key: cord-018483-aj8yknky authors: Ortiz Posadas, Martha R. title: Medical Technology Management in Hospital Certification in Mexico date: 2010-05-28 journal: Healthcare Knowledge Management DOI: 10.1007/978-0-387-49009-0_5 sha: doc_id: 18483 cord_uid: aj8yknky Mexican health policy is promoting the quality of health services by hospital certification meeting the NMX-CC standards family, which is the Mexican equivalent of the ISO 9000 standards family. These standards can help both product- and service-oriented organizations achieve standards of quality that are recognized and respected throughout the world in developing a quality management system (QMS). Mexican health policy is promoting the quality of health services by hospital certification meeting the NMX-CC standards family, which is the Mexican equivalent of the ISO 9000 standards family. These standards can help both product-and serviceoriented organizations achieve standards of quality that are recognized and respected throughout the world in developing a quality management system (QMS). In hospital certification, one important aspect to beevaluated is the availability of technical supplies. In this sense, the incorporation of technical support services into healthcare organizations has become very important. That is why many hospitals in Mexico, both public and private, have incorporated into their organization a Biomedical Engineering Department (BED) with the purpose of integrating all engineering and management processes for assurance of the optimal use of all technological supplies in the hospital, helping in the quality of health services provided to patients. The purpose of this study is to show how the medical technology management done by the BED at the hospitals contributes both to health services quality and as an element required for certification. In general, it describes several projects developed in different hospitals (public and private) with different health levels in Mexico City. Each of them contributed to the certification of different clinical processes. ISO standards are voluntary. As a nongovernmental organization, ISO has no legal authority to enforce their implementation. Some ISO standards (mainly those concerned with health, safety, or the environment) have been adopted in some countries as part of their regulatory framework, or are referred to in legislation for which it serves as the technical basis. Such adoptions are sovereign decisions by the regulatory authorities or governments of the countries concerned; ISO itself does not regulate or legislate. However, although ISO standards are voluntary, they may become a market requirement, as has happened in the case of the ISO 9000 QMSs. By QMS we understand a management strategy that is characterized by: a focus on process management; a focus on quality, based on the participation of all members in the organization; getting profit through client satisfaction and providing benefits to all members in the organization and in the society. For governments, international standards provide the technological and scientific bases underpinning health, safety, and environmental legislation. For consumers, conformity of products and services to international standards provides assurance about their quality, safety, and reliability. For customers, the worldwide compatibility of technology that is achieved when products and services are based on international standards brings them an increasingly wide choice of offers, and they also benefit from the effects of competition among suppliers [1] . In this sense there are some important quality management principles: customer focus, leadership, involvement of people, process approach, system approach to management, continual improvement, factual approach to decision making, and mutually beneficial supplier relationships. In particular, the process approach (from procedures to processes) is based on the following principles: • identifying processes needful for the QMS; • demonstrating the ability of processes to achieve planned results and monitor, measure, analyze, and improve them; • developing information on characteristics and trends of processes; • top management reviewing process performance and improving effectiveness; • greater effectiveness when activities and resources are managed as a process; • more customer focus; • more cost effective; • meeting business objectives, The term ISO 9000 refers to a set of quality management standards. This approach is based on the development of a QMS that meets the new quality standard, in order to control or improve the quality of your products and services, to reduce the costs associated with poor quality, or to become more competitive, or because your customers expect you to do so, or because a governmental body has made it mandatory. You then develop a quality management system that meets the requirements specified by ISO 9001:2000. ., f --- In Mexico, the ISO 9000 2000 family have been translated by the "Spanish Translation Task Group," providing the Mexican standards NMX-CC, a set of standards to assist any organization with implementing a management quality system. In this study we just use the following Mexican standards: • NMX-CC-9000-IMNC-2000. Quality Management System. Concepts and Vocabulary [2] . This describes the fundaments and specifies the terminology for theQMS. • NMX-CC-9001-IMNC-2000. Quality Management System. Requirements [3] . This specifies the requirements for the QMS for any organization which needs to demonstrate its capability to provide products that comply with the legal and their clients' requirements, in order to improve their clients' satisfaction. The National Crusade for Quality in Health Services is a government policy developed by the Health Ministry of Mexico. Its purpose is to lead to more effective medical services in all Mexican health institutions [4] . This policy proposes elevating qualityin health servicesand standardizing it throughout the country. To achievethis purpose, the policyhas been developed through 10statements. One of theseconcernsthe certification of organizations and individuals. This actionhelps public and private institutions improve the satisfaction of both the personnel and the customers (patients). It reduces heterogeneity in the quality level among different typesof healthservice,whetherpublicor private,throughout the country. In addition,the population will gain an improvedperception about the qualityof services with veridical information, which allows people's trust in the health system to be raised. Likewise, it will look to incorporating the population in supervision of quality health services. Manyhospitalsin MexicoCityhavebeenworking to complywiththe requirements of theMexicanstandards NMX-CCin orderto becomecertificated. This procedure certificates each clinical service (in an individual way), which is consideredas a process by the standard. In this sense, hospitals must develop the required documentation for all procedures related to each process, including clinical, technical, and administrative aspects. With regard to technical aspects, the department generally in charge of the medical technology management at a hospital is the BED. Its main functions are medical equipment maintenance (preventive and corrective), medical equipment assessment, training, security, and risk management. However, the most important function that demandsmostof the technical personnel'stime is medicalequipment maintenance [5] . It is clear that all these activities have the objective of assuring optimal functionality of the available medical technology at the hospital. In this way, the technology management turns into a fundamental element in hospital certification, andthus all the servicesandprocedures relatedto medicaltechnology management provide by the BED must also comply with the Mexican standards family NMX-CC. In what follows, we will describe some projects developed in different hospitals in Mexico City related to different clinical services (processes) where the BED developed severalmanualsabout specific proceduresfor medicalequipment management in order to contributeto the certification of these services. Project 1 [6] was developed in a secondary care private hospital with 125 beds. This hospital had implemented a guaranty quality program, based on the NMX-CC-9001-IMNC-2000 standard. It was developed specifically for the managementof radio-diagnostic equipment. This programincludesprocedures concerning physical inspection and equipment functionality according to the manufacturers' technical specifications, as well as quality control tests. Afterwards, the tests were applied according to the Mexican official norm NOM-158-SSA-1996 related to technical specifications for diagnostic medical equipment that uses X-rays. Preventive maintenance tests were developed. These included physical, mechanical, and electrical aspects for monitoring the most significant functionality parameters in the equipment, in order to assure their stability as a function of time. Quality tests were also developed. These evaluate functionality parameters with the objective to get a reference value (control value). These parameters were: focal point, exposure time, performance, field coincidence, center coincidence, fuzzy alignment, exposure rate for conventional fluoroscopy, and dose in breast tumor radiation. Both preventive maintenance and quality tests were applied to 12 items of radio-diagnostic equipment (which included X-ray, CAT,mastograph, and fluoroscopy equipment) at the hospital during three consecutive weeks. Failures were detected in some equipment, and the optimal functionality of other equipment was probed. Project 2 [7] was developed in a 125-bed private hospital that decided to implement a QMS based on the NMX-CC-9001-IMNC-2000 standard. The purpose was to assure the quality of the health services provided to their patients. The hospital developed a quality manual that provides information about the quality plans. These plans are documents that specify the facilities and activities necessary to realize the health processes in an effective way. On the other hand, the hospital's BED has the function to maintain the medical equipment in optimal condition. That is why the objective of this study was to develop a quality plan (based on NMX-CC-9001-IMNC-2000) containing the process related to this activity, in order to support the implementation of a QMS and the certification of three specific health services at the hospital, namely pathology, clinical laboratory, and blood bank. Moreover, this quality plan also provides the necessary information to enable the technical personnel to carry out the maintenance process on the medical equipment. First, we identified three processes related to maintenance. (1) Revision routines, which corresponds to visual and functionality inspection of hospital facilities and medical equipment done in a scheduled way. This requires diagnostic instrumentation, simulators, and noninvasive tests, such as fluids level analysis, temperature, and pressure tests. (2) Preventive maintenance, which is defined as a programmed serial inspection of functionality, security, and calibration realized in regular periods. The purpose is to avoid failures in medical equipment and enable hospital facilities to operate at optimal levels of efficiency. (3) Repair, which covers activities such as spark replacement, component adjustment, reconditioning, etc. whose purpose is to restore the normal function, performance, and security of the equipment in the least possible time. It is important to say that the equipment maintenance could be done by technical personnel from the hospital BED or by externaltechnicalpersonnel,dependingon the technical complexity of the equipment. Thequalityplandeveloped in thisstudy' containsthegeneralprocedureto realize each process witha flow diagramshowingthe graphicsof the process.Likewise, it points out the registerform (service order,revisionprocess,etc.) requiredin each case. Project 3 [8] was developed in a private hospital with 100 beds. It has a surgical area consistingof 12 surgical rooms.Fiveof these have endosuites, surgical suites designed to create the optimal operating environment for the surgeon, staff, and, most importantly, the patient.Todayit is themost versatileroomdesign,andserves a large number of minimally invasive procedures (endoscopy, laparoscopy, and arthroscopy) [3] .The system'sfunctions andimagesaredisplayedon multifunction flat-panel monitors, which are also capable of showing images. The purposeof this study was to developa procedures manualaboutthe use and management of the medicaltechnology utilizedin minimallyinvasive surgeriesat the hospital, in order to provide information about the adequate management of the equipment to the technical personnel from the DIB and adequate use of this equipment for the medical personnel, as well as to contribute to the certification of the surgicalprocess. The procedures were generated by clinical·and technical information. The methodology for obtainingand organizing these procedures is described below. 1. Identification of the types of minimally invasive surgery done in the hospital. They were classified into fivemedicalcategories: gynecology, general surgery, thoracic,orthopedics, and otorhinolaryngology. 2. Identification of the medical technology used in each surgery. Six technology sets were defined, according to the medicalcategoriesidentified. In the case of orthopedics, this requires two different technology sets, i.e. one for shoulder surgeryand other for knee surgery. 3. Weconsulted 16 technicalmanuals with the purpose of obtainingthe technical specifications of the equipment, as wellas the manufacturers'recommendations for the use and management of the equipment. 4. Fourteen technical schedules were developed with the next information: (a) description of the equipment(including alarms); (b) physical inspection procedure; (c) management of the equipment (washing, sterilization (if necessary), warehoused, andcare); and (d) warnings and precautions. This information was incorporated in the procedurein order to provide the technical elements about the functionality of the equipmentto the technicalpersonnel from the BED. 5 . Six generic procedures about the use and management of electronic devices and medical equipment used in each minimally invasive surgery identified were elaborated. It is important to say that biomedical engineering helps the physician in all the procedures related to the minimally invasive surgeries done at the hospital. In this sense, the procedures included in the manual will be an instrument for technical and medical personnel for learning the adequate used of the medical technology, and so the optimization of the resources and the technical capability of the hospital. The procedures developed here are actually incorporated into the documentation of the management quality system of the hospital. This system provides the regulation for optimal functionality of all services (medical and administrative) from the hospital. Project 4 [9] was developed at the National Health Institute in its Infectious Diseases Research Center (CIENI). The center works with the human immunodeficiency virus, Mycobacterium tuberculosis, influenza virus (H5Nl) and the SARS corona virus. It has three laboratories designed with the necessary bio-safety standards, levels BSL2 and BSL3. The laboratory equipment has two kinds of contact with the infectious agents, namely direct and indirect. For example, pipettes have direct contact and C02 incubators have indirect contact because the virus is in Petri boxes. That is why the technology requires specific management and control. The objective of this study was to develop preventive maintenance procedures for the laboratory equipment present in this center, involving aspects about risk management and quality control. The importance of these kinds of procedure is that activities related to the maintenance and the sanitation procedures attending bio-safety should decrease the biological risk for technical personnel. In this sense, the partial goals of this study were to provide to the technical personnel from the BED the bio-safety procedures necessary for minimizing biological risk during the execution of work: • A complete preventive maintenance procedure for each specific piece of equipment. • Technical and quality specifications required during the execution of the maintenance procedures and equipment calibration. • Minimization of equipment failure, assuring continuous operation of the equipment and extending its useful time. • Contribution to the certification process of severalclinical and research laboratory processesat the centerby complyingwiththe Mexican standardMX-NMX-CC. There were 13piecesof equipmentselected: (1) two doors sterilizer, (2) analytical digitalbalance,(3) extraction bench,(4) laminarflux bench,(5) centrifugeand micro-centrifuge, (6) refrigerated centrifugeand ultracentrifuge, (7) laser diffraction particle-size analyzer, (8) C02 incubator, (9) microscope, (10) pipettes, (11) digital potentiometer, (12) refrigerator, (13) ultra-freezer. The procedures were structuredas follows: 1. Introduction. This includesgeneralinformation about the featuresof the different research laboratories at CIENI. 2. General and security rules. These providethe securityprocedures requiredfor access to the center and for equipmentmaintenance. 3. Procedure for preventive maintenance. Each procedurecontains the following information: maintenance periodicity, security procedures (the securityequipment requiredfor doing it), maintenance procedure(including generalexternal cleaning, external inspection, internal cleaning, internal inspection, lubrication, spare parts replacement, calibration, revision of electrical security, and full functionality tests). 4. Equipment, toolsand spare parts. This section provides information about the tools and spare parts necessaryfor carrying out preventive maintenance on the equipment, as well as consumables for the operationand calibration. 5. Quality control. Some actionsrecommended for qualitycontrol were included, such as: a daily registerof parameters (temperature, pressure,humidity, etc.) in order to monitortheir fluctuations; instrumentation necessary for maintenance, certificated by the MexicanEntity of Accreditation [10] . 6. Registrationform. Thisformincludesgeneraldataabouttheequipment(generic name, trademark, model, serial number, inventory number, and the clinic area whereit is placed),periodicity of themaintenance, the reportof thefunctionality tests, electrical security, and calibration. Furthermore, there three appendices were incorporated: AI. Cleanersand lubricators, A 2. Disinfectors' substances, and A 3 • Proceduresin accidentcases [11] . This study had described four different projects related to medical technology management developed by BEDsindifferenthospitalsinMexicoCity. The primary objective of all these projects was to provide knowledge about the maintenance procedures and quality control tests to the technical personnel to carry out their jobs and to contribute to the certification process by the NMX standards for the clinical services at the particularhospital. This study shows the importance of having documented procedures related to the management of medical technology in order to optimize the technical facilities available in the hospital, as well as for the certification. In Mexico, hospital certification is a new process, and projects developed in this way will be very important in the hospital environment in order to guarantee the quality of the clinical services provide. Overview of the ISO system Sistemas de gesti6n de la calidad-fundamentos y vocabulario Sistemas de gesti6n de la calidad-requisitos Funciones de los Departamentos de Ingenierfa Biomedica en Instituciones de Salud Publica y Privada en Mexico Programa de garantfa de calidad para el servicio de radiologfa del Hospital Mocel. Proyecto terminal. Licenciatura en Ingenierfa Biomedica Plan de Calidad de Mantenimiento basado en ISO 9001-2000 para el Departamento de Ingenierfa Biomedica del Hospital Angeles Mocel Procedimientos de Uso y Manejo de la Tecnologfa Medica relacionada con las Cirugfas de Mfnima Invasion en el Hospital Santa Fe Manual de Procedimientos de Mantenimiento y Prevenci6n de Riesgos para Equipo del Centro de In-vestigaci6n en Enfermedades Infecciosas del INER Entidad Mexicana de Acreditaci6n (EMA) Emergency Care Research Institute (ECRI), Health Devices Inspection and Preventive Maintenance System