drug-resistant, including multiple drug-resistant, tuberculosis. London: Department of Health Control of Substances Hazardous to Health Regulations 1999. Approved Codes of Practice. HSE Books Effectiveness of precautions against droplets and contact in prevention of nosocomial transmission of severe acute respiratory syndrome (SARS) Appropriate use of personal protective equipment among healthcare workers in public sector hospitals and primary healthcare polyclinics during the SARS outbreak in Singapore Safe Disposal of Clinical Waste. Sheffield: Health and Safety Executive; 1999. 111. National Audit Office. A Safer Place to Work: improving the Management of Health and Safety Risks to Staff in NHS Trusts. London: The Stationery Office Monitoring sharps injuries: EPINet™ surveillance results Eye of the Needle: United Kingdom Surveillance of Significant Occupational Exposure to Bloodborne Viruses in Healthcare Workers Center for Disease Control and Prevention. Workbook for Designing, Implementing and Evaluating a Sharps Injury Prevention Program Preventing Hospital-acquired Infection: Clinical Guidelines. 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An experimental and clinical study Silver alloy coated catheters reduce catheter-associated bacteriuria The efficacy of sliver alloy-coated urinary catheters in preventing urinary tract infection: A meta-analysis Types of urethral catheters for management of short-term voiding problems in hospitalised adults. (Cochrane Review). The Cochrane Library Systematic Review: Antimicrobial Urinary Catheters To Prevent Catheter-Associated Urinary Tract Infection in Hospitalized Patients Management of short term indwelling urethral catheters to prevent urinary tract infections. A Systematic Review. 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A randomised trial in 100 patients with solid tumors Comparison of infections in Hickman and implanted port catheters in adult solid tumor patients Experience with a totally implantable venous access device (Port-A-Cath) in patients with AIDS Infectious morbidity associated with long-term use of venous access devices in patients with cancer Effects of subcutaneous tunneling on internal jugular catheter-related sepsis in critically ill patient: a prospective randomised multicenter study Use of tunneled femoral catheters to prevent catheter-related infection: a randomised controlled trial Tunneling short-term central venous catheters to prevent catheter-related infection: A meta-analysis of randomized controlled trials Prevention of central venous catheter-related bloodstream infection by use of an antiseptic-impregnated catheter. A randomized controlled trial Evaluation of chlorhexidine and silversulfadiazine impregnated central venous catheters for the prevention of bloodstream infection in leukaemic patients: a randomized controlled trial Influence of triple-lumen central venous catheters coated with chlorhexidine and sliver sulfadiazine on the incidence of catheter-related bacteremia A meta-analysis dealing with the effectiveness of chlorhexidine and silver-sulfadiazine impregnated central venous catheters Anaphylactic shock induced by an antiseptic-coated central venous catheter Cost-effectiveness of antiseptic-impregnated central venous catheters for the prevention of catheter-related bloodstream infection Central venous catheters coated with minocycline and rifampin for the prevention of catheter-related colonization and bloodstream infections. A randomized, double-blind trial Decreasing catheter colonization through the use of an antiseptic-impregnated catheter: a continuous quality improvement project A comparison of two antimicrobialimpregnated central venous catheters Efficacy of antiseptic-impregnated central venous catheters in preventing catheter-related bloodstream infection: a meta-analysis Prevention of intravascular catheter-related infections Prevention of bloodstream infections with central venous catheters treated with anti-infective agents depends on catheter type and insertion time: evidence from a meta-analysis Prolonged antimicrobial activity of a catheter containing chlorhexidine/silver sulfadiazine extends protection against catheter infections in vivo The clinical and cost effectiveness of central venous catheters treated with anti-microbial agents in preventing bloodstream infections: a systematic review and economic evaluation The pathogenesis and epidemiology of catheter-related infection with pulmonary artery Swan-Ganz catheters: a prospective study utilizing molecular subtyping Prospective multicenter study of vascular-catheter-related complications and risk factors for positive centralcatheter cultures in intensive care unit patients Risk of infection due to central venous catheters: effect of site of placement and catheter type Femoral deep vein thrombosis associated with central venous catheterization: results from a prospective, randomized trial Complications of femoral and subclavian venous catheterization in critically ill patients: a randomized controlled trial Deep venous thrombosis caused by femoral venous catheters in critically ill adult patients Incidence of deep venous thrombosis associated with femoral venous catheterization A prospective evaluation of the use of femoral venous catheters in critically ill adults Ultrasound guidance for placement of central venous catheters: a meta-analysis of the literature Guidance on the use of ultrasound locating devices for placing central venous catheters Peripheral access options Skin microbiology: coming of age Risk of catheter-related bloodstream infection with peripherally inserted central venous catheters used in hospitalized patients aseptic technique is very important: maximal barrier precautions during insertion reduce the risk of central venous catheter-related bacteremia Improved sterile technique diminishes the incidence of positive line cultures in cardiovascular patients Prevention of central venous catheter-related infections by using maximal sterile barrier precautions during insertion Infections due to Infusion Therapy Catheter-Related Bloodstream Infections: Evaluation of CDC Guidelines Catheter-related sepsis: an overview -Part 2 Using maximal sterile barriers to prevent central venous catheter-related infection: A systematic evidence-based review Prospective, randomized trial of two antiseptic solutions for prevention of central venous or arterial catheter colonization and infection in intensive care unit patients Prospective randomized trial of povidone-iodine, alcohol, and chlorhexidine for prevention of infection associated with central venous and arterial catheters Prospective, randomized trial of two antiseptic solutions for prevention of central venous or arterial catheter colonization and infection in intensive care unit patients Guideline for use of topical antimicrobial agents Catheter-related sepsis in long-term parenteral nutrition with Broviac catheters. An evaluation of different disinfectants Colonization of central venous catheters A clinical and bacteriologic study of infections associated with venous cutdowns Application of antibiotic ointment to the site of venous catheterization: a controlled trial Risk of infection with indwelling intravenous catheters: effect of application of antibiotic ointment The effects of antibiotic ointments and antiseptics on the skin flora beneath subclavian catheter dressings during intravenous hyperalimentation A comparative study of polyantibiotic and iodophor ointment in prevention of vascular catheterrelated infection Chlorhexidine compared with povidone-iodine solution for vascular catheter-site care: A meta-analysis Combined skin disinfection with chlorhexidine/ propanol and aqueous povidone-iodine reduces bacterial colonisation of central venous catheters (for) Members of the NACRE Study Group. Alcoholic povidone-iodine to prevent central venous catheter colonization: a randomized unit-crossover study Gauze and tape and transparent polyurethane dressings for central venous catheters (Review) Comparison of the sterility of long-term central venous catheterisation using singlelumen, triple-lumen, and pulmonary artery catheters Colonization and bacteremia related to duration of triple-lumen intravascular catheter placement A controlled trial of scheduled replacement of central venous and pulmonary artery catheters Safety of central venous catheter change over a guide wire for suspected catheter-related sepsis: a prospective randomised trial Central venous catheter replacement strategies: A systematic review of the literature Prospective study of catheter replacement and other risk factors for infection of hyperalimentation catheters Catheter infection. A comparison of two catheter maintenance techniques Catheter-related sepsis in patients on intravenous nutrition: a prospective study of quantitative catheter cultures and guide wire changes for suspected sepsis Mechanical complications from insertion of subclavian venous feeding catheters: comparison of de novo percutaneous venipuncture to change of catheter over guide wire Accuracy and cost-effectiveness of new tests for diagnosis of catheter-related bloodstream infections Diagnosis of vascular catheter-related bloodstream infection: a meta-analysis Source and route of microbial colonization of parenteral nutrition catheters Catheter sepsis due to coagulase-negative staphylococci in patients on total parenteral nutrition A prospective study of the catheter hub as the portal of entry for microorganisms causing catheter-related sepsis in neonates Adherence and growth of coagulase-negative staphylococci on surfaces of intravenous catheters Pathogenesis of catheter sepsis: a prospective study with quantitative and semiquantitative cultures of catheter hub and segments A randomized trial on the effect of tubing changes on hub contamination and catheter sepsis during parenteral nutrition Ultrastructural analysis of indwelling vascular catheters: a quantitative relationship between luminal colonization and duration of placement Contamination of stopcocks mounted in administration sets for central venous catheters with replacement at 24 hrs versus 72 hrs: a prospective cohort study Use of disinfectants to reduce microbial contamination of hubs of vascular catheters Effectiveness of disinfectant techniques on intravenous tubing latex injection ports A randomized, prospective clinical trial to assess the potential infection risk associated with the PosiFlow ® needleless connector Prophylactic antibiotics for preventing early central venous catheter Gram positive infections in oncology patients Heparin bonding reduces thrombogenicity of pulmonary-artery catheters The relationship between the thrombotic and infectious complications of central venous catheters Thrombosis as a complication of pulmonary-artery catheterisation within the internal jugular vein Central venous thrombosis associated with intravenous feeding: a prospective study A crosssectional study of catheter-related thrombosis in children receiving total parenteral nutrition at home Catheter-related thrombosis in critically ill children: comparison of catheters with and without heparin bonding A prospective study of femoral catheter-related thrombosis in children Benefit of Heparin in Central Venous and Pulmonary Artery Catheters: A Meta-analysis of Randomized Controlled Trials British National Formulary No. 51. London: British Medical Association and the Royal Pharmaceutical Society Very low doses of warfarin can prevent thrombosis in central venous catheters. A randomized prospective trial Case report: the heparin flush syndrome: a cause of iatrogenic hemorrhage Benefit of heparin in peripheral venous and arterial catheters: systematic review and meta-analysis of randomised controlled trials A meta-analysis of effects of heparin flush and saline flush: quality and cost implications Analysis of the research about heparinized versus nonheparinized intravascular lines