key: cord-0011443-hgzneooy
authors: David, Yadin; Judd, Thomas
title: Evidence-based impact by clinical engineers on global patients outcomes
date: 2019-07-02
journal: Health Technol (Berl)
DOI: 10.1007/s12553-019-00345-0
sha: a2002e72127aeb86799a465227aad6d863b3ac42
doc_id: 11443
cord_uid: hgzneooy

The intersection of technological changes and societal evolution has transformed every aspect of human life. Technological advancements are transforming how healthcare knowledge is expanding and accelerating the outreach of critical medical services delivery (Jamal et al. in Health Information Management Journal 38(3):26–37, 2009). While this transformation facilitates new opportunities simultaneously it also introduces challenges (Jacobzone and Oxley, 2001). Appropriate Health Technology (HT) is vital to new and existing global health care programs. Therefore, qualified professionals who can safely guide the development, evaluation, installation, integration, performance assurance, and risk mitigation of HT must be in position to lead. Trained Clinical Engineers (CE) and Biomedical Engineers (BE) have been recognized by the World Health Organization (WHO) as the essential practitioners to providing this critically needed guidance. Over the past four years, a senior professional group participated in an international project that seeks evidence for the hypothesis - that the engagement of CE and BE in guiding HT - impacts positively on patient outcomes, while the alternative is that there is no difference. The group collected published data that was subjected to peer review screening; additional data qualification conditions are described in this paper. The project was initiated at the Global CE Summit during the first International Clinical Engineering and Health Technology Management Congress (ICEHTMC) in Hangzhou, China in October 2015 (Global Clinical Engineering Summit at the First International Clinical Engineering and Health Technology Management Congress, 2015). Following the adoption of a resolution to investigate CE contributions to the improvement of world health status, an international survey and literature survey were initiated. During the first two years of this project 150 case studies from 90 countries were identified covering the previous ten years. The results of this survey were presented to health leaders at the World Health Organization (WHO) World Health Assembly in 2016. Last year, 250 case studies were added including 35 more countries covering the 2016–2017 period. The combined project contains 400 qualified submissions from 125 countries. The conclusion was that engagement of CE and BME is critical for successful investment in HT and for achieving intended patient outcomes. This paper describes the project’s plan, the results of the literature review performed, and the evidence identified during the process.

The intersection of technological changes and social evolution has transformed every aspect of human life [1] . This transformation is expansive and most obvious in the changes that has been occurring over the past fifty years in the provisioning of healthcare services [2] . The dependence of health, rehabilitation, and wellness programs on technology for the delivery of services has never been greater [3] . Therefore, it is essential that health technology (HT) be strategically guided and optimally managed [4] . Guidance can only be provided by educated and experienced professionals who can safely lead the full life cycle of the technology, starting with innovation and progressing to development, regulatory compliance, evaluation, installation, training, integration, performance assurance, and risk mitigation. However, these professionals must be familiar with the relationship between contributions from HT and their impact on patient outcomes. The understanding of this relationship is a fundamental requirement for achieving optimal return on investment and improvement of outcomes. Such practitioners are critical members of the healthcare team and should be in position to facilitate technology-related plans.

Beyond the ongoing healthcare burdens of population growth, political and economic instability, disease management, disasters, refugees, accidents, terror attacks, and increasing dependence level on technology, our world of healthcare systems is facing enormous challenges to manage its resources in the twenty-first century. The flood of scientific and technological innovation is radically redefining the nature of healthcare in virtually every dimension, from vascular nanoengineered interventions and predictive diagnostic tests to image guided surgery and remote telehealth-based services at the national and global levels. However, most healthcare systems are not adequately staffed to safely and effectively manage these forces of change. Most systems are structured around vertically-expert professions (medical doctors, medical physicists, nurses, administrators), but lack the "horizontal expertise" that trained Biomedical and Clinical Engineers (BE&CE) provide. For example, the expertise in assessing and managing the integration and the performance of complex smart systems that have varying areas of service, durations of technological lifecycle [5] , hardware and software platforms, and middleware in support of integrated medical and surgical services.

Disproving the myth -that there is a lack of evidence to qualify how much the dependency of HT is well-guided by CE expertise and best practice methodologyled to our examination of published literature and formal presentations of case studies in which CEs, BEs, and those in similar roles have participated. This allowed us to answer the question whether their participation contributed to improvement in overall healthcare outcomes. In the field of HT management and CE, the incentives to publish studies are lower than it should be, resulting in limited volume of resources to develop best practice measures. Despite these perceived limitations, our results were recently published [3] . In this paper, the focus is on the process used for the selection of data sources and the methodology to qualify their inclusion, described in the Methodology section of this paper.

On the other hand, over the past 50 years, concerns were expressed that there is a lack of knowledge by Government Agencies and key stakeholders, coupled with limited recognition for those contributions for the practitioners that guide the deployment, creation and safe deployment of health technology. Our data answers these concerns. If the knowledge and the expertise of the global CE community does have a critical role in optimal guidance of HT deployment, how can that expertise be best demonstrated. The collection of the case studies (that were later called success stories) from all over the world can facilitate the determination if there is competency unique to CEs around the world that leads the development and optimal management of these technology life cycles. Having this knowledge can help to reach better understanding of the required strategy to achieve desired patient outcomes when technology is used in care and rehabilitation management.

The Ebola virus disease crisis [6] has demonstrated that multidisciplinary team expertise and collaboration are keys to success. Low resources countries in particular face a challenge of improving their health services because, in addition to the above stated challenges, they also have scarce availability of professional expertise trained to address technology-related issues [7] . Varied availability and state of infrastructure and human resources place higher demand on adequate management of HT innovation and deployment. The effective health workforce of the twenty-first century consists of more individual practitioners caring for complex health-issues and thus charged with deploying the most optimal benefits from medical technology, such as proper selection, effectiveness, timely access, and affordable. In academia, government, and industry, teams of BE&CE translate design innovations and integrate knowledge of science, engineering, standards and regulations with clinical strategy to create new tools that save and improve lives while building more quality into patient outcomes. In hospitals, BE&CE practitioners ensure that proper acquisition, installation, integration and operation of devices and systems are safe and efficient. With the increasing role of technology in the delivery health care services, professional competency of the entire span of the technology lifecycleacross systems and sectorsis critical to achieving the full benefits and best outcomes clinically, economically, and operationally.

Following the resolution adopted at the first International Clinical Engineering and Health Technology Management Congress [8] that took place in Hangzhou, China, in October 2015, senior members from the CE profession from around the world who participated in the Global CE Summit [9] initiated the international project seeking evidence to the hypothesis that the engagement of CE and BE in guiding HT deployment positively impacts patient outcomes while the null hypothesis was that there is no difference. The group identified the volume of published data that and developed criteria for inclusion pertinent and qualified publications. The rules are shown in Fig. 1 below. Several conditions were placed on the total volume of publications and formal presentations that were found. Only sources that responded positive to the challenge of the criteria were included in the final examination. To begin with, the source must be subjected to peer-review screening. Secondly, the source must include care-related outcomes in the body of the manuscript, thirdly the source had to be published in IFMBE [10] sponsored publication or event (meeting) proceedings, fourthly, the source must describe how CE or BME practices led to the second criterion of outcomes, and the fifth criterion limit the source inclusion to specific window of time. This window was defined as 2005-2015 for the first phase of this examination, and 2016-2017 for the second phase.

During the first two years of the project 150 case studies from 90 countries were identified and satisfied the criteria described in Fig. 1 . Searching through the time span over a period of previous ten years (2005) (2006) (2007) (2008) (2009) (2010) (2011) (2012) (2013) (2014) (2015) . The results of the initial review were presented to health leaders from member countries at the WHO World Health Assembly in 2016. The interest generated in the project helped to sustain its work and as a result of the continuation of data analysis the team identified and qualified additional 250 case studies from a total of 125 countries covering the period of the 2016-2017. The combined project's two stages examine and qualified over 400 qualified submissions from 125 countries.

Next, we looked at the methodology of putting together peer recognized clinical engineering experts from around the world, all members of the IFMBE clinical engineering division and issued a call for collections of papers from around the world, that will demonstrate what is the involvement and what is the contribution of individual programs from around the world in the CE arena. Within 6 months, in 2016, we were able to collect a vast volume of evidence that was qualified and filter into 150 specific studies from 90 countries. The literature sources and the results of the examination are presented, grouped into six categories of outcomes impact.

The resulting qualified volume of sources were categories into groups. The six groups were created to facilitate decision if sufficient evidence has been accumulated to support conclusion of outcomes. While the six categories were reviewed independently the significant overall commonality is that they all address different aspects of HT technology's impact on outcomes. Data collected that met the inclusion criteria was grouped into six categories as follows:

Through provision of new HT solutions, adaptation of existing, or a combination to address several issues.

Ease in reaching HT-related health services or facilities in terms of location, time, and ease of approach.

Positive impact from more efficient and effective deployment of HT at national or policy level.

HT's positive impact on health services safety or quality outcomes, or through HT human resource development.

Establishing or improving HTM methodology resulting in improved population health or wellness.

Improvements achieved due to deployment of Internet-based HT tools.Following phases of the technology life cycle the analysis of the data began with the group that starts the cycle -with the innovation phase. Innovation and the provision of new solutions to existing problems. The next group, reasonable progression to health services. Where the question to address was the possible existence of evidence to demonstrate that the access to health care services has increased because of technology management programs. Or, did the HT management program established methodologies that improve the overall finance and/or wellness of the population. After that, review of data was conducted with regard to overall impact on National or regional systems or multi-hospital health systems. Safety and Quality services that dependent on complex technological systems is critical for outcomes and therefore identified with its own group of data Technology management group was the next category to be reviewed where CE/BME contributions to organized, integrate, manage, and improve safe and efficient sustainable HT. Finally, in a way of looking forward the future, the group of e-Technology where telemedicine, image guided interventions, Informatics and disaster response operation were grouped together. Making assumption that with the introduction of complex technological systems improvements in patient care safety and the quality of services receive were evident.

With review of data in these six categories this study was able to cover major activities that are technology-dependent in health. Successful source (or submission) was defined as satisfying objective measures developed by the investigators: timeliness, cost saving, deployment or adoption by care providers, impact on services, and overall projection for success. Each success metric was evaluated using 3-point scale against a statement representing the success construct (1 = strongly disagree; 3 = strongly agree). Timeliness refers to whether the project/submission was implemented in timely manner. This was measure by the statement "The submission will impact outcomes on present time."

The cost measure was evaluated on whether the submission's overall costs were within budget constraints and reasonable for the conditions in the region. This was assessed by the statement, "The submission cost objectives can be met in the region." The final two metrics were combined into the statements "The submission will be deployed by its intended users" and "The submission will have a positive impact on those who will adopt it." Finally, overall submission success was assessed with the statement "All things considered, the submission will be a success." Success was determined when the source received overall rating of 2 or above.

Sources for data collection included the following: IFMBE/ Clinical Engineering Division (CED) 2016 Health Technologies Resources [11] document provided to the World Health Assembly, WHO in May 2016, the 2nd and 3rd Global Forums on Medical Devices [12] organized by the World Health Organization IFMBE/ CED's China and Brazil ICEHTMC [12] October 2015 and September 2017 respectively, others [13] IFMBE journals proceedings and published sources from the period 2016-2017. The results containing criteria inclusive and qualified data were tabulated and categorized into six categories that are described in tables below. The tables provide detailed information about the category of the submission, the region summitted it, the submission title and authors identification. Each of submission is accompanied by hot link facilitating further data and evidence details that the reader is welcome to pursue. The data in these tables with the accompanied links demonstrates that evidence exists for benefit registered in each of the six categories from every region around the world. Overall this review identified evidence from 400 case studies received from 125 countries where management of medical devices (as main component of health technologies) made a positive difference over the past twelve years. The results of first phase of the literature survey were incorporated into a document that in May of 2016 was successfully presented to the world Health Assembly consisting of member country delegations of Ministry of Health from around the world to WHO in Geneva Switzerland [14] .

Data collection and analysis was conducted over three years period employing the same selection factors as shown in Fig. 1 . The analysis shows that volume of evidence exists in the literature to demonstrate the important and critical contributions of CE and BME to the initiation of new and improvement of present care outcomes. These contributions are evident on every continent and every day of the year. Not just randomly but continuously 24x7x365 days. After the completion of the two phases of this literature survey 400 publications from 125 countries document evidence and showing the success of Clinical engineering competency serving on the healthcare delivery team (Tables 1, 2, 3, 4, 5 and 6).

The case studies are actually HT Success Stories demonstrating, in a limited resource environment, that it is desirable to include professional HT expertise, such as clinical engineers, in national decision-making in order to maximize health systems' services. Case studies from the links on the following pages demonstrate these benefits:

& Access: The Ministry of Health HT Unit-led project in Albania that doubled access to critical diagnostic services, such as computed tomography scanners, magnetic resonance and angiography imaging, while reducing equipment downtime to zero, and significantly reducing cost. & Health Systems: Improved coordination between multiple stakeholders in the National Laboratory and its satellites in Colombia, led by the Ministry of Health and clinical engineers who partner with experts from academia and industry. & Quality & Safety: A clinical engineer-led 122-hospital program in the Shanghai region that cooperates with officials, industry, and academic entities, resulting in improved device user satisfaction, tracking of emerging technologies, and closer partnerships with industry.

& Table 1 Innovation & Table 2 Access & Table 3 Management & Table 4 Health Systems & Table 5 e-Technology & Table 6 Quality & Safety

In all of the above mentioned topics, data collection, review and validation continued throughout the project period as access to IFMBE sponsored events and related publications was secured in phases. During 2017 and 2018 we added more evidence that was qualified by our criteria. 250 additional stories from additional of 35 countries, were now increasing the overall count to 400 publications from 125 countries. All with evidence, showing the success from CE involvement in the relationship to improving patient outcomes, and the derived benefits from HT creation, management, and deployment. Involvement that is documented through services provided over 365 days a year, 24 h a day, 7 days a week. To be included in the project evidence database, shown in the tables above, each entry must comply with conditions for inclusion and with performance parameters described earlier of timeliness, costsaving, extent of deployment or adoption by care providers, impact on overall services and estimated projection for the entry success. The timeliness parameter complied if an impact has been described in the entry as immediate as in present tense. Other parameters were similarly considered similarly.

All entries included can be viewed through the on-line links provided in the tables. The hot links to all the resources the task force reviewed and qualified were validated. The tables are color coded to facilitate ease readers interest of seeking additional details for a specific technology category.

Examples of entries from the table above describe details as follow:

In the innovation category, for example, Anne-Louise Smith from Adelaide, Australia, with a team of clinicians identified a need for solution to specific clinical problem related to retrieval to transfusion of fluids of patients who maybe in a shock. No device was able to meet the need of fulfilling the task without external power source. The entry -BME development of non-electric portable blood/fluid warmer for roadside trauma, describe the critical contribution of CE to create solution, test it, identify and resolve usability barriers and bring it to commercialization. Transferring of patients in rural areas is now safer and having better patient outcomes. The engineering expertise and the collaboration with physicians were key factors for the success evident in this entry.

In the Health Systems category: Bilal Beceren, from Turkey, affiliated with Ministry of Health (MoH) of Turkey practices at the National HT management program, involved 800 public hospitals. Prior to 2013 there was no MoH based program and knowledge of the medical technology assets deployed. They embarked on national project in 2015 that built information about medical assets purchasing, commissioning and facilitated better performance support. CE training was initiated, and maintenance support has increased. The outcomes show that medical technology has been acquired under better terms, more efficiently maintained, the uptime of 95% for covered inventory now was reachable facilitating better patient care. Annual audits conducted since show that from unknown level prior to 2013 the program in 2015 reached coverage of 88% of the inventory in the country. National health technology management system for public hospitals in Turkey improve the performance and cost efficiency of the technology that patient management is dependent upon.

In the Access category: Ledina Picari from the MoH in Albania, a clinical engineer by training identified concern about the access to diagnostic services. Diagnostic imaging technology was not properly maintained and equipment up time did not meet patients' need. In 2014 a collaborative national project was initiated to examine the state of equipment management and identify opportunities for increasing access to diagnostic services, to increase clinical availability of diagnostic technology at the local level, and to increase efficient and effective use of public funds. The evidence provided shows that in 2015 the volume of CT examinations more than doubled from 3157 to 6602 exams while the equipment downtime was reduced from almost four months a year down to near 0 days. This is important achievement that in addition delivered the benefit of reducing the maintenance costs from about 10 to 12% before the project was initiated down to 8% of the purchase price per annum afterwards. Diagnostic technology availability significantly improves patient's outcome.

A second example in the Access to health services category that bridges to e-Technology and specifically a Telemedicine program was initiated with CE guidance (Yadin David) in Houston, Texas. The project aimed at connecting rural community in Central America Village In the Safety and Quality category, Li Bin, a CE from Shanghai, China, identified the need for having better technology quality control as there was not clear measure in the management of the technology in large network of care providers before 2005. Network of care providers facilities in community of 23 million population, 122 hospitals above grade two, and about 1000 Ce & BME in the region. As result of this project in 2016 they changed the conditions from lack of quality standards in purchasing and servicing of diagnostic technology they implemented enhanced management program with collaboration of industry. Data sharing and benchmarking information led to better cooperation between the parties, improve service personnel training, the initiation of annual quality improvement reporting and to sustain readiness of technology to serve clinical objectives. They now know that there are 26 billion yuan of medical equipment assets, this is about 4 billion dollars USD that due to CE management improved outcomes for both financial investment in technology and clinical services to patients. The e-technology category has another example of how BE & CE contributed to better outcomes, specifically during the devastating earthquake in Port-au-Prince, Haiti. In that occasion, article of New England Journal of medicine, March 2010, describes how 109 support staff, including CE, arrived at Haiti and within two days after the earthquake, established a field hospital that was able to treat 1100 patients, performed 320 surgeries, and delivered 16 babies. The first baby born there was named by his mother 'Israel'after the group origin that came to establish the field Hospital there.

Finally, in the HT Management category, in Brazilian rainforest, we found another evidence for how CE expertise has helped to achieve better patient outcomes and improving care. Ryan Pinto Ferreira from University of Campinas, optimal transportation method and assembly all the medical devices that clinicians needed. They transport it over the challenge of difficult route, to be placed in a highly humid rainforest environment. They assembled, commissioned, and operated the equipment and provided support for clinical services that those patients needed.

At the WHO, in the Health Systems category, Adriana Velasquez have implemented many technology-based patient care programs that have far reach all over the world. Her collaborative efforts perhaps best known through assembling networking of international stake holders during the successful series of Global Forums on Medical Devices. Another successful contribution she achieved has been the development and dissemination of international publication and resources [65] for addressing HT issues such as creating a resource for global atlas of medical devices, global model for regulatory framework, medical device policies, compendium of new and emerging health technologies, human resources 

HT is vital to health and the dependence of health, rehabilitation, and wellness programs that rely on HT for the delivery of their services has never been greater. Beyond the ongoing healthcare burdens of population growth, political and economic instability, disease management, disasters, the refugee crisis, accidents, and terror attacks, world healthcare technological systems are facing enormous challenges to be innovative and optimally managed. The transition into health programs for the 21st century requires the employment of trained competent CE professionals. Disease prevention, treatment, and rehabilitation is more efficient and effective when health services are provided with appropriate tools. Along with World Health Organization (WHO) [66] , the International It is critical, therefore, that with limited availability of resources, HT must be professionally managed and its creation and deployment over its life-cycle be appropriately guided. This paper describes the extensive study of published data on the vast contributions by CE that positively impact patient outcomes. This finding of this study shows that every region of the world including lowresource regions face a challenge of improving health services while facing varied levels of infrastructure and human resources capacity challenges. CEs play vital roles in all stages of healthcare technology life-cycle management. From creation to planning, and from commissioning to utilization and integration; technology-based systems must and can be managed for optimal performance. In each of the technology life-cycle stages the requirement for trained and competent CE input makes critical difference as evidence show in the analyzed data reviewed above. It is our hope that government agencies and other interested parties will have better understanding of CEs role and thus will support their inclusion in the healthcare team of professionals.

The identified and qualified 400 case studies shown in this manuscript support the need to expand the reach of CE community in order to provide competent guide to management of healthcare technologies around the world. Case studiesgrouped in 6 categoriescan assist to formulate national strategies and plans on how to improve the creation and deployment of HT while improving quality of care and efficient use of scares funding. In several countries, case studies demonstrated, this has best been achieved by developing a HT unit at the level of Ministry of Health that engages the CE community. These studies provide evidence that HT is beneficial; however, at times, deployment of such complex systems when it is not effectively guided and managed may not realize intended outcomes for optimal impact.

The 2007 WHO WHA Resolution 60.29 urges Member States to create national HT management plans in collaboration with clinical and biomedical engineers. WHO further clarified the definition of these personnel in 2017-2018 as part of a global survey [67] in coordination with IFMBE/CED. "Trained and qualified biomedical engineering professionals are required to design, evaluate, regulate, maintain and manage medical devices, and train on their safe use in health systems around the world.5" These occupations have various names in different countries like clinical engineers, medical engineers, … and related professionals and technicians."

We encourage the dissemination of survey tools as describe here to better understand the need for and monitoring of progress towards safe, appropriate and optimal quality care outcomes.

The authors express gratitude for the intense work invested by members of the project task force and for Kallirroi Stavrianou for creating and validating all of evidence links on the tables above.

Conflict of interest The authors declare that they have no conflict of interest.

Ethical approval This article does not contain any studies with human participants or animals performed by any of the authors.

Informed consent Informed consent was not obtained since there were individual participants included in the study.

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