Global Clinical Engineering Journal最新文献

{"title":"A Landscape Study to Determine the Innovation Mortality Rate in Health Technology Innovations Across the Globe","authors":"Sambhu Ramesh, Annie Nithyavathani J, Moinudeen Syed, Kavita Kachroo, Jitendra Kumar Sharma, A. Priyadarshini, Penta Sneha Latha, Sushmita Roy Chowdary","doi":"10.31354/globalce.v6i2.169","DOIUrl":"https://doi.org/10.31354/globalce.v6i2.169","url":null,"abstract":"Introduction : Health technology innovation encompasses many areas, such as medical devices, diagnostics, pharmaceuticals, digital health solutions, telemedicine, health informatics, and more. These innovations aim to enhance healthcare delivery, improve patient outcomes, increase access to services, reduce costs, and advance medical research.\u0000Methodology : We have analyzed health technology innovations reported between January 2011 and December 2022. Regulatory approval for the innovative products was determined based solely on official open-access websites of health agencies, disregarding information from company websites or third-party sources. The search process utilized identified innovation agencies and sources like Primary Health Care (Innovations were thoroughly examined from these sources, focusing on health technologies, and success was gauged through regulatory approval.\u0000Results : The WHO Compendium includes 200 health innovations primarily intended for low-resource settings, with the USA accounting for the highest number, followed by India, the only low- and middle-income country (LMIC) with significant innovations. However, 58% of the listed innovations did not obtain regulatory clearance. Medical devices dominated the listed innovations, while scalable assistive technologies were limited. Global innovation agencies, particularly Grand Challenges, supported many innovations, but the regulatory approval rate remained low. In India, BIRAC supported 92% of the mapped innovations, with a similar trend of low regulatory approval rates.\u0000Conclusion: The study observed the highest number of innovations during 2015-2017, with medical devices being the most prominent category. However, most innovations from both global and domestic agencies were unapproved, raising concerns about regulatory clearance for these health technologies.\u0000Manuscript Highlights: The manuscript presents several important highlights concerning health technology innovation and regulatory approval. It highlights the evaluation of health innovations from 2015 to 2022, focusing on their success rate based on health agency approval. It reveals an uneven distribution of innovations from different countries and emphasizes the need for critical interventions to improve the process. This study emphasizes the significance of innovations in achieving healthcare equity and sustainable development goals.","PeriodicalId":318587,"journal":{"name":"Global Clinical Engineering Journal","volume":"100 24","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-04-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140754273","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Sustainable procurement of medical devices in an international context - Part 3","authors":"Valerio Di Virgilio, Francisco Becerra Posada, Alexia Bouchard Saindon","doi":"10.31354/globalce.v6i2.168","DOIUrl":"https://doi.org/10.31354/globalce.v6i2.168","url":null,"abstract":"Background and Objectives\u0000This article is the third in a series of three manuscripts published in this journal. It aims to describe how sustainable procurement of medical devices (MDs) can be implemented in operational projects in the context of developing countries. It also further details how the biomedical/clinical engineer lead (BCEL) in charge of technical support during the MD procurement process can apply sustainability principles and concepts of value-based procurement.\u0000Material and Methods\u0000Based on the authors’ experience of more than 20 years in procurement projects and implementation of MDs, the role of the BCEL will be developed from a theoretical point of view with the description of the second and third pillars of a sustainable purchase following the needs assessment: the assessment of existing conditions along with local capacities and the evaluation of the use conditions during the lifetime of the medical equipment. The application of these principles in operational projects will be further discussed by analyzing literature and lessons learned from projects implemented in developing countries.\u0000Results/Proposal\u0000The BCEL has a key role in the sustainable procurement of MDs to design the technical specifications of the goods, related services, and post-sales conditions to maximize the benefit of the investment. As the specialist can analyze the local existing conditions and capacities while ensuring efficient use of the MDs during their lifespan, they can contribute to a sustainable implementation of MDs in developing countries.\u0000 \u0000The BCEL shall also be able to analyze the local and international markets to find all possible technological solutions that meet the needs, local conditions, and capacities and ensure quality use during the lifespan of the purchased MD. The BCEL shall have competencies in identifying all the risks related to the use of the MD from the safety risks linked to its installation, use, and maintenance to the sustainability risks linked to obtaining the conditions that guarantee the use of the device and maintaining them as long as possible. Examples of these conditions include the presence of qualified and trained users, availability of maintenance and consumable budgets, availability and maintenance of infrastructure conditions (access, electrical power, water, drainage, medical gasses, etc.), and last but not least, presence of patients requiring a diagnosis or treatment using the purchased MD who were identified during the evaluation of the first pillar: a sound needs assessment.\u0000Conclusion\u0000As an evolution of the BCEL’s traditional biomedical and clinical engineering work, he/she shall assume the responsibility to guarantee the sustainability of the MD purchase. This quality assurance and control role is achieved by a sound theoretical background knowledge based on the three sustainable procurement pillars: the needs, existing and lifetime use conditions assessments, the analysis of the local and internationa","PeriodicalId":318587,"journal":{"name":"Global Clinical Engineering Journal","volume":"28 17","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-04-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140753904","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Healthcare Providers’ Readiness to Address Medical Device Cybersecurity within the Irish Healthcare System","authors":"Dara Keeley","doi":"10.31354/globalce.v6i2.158","DOIUrl":"https://doi.org/10.31354/globalce.v6i2.158","url":null,"abstract":"Medical devices that can diagnose and treat critically ill patients have become sophisticated and complex. Device manufacturers have been developing these systems to meet market requirements as technology evolves. Combining medical devices and ICT into a distributed medical device IT system can be a solution to incorporating continuous monitoring from the patient bedside to interoperability with a clinical information system. These technology innovations aim to manage patient data and configure medical devices into networked systems that can provide functionality and safety. The implementation of a medical device network solution allows a healthcare provider to take advantage of managing the flow of information to improve clinical work practices and implement a system that can be interoperable with other clinical information systems.\u0000 \u0000International Electrotechnical Commission (IEC) 80001-1 was developed to assist healthcare providers in identifying and managing the risks associated with medical devices sharing the same IT network with other systems and software. This standard defines roles, responsibilities, and activities in relation to the management of risk with medical devices on an IT network.\u0000This study aims to determine if the standard International Electrotechnical Commission (IEC) 80001-1 is being implemented and determine familiarity with regulations and appropriate standards and guidance for an effective medical device security risk-management program with Irish healthcare providers.\u0000A literature review highlighted the restrictions healthcare providers face in adopting and implementing IEC 80001-1 and the security threats and risks present when integrating medical devices and IT networks. The study research was conducted with clinical engineering members of the Biomedical and Clinical Engineering Association of Ireland (BEAI). This survey targeted BEAI members due to their wealth of experience, knowledge, and skill level in supporting complex medical device systems. An online anonymous survey was created to determine knowledge, awareness, and familiarity with IEC 80001-1 and other medical device security risk-management guidelines.\u0000The study research results revealed low knowledge, awareness, and familiarity among research participants with IEC 80001-1 and guidelines on medical device security risk management. These results were consistent with the literature review that a key to the success of standard adoption is collaboration between stakeholders and a multidisciplinary approach to compliance.","PeriodicalId":318587,"journal":{"name":"Global Clinical Engineering Journal","volume":"380 ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-04-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140751482","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Sustainable procurement of medical devices in an international context - Part 2","authors":"Valerio Di Virgilio, Alexia Bouchard Saindon, Francisco Becerra Posada","doi":"10.31354/globalce.v6i1.165","DOIUrl":"https://doi.org/10.31354/globalce.v6i1.165","url":null,"abstract":"Background and Objectives: This article describes how sustainable procurement of medical devices (MDs) can be implemented in operational projects in developing countries. It also further details how sustainability principles and the needs assessment can be applied by the biomedical/clinical engineer lead (BCEL) responsible for the technical and quality aspects of the procurement process of MDs. It also emphasizes the importance of the BCEL considering the country’s or region’s specific healthcare context when working on MD procurement projects in developing countries.Material and Methods: This article describes how sustainable procurement of medical devices (MDs) can be implemented in operational projects in developing countries. It also further details how sustainability principles and the needs assessment can be applied by the biomedical/clinical engineer lead (BCEL) responsible for the technical and quality aspects of the procurement process of MDs. It also emphasizes the importance of the BCEL considering the country’s or region’s specific healthcare context when working on MD procurement projects in developing countries.Results: The BCEL has a key role in the sustainable procurement of MDs as an integrator able to understand clinical needs and translate them into requirements while being aware of the sustainability and safety risks linked to technology implemented in the fragile environment of a developing country with limited resources. This context also creates additional challenges that can be managed if the BCEL is conscious of the country’s health expenditure, geopolitical, healthcare, model of care, regulatory, infrastructure, and logistical conditions in which the MDs will be installed. Many equipment may remain unused if the technology implementation is not in line with the needs of the beneficiaries. Therefore, a thorough needs assessment performed by the BCEL to obtain the detailed list of MDs, their technological level and estimated budget is of utmost importance to increase the project’s sustainability and mitigate the risk of unused MDs.Conclusion: Besides traditional disciplines in biomedical and clinical engineering, the BCEL shall also learn at least basic principles in public health, healthcare planning, project management, health infrastructure, and development aid to facilitate the dialogue with stakeholders based on knowledge, flexibility, and capacity to anticipate and solve practical issues on the ground. To this extent, it is advisable for a BCEL new to the environment of developing countries to have progressive exposure to more complex projects and to extensively use the peer review mechanism to assure sustainability and quality during project implementation. A theoretical background based on sustainable procurement principles, analysis of the local and national health context and regulations, and knowledge of lessons learned from past projects should guide the BCEL’s approach to performing the needs assessment while ","PeriodicalId":318587,"journal":{"name":"Global Clinical Engineering Journal","volume":"1 5","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-12-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138584783","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Clinical Engineering and health policies in Venezuela: challenges and achievements in a changing political context","authors":"Rodrigo Mijares","doi":"10.31354/globalce.v6i1.161","DOIUrl":"https://doi.org/10.31354/globalce.v6i1.161","url":null,"abstract":"This article summarizes the evolution of clinical engineering in Venezuela and its interaction with the political environment and health policies.\u0000Method: The study consists of a comprehensive review of publications from the Health Technologies Management Unit of Simón Bolívar University throughout 1992-2023, organized into three thematic areas: Technological and Environmental; Relationship with Public Health Policies; and Influence of the Political System.\u0000Conclusions: The early history of clinical engineering in Venezuela stands out for its impact on training and technological management to ensure quality and efficiency in the Venezuelan healthcare system. In the first area, it demonstrated the potential for improvement in medical technologies, generating high expectations. The second area focuses on the relationship between technologies and health policies, emphasizing the need to align public policies and technological management. However, challenges identified include the lack of evaluation and selection of appropriate medical technologies and political influence in acquisitions. The third area addresses political influence on the quality of medical care, emphasizing the importance of considering political and technological aspects in decision-making.","PeriodicalId":318587,"journal":{"name":"Global Clinical Engineering Journal","volume":"54 3","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-12-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138982420","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Internet of Things and Digital Twin Technology-Based Management System of Medical Equipment","authors":"Wanrong Liu, Bin Li, Zhiyong Ji","doi":"10.31354/globalce.v6i1.164","DOIUrl":"https://doi.org/10.31354/globalce.v6i1.164","url":null,"abstract":"Background: In recent years medical technology has progressed with the rapid development of medical services and required optimization of medical equipment. However, a lack of effective management methods has led to the inefficient use of medical equipment. Therefore, an effective medical equipment management mode is urgently needed to address these problems and challenges.\u0000Methods: The Internet of Things and digital twin technology are applied to intelligent medical equipment management as the current standard of medical equipment management.\u0000Results: The intelligent perception terminal can realize the dynamic acquisition of real data, such as the location, process, and efficient use of medical equipment, and help carry out digital, networked, and intelligent monitoring and analysis. Meanwhile, applications such as dynamic management software, real-time positioning software, and space-environment quality monitoring software are being developed.\u0000Conclusion: Automatic, intelligent, and visual management of medical equipment configurations, operations, and performance evaluation, combined with good management based on digital twinning, can improve collaborative management efficiency and operation resource support.","PeriodicalId":318587,"journal":{"name":"Global Clinical Engineering Journal","volume":"2 7","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-12-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138584910","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Analysis of Adverse Event Reports in FDA’s MAUDE Database","authors":"Spilios Zisimopoulos, Nicolas Pallikarakis","doi":"10.31354/globalce.v6i1.157","DOIUrl":"https://doi.org/10.31354/globalce.v6i1.157","url":null,"abstract":"Background and Objective: Medical devices (MDs) play a pivotal role in the modern healthcare environment. Adverse events are an expected part of an MD’s lifecycle. To prevent the recurrence of such events, various vigilance systems have been established worldwide. The Manufacturer and User facility Device Experience (MAUDE) database of the US Food and Drug Administration (FDA) is a publicly accessible database that contains data of medical device reports (MDRs) submitted to FDA since 1991. The aim of this study is to examine the evolution of MD adverse event reports and analyze several characteristic parameters, as they evolved during the last three decades. \u0000Material and Methods: An analysis of MAUDE data was performed to examine the outcomes and device characteristics of adverse event reports from 1991 up to 11/2022. These outcomes included the event type, remedial action, report source, reporter occupation and device evaluation by manufacturer. Specific MD groups were analyzed separately to examine their effect on the event outcomes. Segregated files of the database that contain different types of information on adverse event reports were combined to investigate the various aspects of these reports. \u0000Results: Event outcomes are presented as annual histograms. An overall of about 15 million reports have been submitted to MAUDE during the 30 years period examined with more than 2.5 million of them during the first 10 months of the year 2022. This number is growing at an increasing rate. Most of the events (63.5%) have resulted in simple device malfunction, without serious implications to the patient. Depending on the device type however, the health risks may be higher (98.4% injuries from specific dental implants and 3.2% deaths from implantable defibrillators). About 20% of the reports have led to recalls or other corrective actions. Most of the reports (96%) are submitted by manufacturers and over 70% of the devices returned to them are evaluated, following the requirements of FDA 21 CFR, 803. The reporter’s occupation was found to be related to the types of devices associated with the event. Finally, the average device age was found to be 4 years, with an increasing tendency observed over the years, while still most of the events occur during the first year of operation. \u0000Conclusion: A medical device adverse event reporting system is a critical component of safety in the use of medical technology in modern healthcare. The information available in MAUDE and its use continues to grow at an accelerated rate and allows critical improvements of MDs, especially in terms of risk prevention, as it gives perception about their safety issues. FDA has taken various steps to encourage and facilitate adverse event reporting and make the data available to the public.","PeriodicalId":318587,"journal":{"name":"Global Clinical Engineering Journal","volume":"4 8","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-12-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138585006","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Application of statistical processes control for the performance improvement of a clinical engineering department","authors":"Edgar González Campos","doi":"10.31354/globalce.v6i1.160","DOIUrl":"https://doi.org/10.31354/globalce.v6i1.160","url":null,"abstract":"This article addresses the fundamental role of Statistical as a quality tool in the field of clinical engineering, to improve and optimize internal processes. This study describes the methodology used to apply the SPC in a reference hospital's clinical engineering department. Data was collected over an extensive period, involving multiple medical equipment and verification procedures. These data were analyzed using various statistical tools, such as control charts, Pareto charts, and descriptive statistics.\u0000The results showed stability in the department's processes, which made it possible to identify areas for potential improvement. Statistical analyses revealed behavior patterns and trends that were not previously apparent. Based on these conclusions, specific modifications were proposed in the department's processes to optimize efficiency, reduce costs, and improve service quality.\u0000The implementation of these modifications based on evidence suggests that they would positively impact the general performance of the clinical engineering department if applied Key indicators could improve significantly, reflecting increased medical equipment reliability and availability, decreased unscheduled downtime, and increased satisfaction for department staff and equipment users.\u0000In summary, this study highlights the importance of using SPC as a powerful improvement tool in clinical engineering. By adopting an approach based on data and scientific evidence, clinical engineering departments can achieve more efficient and effective management of their processes, contributing to higher-quality medical care and patient safety.","PeriodicalId":318587,"journal":{"name":"Global Clinical Engineering Journal","volume":"6 14","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-12-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138584891","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Application of Molecular Sieve Oxygen Generation Mini-plant under Harsh Environment","authors":"Ji-xue Liu, Chao Qiu, Jianxiong Zuo, Xiaomin Lou","doi":"10.31354/globalce.v5i3.148","DOIUrl":"https://doi.org/10.31354/globalce.v5i3.148","url":null,"abstract":"Pressure Swing Adsorption (PSA) oxygen generation mini-plant is widely used in all various hospitals for its fast, convenient, and cost-effective features. However, considering the landscape of global markets, the PSA medical oxygen generation mini-plant design basis varies from location to location. Therefore, it forces the manufacturer to design and build the PSA oxygen generation mini-plant more flexibly to enable its compatibility in different extreme ambient conditions (temperature, humidity, pressure, cleanliness) of installation location. For the sake of these concerns, this paper employs the concept of modularity as an approach to PSA medical-grade oxygen generation mini-plant design and application and elaborates 10 key components for 4 modules of PSA medical-grade oxygen generation mini-plant, namely (a) air compressor module; (b) PSA module; (c) oxygen compressor module; (d) smart control module. Under this modularized design approach, this paper investigates the technical features and the design criticality of modular and key components in fulfilling the expected performance, finally achieving and maintaining the overall performance of PSA oxygen generation mini-plant with the selected modules which may be installed worldwide. This paper helps to highlight the variability of PSA oxygen generation mini-plants in harsh environments in four dimensions (temperature, humidity, pressure, cleanliness) and briefs the methodology of the phase gate model for modular approach in oxygen generation mini-plant. It contributes to the literature on this important subject in the modularized design method, adsorption technology, air separation process, etc.","PeriodicalId":318587,"journal":{"name":"Global Clinical Engineering Journal","volume":"1 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-07-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"130320931","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Engineering Report","authors":"Y. David","doi":"10.31354/globalce.v5i3.154","DOIUrl":"https://doi.org/10.31354/globalce.v5i3.154","url":null,"abstract":"Engineering report by Yadin David.","PeriodicalId":318587,"journal":{"name":"Global Clinical Engineering Journal","volume":"14 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-07-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"133402246","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}