Evaluation of hydrophilic polymer embolization from endovascular sheath devices in an in vitro perfusion system.

Objective: Case reports, tissue pathology, and autopsies have suggested that the hydrophilic polymer coating designed to improve endovascular deliverability and minimize vessel trauma can embolize and be associated with adverse outcomes such as ischemia, infarction, and death. This study sought to determine whether hydrophilic polymers shed off commercially available sheaths in a controlled in vitro environment, with the hypothesis that significant differences between coated and uncoated (control) sheaths would be found. Methods: Six sheaths from each manufacturer, including Zenith Alpha abdominal endovascular stent grafts (Cook Medical), DrySeal sheaths (W.L. Gore & Associates), and Sentrant Introducer sheaths (Medtronic), were tested in an in vitro environment. Noncoated Check-Flo performer introducer sheaths (Cook Medical) were used as controls. Each test circuit ran for 150 minutes at an output of 3 L/min, the circuit was then drained and the fluid collected. Quantitative analysis included weighing the dried filter paper and using particle size light scattering to quantify the particle size and count. Attenuated total reflectance spectroscopy was also used. Results: Each of the three coated sheaths had significantly greater shedding compared with the control sheaths. The Cook Zenith alpha sheath had significantly more residue weight (2.87 ± 0.52 mg/L) than the Gore DrySeal (1.07 ± 0.06 mg/L) and Medtronic Sentrant introducer (0.98 ± 0.14 mg/L) sheaths. The average particle size was not significantly different between the coated and uncoated (control) sheaths. Attenuated total reflectance spectroscopy identified sheath particulate in the Cook Zenith Alpha and Medtronic Sentrant samples. Conclusions: Polymer embolization was present and significantly greater in all three commercially available hydrophilic sheaths compared with the control group. Further investigation is needed into the clinical significance of these findings.

Evidence-based clinical engineering: Health information technology adverse events identification and classification with natural language processing.

The primary goal of this project is to create a framework to extract Real-World Evidence to support Health Technology Assessment, Health Technology Management, Evidence-Based Maintenance, and Post Market Surveillance (as outlined in the EU Medical Device Regulation 2017/745) of medical devices using Natural Language Processing (NLP) and Artificial Intelligence. An initial literature review on Spontaneous Reporting System databases, Health Information Technologies (HIT) fault classification, and Natural Language Processing has been conducted, from which it clearly emerges that adverse events related to HIT are increasing over time. The proposed framework uses NLP techniques and Explainable Artificial Intelligence models to automatically identify HIT-related adverse event reports. The designed model employs a pre-trained version of ClinicalBERT that has been fine-tuned and tested on 3,075 adverse event reports extracted from the FDA MAUDE database and manually labelled by experts.

The digitization process and the evolution of Clinical Risk Management concept: The role of Clinical Engineering in the operational management of biomedical technologies.

Introduction: Digital transformation and technological innovation which have influenced several areas of social and productive life in recent years, are now also a tangible and concrete reality in the vast and strategic sector of public healthcare. The progressive introduction of digital technologies and their widespread diffusion in many segments of the population undoubtedly represent a driving force both for the evolution of care delivery methods and for the introduction of new organizational and management methods within clinical structures. Methods: The CS Clinical Engineering of the "Spedali Civili Hospital in Brescia" decided to design a path that would lead to the development of a software for the management of biomedical technologies within its competence inside the hospital. The ultimate aim of this path stems from the need of Clinical Engineering Department to have up-to-date, realistic, and systematic control of all biomedical technologies present in the company. "Spedali Civili Hospital in Brescia" is not just one of the most important corporate realities in the city, but it is also the largest hospital in Lombardy and one of the largest in Italy. System development has followed the well-established phases: requirement analysis phase, development phase, release phase and evaluating and updating phase. Results: Finally, cooperation between the various figures involved in the multidisciplinary working group led to the development of an innovative management software called "SIC Brescia". Discussion: The contribution of the present paper is to illustrate the development of a complex implementation model for the digitization of processes, information relating to biomedical technologies and their management throughout the entire life cycle. The purpose of sharing this path is to highlight the methodologies followed for its realization, the results obtained and possible future developments. This may enable other realities in the healthcare context to undertake the same type of pathway inspired by an accomplished model. Furthermore, future implementation and data collection related to the proposed Key Performance Indicators, as well as the consequent development of new operational management models for biomedical technologies and maintenance processes will be possible. In this way, the Clinical Risk Management concept will also be able to evolve into a more controlled, safe, and efficient system for the patient and the user.

A robotic arm for safe and accurate control of biomedical equipment during COVID-19.

Purpose: Hospital facilities and social life, along with the global economy, have been severely challenged by COVID-19 since the World Health Organization (WHO) declared it a pandemic in March 2020. Since then, countless ordinary citizens, as well as healthcare workers, have contracted the virus by just coming into contact with infected surfaces. In order to minimise the risk of getting infected by contact with such surfaces, our study aims to design, prototype, and test a new device able to connect users, such as common citizens, doctors or paramedics, with either common-use interfaces (e.g., lift and snack machine keyboards, traffic light push-buttons) or medical-use interfaces (e.g., any medical equipment keypad). Method: To this purpose, the device was designed with the help of Unified Modelling Language (UML) schemes, and was informed by a risk analysis, that highlighted some of its essential requirements and specifications. Consequently, the chosen constructive solution of the robotic system, i.e., a robotic-arm structure, was designed and manufactured using computer-aided design and 3D printing. Result: The final prototype included a properly programmed micro-controller, linked via Bluetooth to a multi-platform mobile phone app, which represents the user interface. The system was then successfully tested on different physical keypads and touch screens. Better performance of the system can be foreseen by introducing improvements in the industrial production phase. Conclusion: This first prototype paves the way for further research in this area, allowing for better management and preparedness of next pandemic emergencies.

Biomedical/clinical engineering education and certification: fifty years of actions.

Health care is today technology driven and biomedical engineering is behind the impressive developments that reshaped medicine during the last 50 years. Biomedical Engineers (BMEs) as professionals are playing a vital role during the whole life cycle of Medical Devices (MDs), from the innovative idea to their final use and decommissioning. This rapid evolution creates a constant pressure for new knowledge and skills for the BMEs and therefore for continuous curriculum updates of education in BME, to meet current trends and market demands. Biomedical Engineering is relatively new when compared with other engineering disciplines. The earliest programs during the 1970s, most of which were at Doctoral and M.Sc. levels. B.Sc. programs were developed in most European Universities from the 1990s. Today there is an impressive trend to create new programs and the number of higher education institutions offering a BME degree is almost two hundred, just in Europe. Although biomedical engineering is playing a vital role in innovation, development, maintenance, and safe use of medical technology, BMEs are not yet recognized as a distinct professional entity and do not appear in the International Labour Organisation (ILO) lists. This is partly because biomedical engineering covers a very broad domain and includes professionals with very heterogeneous areas of specialization. Unlike in other engineering fields, where certification is a prerequisite for being a licensed professional, even for the clinical engineering, certification is not widely applied. This is mainly due to the lack of motivation since certification is not mandatory. In contrast with other health care professionals, that cannot practice their profession if they are not officially registered, such requirement does not exist for clinical engineers. In the present paper a review of the developments in BME educational programs in Europe, fifty years long, is attempted, focusing on some important initiatives and actions well known to the author. Additionally, some aspects of Clinical Engineering certification are addressed.

Development and efficacy testing of a portable negative pressure enclosure for airborne infection containment.

OBJECTIVES: To overcome the shortage of personal protective equipment and airborne infection isolation rooms (AIIRs) in the COVID-19 pandemic, a collaborative team of research engineers and clinical physicians worked to build a novel negative pressure environment in the hopes of improving healthcare worker and patient safety. The team then sought to test the device's efficacy in generating and maintaining negative pressure. The goal proved prescient as the US Food and Drug Administration (FDA) later recommended that all barrier devices use negative pressure. METHODS: Initially, engineers observed simulations of various aerosol- and droplet-generating procedures using hospital beds and stretchers to determine the optimal working dimensions of the containment device. Several prototypes were made based on these dimensions which were combined with filters and various flow-generating devices. Then, the airflow generated and the pressure differential within the device during simulated patient care were measured, specifically assessing its ability to create a negative pressure environment consistent with standards published by the Centers for Disease Control and Prevention (CDC). RESULTS: The portable fans were unable to generate any airflow and were dropped from further testing. The vacuums tested were all able to generate a negative pressure environment with the magnitude of pressure differential increasing with the vacuum horsepower. Only the 3.5-horsepower Shop-Vac, however, generated a -3.0 pascal (Pa) pressure gradient, exceeding the CDC-recommended minimum of -2.5 Pa for AIIRs. CONCLUSION: A collaborative team of physicians and engineers demonstrated the efficacy of a prototype portable negative pressure environment, surpassing the negative pressure differential recommended by the CDC.

3D-printed activated charcoal inlet filters for oxygen concentrators: A circular economy approach.

As of May 2021, the current COVID-19 pandemic is still plaguing the world, challenging all the countries and their health systems, globally. In this context, conditions typical of low-resource settings surfaced also in high-resource ones (e.g., the lack of essential medical equipment, of resources etc.), while exacerbating in the already resource-scarce settings, because of COVID-19. This is the case of oxygen concentrators that are one of the first-line medical devices for treating COVID-19 patients. Since the beginning of 2020, their demand has been rapidly growing worldwide, aggravating the situation for low-resource settings, where the availability of devices providing oxygen-enriched air was already scarce. In fact, due to their delicacy, the lack of spare parts and of an appropriate health technology management system, oxygen concentrators can often be found broken or not working properly in these settings. The underlying problems have deep roots. The current regulatory frameworks and standards, which are set by high-income countries, are too stringent, and do not take into account the limited resources of poorer settings. Thus, they are often inapplicable in such settings. One of the main issues affecting the oxygen concentrators, is that related to the filters, which are designed to filter out dust, particles, bacteria, and to be used in medical locations complying with international standards (e.g., the air filtration level in a surgical theatre in Italy is at 99.97%). When used in low-resource settings, which do not comply with these standards and face several challenges (e.g., dust), these filters have a much-reduced lifespan. For these reasons, this paper aims to present the redesign of the inlet filter of an oxygen concentrator, which is used to prevent gross particles to enter the device. The redesign is based on a reverse engineering approach, and on the use of 3D-printing along with activated charcoal. After testing the filtration efficiency with a particle counter, the filter design has been refined through several iterations. The final prototype performs particularly well when filtering particles above 1 µm (with a filtration efficiency of 64.2%), and still has a satisfactory performance with any particle size over 0.3 µm (with a filtration efficiency of 38.8%). Following the United Nations Sustainable Development Goals, this project aims to empower local communities, and start a positive trend of self-sustained supply chain of simple spare parts for medical devices, leveraging on frugal engineering, 3D-printing, locally produced activated charcoal, and circular economy.

Context Matters-Why We Need to Change From a One Size Fits all Approach to Made-to-Measure Therapies for Individual Patients With Pancreatic Cancer.

Pancreatic cancer is one of the deadliest cancers and remains a major unsolved health problem. While pancreatic ductal adenocarcinoma (PDAC) is associated with driver mutations in only four major genes (KRAS, TP53, SMAD4, and CDKN2A), every tumor differs in its molecular landscape, histology, and prognosis. It is crucial to understand and consider these differences to be able to tailor treatment regimens specific to the vulnerabilities of the individual tumor to enhance patient outcome. This review focuses on the heterogeneity of pancreatic tumor cells and how in addition to genetic alterations, the subsequent dysregulation of multiple signaling cascades at various levels, epigenetic and metabolic factors contribute to the oncogenesis of PDAC and compensate for each other in driving cancer progression if one is tackled by a therapeutic approach. This implicates that besides the need for new combinatorial therapies for PDAC, a personalized approach for treating this highly complex cancer is required. A strategy that combines both a target-based and phenotypic approach to identify an effective treatment, like Reverse Clinical Engineering® using patient-derived organoids, is discussed as a promising way forward in the field of personalized medicine to tackle this deadly disease.

The Effects of 3D Immersion Technology (3Scape) on Mental Health in Outpatients From a Short-Term Assessment, Rehabilitation, and Treatment Program: Feasibility Protocol for a Randomized Controlled Trial.

BACKGROUND: Mental health conditions are prevalent among Canadians and are a leading cause of disability. Each year, 1 in 5 Canadians experiences a mental health issue. A total of 5% of people aged ≥65 years perceive their mental health as fair or poor, and 6.3% of them have mood disorders. Regarding older adults with cognitive impairments such as dementia, up to 40%-50% of them experience depression at some point. We believe that older adults can benefit significantly from information and telecommunication technologies as a strategy for improving mental health conditions such as depression and anxiety, while simultaneously improving their quality of life. 3Scape Systems Inc is an Alberta-based private company that has produced a series of specialized 3D videos designed to simulate real-life events and engage individuals living with mental health disorders and cognitive impairments such as dementia. OBJECTIVE: This study aims to explore the trial design and effects of 3Scape videos on older adults' symptoms of depression and anxiety and the efficacy of this technology in improving the quality of life of patients attending the Short-Term Assessment, Rehabilitation, and Treatment Psychiatry Day Hospital program at Glenrose Rehabilitation Hospital and to provide data to estimate the parameters required to design a definitive randomized controlled trial. METHODS: The trial will use a randomized controlled design comprising 15 intervention participants and 15 control group participants. The participants will be adults aged ≥65 years who are cognitively intact or have minimal cognitive impairment (ie, Montreal Cognitive Assessment score ≥18), and are clients of the Short-Term Assessment, Rehabilitation, and Treatment Psychiatry Day Hospital program at Glenrose Rehabilitation Hospital. This study's primary outcome variables are related to clients' depressive and anxiety symptoms and their quality of life. The control group will receive the standard of care (ie, the Short-Term Assessment, Rehabilitation, and Treatment Psychiatry Day Hospital program at Glenrose Rehabilitation Hospital). The intervention group will receive the same standard of care as the control group and will use 3Scape Systems videos for therapeutic activities. RESULTS: Our study is currently on hold because of the COVID-19 pandemic. The recruitment process is expected to resume by November 2021, and the primary impact analysis is expected to be conducted by February 2022. CONCLUSIONS: This study will provide valuable information such as the measurement of comparative intervention effects, perception of older adults and mental health therapists about the 3Scape Systems, the associated costs of treatment, and product costs. This will contribute to the evidence planning process, which will be crucial for the future adoption of 3Scape Systems. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number (ISRCTN): 93685907; https://www.isrctn.com/ISRCTN93685907. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/25017.

Caracterización de una IPS de mediana complejidad en Ingeniería Clínica en Norte de Santander, Colombia / Characterization of a Médium Complexity Healthcare Institution in Clinicai Engineering in Norte de Santander, Colombia

RESUMEN Objetivo Caracterizar, en lo que a ingeniería clínica se refiere, el estado actual de una IPS de nivel II de mediana complejidad del departamento de Norte de Santander (Colombia). Metodología Se recopiló información de referencia sobre la disponibilidad de servicios de salud y los equipos médicos con el fin de determinar necesidades en tecnologías sanitarias basados en el análisis de los datos demográficos y epidemiológico. Resultados En el estudio se encontró que el área de influencia es grande para la poca capacidad instalada con la que cuenta la IPS. Se debe priorizar la adquisición de equipos biomédicos para las enfermedades no transmisibles. Se determinó que existen necesidades en cuanto al equipamiento biomédico y recursos humanos para el oportuno desarrollo de la prestación de los servicios. Discusión Teniendo en cuenta la situación actual de la pandemia ocasionada por el COVID-19, se evidencia que las IPS requieren que estas necesidades sean cubiertas con el fin de evitar un aumento en los casos de infectados y dar una atención oportuna a quienes padezcan esta enfermedad. Por ello se requiere un aumento de la capacidad Instalada de equipos biomédicos y servicios asistenciales. Esta caracterización va a permitirles a las IPS determinar cuáles son las carencias en equipos biomédicos, lo cual se hace fundamental en este momento, cuando se requiere un fortalecimiento de los servicios de salud que se prestan en el país.

ABSTRACT Objective To characterize the current state of the clinical engineering in a medium complexity (level 2) health institution in Norte de Santander, a State of Colombia, South America. Methodology Reference information was collected on the availability of health services and medical equipment to determine needs in health technologies based on the analysis of demographic and epidemiological data. Results The study resulted in that the area of influence is big y this have a little installed capacity, the acquisition of biomedical equipment for non-communicable diseases should be prioritized. It was determined that there are needs in terms of biomedical equipments and human resources for the timely development of the provision of services. Discussion Due to the current situation of the pandemic caused by COVID-19, it is evident that the IPS require that the needs be covered to avoid an increase in the cases of ¡nfected and assist the sick people, for that reason, an increase in the installed capacity of biomedical equipment and healthcare services is required. Finally, according to the economic aspect of the IPS, there are possible limitations for the acquisition of necessary biomedical equipment. This characterization will allow the IPS to determine what are the shortcomings in biomedical equipment, which is essential at this time when a strengthening of the health services provided in the country is required.

Determining the Effectiveness of a New Device for Hand Therapy (The FEPSim Device): Feasibility Protocol for a Randomized Controlled Trial Study.

BACKGROUND: Impairments of the forearm, wrist, and hand affect a sizable proportion of individuals and impose a significant economic burden on health care systems. FEPSim is a medical device for hand and wrist rehabilitation. The FEPSim device could be part of the standard of care for upper extremity rehabilitation during therapeutic activities to increase range of motion, dexterity, and strength. FEPSim has not yet been tested in a health care setting; therefore, a trial of the effectiveness of FEPSim in upper extremity rehabilitation is warranted. OBJECTIVE: This study aims to assess the feasibility of conducting a definitive trial in terms of recruitment, eligibility criteria, the type and number of diagnoses included, the length and dosage of the intervention, and data collection methods. This study also aims to gather clinical and statistical information as well as information related to the cost and usability, which allows for an economic evaluation of the device. METHODS: The trial will use a randomized controlled design comprising 47 intervention participants and 47 control group participants. Participants will be adults (age≥18 years) attending outpatient rehabilitation with limitations in their forearm, wrist, or hand function due to distal radial or ulnar fractures, stroke, or osteoarthritis. This study's primary outcome variables are related to patients' range of motion and strength, specifically active and passive wrist flexion and extension range of motion; active and passive forearm pronation and supination range of motion; grip strength; and pinch strength. The secondary outcome variables are related to patients' perceived wrist pain and disability in activities of daily living. The patients' perceived wrist pain and disability in activities of daily living will be measured using the patient-rated wrist evaluation questionnaire. The control group will receive the standard of care at each of the 2 hospital facilities (Glenrose Rehabilitation and Royal Alexandra Hospitals). The intervention group will receive the same standard of care as the control group at each facility and will use the FEPSim device for therapeutic activities to increase strength, range of motion, resistance, and dexterity. All the participants will be assessed at baseline (week 0); weeks 2, 4, and 8; and postintervention (week 10). RESULTS: The FEPSim study was launched in April 2020. This study is currently on hold because of the global COVID-19 pandemic. The recruitment process is expected to resume by September 2020, and the primary impact analysis is expected to be conducted by December 2020. CONCLUSIONS: This study will provide valuable information on the measurement of comparative intervention effects, technology acceptance by hand therapists, and how associated treatment and product costs will contribute to the evidence planning process, which will be crucial for the future adoption of FEPSim. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number Registry ISRCTN13656014; https://www.isrctn.com/ISRCTN13656014. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/22145.

Optimisation of medical equipment replacement using stochastic dynamic programming.

In this paper, the medical equipment replacement strategy is optimised using a multistage stochastic dynamic programming (SDP) approach. The outcome is an optimal path which shows whether to keep an existing piece of medical equipment (defender) or replace it with a more economical alternative (challenger). We assume that each decision can result in a number of different possible outcomes, each with a known probability. Contrary to deterministic dynamic programming, the state at the next stage is not completely determined by the state and policy decision at the current stage. Instead, the next stage depends on the operation and maintenance cost which is modelled as a stochastic variable. A Keep-Replace sequence of the highest returns (lowest costs) is the result of solving the problem using forward decision making. The benefit of the SDP solution versus that of keeping medical equipment until the end of its expected life is investigated for three scenarios: (1) no revenue for the defender and the challenger, (2) equal revenues for both, and (3) higher revenue for the challenger. The percentage of benefits relative to the current acquisition cost for the three scenarios are 616.9%, 728.2%, and 789.29%, respectively. Each percentage represents the relative difference between the equipment life cycle cost of the optimal sequence and that of the conventional sequence.

Evidence-based impact by clinical engineers on global patients outcomes.

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.

Estado del Arte de la Evaluación de Tecnologías en Salud en América Latina / State of the Art of the Evaluation of Health Technologies in Latin America

Resumen El surgimiento y desarrollo de las tecnologías en salud ha hecho que se intensifique el papel de su evaluación en los últimos años, provocando un interés creciente en la Evaluación de Tecnologías en Salud (ETES) en América Latina, a través de intentos por proporcionar información útil al tomador de decisiones. Este artículo presenta una revisión del estado del arte de ETES en Latinoamérica, a partir del análisis de publicaciones en revistas y eventos especializados. Se abordaron tres aspectos: elementos de evaluación, métodos que se aplican y políticas resultantes. Se encontraron los siguientes aspectos de evaluación: seguridad, eficacia, efectividad y eficiencia, económico-financieros, clínicos y técnicos, estos últimos con mayor desarrollo. Con respecto a los métodos, se encontraron propuestas de estrategias empíricas para el análisis de la información y la toma de decisiones. La generación de políticas públicas relacionadas con la ETES en América Latina es incipiente, apenas se están identificando las problemáticas nacionales y las estrategias a seguir para su solución. Por lo tanto, se aprecia una necesidad de seguir trabajando en el desarrollo de políticas, estrategias y métodos de ETES en la región Latinoamericana que permitan responder a las problemáticas en salud de la población de cada país.

Abstract The emergence and development of health technologies have intensified the role of their evaluation in recent years, causing a growing interest in the Evaluation of Health Technologies (ETES) in Latin America, through attempts to provide useful information to the decision-maker. This article presents a review of the state of the art of ETES in Latin America, from the analysis of publications in journals and specific events. Three aspects were addressed: evaluation elements, methods that are applied, and resulting policies. The following evaluation aspects were found: safety, efficacy, effectiveness and efficiency, economic-financial, clinical and technical, the latter with more significant development. Concerning the methods, proposals for empirical strategies for the analysis of information and decision making were found. The generation of public policies related to the HTA in Latin America is under development, national problems are hardly being identified, and the strategies to be followed for their solution. Therefore, there is a need to continue working on the development of policies, and methods of HTA in the Latin American region that allow responding to the health problems of the population of each country.

Evidence-based medical equipment management: a convenient implementation.

Maintenance is a crucial subject in medical equipment life cycle management. Evidence-based maintenance consists of the continuous performance monitoring of equipment, starting from the evidence-the current state in terms of failure history-and improvement of its effectiveness by making the required changes. This process is very important for optimizing the use and allocation of the available resources by clinical engineering departments. Medical equipment maintenance is composed of two basic activities: scheduled maintenance and corrective maintenance. Both are needed for the management of the entire set of medical equipment in a hospital. Because the classification of maintenance service work orders reveals specific issues related to frequent problems and failures, specific codes have been applied to classify the corrective and scheduled maintenance work orders at Careggi University Hospital (Florence, Italy). In this study, a novel set of key performance indicators is also proposed for evaluating medical equipment maintenance performance. The purpose of this research is to combine these two evidence-based methods to assess every aspect of the maintenance process and provide an objective and standardized approach that will support and enhance clinical engineering activities. Starting from the evidence (i.e. failures), the results show that the combination of these two methods can provide a periodical cross-analysis of maintenance performance that indicates the most appropriate procedures. Graphical abstract The left side shows a block diagram of the process needed to calculate the proposed set of KPIs, starting from technological, organizational and financial data. On the upper right it is shown an example of scheduled maintenance analysis for a specific class of equipment (legend in the article body). The bottom right part shows how the KPIs can be implemented in a business intelligence dashboard.

Reducción del Riesgo en Equipos Biomédicos y en Instalaciones Eléctricas de Entornos Clínicos / Risk Reduction in Electrical Networks and Safety of Biomedical Equipment in Clinical Settings

Resumen Se analizan 112 auditorías de instalaciones eléctricas y seguridad de equipos biomédicos en 78 Institutos de Medicina Altamente Especializada (IMAE) del Uruguay, realizadas a lo largo de 14 años, clasificando el nivel de riesgo y de cumplimiento de normas desde el punto de vista de Ingeniería Clínica. Cada visita incluye una encuesta al personal encargado de mantener y gestionar la infraestructura eléctrica y el equipamiento biomédico, que abarca el estado de mantenimiento, el control y la documentación de las instalaciones eléctricas y del equipamiento biomédico. Se evalúa el riesgo con un puntaje de 0 a 4. En 2004-2007 el 74% de los IMAE tenía irregularidades en la instalación eléctrica, gestión de equipamiento, control de calidad o documentación. Además, un 15% de los que tenían problemas, tenía en particular equipamiento indicado como "equipo peligroso". En los períodos siguientes esta proporción baja paulatinamente hasta 0% en 2016-2017. No obstante, continúa existiendo un déficit en la gestión del equipamiento y en la documentación formal. El aporte de la Universidad en el seguimiento técnico de los IMAE se ha materializado en una mejora en materia de seguridad.

Abstract 112 field inspections to 78 high technology medical centers (IMAE is the Spanish acronym) over 14 years are analyzed. All visits were evaluated as to Clinical Engineering good practices and were assigned a risk level. All audits included a questionaire to maintenance management personnel on electrical network operation as well as on biomedical equipment follow-up and documentation from acquisition to disposal. Risk is assigned a level 0 to 4 at each visit. In 2004-2007, 74% of IMAEs had safety problems in one or more of electrical network, maintenance management or documentation, and 15% of the IMAEs with safety problems had one piece of equipment described as simply "dangerous". Electrical safety problems were eventually reduced to 0% in 2016-2017, probably as a consequence of regular audit and counseling by this University Clinical Engineering Program.

Avaliação de indicadores de desempenho da área de engenharia clínica: uma proposta para um hospital público universitário / Evaluation of clinical engineering performance indicators: a proposal for a university public hospita

RESUMO Objetivo: Propor um conjunto de indicadores de desempenho para o Departamento de Engenharia Clínica (EC) de um hospital público universitário. Metodologia: Após pesquisa bibliográfica dos indicadores da área de engenharia clínica citados na literatura, foi elaborado um questionário aplicado a gestores de hospitais de alta complexidade, docentes e especialistas para avaliar a pertinência, credibilidade do resultado, esforço de apuração, simplicidade de interpretação e de algoritmo de cálculo dos indicadores. Resultados:Foram propostos 14 indicadores para o departamento de EC: percentual de conclusão do programa de manutenção preventiva, tempo médio de atendimento, tempo médio de paralisação de máquina, número de reparos repetidos, percentual do total de ordens de serviço concluídas, número de ordens de serviço por área, percentual de reparos realizados externamente, percentual de reparos realizados por erro do usuário, custo de manutenção versus custo de aquisição, custo total de manutenção, satisfação do funcionário, treinamento da equipe técnica, satisfação do cliente e treinamento de usuários. Conclusões: Numa instituição pública de grande porte e nível terciário, a escolha dos indicadores para compor um painel para a gestão do Departamento de EC, bem como a apuração dos resultados deve ser ponderada, tendo em vista que, instituições governamentais sofrem impactos diretos quanto à disponibilidade de verba e entraves burocráticos que, muitas vezes, geram impasses difíceis de serem solucionados. É importante que exista um trabalho de conscientização dos funcionários quanto ao seu papel nos resultados dos indicadores e na busca das metas estabelecidas pela organização, pois, somente esse conjunto vai permitir uma gestão de sucesso (AU)

Objective: To propose a set of performance indicators for the Clinical Engineering Department (CE) of a public university hospital. Methodology: After a bibliographic search of clinical engineering indicators cited in the literature, a questionnaire was applied to hospital managers of high complexity, professors and specialists to evaluate the relevance, credibility of the result, calculation effort, sim-plicity of interpretation and calculation algorithm of indicators. Results: 14 indicators were proposed to the CE Department: percentage of completion of the preventive maintenance program, average service time, average machine downtime, number of repeated repairs, percentage of total work or-ders completed, number of service orders by area, percentage of repairs performed externally, per-centage of repairs performed by user error, maintenance cost versus cost of acquisition, total cost of maintenance, employee satisfaction, technical team training, customer satisfaction and user training. Conclusions: In a large public institution and tertiary level, the choice of the indicators to compose a panel of indicators for the management of the CE Department, as well as the calculation of the results, should be considered, since State institutions suffer direct impacts on the availability of funds and bu-reaucratic obstacles that often generate impasses that are difficult to solve. It is important that there is a work of awareness of the employees about their role in the results of the indicators and the search of the goals established by the organization since only this set will allow successful management (AU)

Web-Based Experience Sharing Platform on Medical Device Incidents for Clinical Engineers in Hospitals.

The aim of this study was to establish a web-based platform for exchanging medical device management and maintenance experiences to enhance the professional competency of clinical engineers (CEs), which ensures the quality of medical devices and increases patients' satisfaction with medical services. Medical devices play an essential role in diagnosis and disease management. CEs are responsible for providing functional medical devices that contribute worthwhile functions to a medical service to improve patients' health and safety. The purpose of the platform is to facilitate collection and sharing of medical device incidents experiences to improve CEs' capability. To provide useful and practical information for CEs, an event review committee, composed of experts with more than 20 years of clinical engineering experience who were recruited as reviewers, was established under the platform. Cases submitted to the platform were required to have comprehensive descriptions of the device and events. Each case was evaluated by at least two reviewers based on five evaluation indices: (1) severity, (2) breadth, (3) frequency, (4) insidiousness, and (5) correctness. After being reviewed, each final report was published on the platform to be shared with the event submitters and other members. The results show that 116 staffs from 32 different hospitals, registered to join this platform. From January 2015 to December 2016, 70 events were submitted with 56 reports. This study also assessed the platform's benefits for CEs. A total of 93 respondents completed a questionnaire survey: 93% of the CEs agreed that the information from the platform helped them do their job. The web-based platform has high value as an experience-sharing interface for medical devices. The CEs obtained extremely useful information from the platform for medical device management and their daily duties. This study provided an online training model with systematic methods to improve the quality and effectiveness of medical device management.