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Medical Equipment Maintenance: Management and Oversight

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Abstract

Medical equipment is not only essential for safe and effective patient care but also has significant impact on the income of healthcare organizations. For this reason, its maintenance and management requires careful supervision by healthcare administrators who may not have the technical background to understand all the relevant factors. This lecture presents the basic elements of medical equipment maintenance and management for healthcare leaders with the responsibility of managing or overseeing this function so they know what is expected of them, what they should expect from their supervised staff, and how to measure and benchmark the performance of the staff against similar organizations. First, the laws, regulations, codes and standards that are applicable to the maintenance and management of medical equipment in healthcare organizations are summarized to provide a sound foundation. Next, the core functions of the team responsible for maintenance and management are described in sufficient detail for managers and overseers. Then the methods and measures for determining the effectiveness and efficiency of the maintenance and management are presented to allow performance management and benchmarking comparisons. The challenges and opportunities of managing healthcare organizations of different sizes, acuity levels, and geographical locations are discussed. Extensive bibliography and information sources are provided to assist healthcare leaders interested in acquiring more detailed knowledge.
... Therefore, taking a cost effective maintenance policy is required to achieve higher availability and safety and then lower operational costs [2]. This goal seems rather similar to that of healthcare or medicine, particularly, evidence-based medicine (EBM), where professionals supplement the scientific community with the results of the most recent comparative effectiveness studies, such as those conducted using randomized clinical trials on drugs, devices, and procedures [3]. Likewise, instead of merely following laws, regulations, codes, standards, industry practices, and manufacturers' recommendations, clinical maintenance managers need to learn from their colleagues and extend their engineering education with up-to-date results of the maintenance effectiveness studies, which evaluate critically different maintenance strategies, procedures, and frequencies [3], [4]. ...
... This goal seems rather similar to that of healthcare or medicine, particularly, evidence-based medicine (EBM), where professionals supplement the scientific community with the results of the most recent comparative effectiveness studies, such as those conducted using randomized clinical trials on drugs, devices, and procedures [3]. Likewise, instead of merely following laws, regulations, codes, standards, industry practices, and manufacturers' recommendations, clinical maintenance managers need to learn from their colleagues and extend their engineering education with up-to-date results of the maintenance effectiveness studies, which evaluate critically different maintenance strategies, procedures, and frequencies [3], [4]. This goal based approach has been termed evidence-based maintenance (EBM), which can be considered as a continual improvement process that scrutinizes maintenance excellence in comparison to outcomes achieved previously or elsewhere and regulates necessary adjustments to maintenance planning and performance [1], [3]. ...
... Likewise, instead of merely following laws, regulations, codes, standards, industry practices, and manufacturers' recommendations, clinical maintenance managers need to learn from their colleagues and extend their engineering education with up-to-date results of the maintenance effectiveness studies, which evaluate critically different maintenance strategies, procedures, and frequencies [3], [4]. This goal based approach has been termed evidence-based maintenance (EBM), which can be considered as a continual improvement process that scrutinizes maintenance excellence in comparison to outcomes achieved previously or elsewhere and regulates necessary adjustments to maintenance planning and performance [1], [3]. In this context, several investigation studies have been presented to highlight the importance of EBM in healthcare domain. ...
Conference Paper
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The concern for patient safety and regulatory requirements classically based on manufacturers’ recommendations discouraged evidence based maintenance, and thus limited the possibility of maintenance optimization within healthcare organization. Although, the need for preventive maintenance and its appropriate frequency have been debated extensively for decades, very few studies have been conducted to revise healthcare maintenance strategy and improve the effectiveness of clinical engineers work, as well as focus on tasks that could provide the highest return for their limited resources. In this paper, the shift from a compliance-based to a goal-based approach is well established in an improved proportional delay time framework taking into account hidden nature of failures, the influence of the utilization rate and maintenance effectiveness on medical devices degradation. To illustrate the model capabilities, a real case study from the healthcare domain is presented, the model parameters are estimated entirely using the collected maintenance data. Then, the optimal maintenance policy is determined by a multi-objective optimization to achieve the desired cost effectiveness.
... Maintenance excellence can be achieved by making the rational maintenance decision balancing costs and industrial performance [4]. It is worth mentioning that the amount, multiplicity, sophistication, and costs of medical equipment are abruptly rising, which make that their maintenance complexity and costs also escalate sharply in the last few years [5]. In addition to maintenance expenditure, medical devices (MD) are frequently involved in patient incidents (death or injury) [6]. ...
... Likewise, [22] recapped several types of MD maintenance activities consisting of repair, replacement, or inspections. The paper [5] dispelled a misunderstanding related to MD maintenance which is "the more maintenance the better" and introduced the analogous concept "evidence-based maintenance." A high completion rate of scheduled maintenance is not a good indicator of maintenance effectiveness (reliabilityavailability-safety) and efficiency (overall costs), to the extent that evidence-based maintenance would be a continual improvement process that analyzes the effectiveness and efficiency of maintenance policy deployed in comparison to outcomes attained. ...
... In the healthcare domain, optimization models limited scope by considering a single objective (mainly the overall cost) is another limitation perceived in this review [47][48][49], which is often not the case of real industrial environment. The paper [5] confirms that, in addition to reliability, safety, and maintenance efficiency measure, availability is an important indicator of maintenance effectiveness. This statement is argued in [38,50] study. ...
Article
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Although medical equipment maintenance has been carefully managed for years, very few in-depth studies have been conducted to evaluate the effectiveness and efficiency of these implemented preventive maintenance strategies, especially after the debate about the credibility of manufacturer’s recommendations has increased in the clinical engineering community. Facing the dilemma of merely following manufactures maintenance manual or establishing an evidence-based maintenance, medical equipment maintenance could have exploited an advanced area in operations research which is maintenance optimization research. In this paper, we review and examine carefully the status of application oriented research on preventive maintenance optimization of medical devices. This study addresses preventive healthcare maintenance with a focus on factors influencing the maintenance decision making. The analysis is structured by defining different aspects necessary to construct a maintenance optimization model. We conclusively propose directions to develop suitable tools for better healthcare maintenance management.
... The specialised equipment extensively assists healthcare practitioners during the early phase of symptom detection to curb health deterioration (5). Healthcare services delivery is almost impossible without proper maintenance of medical equipment (6). In addition, the devices need to be monitored for upkeeping performance in calibration, maintenance, restoration, training, and decommissioning, which are typically managed by clinical engineers (7). ...
... The clinical engineers in a healthcare facility are responsible for regulating and introducing an effective management programme for medical equipment reliability and safety (8). High technology innovation has elevated medical equipment complexity and eventually escalated the procurement and maintenance expenditures (6). ...
Article
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The advancement of technology in medical equipment has significantly improved healthcare services. However, failures in upkeeping reliability, availability, and safety affect the healthcare services quality and significant impact can be observed in operations' expenses. The effective and comprehensive medical equipment assessment and monitoring throughout the maintenance phase of the asset life cycle can enhance the equipment reliability, availability, and safety. The study aims to develop the prioritisation assessment and predictive systems that measure the priority of medical equipment's preventive maintenance, corrective maintenance, and replacement programmes. The proposed predictive model is constructed by analysing features of 13,352 medical equipment used in public healthcare clinics in Malaysia. The proposed system comprises three stages: prioritisation analysis, model training, and predictive model development. In this study, we proposed 16 combinations of novel features to be used for prioritisation assessment and prediction of preventive maintenance, corrective maintenance, and replacement programme. The modified k-Means algorithm is proposed during the prioritisation analysis to automatically distinguish raw data into three main clusters of prioritisation assessment. Subsequently, these clusters are fed into and tested with six machine learning algorithms for the predictive prioritisation system. The best predictive models for medical equipment's preventive maintenance, corrective maintenance, and replacement programmes are selected among the tested machine learning algorithms. Findings indicate that the Support Vector Machine performs the best in preventive maintenance and replacement programme prioritisation predictive systems with the highest accuracy of 99.42 and 99.80%, respectively. Meanwhile, K-Nearest Neighbour yielded the highest accuracy in corrective maintenance prioritisation predictive systems with 98.93%. Based on the promising results, clinical engineers and healthcare providers can widely adopt the proposed prioritisation assessment and predictive systems in managing expenses, reporting, scheduling, materials, and workforce.
... Nowadays, it is simply impossible to provide healthcare at a high level without healthcare equipment. Unlike other technologies (e.g., drugs, implants, etc.) material and technical equipment requires additional maintenance (scheduled and unscheduled) throughout its lifetime (Wang, 2012). If the quality and progressiveness of the equipment increase, the purchase price and maintenance increase as well. ...
... If the quality and progressiveness of the equipment increase, the purchase price and maintenance increase as well. Studies based on data collected from hundreds of hospitals say that every hospital has on average 15-20 types of healthcare equipment for each occupied bed, which costs about 150 to 320,000 €/bed (Wang, 2012). It is therefore apparent that the purchase and maintenance of equipment is often one of the biggest investment of each healthcare organisation right after the investment in property (e.g., the rent or purchase of premises, land, etc.). ...
Article
The use of healthcare technology, which effectively assists in diagnosing diseases, significantly increases comfort and satisfaction of the patients. Prices increase with rising quality and offered possibilities. Since purchase of any equipment in healthcare is a significant expense, especially for a private surgery, it is necessary to carefully consider the advantages and disadvantages of each decision. The aim of this study is to evaluate healthcare equipment in electrocardiography, when the result is determined by a group of decision makers. To obtain individual decisions we applied the AHP to the views of any decision makers. Subsequently these decisions are aggregated into one group vector with the assistance of the AMM and WAMM. The WAMM, uses the view significance of each decision maker during the process of aggregating weights. This study also contains an overview of the past AHP applications in the healthcare and health technology assessment from other authors.
... In the last decade of the 19th century, the US spent 50% of its construction budget to repair and maintain built facilities (Shah Ali 2009). Furthermore, maintenance costs rose in hospitals abruptly in the recent decades due to the escalation of complexity and equipment costs (Wang 2012). ...
... Medical devices are important assets in a hospital (Bahreini et al. 2019;Wang 2012). Hospitals need to continuously ensure medical devices' reliability and performance because of their role in diagnosing and treating patients (Jamshidi et al. 2014). ...
Article
The reliable maintenance management system of medical equipment influences the patients’ treatment and the hospitals’ performance. Although building information modeling (BIM) technology has evolved the construction industry, it does not fully comply with the facility management (FM) industry, particularly with repair and maintenance. BIM-based FM provides a structured platform to effectively capture necessary data during the construction stage for effective facility maintenance management (e.g., prioritizing maintenance work orders). Despite the design improvements and preventive maintenance plans, unplanned failures are inevitable and need quick and appropriate reactions. This paper introduces an integrated BIM-based framework for effective facility maintenance management. This framework consists of an integrated maintenance database for medical equipment, a scheduling engine to prioritize and sequence work orders, and a 4D simulation module to visualize the work-order handling process semiautomatically. Case-based reasoning (CBR) is also employed in the simulation engine to capture expert knowledge and facilitate the sequencing process. The proposed framework’s capabilities are demonstrated by applying and validating in a national healthcare facility in Iran.
... The same study (Jamshidi et al., 2014) indicates that maintenance costs represent nearly 1% of the total hospital budget, so hospitals use up around 8 million US$/year. As well as high maintenance costs, statistics ensued by Joint Commission (TJC) highlight that medical equipment is often engaged in patient incidents that lead to grave injuries and deaths (Wang, 2012). In fact, inadequate maintenance and performance degradation of medical devices create an unacceptable risk level. ...
... Accordingly, clinical engineers have been developing Medical Equipment Management Programs (MEMP) to reduce risks and improve the safety of medical equipment in support of patient care. These programs appeal for an effective and efficient framework to prioritize medical devices for appropriate maintenance decisions based on key criteria (Wang, 2012). The boosted complexity of the organizational context resulted in numerous variables to consider among numerous alternatives. ...
Article
Full-text available
Clinical engineering departments have to establish and continuously regulate a Medical Equipment Management Program (MEMP) to ensure a high reliability and safety of their critical medical devices. Asset criticality assessment is an essential element of reliability centered maintenance and risk-based maintenance, especially when enormous various devices exist and the worst failure consequences are not evident. This paper presents a new risk-based prioritization framework for maintenance decisions. We propose a Multi-Expert Multi-Criteria decision making (MEMC) model to classify medical devices according to their criticality and we describe how obtained scores are used to set up guidelines for appropriate maintenance strategies. © 2016 Hassana Mahfoud, Abdellah El Barkany and Ahmed El Biyaali.
... Medical equipment maintenance has different types: inspection and preventive maintenance (IPM) and corrective maintenance (WHO, 2011). Effective management of maintenance and repairs (Kinley, 2012) shall be planned and implemented using appropriate maintenance strategies to keep the devices safe and functional according to basic functional specifications (Wang, 2012). In addition to high initial investment, the medical equipment requires continual and costly maintenance during its useful life (Cheng and Dyro, 2004). ...
... The ultimate goal of maintenance is reliability and safety. It should always be safe for both patients and users (Wang, 2012). Maintenance management has had an extraordinary impact on the ability of organizations to achieve their objectives (Duffuaa et al., 2002). ...
Article
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Purpose Effective maintenance management of medical equipment is one of the major issues for quality of care and cost-effectiveness especially in modern hospitals. An effective medical equipment maintenance management (MEMM) consists of adequate planning, management and implementation. This is essential for providing good health services and saving scarce resources. Considering the importance of the subject, the purpose of this paper is to extract the influential factors on MEMM using a qualitative approach. Design/methodology/approach Documents review and interviews were main methods for data collection. Semi structured interviews were conducted with a purposive sample of 14 clinical engineers with different degree of education and job levels. Interviews were voice recorded and transcribed verbatim. Qualitative data were analyzed using a content analysis approach (inductive and deductive) to identify the underlying themes and sub-themes. Findings Factors influencing an effective and efficient MEMM system categorized in seven themes and 19 sub-themes emerged. The themes included: “resources,” “quality control,” “information bank,” “education,” “service,” “inspection and preventive maintenance” and “design and implementation.” Originality/value The proposed framework provides a basis for a comprehensive and accurate assessment of medical equipment maintenance. The findings of this study could be used to improve the profitability of healthcare facilities and the reliability of medical equipment.
... Many medical technologies require the services of clinical engineers and/or biomedical engineering technicians (BMETs) to ensure proper use. 32,[83][84][85] The clinical engineering team is responsible for all aspects of health technology management: (i) checking technical specifications, (ii) recommending specific products for procurement, (iii) configuring the device, (iv) training clinical staff in its use, (v) communicating with the manufacturer, (vi) establishing test and maintenance protocols, (vii) scheduling its use to optimize availability, (viii) maintaining a suitable supply of consumables, (ix) device replacement, and (x) eventual decommissioning. 84,85 The BMET is responsible for performing routine maintenance and repairs, which is often sufficient to keep critical equipment in condition for safe and reliable operation. ...
... 32,[83][84][85] The clinical engineering team is responsible for all aspects of health technology management: (i) checking technical specifications, (ii) recommending specific products for procurement, (iii) configuring the device, (iv) training clinical staff in its use, (v) communicating with the manufacturer, (vi) establishing test and maintenance protocols, (vii) scheduling its use to optimize availability, (viii) maintaining a suitable supply of consumables, (ix) device replacement, and (x) eventual decommissioning. 84,85 The BMET is responsible for performing routine maintenance and repairs, which is often sufficient to keep critical equipment in condition for safe and reliable operation. However, some manufacturers require that maintenance and repairs be performed by a technician employed by the manufacturer or by an independent technician who has specific certification on that device. ...
Article
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In the two decades after 1990, the rates of child and maternal mortality dropped by over 40% and 47%, respectively. Despite these improvements, which are in part due to increased access to medical technologies, profound health disparities exist. In 2015, a child born in a developing region is nearly eight times as likely to die before the age of 5 than one born in a developed region and developing regions accounted for nearly 99% of the maternal deaths. Recent developments in nanotechnology, however, have great potential to ameliorate these and other health disparities by providing new cost-effective solutions for diagnosis or treatment of a variety of medical conditions. Affordability is only one of the several challenges that will need to be met to translate new ideas into a medical product that addresses a global health need. This article aims to describe some of the other challenges that will be faced by nanotechnologists who seek to make an impact in low-resource settings across the globe.
... Maintenance can be defined as those actions (scheduled and unscheduled) for retaining a piece of equipment in, or restoring it to, a given safe and reliable condition [1]. The annual cost of maintenance (corrective and preventive), as a fraction of the total operating budget can be as high as 40%50% for the mining industry [2], 20%-30% for the chemical industry [3], and 1% for medical devices in hospital settings [4]. Unavailability of devices causes economical loses in production lines. ...
Chapter
This paper aims to implement and validate a Monte Carlo-based algorithm to determine the optimal interval of preventive maintenance of medical devices. The optimization criterion used was that which maximizes the equipment’s achieved availability. The Monte Carlo algorithm was implemented and tested using maintenance data from infusion pumps, electrocardiographs, and ECG monitors from both primary and secondary data source of information. The performance of the algorithm behaved well; it had a 65-sec response time for 10,000 simulations. The accuracy of the calculations did not exceed 1%. In addition to that, the implementation of the Monte Carlo algorithm was able to determine the better availability curve for the interval of preventive maintenance “tuned” with the mean time to failure for each medical devices population type.
... Unlike other healthcare technologies (drugs, implants, and disposable products), medical equipment need to undergo maintenance in order to maintain the high-level performance and prevent the sudden failure especially when they are serving in critical departments like for example the intensive care unit (ICU); because the failure in such cases might lead to death. Moreover, the continuous development of complex and sophisticated medical equipment is increasing their cost and hence the cost of maintenance is rising too [1]. Therefore, there is an increasing and stressing need to consider the maintenance of medical equipment from a technical point of view and a managerial point of view as well in order to have a successful maintenance program which reduces the cost of maintenance, failure rate and ensures the high reliability of devices. ...
... The delivery of healthcare services to the communities are significantly affected without effective management implementation (3)(4)(5). Medical equipment is a crucial asset that substantially contributes to the effectiveness and healthcare services quality enhancement (6,7). As the medical equipment aids various services in the healthcare sector, the management representative, such as clinical engineers, must monitor and upkeep the assets by performing several maintenances works throughout the equipment life cycle (8,9). ...
Article
Full-text available
Medical equipment highly contributes to the effectiveness of healthcare services quality. Generally, healthcare institutions experience malfunctioning and unavailability of medical equipment that affects the healthcare services delivery to the public. The problems are frequently due to a deficiency in managing and maintaining the medical equipment condition by the responsible party. The assessment of the medical equipment condition is an important activity during the maintenance and management of the equipment life cycle to increase availability, performance, and safety. The study aimed to perform a systematic review in extracting and categorising the input parameters applied in assessing the medical equipment condition. A systematic searching was undertaken in several databases, including Web of Science, Scopus, PubMed, Science Direct, IEEE Xplore, Emerald, Springer, Medline, and Dimensions, from 2000 to 2020. The searching processes were conducted in January 2020. A total of 16 articles were included in this study by adopting Preferred Reporting Items for Systematic Review and Meta-Analyses (PRISMA). The review managed to classify eight categories of medical equipment reliability attributes, namely equipment features, function, maintenance requirement, performance, risk and safety, availability and readiness, utilisation, and cost. Applying the eight attributes extracted from computerised asset maintenance management system will assist the clinical engineers in assessing the reliability of medical equipment utilised in healthcare institution. The reliability assessment done in these eight attributes will aid clinical engineers in executing a strategic maintenance action, which can increase the equipment's availability, upkeep the performance, optimise the resources, and eventually contributes in providing effective healthcare service to the community. Finally, the recommendations for future works are presented at the end of this study.
... It is well-known that medical equipment is one of the largest capital investments of every healthcare organisation, often involved in patient incidents that resulted in serious injuries or deaths. [7] At present, our system guarantees preventive maintenance for equipment, but safety is not ensured. International Standard Guideline IEC 62353-2007 'medical electrical equipment-recurrent test and test after repair of medical electrical equipment', document applies to testing of medical equipment and medical electrical systems, which comply with IEC 60601-1 before putting into service, during maintenance, inspection, servicing and after repair or on occasion of recurrent test to assess the safety of such medical equipment. ...
Article
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A tertiary care 1000 bedded hospital contains more than 10,000 pieces of equipment worth approximately 41 million USD, while the power cords supplied along with the imported equipment type D/M plug to complete installation and also on-site electrical safety test is not performed. Hence, this project was undertaken to evaluate the electrical safety of all life-saving equipment purchased in the year 2013, referring to the guidelines of International Electrotechnical Commission 62353, the Association for the Advancement of Medical Instrumentation (AAMI) and National Fire Protection Association (NFPA)-99 hospital standard for the analysis of protective earth resistance and chassis leakage current. This study was done with a measuring device namely electrical safety analyser 612 model from Fluke Biomedical.
... . Mean time to repair (MTTR) is one of the widely used technical measures of the maintainability for repairable devices or components [25]. It is the average time required to perform corrective maintenance in a device or system [21]. ...
... This would be analogous to improving location accuracy of a global positioning system (GPS) with more satellites. In fact, a multidimensional model has been proven to work fairly well in comparing or predicting hospital equipment MC. 10 In essence, maintenance professionals should consider abandoning MC/AV or at least supplement it with additional benchmarks. There is no irrefutable reason that MC should be related to AV, be it purchasing or replacement cost. ...
... Studies conducted using data collected from hundreds of acute-care hospitals indicate that on average, each hospital acquired about 15-20 pieces of medical equipment for each staffed bed, with a capital investment of around US$200-400.000/staffed bed [34,35]. In addition to high initial investment, the fact that medical equipment re-quires continual and costly maintenance, as well as supplies and specialized users, means that the initial purchasing cost of medical equipment, actually, represents only a small fraction of the total cost. ...
Chapter
Biomedical technologies are the basis of a functioning health system, in particular, medical devices are essential for the prevention, diagnosis, treatment of diseases. However, while developed country hospitals are renewing their fleet of machines by divesting large quantities of biomedical equipment annually, there is a chronic lack of biomedical technology in developing countries to support clinical activities, which could be met by the reuse of used equipment, adapted to the new hospital environment. However, even if the donations of biomedical technologies are generally made with good intentions and not-profit making as in the case under study, obtained results are not what we expected also due to a not perfect communication between donors and recipients and a lack of culture about technology maintenance in the developing countries. At the moment, there is little documented evidence to support these statements. For this reason, the aim of this paper is to quantify the donated medical equipment that are out of service in two different hospitals in Benin. The information was collected on the type of communication existing between donors and beneficiaries and on the type of support that donors provide in terms of staff training, manuals and maintenance. It was observed that more than 50% of the donated equipment is not functional. In addition in more than 70% of the cases the donors do not support the beneficiaries nor training sessions and staff formation are provided. An in-depth assessments of beneficiary structures should be carried out and all donations must be accompanied by initial user training and monitoring by donors regarding the functionality of the system. Donors-beneficiaries communication results as a key elements in the management of health technologies in low-income countries.
... In this regard, implementation of appropriate maintenance strategies requires the following types of resources: human resources, material resources, financial resources and documentation. Our findings also point to the importance of these resources [21]. ...
Article
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Background Effective maintenance management of medical equipment is one of the major issues for quality of care, for providing cost-effective health services and for saving scarce resources. This study aimed to develop a comprehensive checklist for assessing the medical equipment maintenance management (MEMM) in the Iranian hospitals. Methods This is a multi-methods study. First, data related to factors which affect the assessment of MEMM were collected through a systematic review in PubMed, ProQuest, Scopus, Embase, and web of science without any time limitation until October 2015, updated in June 2017. Then, we investigated these factors affecting using document review and interviews with experts in the Iranian hospitals. In the end, the results of the first and second stages were combined using content analysis and the final checklist was developed in a two-round Delphi. Results Using a combination of factors extracted from the systematic and qualitative studies, the primary checklist was developed in the form of assessment checklists in seven dimensions. The final checklist includes 7 dimensions and 19 sub-categories: “resources = 3,” “quality control = 3,” “information bank = 4,” “education = 1,” “service = 3,” “inspection and preventive maintenance = 2” and “design and implementation = 3.” Conclusions Developing an assessment checklist for MEMM provide a comprehensive framework for the proper implementation of accurate assessment of medical equipment maintenance. This checklist can be used to improve the profitability of health facilities and the reliability of medical equipment. In addition, it is implicated in the decision-making in support of selection, purchase, repair and maintenance of medical equipment, especially for capital equipment managers and medical engineers in hospitals and also for the assessment of this process.
... Monitoring during the sterilization process is crucial to do [7]. One of the objectives is to determine the conditions during which the autoclave is used based on its parameters [8]. The main parameters of the autoclave are temperature, pressure, and working time [9]. ...
... In addition to its high maintenance costs, medical equipment is often involved in patient incidents that resulted in serious injuries or deaths. In fact, statistics accumulated by The Joint Commission (TJC) show medical equipment-related "sentinel events1" is typically among the top ten types every year [2]. Therefore, Hospitals and healthcare organizations must ensure that their critical medical devices are safe, accurate, reliable and operating at the required level of performance. ...
Conference Paper
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Modern medical devices and equipment have become very complex and sophisticated and are expected to operate under stringent environments. Hospitals must ensure that their critical medical devices are safe, accurate, reliable and operating at the required level of performance. Even though the importance, the application of all inspection, maintenance and optimization models to medical devices is fairly new. In Canada, most, if not all healthcare organizations include all their medical equipment in their maintenance program and just follow manufacturers' recommendations for preventative maintenance. Then, current maintenance strategies employed in hospitals and healthcare organizations have difficulty in identifying specific risks and applying optimal risk reduction activities. This paper addresses these gaps found in literature for medical equipment inspection and maintenance and reviews various important aspects including current policies applied in hospitals. Finally we suggest future research which will be the starting point to develop tools and policies for better medical devices management in the future.
Article
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Purpose – The aim of this paper is to review maintenance strategies within healthcare domain and to discuss practical needs as gaps between research and practice. Design/methodology/approach – The paper systematically categorizes the published literature on clinical maintenance optimization and then synthesizes it methodically. Findings – This study highlights the significant issues relevant to the application of dependability analysis in healthcare maintenance, including the quantitative and qualitative criteria taken into account, data collection techniques, and applied approaches to find the solution. Within each category, the gaps and further research needs have been discussed with respect to both an academic and industrial perspective. Practical implications – It is worth mentioning that medical devices are becoming more and more numerous, various and complex. Although, they are often affected by environmental disturbances, sharp technological development, stochastic and uncertain nature of operations and degradation and the integrity and interoperability of supportability system, the associated practices related to asset management and maintenance in healthcare are still lacking. Therefore, the literature review of applied based research on maintenance subject is necessary to reveal the holistic issues and interrelationships of what has been published as categorized specific topics. Originality/value – The paper presents a comprehensive review that will be useful to understand the maintenance problem and solution space within the healthcare context. Keywords Healthcare, Medical device, Maintenance decision making, Dependability, Maintenance optimization model
Chapter
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With the research presented in this chapter we aim to investigate the importance of the concurrent engineering (CE) philosophy in the engineering-medical multidisciplinary environment for integrated product development process (IPDP) of medical equipment. We address the requirements of a health professional user as well as patient’s needs. We have identified and contextualized the medical equipment lifecycle, the importance of CE in the IPDP of medical equipment and present propositions for the insertion of software tools that support product development phases. A discussion is included on the use of CE and IPDP oriented towards medical equipment conception and development, perspectives of engineering modular development and interface between Health and Engineering information areas for increasing technical, clinical and economic quality.
Article
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: To be accredited, every healthcare organization is required by JCAHO to determine which equipment should be included in its medical equipment management plan. Traditionally, most organizations have adopted the equipment inclusion criteria proposed by Fennigkoh and Smith (1989). This classic interpretation of JCAHO standard uses three criteria (equipment function, physical risks, and maintenance requirements) to establish a numerical value, called the equipment management (EM) number. Only equipment with an EM value higher than a predetermined threshold is included in the management plan. A fourth criterion (incident history) can be used to modify the EM number if data are available. If followed literally, this interpretation can lead to confusion and, occasionally, unreasonable conclusions that might result in inefficiencies and potentially unsafe conditions. A new interpretation of the inclusion criteria is proposed here. The major difference is in reinterpreting the equipment-function criterion as the equipment's importance within the organization's global mission. This helps to balance risk to a single patient with the organization's commitment to its entire community. An additional factor that should be considered is the equipment utilization rate; heavily used items require more frequent inspection and higher priority for repairs. Together, these two elements form an interpretation that is more attuned to JCAHO's new directive (and general business management principles) and encourages greater concurrence with the organization's mission and vision. (C)2000Aspen Publishers, Inc.
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Historically, staphylococci, pseudomonads, and Escherichia coli have been the nosocomial infection troika; nosocomial pneumonia, surgical wound infections, and vascular access-related bacteremia have caused the most illness and death in hospitalized patients; and intensive care units have been the epicenters of antibiotic resistance. Acquired antimicrobial resistance is the major problem, and vancomycin-resistant Staphylococcus aureus is the pathogen of greatest concern. The shift to outpatient care is leaving the most vulnerable patients in hospitals. Aging of our population and increasingly aggressive medical and surgical interventions, including implanted foreign bodies, organ transplantations, and xenotransplantation, create a cohort of particularly susceptible persons. Renovation of aging hospitals increases risk of airborne fungal and other infections. To prevent and control these emerging nosocomial infections, we need to increase national surveillance, "risk adjust" infection rates so that interhospital comparisons are valid, develop more noninvasive infection-resistant devices, and work with health-care workers on better implementation of existing control measures such as hand washing.
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Book
Reliability-Centered Maintenance provides valuable insights into current preventive maintenance practices and issues, while explaining how a transition from the current "preserve equipment" to "preserve function" mindset is the key ingredient in a maintenance optimization strategy. This book defines the four principal features of RCM and describes the nine essential steps to achieving a successful RCM program. There is an easy to follow example illustrating the Classical RCM systems analysis process using the water treatment system for a swimming pool. As well as the use of software in the system analysis process, making a specific recommendation on a software product to use. Additionally, this new edition possesses an appendix devoted to discussing an economic model that has been used successfully to decide the most cost effective use of maintenance. Top Level managers, engineers, and especially technicians who rely on PM programs in their plant operations can't afford to miss this inclusive guide to Reliability-Centered Maintenance.
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A NEW paradigm for medical practice is emerging. Evidence-based medicine de-emphasizes intuition, unsystematic clinical experience, and pathophysiologic rationale as sufficient grounds for clinical decision making and stresses the examination of evidence from clinical research. Evidence-based medicine requires new skills of the physician, including efficient literature searching and the application of formal rules of evidence evaluating the clinical literature.An important goal of our medical residency program is to educate physicians in the practice of evidence-based medicine. Strategies include a weekly, formal academic half-day for residents, devoted to learning the necessary skills; recruitment into teaching roles of physicians who practice evidence-based medicine; sharing among faculty of approaches to teaching evidence-based medicine; and providing faculty with feedback on their performance as role models and teachers of evidence-based medicine. The influence of evidencebased medicine on clinical practice and medical education is increasing.CLINICAL SCENARIO A junior medical resident working in a teaching hospital
Article
During the early years of clinical engineering (CE), CE professionals in the United States devoted a significant portion of their resources to detect failures through inspections (incoming and scheduled) and prevent failures through periodic parts replacement, lubrication, and other tasks (preventive maintenance), with the goal of reducing patient risks. With the rapid evolution of technology in the last 3 decades that increased medical equipment reliability, it is unclear whether CE professionals should continue to focus their attention on equipment failure detection and prevention or broaden their scope to enhance further patient safety. Using scheduled and unscheduled maintenance data collected for almost 2 years from 8 hospitals and a standardized failure classification method, 22 equipment types were analyzed in terms of actions that CE can undertake to improve safety: directly, indirectly, or in the future. For each of these 3 CE action groups, the risk associated with the use of equipment was estimated from the respective failure probability and severity of harm. The results show that, for most equipment types, CE professionals have reached the saturation point of what they can do to reduce risks, although some redirection of their attention from certain equipment types to others would optimize the use of limited resources. On the other hand, plenty of opportunities exist in helping the users and other allied health professionals to reduce risks significantly through further training, better communication, and better selection in future acquisitions.
Article
Almost since the beginning of clinical engineering as a profession, the need for scheduled maintenance (mostly safety and performance inspections) and its appropriate frequency have been debated extensively but could not be resolved conclusively because of the lack of comparable data. The combination of regulatory requirements typically based on manufacturers' recommendations and concern for patient safety discouraged experimentation by clinical engineering professionals and thus limited the possibility of comparisons within the same organization. Lateral comparisons among different hospitals have been difficult because of different computerized maintenance management systems, failure classification, and reluctance to share information. Using a small set of standardized failure codes, more than 62,000 work orders were classified by dozens of biomedical technicians at 8 hospitals for almost 2 years. These data were used to compare different maintenance strategies adopted for 7 types of medical equipment commonly encountered in acute-care hospitals. No prominent differences were found among the data collected from hospitals that adopted different maintenance frequencies, statistical sampling, and even run-to-failure strategies. Most of the small differences were comparable to the SDs calculated from the data for each maintenance strategy. These results suggest that it is justifiable to adopt a less resource-demanding maintenance strategy for most equipment types, except for the scheduled replacement of wearable parts that was outside the scope of this study.
Article
Prior studies suggested that the only valid benchmark for clinical engineering (CE) would be the ratio of total CE expenses and total equipment acquisition costs. This article provides data to support the global failure rate (GFR) as a promising benchmark for measuring CE performance. Although GFR appears to work mostly for biomedical equipment, it is an outcome metric that not only measures repair activities but also measures the efforts invested in equipment planning and acquisition, preventive maintenance, user training, and controlling environmental factors. Nonetheless, GFR should not be used alone or in conjunction with financial metrics to assess CE performance. Instead, comprehensive performance tools such as the balanced-scorecard approached should be used to truly evaluate the contribution of CE to a healthcare organization.
Article
Regulatory requirements, risk factors and liabilities, and a requirement for better asset management are generating intense interest in computerized maintenance management system (CMMS) software. CMMS programs provide corrective and preventive maintenance scheduling and record keeping. A common database can share information for repair trending, equipment histories, device tracking and contract warranty information. With the proliferation of medical equipment available, CMMS is viewed as a necessity in most healthcare institutions due to Joint Commission for the Accreditation of Healthcare Organization requirements under the Environment of Care Standards. This article will provide selection criteria, evaluation processes and review of available CMMS software. (C)1998Aspen Publishers, Inc.
Article
Although medical equipment maintenance has been well planned and executed for more than 30 years, very few studies have been conducted to measure and evaluate its effectiveness in terms of reliability and seriousness of failures. The lack of factual evidence limits the ability of clinical engineering (CE) professionals to revise maintenance strategy and improve the effectiveness of their work, as well as focus on the equipment and tasks that could provide the highest return for their limited resources. Using a small set of failures codes, data were collected from 8 hospitals for a period of up to 24 months, covering more than 40,000 pieces of equipment. Careful analysis of more than 62,000 work orders collected showed that the failures found for each type of equipment within a single hospital tend to converge to a stable pattern with less than 100 work orders. Furthermore, failure patterns obtained from different hospitals for the same equipment type seem to be within statistical variation of each other, although these hospitals may use different brands and models of equipment, in addition to obvious differences in user care and training, utilization intensity, and other environmental factors. The failure data collected were used to determine the probability of failure that will be used in subsequent papers of this series to compare different maintenance strategies adopted at different hospitals, as well as to determine additional opportunities for CE professionals to contribute to enhance patient safety beyond increasing equipment reliability through maintenance.
Article
Operational and financial clinical engineering (CE) data from 253 acute care hospitals were analyzed for indicators that are statistically valid and useful for measuring, monitoring, and improving performance. The sample is mostly composed of nonprofit public and religious hospitals and is evenly distributed among major and minor teaching hospitals and nonteaching institutions. Almost all CE departments manage all biomedical equipment and provide technology management support, but only some manage imaging, laboratory, nonmedical devices, and beds. Clinical engineering departments typically use 2.5 full-time-equivalent employees per 100 staffed beds or 1 full-time-equivalent employee per 4000 adjusted discharges. Administrative support is available only at large departments. Most of the CE budget is typically spent on service contracts, whereas approximately 20% is dedicated to internal labor. One scheduled maintenance and 1 repair are typically performed per capital device per year. Although the ratio of total CE expense and total equipment acquisition costs was confirmed to be a good indicator at around 4%, several other denominators also emerged as valid and, perhaps, even more widely available for comparisons, for example, staffed beds, adjusted discharges, and number of capital devices. Overall, CE budget is around 0.5% of the hospital's total operating budget. Because of uneven data quality and impossibility of validation, each indicator should not be used individually for precise benchmarking. On the other hand, when used together, multiple indicators provide not only valuable ballpark comparisons but also insights into deviations that warrant further investigation for potential uniqueness and/or improvement opportunities.
Book
Technology is essential to the delivery of health care but it is still only a tool that needs to be deployed wisely to ensure beneficial outcomes at reasonable costs. Among various categories of health technology, medical equipment has the unique distinction of requiring both high initial investments and costly maintenance during its entire useful life. This characteristic does not, however, imply that medical equipment is more costly than other categories, provided that it is managed properly. The foundation of a sound technology management process is the planning and acquisition of equipment, collectively called technology incorporation. This lecture presents a rational, strategic process for technology incorporation based on experience, some successful and many unsuccessful, accumulated in industrialized and developing countries over the last three decades. The planning step is focused on establishing a Technology Incorporation Plan (TIP) using data collected from an audit of existing technology, evaluating needs, impacts, costs, and benefits, and consolidating the information collected for decision making. The acquisition step implements TIP by selecting equipment based on technical, regulatory, financial, and supplier considerations, and procuring it using one of the multiple forms of purchasing or agreements with suppliers. This incorporation process is generic enough to be used, with suitable adaptations, for a wide variety of health organizations with different sizes and acuity levels, ranging from health clinics to community hospitals to major teaching hospitals and even to entire health systems. Such a broadly applicable process is possible because it is based on a conceptual framework composed of in-depth analysis of the basic principles that govern each stage of technology lifecycle. Using this incorporation process, successful TIPs have been created and implemented, thereby contributing to the improvement of healthcare services and limiting the associated expenses.
Article
Data collected from clinical engineering departments in Canada, the USA, the European Economic Community and two Nordic countries, Sweden and Finland, have led to an evaluation of their functional involvement in their healthcare institutions and of the level of recognition which they have achieved.
Article
Results of the first year of the Association for the Advancement of Medical Instrumentation (AAMI) Validating Metrics pilot project are described. The intent of the pilot project was to find direction in the measurement of medical equipment service costs and quality metrics. The pilot project collected repair and maintenance cost, turnaround time and work order count data from eight hospital-based Clinical Engineering departments using a common set of definitions for all the measured parameters. The projects history, data collection methodology, data analysis, results and direction for future work are described. The project shows that acquisition cost is the most useful indicator of service costs of those indicators evaluated to date and that bed count and device count are not valid aggregate service cost indicators.
Article
Inter-institutional comparisons of productivity and cost-effectiveness can be a valuable source of feedback to the in-house biomedical or clinical engineering services manager. But for such comparisons to be valid, all institutions must use the same criteria. As yet, there are no standard definitions for such criteria and, in most cases, the necessary data are not kept. Therefore, reliable comparisons are not possible. It is possible, however, to keep data on the variety of tasks common to all clinical engineering departments that can then be compared inter-institutionally. As task comparisons become more common, "norms" will evolve that can become standards for the profession. From there, it is a realizable step to standards that permit comparison of productivity and cost-effectiveness. A national organization, like the American Hospital Association could help by including clinical engineering data as part of their annual hospitals survey.
Article
Finances have become the dominant concern of hospital administrators and department heads. Clinical Engineering (CE) can make significant contributions to the financial health of a hospital by increasing CE departmental productivity and by improving the utilization of resources in clinical departments. Several measures of productivity and cost-effectiveness have been applied to the Biomedical Engineering Department of the University Medical Center. The Department provides a wide range of technical services that are integrated into the clinical and administrative activities of the hospital. The Department has accumulated data regarding the financial benefits provided to the hospital, and the data reveal significant savings which show that CE can be viewed as a cost-effective investment. The greatest savings occur in capital equipment acquisition (selection and installation) and maintenance, and result from CE involvement in clinical activities and administrative decision making.
Article
There exists a need for a standard set of definitions to describe and measure the tasks performed by the staffs of clinical engineering departments. Too often, in discussions and publications on productivity, inconsistencies exist that make comparisons difficult between the author's methodology and that used by readers or other authors. To avoid this, there needs to be uniformity in the classification of which tasks are productive and the way those tasks are documented, tabulated, and reported. This paper presents some concepts from industrial engineering, as well as descriptions of staff labor and financial terms. Definitions for productivity and other measures of departmental performance are also developed.
Article
Two approaches to the problem of human fallibility exist: the person and the system approaches. The person approach focuses on the errors of individuals, blaming them for forgetfulness, inattention, or moral weakness. The system approach concentrates on the conditions under which individuals work and tries to build defences to avert errors or mitigate their effects. High reliability organisations - which have less than their fair share of accidents - recognise that human variability is a force to harness in averting errors, but they work hard to focus that variability and are constantly preoccupied with the possibility of failure.
Article
Clinical engineering professionals need to continually review and improve their management strategies in order to keep up with improvements in equipment technology, as well as with increasing expectations of health care organizations. In the last 20 years, management strategies have evolved from the initial obsession with electrical safety to flexible criteria that fit the individual institution's needs. Few hospitals, however, are taking full advantage of the paradigm shift offered by the evolution of joint Commission standards. The focus should be on risks caused by equipment failure, rather than on equipment with highest maintenance demands. Furthermore, it is not enough to consider risks posed by individual pieces of equipment to individual patients. It is critical to anticipate the impact of an equipment failure on larger groups of patients, especially when dealing with one of a kind, sophisticated pieces of equipment that are required to provide timely and accurate diagnoses for immediate therapeutic decisions or surgical interventions. A strategy for incorporating multiple criteria to formulate appropriate management strategies is provided in this article.
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