The desire for earthquake hazard mitigation has been the focus of many researchers and governments for decades. This is paramount because an earthquake disaster can quickly cause many injuries, fatalities, and damages. The global database of the 21,000 most devastating disasters (earthquakes included) since 1900 indicates that 50% of them with the most significant number of injuries occurred only during the past 20 years. In human history, the Xaanxi earthquake is ranked third among the disasters that claimed more lives. In addition, earthquakes contributed to six of the most deadly disasters of the past two decades and 21% of the economic losses. In the same period, the earthquakes due to the Virunga volcanic activity were responsible for more than 100 deaths and extensive material and infrastructure damage. The referenced information and statistical data about the earthquake occurrence process, adverse effects, economic losses, and the current technological success in reducing its risks through warning systems are the basis for developing this paper. The authors aim to raise awareness and recommend that the Virunga region countries (Democratic Republic of the Congo, Rwanda, and Uganda) be a good place for an Earthquake Early Warning System and Earthquake Management Plan. An Earthquake Early Warning System even caught the attention of the United Nations, where the endorsed Sendai Framework for Disaster Risk Reduction (UNISDR, 2015) specified that early warning must be a priority and has to be substantially evolved by 2030.

Many colleagues have written about the global reliance on health technologies whose innovation, deployment and supportcontinue to improve worldwide healthcare and its delivery. The World Health Organization’s-WHO 2007 Resolution WHA60.29called for the effective use of health technologies (HT), in particular medical devices, through proper planning, assessment,acquisition and management.The community of professional clinical engineering (CE) practitioners’ pre-COVID19 stories are captured in the Global ClinicalEngineering Journal. An article from 2022 shows the reasons for the increased contributions of this community especially duringthe pandemic in The Growing Role of Clinical Engineering: Merging Technology at the Point of Care.This article will answer questions such as to how this global reliance was demonstrated during the COVID19 period. How thestatus of the Clinical/Biomedical Engineering (CE/BME) profession that serves at the point of care changed as the world emergesfrom the huge stresses of the pandemic. The article reviews the evolution of the CE profession since 2020, how it partneredwith WHO between 2020-2022 and what lessons were learned in the process. It reports future CE priorities to improve country,regional, and global practice in 2023 and beyond. This timely preliminary report shares important findings related to patientcare support services.

Surgical procedures using rigid endoscopes are well known for having advantages over conventional surgical procedures. However, these instruments are fragile and are subject to breakage. The objective of this study was to record and analyze the frequency and types of repairs required for different types of rigid endoscopes used in surgical procedures. As a result, it was possible to correlate the number of defects with the amount and types of procedures, incidences of repairs by types of optics, and types of defects by types of rigid endoscopes. According to the survey, smaller instruments are more subject to damage and need repairs.

Re-publication of the article published in National Academy of Engineering Perspectives, May 27, 2022, The Growing Role of Clinical Engineering - Merging Technology at the Point of Care | National AcademiesCopyright and Credit belong to National Academy of Sciences (all rights reserved).

Choosing the best instruments, measurement techniques and the most qualified service provider is of paramount importance for an equipment calibration service. For the definition of the most qualified company, selection criteria and weights related to the criteria will be used. Thus, the main objective of this work is to choose the best service provider, that is, the most qualified to perform the calibration services of medical and hospital equipment, considering the listed criteria. The method used was AHP (Analytic Hierarchy Process). It makes it possible to prioritize, give weight and validate the consistency of the evaluation criteria (considering the importance and relevance). As a result, the validation of the criteria weights was obtained. The company that obtained the best score was the company hired for the service.

The health technology sector of low- and middle-income countries (LMICs) is bedeviled by performance failures that make it a significant obstacle to effective patient healthcare interventions. The predominant factors behind the sector’s poor performance have been identified as (a) inadequately trained technical personnel and (b) the unserviceable condition of medical equipment. Past studies show that after adequate training, there is an increase in the proficiency of in-hospital biomedical engineers, but the studies have been limited to the maintenance job description of the engineers. We present a case study of the successful installation of sophisticated medical equipment by an in-hospital engineer to demonstrate that comprehensive training can also develop the installation expertise of local engineers. The installation, which is usually accomplished by the equipment manufacturer, was delegated to the trained in-hospital engineer due to the COVID-19 pandemic. Furthermore, the bulk of medical equipment in LMICs is imported, which has led to an over-dependence of their health sectors on non-indigenous technology to the detriment of local alternatives and know-how. The World Health Organization estimates that 7 out of 10 sophisticated medical equipment imported by LMICs are unserviceable due to the issue of compatibility and adaptability with the setting. Previous research focuses on equipment subsidy, frugal innovation, and health technology management to better adapt foreign equipment to the environment. Still, this paper explores the option of indigenous technology and expertise to provide in-country development of suitable and sustainable medical equipment.

This book review is about the Elsevier Academic Press newly published Cybersecurity for Connected Medical Devices by author Arnab Ray, Ph.D.

Sleep stage scoring is necessary for diagnosing several sleep disorders. However, it is an intensive and repetitive task and a vital automation candidate. This work seeks to evaluate different kinds of Machine Learning based classification algorithms available in the scientific literature to determine which one fits better the clinical practice requirements. The comparison is made with a predefined experimental design, using electroencephalography, electrooculography, and electromyography signals from the polysomnographic records of the Sleep-EDFx dataset. The comparison considers the accuracy and speed of algorithms based on Linear Discriminate Analysis, Support Vector Machines, Random Forests, and Artificial Neural Networks. The latter group includes the Deep Neural Networks DeapFeatureNet, based on Convolutional Neural Networks, and DeepSleepNet, additionally based on Recurrent Neural Networks. It is determined that several of the tested algorithms boast high accuracy levels (85%). From them, DeepSleepNet is chosen as the fittest due to its considerable advantage in execution time. Nevertheless, the final result should always be reviewed by the experts.

Clinical Engineering professionals have a key role in healthcare institutions during the pandemic caused by the COVID-19 disease, mainly by supporting the front line by allowing the proper and timely access of the medical equipment required to diagnose and treat patients affected. But another one of their roles, probably one not so expected, has been their contributions for the development of emergency use medical devices, especially those for respiratory and oxygen therapy. By using the case of critical care use ventilators, and as presented during an IFMBE-CED webinar on the topic, this paper mentions the role of Clinical Engineers for the rapid response manufacturing of such vital care devices, in three main aspects: development, regulation and education. The results from such efforts have paid off by having safe and efficient support equipment while the shortage from commercial products have been receding, by establishing international guidelines for future innovators to take into consideration and by leaving valuable knowledge in the form of educational and training videos for future generations to consult from.

Healthy population is regarded as the most valuable asset of any country. Unfortunately, the health challenges that hinder mankind's wellbeing are enormously increasing. Examples include but are not limited to: the diversity of emerging diseases afflicting the global population, the projected demographic growth of elderly people who need consistent monitoring, the deficiency in medical staff, the lower density of physicians, and the challenging geographical location of the population from healthcare providers. The mitigation of such health challenges calls for novel technologies to improve patient outcomes. In this article, seven emerging technologies, namely: Wearable Devices and Internet of Things, Artificial Intelligence, Blockchain Technology or Distributed Ledger Technology, Robotics Technology, Telehealth and Telemedicine, Big Data Technology and Nanomedicine have been highlighted. For each discussed technology, its historical background, development drivers, market status and trends, significance to healthcare, key player companies, and associated challenges have been presented. The information contained in this paper was collected from different journal articles, websites, reports, conference proceedings, and books. It was observed that though the technologies discussed in this article show growth at different rates, healthcare technology development and implementation are very promising in revolutionizing the health sector and improving the health of the population. Therefore, healthcare providers and countries are recommended to put in place Healthcare Technology Assessment Programs to help them collect data regarding the technology efficacy, relevance, safety, outcomes, and alternative technologies towards better planning for healthcare services improvement.

Backgrounds and Objective: Advancements in technology have led to great strides in research and innovation that have improved healthcare provision around the world. However, the majority of the technology available is underutilized in Sub-Saharan Africa. In addition, the ever-increasing sophistication and cost of medical equipment means that access and proper use is limited in low- and middle-income countries (LMICs). There is, however, a general paucity of well-documented evidence for the utilization of medical equipment in LMICs. Therefore, this study evaluates the current availability and utilization of medical equipment in tertiary hospitals and research facilities in Uganda and provides baseline information to clinical/biomedical engineers, innovators, managers, and policymakers. Material and Methods: The study evaluated the equipment currently used in 9 purposively selected public tertiary hospitals and 5 research laboratories representing different regions of Uganda. Data were collected by personnel specialized in biomedical engineering utilizing a mixed-method approach that involved inventory taking and surveys directed to the health workers in the designated health facilities. Results: The hospitals contributed 1995 (85%) pieces of medical equipment while the research laboratories contributed 343 (15%) pieces amounting to 2338 pieces of equipment involved in the study. On average, 34% of the medical equipment in the health facilities was faulty, and 85.6% lacked manuals. Discussion and conclusion: Although innovative solutions and donated equipment address the immediate and long-term goals of resource-constrained settings, our study demonstrated several issues around existing medical devices, and these need immediate attention.

Objective: To discuss and analyze the common causes of dental unit failures and summarize maintenance experiences. Methods: The failures were studied through retrospective analysis in our dental clinic from January 2019 to December 2019. Causes for four common failures were analyzed deeply, and the corresponding improvement solution was implemented. Results: These solutions reduced the failure rate for dental units and improved understanding of the importance of using and maintaining the equipment correctly.Conclusion: Analysing and improving proper maintenance can save costs for the hospital and effectively enhance the management level of medical equipment maintenance.

On behalf of the organizers and sponsors of the 3rd International Clinical Engineering and Health Technology Management Congress (ICEHTMC) it is our honor to offer this publication that contains all of the accepted abstracts for the oral and poster sessions. With the amazing support from the Scientific Program Committee, consisting of several dozen reviewers from all over the world, all the submissions were subjected to strict peer review and the event has broken all previous CE congresses’ records for quality and quantity. Major recognition must be given to the Italian Clinical Engineers Association (AIIC) and IFMBE/Clinical Engineering Division (CED) for hosting and collaborating on the organization of this event and for engaging early on practitioners around the world to respond to the Call for Papers and vendors to exhibit their ware. This is also the first time that the Congress’s proceedings are published and available in print and on-line (GlobalCE.org). The Global Clinical Engineering Journal’s commitment to the promotion and sharing of knowledge is evident by committing to and the timely accomplishment of this major task.

On behalf of the organizers and sponsors of the 4th International Clinical Engineering & Health Technology Management Congress (ICEHTMC), it is our honor to offer this publication that contains all of the abstracts accepted for the oral sessions in this Congress. Through the amazing support received from the Scientific Program Committee, consisting of several dozen experienced reviewers from all over the world, all of the submissions received were subjected to strict peer review process. This made the Congress’s scientific program an event that exceeded all previous Congress records for quality, quantity, and registration. Major recognition must be given to the unique cooperation between the Global Clinical Engineering Alliance (GCEA), the IFMBE Clinical Engineering Division (IFMBE CED), and AAMI for hosting and collaborating on the organization of this event. Especially, since due to the curtail of international travel during this COVID-19 era, the organizers had to convert the Congress from in-person to a global virtual congress, a first for the international clinical engineering field. The unabated commitment of organizers led by Tom Judd and Yadin David who were endlessly supported by Kallirroi Stavrianou, and Luis Fernandez resulted in the engagement of Clinical Engineering practitioners from around the world, including pre-recording of over 200 presentations. Keynote presentations included globally recognized speakers from the World Health Organization, India and the USA. Support and presentations from sponsors Zoom for Healthcare, R-Zero, Healiom, and Schiller Americas provided a unique opportunity for global health technology shared learning and professional networking. This is the second time that the Congress’s proceedings are published and available in on-line format (GlobalCE.org). The Global Clinical Engineering Journal’s commitment to the promotion and sharing of knowledge is evident through its commitment to timely publication of subjects at the cross between engineering, technology, and patient care outcomes. These proceedings are a great accomplishment that well serve the ongoing and growing Global Clinical Engineering publication task. Conducting a virtual Congress presents a different stage and an opportunity to engage with more members within our field as well as with other stakeholders around professional development, scientific debate, networking, strengthening friendships, and learning more about best practices from places we cannot yet visit in person. We thank all the participants and are confident that you will find these proceedings useful. We wish you success and hope to meet you at our next Congress.

In this paper, we examine the practice level of engineers and discuss whether Clinical Engineering is a profession or an occupation. Many think that occupation and profession are synonyms, but are they? One must explore the difference, if it exists, between these terms, and to accomplish that, clarification of these terms is being offered and established first. We conducted a review of the terms and proceeded to identify if the tenants that are expected to be associated with professional standing are included in applying clinical engineering practices and to what level if it is. Engineering is a profession that improves the quality of living and for the common good. The professional education of engineers requires the education to contain a body of specialized knowledge, problem-solving skills, ethical behavior, and good analytical judgment in the service of all people. The engineering education domains aim to form individuals who are intellectually trained, practically adept, and ethically accountable for their work. Especially within the healthcare delivery system, engineering work engages problem-solving dependent upon sufficient body of knowledge to deal with practical problems by understanding the why, knowing how and identifying the when. There are various levels of the expected body of knowledge within the clinical engineering field ranging from engineers with formal academic training at undergraduate and graduate levels to clinical engineering technologists and technicians having graduated from between 1-4 years of academic training. Engineers may further select to publicly proclaim their adequate preparation and mastering of knowledge to conduct their work through a credentialing process that can confer the term professional, registered, or certified engineer if successfully achieved. Once the differences of working characteristics and obligations between occupation and profession are understood, it is clear that clinical engineers must continuously commit to pursue and fulfill these obligations. Therefore, every professional engineer is called on to achieve a certain degree of intellectual and technical mastery and acquire practical wisdom that brings together the knowledge and skills that best serve a particular purpose for the good of humanity. Clinical engineers and technologists are critical for sustaining the availability of safe, effective, and appropriate technology for patient care. It is as important for their associations to collaborate on compliance with professional obligations that their jobs require.

Backgrounds and Objective: The Intensive Care Unit (ICU) receives patients whose situation demands high complexity tasks. Their recovery depends on medical care, their response to medications and clinical procedures, and the optimal functioning of the medical devices devoted to them. Adverse events in ICU due to failures in the facilities, particularly medical devices, have an important impact not only on the patients but also on the operators and all those involved in their care. The origins of the technological failures seem to be more oriented to the interaction between the equipment and the operator: once the medical equipment is functioning, we must guarantee its correct execution to meet both the clinical service's objectives and the expectations of those involved in care, including the patients themselves. We present an approach to quality management based on failure analysis as the source of risk for medical devices' functioning and operation in the ICU. We decided to address it through a systematic approach by using the Failure Mode and Effects Analysis (FMEA) method and the Ishikawa diagrams' support to obtain the causes graphically. Material and Methods: We used the risk analysis framework as a basis of the methodology. By obtaining the causes and sub causes of technological failures in the ICU for adult patients, we applied the FMEA method and the Ishikawa diagrams to analyze the relationship between cause and failure. The ICU devices came from the Official Mexican Standard and WHO information related to the ICU operation and facilities. The data from the causes of failure came from specialized consultation and discussion forums on medical devices where these topics were addressed; we searched for over five years in Spanish forums. We proposed a calculation of the Risk Priority Number based on the information subtracted from the forums. Then, we defined an indicator showing the priority level that can be used to address the issue. Results: In general, the results showed that most of the medical equipment failure causes have medium and high-risk priority levels and, in some cases, the cause presented as the most prevalent didn't match with the reported in official documents such as technical or operation manuals. The most frequent causes found are related to electrical system issues and operation skills. We presented three study cases: defibrillator, vital sign monitor, and volumetric ventilator, to show the risk level designation. The conclusions inferred from these cases are oriented to training strategies and the development of support material in Spanish. Conclusion: The development of risk management methodologies that aim to monitor and solve potential hazard situations in critical areas is valuable to the health technology management program. The FMEA method showed to be a strong basis for the risk assessment processes, and its application to the ICU medical technology allowed the creation of the evidence supporting the decision-making process concerning strategic solutions to guarantee patient safety

The use of medical technologies has grown steadily in all health fields, offering numerous benefits to patients. However, related adverse events, which may cause severe consequences for patients, also have increased. Technical factors and human aspects that cause dangers to patients may be related to the complexity of the devices, quality control in manufacturing, software used, maintenance procedures, materials, and mode of use. Thereby, our objective is to present the main alerts, dangers, and failures related to medical equipment and ways to attenuate them. For that purpose, we performed an analysis of adverse events reported for medical equipment in the Food Drugs Administration (FDA/USA) and the Brazilian Health Surveillance Agency (ANVISA) databases, since 2016. Finally, we classified the events into different categories, according to similarity. The results show a total of 3,100 cases registered in the FDA for six types of equipment at the study and 75 cases in ANVISA for two of these equipment. Based on the top ten health hazards (2016-2020) provided by the Emergency Care Research Institute (ECRI) we were able to understand which equipment most offers hazards and the main ways to mitigate them. We found that the risks are common to medical devices, therefore, it is crucial that there are preventative measures to avoid them, for example, training users to use the products, maintenance, improving quality, and reporting adverse events to manufacturers.

Many challenges exist in the management of non-hospital-owned medical equipment. This paper proposes implementing a novel kind of lean and computerized management method, including the management policy, procedures, agreement signing, equipment installation, acceptance and maintenance, and exit procedure. The result shows that the Lean and computerized management system can improve oversight and assure the safe integration of non-hospital-owned equipment to reduce liability exposure and increase compliance with regulations.

Objective: To establish a total life cycle information management system for medical equipment based on our hospital’s actual situation. Methods: Per the definition of the total life cycle for the particular item of medical equipment, the function modules were designed and distributed according to different staff postings and then implemented on the WeChat public account-a series of API and services to develop custom features, a mobile app, and a computer web browser. Results: After implementation, the system can cover a series of management stages of the entire life cycle for medical equipment and the information exchanged among various stages. The relevant staff in different posts can operate the medical equipment management information on any of the three platforms. Conclusion: The improvement and efficiency aid staff in various settings in managing medical equipment and medical behaviors and patient safety is increased.

This technical report presents the quality assessment process for the emergency corrective maintenance of critical care ventilators in a node, IPT-POLI, of a voluntary network that is part of the initiative +Maintenance of Ventilators, led by the National Service of Industrial Training (SENAI) and its Integrated Manufacturing and Technology Center (CIMATEC) to perform maintenance on unused mechanical ventilators in the context of the COVID-19 pandemic in Brazil. A procedure was established for the quality assessment of equipment subjected to corrective emergency maintenance, covering the essential aspects of the three primary standards (ABNT NBR IEC 60601-1: 2010+A1:2016, ABNT NBR ISO IEC 62353: 2019, and ABNT NBR ISO 80601-2-12:2014) for performance and safety assessment. A set of nine critical care ventilators was evaluated considering the following parameters: leakage current, protective ground resistance, control accuracy, delivered oxygen test, and alarms. The evaluated ventilators underwent corrective emergency maintenance before performance and safety assessments. In the electrical safety tests, all equipment presented values prescribed for the standard. However, the assessment of ventilator parameters revealed that their performance was below the standard. Finally, quality assessment reports were sent to the clinical engineering departments at hospitals. Thus, it can be concluded that criteria selection for the quality assessment in critical care ventilators is crucial and of great significance for future pandemic scenarios, such as the situation experienced during the COVID-19 pandemic.

In recent times the approach to health care has been mostly influenced by the growing number of biomedical equipment used in hospitals, which needs the presence of the Clinical Engineering Service (CES). The aim of this work is to suggest a methodology to improve the performance of a CES through the application of Pareto principle to main Key Performance Indicators (KPIs). The methodology is applied by focusing on the use of KPIs that represent a quantifiable measure of achieving goals set by an organization. In this study five KPIs are considered: Uptime, MTTR (mean time to repair), PPM (percentage preventive maintenance), MTBF (mean time between failures) and the COSR (cost of service ratio). The first three indicators express the measure of CES efficiency in ensuring regular maintenance. The first step consists in retrieving data related to work orders for the years 2015-2016 on 6000 installed devices, carried out by a management software. The second step is to get the results through the use of an environment for numerical calculation and statistical analysis. In order to identify the main critical issues that may be present, three indicators (Uptime, MTTR and MTBF) are analyzed by applying the Pareto principle (i.e. 20% of the causes produce 80% of the effects). Considering the totality of work orders, therefore, it is possible to concentrate on only 20% of them in order to focus on a small group to understand the correlations between them. Identifying these characteristics means identifying the main critical issues that are present, on which action must be taken, and which affect 80% of the overall behavior. The COSR and PPM indicators, instead, suggest distribution models that allow to focus attention on the most critical devices. In conclusion, the way to analyze the results is obtained, when possible, by applying Pareto principle. Therefore, a CES will be able to focus on a few causes of poor performance. The achievement of these results could allow the standardization of the method used, enabling it to be applied to any healthcare system.

Background: Because of the health systems globalization, it is important to examine health systems organization in Africa, in terms of patient care, to highlight the failures and propose possible solutions. Objective: Modeling based on the Internet of Things (IoT) an Integrated Network for Monitoring Patient Data in West African Health Systems. Methodology: To achieve this, three steps have been followed. 1) Identification of the different characteristics of IoT-based health surveillance systems, WBAN systems and physiological parameters monitorable on a patient. 2) The modeling of the architecture of West African health systems in the form of a cloud of Technocentres. 3) Cross analysis between different IoT technologies, characteristics and functional requirements identified. All this is based on wireless medical sensor networks in Wireless Body Area Network (WBAN) systems. Result: This work has been used to model health systems in Africa as a remote monitoring network for patients. Conclusion: The implementation of this model of monitoring networks will be a tool for supporting large-scale decision-making for a health system in Africa. It will enable the West African health system to have an information database.

This work has as its proposition, to present a project whose main goal is to suggest the establishment of a flow with detailed stages, from the moment that it is defined the discarding of an electro- electronic equipment used in hospital environment until the reuse of possible material to the manufacturing of new equipment. The suggestion is applying to all the equipment electro-electronic used in the hospital (be the biomedical, electro-mechanic in general, computer, refrigerator, air conditioner etc.). And thus contributing to issues socio-environmental, as well as economic – financial, through an appropriated discarding process

Dear Editor, It is clear that potential COVID pandemics will be recurring events and the use of PPE is basic and vital. Everyone will need such simple devices to protect themselves and others. The consequence of no PPE protection could be disastrous for global health! Stockpiling PPE is not for everyone. Healthcare facilities in low resources countries have limited PPE supplies. Furthermore, transportation and distribution across the country are problems, particularly in rural areas. Home-made PPE is the most practical solution but this needs effective global efforts to educate and guide global populations. In the past 3 months, the IFMBE/CED, in collaboration with WHO and different professionals, has conducted an excellent series of webinars to inform the world about medical devices in combating the Covid-19 pandemic bringing invaluable information for global healthcare. We wonder if IFMBE/CED would pioneer another important initiative to advocate, and together with WHO, to co-ordinate the resources from different organizations and individual professionals to compose a manual on home-made PPE’s with basic knowledge on cleaning and sterilization so that laypersons can make PPE to protect themselves and others. A highly successful public health education publication “Where there is no doctors” [1] is an example. Preventing SARS and other flu disease is a global problem currently relies mainly on isolated and scattered national solutions. It is urgent that international organizations such as IFMBE and WHO provide trusted advice to countries worldwide to create a global protection-sensitive culture against pandemics.

To determine the maturity of a profession one must have knowledge of the individual attributes of the practitioners of that profession and the universal strength of unique skills among them. We have conducted an international survey of Clinical Engineering (CE) professionals associated with the management of technological tools developed for and deployed within the healthcare delivery system. The survey targeted participants who are practicing engineering tasks related to the safe and efficient management of technology used in the delivery of healthcare services. The participants, consisted of cohort of individuals whose contact information was collected from attendees at previous clinical and biomedical engineering events including: (1) presentation at congresses/regional meetings, (2) serving on international technical committees or task forces, (3) attending virtual clinical engineering events, or (4) subscribing to the Global Clinical Engineering Journal. The purpose of the survey was to identify the state of organization of CE professionals and the potential gaps, if any exists, in meeting their professional development needs. The survey was developed and conducted using on-line internet apps and links that provided access to a questionnaire in six different languages to facilitate optimal participation and response accuracy in as many geographical regions as possible. The survey was conducted in the early part of 2020 over period of 6 weeks. The overall response rate1 was over 5% (total of 14,400 individual contacts less estimated 1,750 contacts who did not open/bounced back). A total of 667 responses from 89 countries were received. This survey is considered an improvement, over previously reported international surveys2,3, with regard to response volume and rate. The strength of this survey, having larger response volume and geographical representation, when compared with previously documented CE surveys has improved even with narrower time window of data collection. The current survey consisted of twelve questions, beginning with information request about the respondent professional affiliation and moves on to request the ranking of the criticality of C.E. specific issues, while another question provided for comments in free formatting text style. The responses received were in all of the seven languages posted and included representation from all the continents. The analysis of the survey responses shows that about 60% of the responders identified themselves as clinical engineers, 16% as other type of engineers, 13% as technicians, and 12% as health professionals. Responses to particular questions demonstrate highest ratio of number of affirmative to negative responses. They were related to the perceived value responders placed on stronger international collaboration and on their willingness to engage in it. A conclusion, based on the analysis of the responses to this international survey, that the CE profession is awaiting the consolidation of the momentum generated by growing healthcare needs and present global conditions. The identified gap is lack of a dedicated international representation that is clearly identifiable within the CE field. Analysis of the survey data suggests the need of an international framework focusing on the various CE professional groups/associations and their members to face present challenges. The establishment of a global alliance to clearly identify the field of clinical engineering; to promote public awareness; to form liaison with government agencies and other healthcare decision makers, will improve global cooperation and inter CE societal relations that will serve patients as well.

Sterile processing errors in medical and dental offices are ranked the third highest hazard according to the annual ECRI ‘Top 10 Health Technology Hazards’ 2020 report. Other experts have raised similar concerns with sterilisation processes. For example, the WHO and the Clinical Engineering Division of International Federation of Medical and Biological Engineering (IFMBE) have partnered to provide a series of webinars with international experts exchanging knowledge on COVID-19 related critical topics. A recent webinar addressed the critical challenge of decontamination and disinfection of COVID-19 medical equipment in low-income and middle-income countries. During the webinar, participants asked about methodologies to assess whether the transmission of infection is borne by technological tools used to fight the disease. How can critical lifesaving breathing equipment be safely and quickly sterilised and moved from one patient to the next? The WHO/IFMBE webinar2 stated that ‘engineers and infection control professionals seem to be working in different silos’. Such silos must be dismantled because medical technology is indispensable in the provisioning of healthcare services. Disinfection and sterilisation of medical equipment are key concerns for healthcare organisations, and they require serious consideration of sociotechnical system interactions. The annual ‘top 10 Health Technology Hazards report’ is based on retrospective studies, yet management of COVID-19 safety requires capacity to process real- time data and the input of experts to predict where risks may occur and how to deploy plans to maintain a safe healthcare environment.

This paper describes the guidelines for writing effective manuscript that complies with general scientific writing style and in particular with those that are incorporated by the editors and reviewers of the Global Clinical Engineering Journal (www.GlobalCE.org) when they evaluate submission of manuscripts. Readers of this paper will gain understandings of the manuscript preferred writing format and of the submission’s individual sections. Examples are provided for each of individual sections that further explain their purpose and contrast of their various styles. When the guidance provided in this paper is incorporated into a new submission, it is expected to elevate the quality of the writing as well as the desire of young clinical engineers to publish about their work and the interest of the scientific community to read it.

GLOBAL DISASTER UNPREPAREDNESS - The global COVID-19 crisis of 2020 has thrown a disturbing spotlight on the many ways in which healthcare systems, governments, medical industries, markets, and healthcare professions have been dangerously fragmented, unprepared, under-resourced, tragically slow and uncoordinated in responding to the most disruptive medical disaster of our times. Despite numerous threat-analysis studies, detailed pandemic scenarios and simulations by state and Federal agencies, despite billions of dollars spent on post-9/11 international disaster preparedness, and repeated top-levels warnings, the world’s governments, markets and healthcare systems have failed to prepare and prevent a health disaster from exploding into a multi-dimensional catastrophe. The fragmentation of plans and competencies across sectors, complicated by political decision-making, clearly demand mission-critical re-organization among the institutional players, with more coordinated, integrated, and systems-oriented professional approaches worldwide, and active cultivation of public health intelligence. For the reasons that follow, Clinical and Biomedical Engineers are among the best-suited health professionals to assume an expanded and comprehensive leadership role in this urgently needed transformation.

In this study it is presented the implementation of a low-cost automated prototype, in an open code platform, that simulates maternal fetal signals, allowing test executions and fetal detectors. The goal is guaranteeing the use of these equipments in a safe, effective way in the monitoring of maternal fetal signals in hospital environments, since the simulator is used to evaluate the correct use of the equipment. Another possible application of the simulator is as a teaching tool. The results are demonstrated in a man-machine interface, the views of the measurements of fetal movement, uterine activity and fetal heart rate, generated by the simulator. The values demonstrated in the man-machine interface can be compared with the ones presented by the fetal monitor. With this comparison it is possible to check the correct functioning of the equipment tested.

Medical equipment that supports life, relieves diseases, and overcomes disabilities can also cause damage and death due to operational failures, user failures, and misuse. Hemodialysis machines include roller pumps that control the flow of blood, and these pumps have to be calibrated accurately to ensure they are working properly. This article describes the development of a low-cost, open source prototype that automates the flow analysis (measurement and recording) of the blood pumps in hemodialysis machines. Being able to accurately inspect the machine’s operation improves the quality and safety of its use. Through this technology (this process automation), it is believed equipment downtime and total tests cost will be reduced. This device has a system that collects data in real time, generated by the blood pump dialysis. Mathematical calculations are used to present flow information, including the standard deviation of the measurement, which is reported at the end of the test in an objective and simple way. Through a software and human machine interface (HMI), the test can be monitored and generate a report that contains the name and model of the equipment, the quantitative results of the flows, and the standard deviations of the measurements. The device can be used by clinical engineering teams in preventive maintenance and after corrective maintenance, as a control practice, making the calibration process easier and more cost-effective.

Background and Objective: Venezuela presents a health, socio-economic crisis (minimum wage of 2.32 US dollars monthly), and a political one. Apart from having very poor quality public services and coverage, such as water, public transport, electricity, and the Internet. In this context, COVID-19 appears. This pathology quickly became a pandemic since its transmission occurs mainly through contact with the secretions of infected patients or with contaminated surfaces. Health workers face a higher risk of infection than the rest of the population. For this reason, the objective of the work was to reduce this threat while working with patients with COVID-19, redesigning the original "spray box". To carry out this work, the university, private health providers and private companies had to be united. Material and Methods: The following phases were carried out: a) A sketch is created; b) A 3D CD model is created; c) The prototype is manufactured; d) The prototype is improved; and e) The effectiveness and safety tests are carried out. Results: As a result, the medical team obtained a tool to limit the spread of COVID 19 and thereby improve the health of the health workers involved. This instrument is called "Cube de Vie" (CubeDV). Conclusions: to carry out a job in Venezuela is very complicated under the circumstances it presents, however, the joint work of three organizations such as the university, private health providers and private companies can generate solutions to the serious situation that the pandemic presents. .

Health Technology Assessment focuses on equal appraisal of health technologies introduced into the market. This has made regulators and the governance of innovation reactive and dependent on the initiatives innovators take for technology development, thus making it supply driven. The policy makers’ role has become one of appraising technologies that are already developed rather than guiding the development agenda. This severely limits the possibility to ensure that health technologies sufficiently address major issues such as burden of disease, trade deficit and health inequalities. It places governments outside of the actor arena that co-shapes technologies in the early stages, restricting the involvement to facilitating scale up or not. It makes it hard to achieve health technology governance practices that maximally contribute to ensure technological developments that actually address public concerns. What is the potential of frameworks for changing this dynamics and how can evidence shape technology development agenda’s without falling into the traps of regulator lock-in or social engineering? The methodology presented in this study takes first but important steps towards an evidence based framework for priority setting to guide innovations, particularly in health and social sectors

Background and objective: medical devices and supplies increase productivity in health institutions, contributing to the reduction of morbidity and mortality rates. However, the use of medical devices has an associated level of risk. A third party must guarantee the safety and effectiveness of the medical team to grant a quality certification. In Venezuela, one of the institutions authorized by the regulatory entity (Ministry of Popular Power for Health) that grants quality certification is the Health Technology Management Unit (UGTS) attached to the Research and Development Foundation (FUNINDES ) from the Simón Bolívar University (USB). The objective of this work is to show the certification protocol by the UGTS and its results. Material and Methods; It based on the ISO 9001 standard for the processes. Five activities were determined: Prepare the teaching, technical and administrative staff as ISO auditors. Carry out an external audit, in order to make proposals for improvement; Plan changes in our quality management system and processes and Qualify as a supplier guided by the ISO 9001 philosophy by a prestigious international company. Results: Based on the results, general and particular proposals were proposed to improve the process. These were adopted by the group and later in the evaluation of an international company the USB was qualified as an approved supplier for the analysis of medical devices by the company Johnson & Johnson Medical S.C.S. when complying with ISO 9001 Standard. Conclusions: The UGTS is authorized by the Ministry of Popular Power for Health (MPPS) through the Sanitary Comptroller's Office to issue quality certificates to medical teams since 1999. Approximately 55 companies that have received service are registered in its database. In the period audited (2012 - 2014), 25 files were created. Its processes comply with ISO 9001.

This work investigates the validity and reliability of a novel biomechatronic device providing an interactive environment in Augmented Reality (AR) for neuromotor rehabilitation. A RGB-depth camera and telemonitoring/remote signaling module are the main components of the device, together with a PC-based interface. The interactive environment, which implements some optimized algorithms of body motion capture and novel methodologies for human body motion analysis, enables neuromotor rehabilitation treatments that are adaptable to the performance and individual characteristics of the patient. The RGB-Depth camera module is implemented through a Microsoft Kinect, ORBBEC ZED2K devices; the telemonitoring module for teleassistance and therapy supervision is implemented as a cloud service. Within the module of body motion tracking, the abduction and adduction movements of the limbs of the full-body structure are tracked and the joints angles are measured in real-time; the most distinctive feature of the tracking module is the control of the trunk and shoulder posture during the exercises performed by the patient. Indeed, the device recognizes an incorrect position of the patient's body that could affect the objective of the exercise to be performed. The recognition of an incorrect exercise is associated to the generation of an alert both to the patient and the physician, in order to maximize the effectiveness of the treatment based on the user's potential and to increase the chances of a better biofeedback. The experimental tests, which have been carried out by reproducing several neuromotor exercises on the interactive environment, show that the feature recognition and extraction of the joints and segments of the musculo-skeletal structure of the patient's, and of wrong posture during exercises, can achieve good performance in the different experimental conditions. The developed device is a valid tool for patients affected by chronic disability, but it could be extended to neurodegenerative diseases in the early stages of the disease. Thanks to the enhanced interactivity in augmented reality, the patient can overcome some difficulties in interaction with the most common IT tools and technologies; at the meanwhile she/he can perform rehabilitation at home. The physician can also check in real time the results and customize the care pathway. The enhanced interactivity provided by the device during rehabilitation session increases both the motivation by the patient and the continuity of the care, as well as it supports low-cost remote assistance and telemedicine by optimizing therapy costs. The key points are: i) making rehabilitation motivating for the patient, becoming a "player"; ii) optimize effectiveness and costs; iii) possibility of low-cost remote assistance and telemedicine.

It is under development in health establishment, a quality control through the calibration of biomedical equipment, in a systematic and comprehensive way of the wide range of available hospital technology. Thus, this work aims to propose and demonstrate a method of qualification of the apheresis equipment through of the equipment calibration, before to release it for the first time use. As results are shown the values obtained in a calibration of an apheresis equipment, relating to the MNC protocol (removal of mononuclear cells), the pressure of access and return pressure.

Background and Objective: We aimed to assess and verify the measurement accuracy and feasibility of semi-automatic magnetic resonance imaging (MRI) volume of interest (VOI) method by comparing its measurements with actual skeletal muscle volumes and discuss the clinical significance. Material and Methods: A total of 18 muscles from 2 pigs were measured by drainage method, VOI method (VVOI), the summation method (Vsum), and maximum section method (Vmax) respectively after MRI scanning. All measurements were performed by 2 musculoskeletal radiologists and repeated at 6 different times, recording the consuming time (minutes) of every muscle. The average result of the 2 radiologists was adopted. Results: The 3-D structure of the skeletal muscles was distinct and vivid. A Friedman test and the inter-class correlation coefficient (ICC) indicated the VOI method had a high intra- and inter-reliability. The root mean square error (RMSE) over 6 time-points was 1.101 mL. A Bland-Altman plot represented a superior consistency. Pairwise Mann–Whitney U testing demonstrated that the consuming time to measure each muscle by VOI method was short. Conclusions: The VOI method could semi-automatically display the 3-D reconstruct of the skeletal muscle clearly, conveniently, with a great accuracy, and high repeatability.

Background and Objective. The deliberation n.7301 of 31/12/2001 provides for the inclusion of a call system with acoustic and luminous signalling within the minimum equipment of the recovery ward. However, traditional call systems are inefficient since they are based on the following incorrect assumptions: patients and staff are unmoving, information sources are static and assistance is unidirectional. Taking care of a patient involves different figures who should be dynamic and should be able to exchange information. Furthermore, the high number of clinical calls and alarms might be an issue, because on one hand they are essential to fulfil patients’ needs, but on the other hand they could cause stress and additional workload on medical staff. Indeed, they sometimes ignore some calls or waste a lot of time on non-urgent requests. In addition, the identification of an alarm and the prompt intervention seems to be more difficult during travelling. An ideal alarm system should have 100% sensitivity and specificity. Nevertheless, the alarms are designed to be extremely sensitive, at the expense of specificity. The alarm fatigue, that is the work overload due to an excessive alarms number exposition, is a critical problem in terms of safety in the current clinical practice because it involves desensitization and alarm loss, causing sometimes even the patient's death. Material and Methods. Therefore, appropriate approaches to notifications should be evaluated, including the effectiveness of mobile wireless technologies: linking patients, staff, data, services and medical devices simplifies communications and workflows. Several issues related to the communication among staff members, between patient and caregiver and to the alarms and vital parameters distribution in care-intensive environments have been analysed, focusing on the clinical effectiveness analysis of an innovative technology to support the Emergency Department of the Azienda Ospedaliera dei Colli activities. Afterwards, we have created a simulation model with Simul8, so that a digital twin reproduces direct and indirect activities in two cases: with and without (What If and As Is model) the aid of the technology. Results and conclusions. The model provides a set of Key Performance Indicators (number of performing activities, average alarm resolution time, waiting time) on which the compensatory aggregation method is applied to elaborate a single final score in both cases. This score is 52,5 in the As Is Model and 80 in the What If model. So, the clinical effectiveness has been demonstrated.

Transcript of March 24, 2020 Webinar (on behalf of AIIC & IFMBE/CED)

On the basis of reports and questions forwarded to the Clinical Risk Managers of the Italian Network for Health Safety (INSH) from physicians working on the front line, a series of recommendations have been developed referring to documents and papers published by national institutions (ISS) and Italian and international scientific societies and journals. We have arranged the process to describe organising the work system according to the SEIPS Human Factors approach. This document is re-posted with permission from Riccardo Tartaglia (President of Italian Network for Safety in Health Care).