(searched for: doi:(10.31354/*))
Published: 1 June 2021
Global Clinical Engineering Journal, Volume 4; https://doi.org/10.31354/globalce.v4i2.129
Published: 1 June 2021
Global Clinical Engineering Journal, Volume 4, pp 5-14; https://doi.org/10.31354/globalce.v4i2.121
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.
Published: 1 June 2021
Global Clinical Engineering Journal, Volume 4, pp 26-35; https://doi.org/10.31354/globalce.v4i2.131
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.
Published: 1 June 2021
Global Clinical Engineering Journal, Volume 4, pp 15-25; https://doi.org/10.31354/globalce.v4i2.124
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
Published: 1 March 2021
Global Clinical Engineering Journal, Volume 4, pp 27-36; https://doi.org/10.31354/globalce.v4i1.108
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.
Published: 1 March 2021
Global Clinical Engineering Journal, Volume 4, pp 2-3; https://doi.org/10.31354/globalce.v4i1.122
Published: 1 March 2021
Global Clinical Engineering Journal, Volume 4, pp 14-21; https://doi.org/10.31354/globalce.v4i1.87
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.
Published: 1 March 2021
Global Clinical Engineering Journal, Volume 4, pp 5-13; https://doi.org/10.31354/globalce.v4i1.78
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.
Published: 1 March 2021
Global Clinical Engineering Journal, Volume 4, pp 22-26; https://doi.org/10.31354/globalce.v4i1.99
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.
Published: 1 March 2021
Global Clinical Engineering Journal, Volume 4, pp 37-38; https://doi.org/10.31354/globalce.v4i1.123
Published: 1 December 2020
Global Clinical Engineering Journal, Volume 3, pp 5-14; https://doi.org/10.31354/globalce.v3i2.111
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.
Published: 1 December 2020
Global Clinical Engineering Journal, Volume 3, pp 32-37; https://doi.org/10.31354/globalce.v3i2.56
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
Published: 1 December 2020
Global Clinical Engineering Journal, Volume 3, pp 19-31; https://doi.org/10.31354/globalce.v3i2.85
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.
Published: 1 December 2020
Global Clinical Engineering Journal, Volume 3, pp 38-39; https://doi.org/10.31354/globalce.v3i2.110
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”  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.
Published: 1 December 2020
Global Clinical Engineering Journal, Volume 3, pp 15-18; https://doi.org/10.31354/globalce.v3i2.116
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.
Published: 1 December 2020
Global Clinical Engineering Journal, Volume 3, pp 1-2; https://doi.org/10.31354/globalce.v3i2.115
Published: 1 September 2020
Global Clinical Engineering Journal, Volume 3, pp 44-49; https://doi.org/10.31354/globalce.v3i1.57
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.
Published: 14 July 2020
Global Clinical Engineering Journal, Volume 3, pp 33-43; https://doi.org/10.31354/globalce.v3i1.102
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.
Published: 6 July 2020
Global Clinical Engineering Journal, Volume 3, pp 27-32; https://doi.org/10.31354/globalce.v3i1.104
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. .
Published: 30 June 2020
Global Clinical Engineering Journal, Volume 3, pp 10-26; https://doi.org/10.31354/globalce.v3i1.98
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.
Published: 25 June 2020
Global Clinical Engineering Journal, Volume 3, pp 5-9; https://doi.org/10.31354/globalce.v3i1.59
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.
Published: 22 June 2020
Global Clinical Engineering Journal, Volume 3, pp 1-2; https://doi.org/10.31354/globalce.v3i1.107
Published: 29 May 2020
Global Clinical Engineering Journal, Volume 2, pp 45-56; https://doi.org/10.31354/globalce.v2i3.86
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.
Published: 21 May 2020
Global Clinical Engineering Journal, Volume 2, pp 35-44; https://doi.org/10.31354/globalce.v2i3.89
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.
Published: 19 May 2020
Global Clinical Engineering Journal, Volume 2, pp 24-34; https://doi.org/10.31354/globalce.v2i3.84
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
Published: 14 May 2020
Global Clinical Engineering Journal, Volume 2, pp 1-2; https://doi.org/10.31354/globalce.v2i3.101
Published: 11 May 2020
Global Clinical Engineering Journal, Volume 2, pp 15-23; https://doi.org/10.31354/globalce.v2i3.90
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.
Global Clinical Engineering Journal, Volume 2, pp 8-14; https://doi.org/10.31354/globalce.v2i3.83
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.
Global Clinical Engineering Journal, Volume 2, pp 4-7; https://doi.org/10.31354/globalce.v2i3.60
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.
Published: 26 April 2020
Global Clinical Engineering Journal, Volume 2, pp 5-6; https://doi.org/10.31354/globalce.v2i.100
Published: 22 April 2020
Global Clinical Engineering Journal, Volume 2, pp 35-38; https://doi.org/10.31354/globalce.v2i.97
COVID-19 was raging wildly across China. Although it is a war without gunpowder smoke, it is extremely fierce. Countless Medical staff at the frontline is fighting with death and the virus just to protect those infected who firmly believe in them.This artical describes the work of clinical engineers in Shanxi Province of China to fight against COVID-19.
Published: 17 April 2020
Global Clinical Engineering Journal, Volume 2, pp 39-49; https://doi.org/10.31354/globalce.v2i.88
This article seeks to share our experience on the consequences of a poorly managed conflict and its impact on a healthcare institution. We further try to talk on what it takes to relocate, especially such a vital sector like cardiac surgery amidst the socio-economic and socio-political context in which the hospital happens to be situated. Bearing in mind that the promptness of a patient’s recovery in a healthcare facility depends immensely on how accurate the engineers were during the design and construction phase, how precise international standards are implemented in the various engineering sectors of the hospital is of capital importance. Following the Cameroonian mind set, wherein division of labor and meritocracy are usually far fetch realities, it is therefore of prime importance to choose experienced and qualified contractors, architects, project managers to take part in the implementation of healthcare projects. The process of relocating either temporarily or permanently some health services from a crisis stricken zone to a safer environment also demands a lot of tactfulness in decision making as well as personnel involvement. All personnels from the various sectors being relocated must work closely with the team leader such that all necessary equipment, consumables, surgical materials are put together in order to simplify logistics and even safeguard the logistical process.
Published: 15 April 2020
Global Clinical Engineering Journal, Volume 2, pp 31-34; https://doi.org/10.31354/globalce.v2i.95
Transcript of March 24, 2020 Webinar (on behalf of AIIC & IFMBE/CED)
Published: 13 April 2020
Global Clinical Engineering Journal, Volume 2, pp 7-30; https://doi.org/10.31354/globalce.v2i.94
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).
Published: 31 March 2020
Global Clinical Engineering Journal, Volume 2, pp 1-2; https://doi.org/10.31354/globalce.v2i.92
Published: 1 March 2020
Global Clinical Engineering Journal, Volume 2, pp 26-36; https://doi.org/10.31354/globalce.v2i2.49
BACKGROUND AND OBJECTIVE: There are in Brazil 896.917 indigenous and 47% of them dwell in the Amazon rainforest region. In order to avoid expensive displacement for this population, especially for surgeries such as hernias and cataracts, the Expedicionários da Saúde NGO attends this specific population three times a year since 2003 organized as a work party regime. This attending is done through a Field Hospital (FH) and is supported by Clinical Engineering (CE). This article presents the characteristics of logistics as well as operation of medical and hospital devices in remote sites of Amazon region. The object of this paper is to describe the transportation processes, installation, operation and maintenance used to ensure safe use of medical devices in one FH in the Amazon forest and to present solutions to proposed adverse conditions throughout the course of several expeditions. MATERIAL AND METHODS: It was Initially done a survey of the processes of transportation, installation, operation and maintenance of medical devices collected from 24 expeditions to the Amazon forest in a period of 8 years, since the implementation of CE team. A Task Analysis processes was performed to systematically identifying the process used for plan, prepare, transport and operate the medical devices in those past expeditions. Understanding the complexity and the specificities of each expedition a evolutive planning process based on Software Development Spiral Model was used to describes a continuous activity flow, prone to implement and test improvements in each new expedition. Besides the continuous improvement the model also takes in consideration budget solutions once all the work done by the ONG is voluntary. The efficacy of the method was evaluated from indicators of use of medical equipment, the assessment of reported adverse events and the interviews with the professionals of the EC team, users of the medical devices and opinion of the responsible for the managing of the expedition. RESULTS: Several improvements were observed speciality in the transporting and installation processes, mainly through the adoption of customized packages and manuals for assembly and disassembly of the parts of the medial equipment. Further enhancements were obtained through customizations and adaptations of the devices to the hostile characteristics of the environment. Both physicians and nurses were satisfied with the performance of the devices, and few procedures for repair and calibrate were required after the equipments were installed. CONCLUSION: The CE team is crucial to the implementation of FHs, being essential in the management of medical technology and in the planning and operation of this type of health structure. The spiral planning method were shown to be very satisfactory mainly because it takes into account the experiences and needs of the past expeditions and for allowing the continuous improvement of the already used processes. Given the great complexity of the RainForest environment in which the technologies will be used and the unpredictability of the risks and challenges to be faced by the EC team the evolutionary work approach presents itself as an applicable solution to planning of future expeditions.
Published: 24 February 2020
Global Clinical Engineering Journal, Volume 2, pp 17-21; https://doi.org/10.31354/globalce.v2i2.52
– The medical equipments (EM) are increasingly decisive and essential in modern medicine and medical and hospital care. For the EM contribute effectively and to the health organizations to use them more productively, it is necessary to carry out the management of the life cycle of the same. A decisive factor in this cycle of life is to know when a piece of equipment must be replaced. It is observed the absence of defined and clear methods to assist in the clinical engineering and hospital management, in deciding and prioritizing which EM need to be replaced. This work demonstrates a practical application in an equipment park. As a result, the classification of EM as the prioritization of substitution was obtained with respect to diversity, quantity and cost of the equipment shown to be replaced. The application of this method may contribute to increased quality of installed equipment and budget planning of hospital investments.
Published: 14 February 2020
Global Clinical Engineering Journal, Volume 2, pp 22-25; https://doi.org/10.31354/globalce.v2i2.79
The IFMBE/Clinical Engineering Division (IFMBE/CED) has established an International Credentialing Board (ICB) to recognize organizations that certify or register clinical engineering practitioners (CEPs). The ICB has 9 members appointed by the CED Board and the members are experienced Clinical Engineering Practitioners with several certified or registered. The ICB will maintain a list of recognized organizations that certify or register CEPs but will not maintain a list of the individuals certified/registered. The National Examining Authority (NEA) that performs certification/registration can submit information on their program to the ICB for recognition. This will include detail information on the program and how it goes about certifying or registering individuals. Once recognized a program will have a renewal every three years to assure that it is still an operational program. Since there are no specific guidelines for programs to certify/register CEPs, the ICB will have to evaluate each NEA submission in detail. The ICB will need to determine that the individuals certified/registered are qualified practicing CEPs and the program is well managed. The NEA must have a set of By-Laws and a Code of Ethics. Certification programs may be based on credentials only or programs based on exams and credentials. Registration programs may be based on credentials including experience. The recommendations are that certification/registration programs should meet individual countries needs and how clinical engineering is practiced in a country. It is not recommended that an engineering degree be required since all clinical engineering practitioners do not have engineering degrees The ICB will also aid professional groups that are trying to establish certification/registration programs for CEPs.
Published: 11 February 2020
Global Clinical Engineering Journal, Volume 2, pp 37-38; https://doi.org/10.31354/globalce.v2i2.81
Published: 9 February 2020
Global Clinical Engineering Journal, Volume 2, pp 8-16; https://doi.org/10.31354/globalce.v2i2.67
Background and Objective Accurate measurement of body temperature is a key part of patient observations and can influence important decisions regarding tests, diagnosis and treatment. For routine measurements in hospitals, non-invasive thermometers such as tympanic infra-red ear thermometers are very widely used even though non-invasive thermometers are not as accurate as core thermometry. However, there are known issues regarding the accuracy of these thermometers due to user errors including dirty probe covers and not straightening the ear canal. We were therefore keen to understand if there was evidence to support the use of alternative non-tympanic, non-invasive thermometer that could be easily and widely deployed across Nottingham University Hospitals NHS Trust. Material and Methods A search of the published literature via the NICE HDAS was undertaken to identify the evidence on the use of temporal artery (TAT) or non-contact infra-red forehead (NCIT) thermometers compared to a core body temperature thermometer in a clinical setting. The relevant literature was identified, appraised and summarised. Results 15 papers described the use of TAT but only 5 reported results that were considered within clinically acceptable limits of which 2 included febrile patients. Nine of the 10 studies where TAT was considered not to be within acceptable limits included febrile patients. For the NCIT, 3 studies were identified but only 1 reported results within acceptable limits and this did not include febrile patients. Conclusion A review of the literature for both TAT and NCIT has indicated that neither is currently suitable as a replacement for tympanic IR ear thermometers in clinical practice. In particular, the evidence suggests that they are not acceptable methods for detecting temperatures outside the normothermic range and do not detect fever accurately. In addition, the potential for user error with TAT is considered unacceptable.
Published: 3 February 2020
Global Clinical Engineering Journal, Volume 2, pp 4-7; https://doi.org/10.31354/globalce.v2i2.80
Published: 18 December 2019
Global Clinical Engineering Journal, Volume 2, pp 1-2; https://doi.org/10.31354/globalce.v2i2.76
Published: 1 December 2019
Global Clinical Engineering Journal, Volume 2, pp 28-35; https://doi.org/10.31354/globalce.v2i1.74
Biomedical Engineering is playing a leading role in the development of medical technology which is one of the pillars of Modern medicine, or as differently expressed at the European Economic and Social Committee (EESC) opinion paper: “Biomedical Engineering is not simply a subset of modern medicine. Modern medicine predominantly secures important advances through the use of the products of biomedical engineering”1. Health technology, according to World Health Organization (WHO), refers to the application of organized knowledge and skills in the form of devices, medicines, vaccines, procedures and systems developed to solve a health problem and improve quality of lives. Therefore, Medical Devices (MDs) belong to the Health Technologies, and Radiotherapy (RT) is an important subgroup of them. Radiotherapy refers to high-tech medical devices that are of high capital value both in terms of initial investment and operation, requiring specially trained personnel for its use and needs regular quality control, preventive maintenance and management procedures, to function properly and safely. Clinical Engineering plays a major role in facing of the afore mentioned challenges. The present paper provides an overview of the results of a study under the WHO action on Strengthening Capacity for Universal Coverage Greece/Phase 2 (SCUC2)2aiming to: Assess the sufficiency and equity in the distribution of RT and its use in Greece Identify eventual inequalities in terms of geographical coverage, specific needs and lack of RT Asses the current status of staffing in RT units Estimate the costs for the use of High Value Capital Medical Equipment (HVCME) Since a country-wide medical equipment inventory for Greece does not exist, various sources were used to obtain a clear picture of the installed units in public Greek hospitals and private clinics. As a result, it came out that, in terms of number of units the per million population the number of RT units rose by 23% from 4.3 in 2009 to 5.3 in 2017. In terms of number of acts, a general increasing trend is noticed, resulting to a total cost increase of 25% from 2013 to 2016. The study revealed that in Greece, there are quite pronounced inequalities in terms of availability of RT technologies in different regions. Long term strategic planning is needed based on evidence, such as updated inventory of MDs, acts performed, associate costs etc , which are unfortunately lacking in Greece. Additionally, the role of clinical engineers in the effective management and safe use of this technology should be widely recognised and regulated.
Published: 9 November 2019
Global Clinical Engineering Journal, Volume 2, pp 15-22; https://doi.org/10.31354/globalce.v2i1.70
Background and Objective: Clinical Engineering professionals are fundamental to the deployment of healthcare technology and to the management of its life cycle. As the role of technology grows in healthcare, so does the need for trained clinical engineering practitioners and the dynamic nature of the domain requires them to maintain their skills. However, the skills and activities required from clinical engineers around the world are not homogeneous, so the Clinical Engineering Division at IFMBE promoted a global survey to identify a common body of knowledge and body of practices for the profession. Material and Methods: This survey, based on a previous one conducted by the ACCE, was aimed at collecting data about CE practices and the importance of certain competencies for their practitioners. Results: Survey results indicate the profession still maintains certain traditional characteristics, such as the predominance of professionals with a background in electrical, electronic, or mechanical engineering and the prevalence of hospitals and clinics as employers. Some patterns in the perceived relevance of certain kinds of knowledge among different regions were also identified. Conclusion: Overall, the survey seems adequate to reveal which skills and activities clinical engineers considered the most relevant, but more responses are required before a solid Body of Knowledge and Body of Practice can be defined.
Published: 3 November 2019
Global Clinical Engineering Journal, Volume 2, pp 23-27; https://doi.org/10.31354/globalce.v2i1.58
This article presents an integration project between the anesthetic station used in the step of trans-operative (life signals multiparameter monitor, anesthesia device and controlled target infusion pump) and the system of hospital information. The main goal of this project is to capture in an automatic way the vital signals from the medical equipment and the records trans-operatives and provide an anesthesia record to be storage in the patient’s electronic medical record (PEMR). The integration mode is through a gateway that execute the conversion of the machine - specific language into data/information of the HL7 standard. This interaction will allow to integrate data and information from multiparametric monitors, anesthesia devices, Controlled target Infusion pumps and the intra-operative anesthesiologist inputs.
Published: 3 November 2019
Global Clinical Engineering Journal, Volume 2, pp 7-14; https://doi.org/10.31354/globalce.v2i1.54
This project aims to demonstrate a multi-parametric method of hospital technology comparison. The main goal was to develop a method to assist the clinical and hospital engineering team, in the process of acquisition and incorporation of medical-hospital equipment, to be used as a tool in the comparison stage of brand options and models of available equipment in the market. The method is composed by groups of criteria or characteristics that can be evaluate referring to the technologies to be compared. This method was applied to compare autoclaves and disinfecting machines that would be purchased to install in a Material Central and Sterilization (CME) in a hospital in the south of Brazil. As a result, it was obtained the classifications with the final scoring referring to each brand and model of technology. It also contributed significantly to assist the choice definition of the equipment, considering the hospital and technology profile, as well as the requirements and expectations of the multi-professional technical group of evaluators and users.
Published: 2 August 2019
Global Clinical Engineering Journal, Volume 2, pp 5-6; https://doi.org/10.31354/globalce.v2i1.68
Published: 11 July 2019
Global Clinical Engineering Journal, Volume 2, pp 2-3; https://doi.org/10.31354/globalce.v2i1.66
Published: 29 June 2019
Global Clinical Engineering Journal, Volume 1, pp 35-42; https://doi.org/10.31354/globalce.v1i2.61
Background & Objective:The need for surgery is currently not met in Sub-Saharan Africa, requiring both extra workforce and surgical equipment. Currently, there is a gap in the availability of surgical equipment which, among others, limits the provision of safe surgery. To design strategies to increase availability, the use of surgical equipment in this context needs to be understood. This study aims to: 1) identify the different phases surgical equipment goes through during its lifespan (i.e. the surgical equipment journey) in Kenya, and to 2) identify barriers that are perceived by biomedical equipment technicians (BMETs). Material & Methods:Seven semi-structured in-depth interview sessions were conducted with a total of 17 BMETs working in Kenya. Participants worked in six different hospitals (four public, one private and one mission). Interviews were conducted between December 2016 and December 2018. Participants were asked to describe or draw the surgical equipment journey and describe the perceived barriers during this journey. Results:The surgical equipment journey consists of three phases: procurement, usage, and disposal. Stakeholders involved in the surgical equipment journey are users, BMETs, procurement officers, local distributors and in case of donations, donation agencies. Bureaucracy during procurement, difficulties to obtain consumables and spare parts (especially for donated equipment), cleaning with heavy chemicals, and usage in challenging environments were identified as barriers during the surgical equipment journey. Conclusion:Sustainable interventions at multiple organisational levels are required to optimize the surgical equipment journey in hospitals in Kenya. Different strategies that can be applied in parallel to increase availability of surgical equipment in Kenya were identified by the participants in this study: policies on donations, procurement of durable equipment, more well-trained BMETs and university-trained biomedical engineers, and designs and business models that fit the local use in Kenya and presumably other countries in Sub-Saharan Africa.
Published: 15 April 2019
Global Clinical Engineering Journal, Volume 1, pp 22-34; https://doi.org/10.31354/globalce.v1i2.44
Background and Objective: Although developing countries have been receiving donations of medical equipment for many years, a number of studies have indicated that a high percentage of donated equipment is never put into use. [1,3,4] Many of the reasons for this can be traced back to inadequate donation practices on the part of donor organizations. The objective of this study was to gain an improved understanding of the practices and challenges associated with medical equipment donations by Canadian charitable organizations. Material and Methods: Forty-one organizations (registered and non-registered charities, non-governmental organizations (NGOs), non-profit organizations, medical clinics, and hospitals) completed an online survey, and 16 respondents were interviewed via telephone or in person. In addition, representatives from 28 hospitals in Ghana were interviewed in person to gain an understanding of the recipient experience. Results: We observed that for many Canadian donor organizations there is room for improvement in formalizing procedures, testing to verify equipment functionality before shipping, providing additional support for recipients in the form of manuals, spare parts and training, and long-term monitoring of donated items to measure effectiveness. For recipients, the most common challenges faced were lack of spare parts, and lack of operating or service manuals. Despite these challenges, all of the Ghanaian survey respondents said that donated medical equipment benefited their hospitals. Conclusion: We concluded that because of staffing limitations in smaller donor organizations, and in order to better meet the needs of recipients, it would be beneficial for Canadian organizations to communicate and collaborate with one another to share resources and expertise when planning donations overseas.