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Clinical Engineering Role in the Development of Emergency Use Medical Devices 临床工程在紧急医疗器械开发中的作用
Pub Date : 2022-03-01 DOI: 10.31354/globalce.v4i3.137
Roberto Ayala
Clinical Engineering professionals have a key role in healthcare institutions during the pandemic caused by the COVID-19 disease, mainly by supporting the front line by allowing the proper and timely access of the medical equipment required to diagnose and treat patients affected. But another one of their roles, probably one not so expected, has been their contributions for the development of emergency use medical devices, especially those for respiratory and oxygen therapy. By using the case of critical care use ventilators, and as presented during an IFMBE-CED webinar on the topic, this paper mentions the role of Clinical Engineers for the rapid response manufacturing of such vital care devices, in three main aspects: development, regulation and education. The results from such efforts have paid off by having safe and efficient support equipment while the shortage from commercial products have been receding, by establishing international guidelines for future innovators to take into consideration and by leaving valuable knowledge in the form of educational and training videos for future generations to consult from.
在2019冠状病毒病大流行期间,临床工程专业人员在医疗机构中发挥着关键作用,主要是通过允许适当和及时地获得诊断和治疗受影响患者所需的医疗设备来支持一线。但他们的另一个作用,可能是一个不太期望的作用,是他们对急救医疗设备的发展做出的贡献,特别是那些用于呼吸和氧气治疗的设备。通过使用重症监护使用呼吸机的案例,并在IFMBE-CED关于该主题的网络研讨会上提出,本文在三个主要方面提到了临床工程技术人员在快速反应制造这种重症监护设备方面的作用:开发,监管和教育。这些努力的成果取得了回报,有了安全有效的支助设备,而商业产品短缺的情况正在减少,制定了供未来创新者考虑的国际准则,并以教育和培训录象的形式留下宝贵的知识供后代参考。
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引用次数: 0
Analysis and Solution of Dental Unit Failure 牙单元故障的分析与解决方法
Pub Date : 2022-03-01 DOI: 10.31354/globalce.v4i3.134
Jinjiang Jin
Objective: To discuss and analyze the common causes of dental unit failures and summarize maintenance experiences. Methods: The failures were studied through retrospective analysis in our dental clinic from January 2019 to December 2019. Causes for four common failures were analyzed deeply, and the corresponding improvement solution was implemented. Results: These solutions reduced the failure rate for dental units and improved understanding of the importance of using and maintaining the equipment correctly.Conclusion: Analysing and improving proper maintenance can save costs for the hospital and effectively enhance the management level of medical equipment maintenance.
目的:探讨和分析牙单元故障的常见原因,总结维修经验。方法:回顾性分析2019年1月至2019年12月我院牙科门诊患者的失败情况。深入分析了四种常见故障的原因,并实施了相应的改进方案。结果:这些解决方案降低了牙科单元的故障率,提高了对正确使用和维护设备重要性的认识。结论:分析和改进适当的维修,可为医院节约成本,有效提高医疗设备维修管理水平。
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引用次数: 0
Status of Medical Devices and their Utilization in 9 Tertiary Hospitals and 5 Research institutions in Uganda 乌干达9所三级医院和5所研究机构医疗器械现状及其使用情况
Pub Date : 2022-03-01 DOI: 10.31354/GLOBALCE.V4I3.127
R. Ssekitoleko, B. N. Arinda, Solomon Oshabahebwa, L. K. Namuli, Julius Mugaga, C. Namayega, E. Opolot, Jackline Baluka, C. Ibingira, I. Munabi, M. Joloba
Backgrounds and Objective: Advancements in technology have led to great strides in research and innovation that have improved healthcare provision around the world. However, the majority of the technology available is underutilized in Sub-Saharan Africa. In addition, the ever-increasing sophistication and cost of medical equipment means that access and proper use is limited in low- and middle-income countries (LMICs). There is, however, a general paucity of well-documented evidence for the utilization of medical equipment in LMICs. Therefore, this study evaluates the current availability and utilization of medical equipment in tertiary hospitals and research facilities in Uganda and provides baseline information to clinical/biomedical engineers, innovators, managers, and policymakers.Material and Methods: The study evaluated the equipment currently used in 9 purposively selected public tertiary hospitals and 5 research laboratories representing different regions of Uganda. Data were collected by personnel specialized in biomedical engineering utilizing a mixed-method approach that involved inventory taking and surveys directed to the health workers in the designated health facilities. Results: The hospitals contributed 1995 (85%) pieces of medical equipment while the research laboratories contributed 343 (15%) pieces amounting to 2338 pieces of equipment involved in the study. On average, 34% of the medical equipment in the health facilities was faulty, and 85.6% lacked manuals.Discussion and conclusion: Although innovative solutions and donated equipment address the immediate and long-term goals of resource-constrained settings, our study demonstrated several issues around existing medical devices, and these need immediate attention.
背景和目的:技术的进步导致了研究和创新的巨大进步,改善了世界各地的医疗保健服务。但是,在撒哈拉以南非洲,现有的大多数技术没有得到充分利用。此外,医疗设备的复杂性和成本不断提高,意味着在低收入和中等收入国家获得和正确使用医疗设备的机会有限。然而,关于中低收入国家使用医疗设备的充分证据普遍缺乏。因此,本研究评估了乌干达三级医院和研究机构目前医疗设备的可用性和利用率,并为临床/生物医学工程师、创新者、管理人员和决策者提供了基线信息。材料和方法:该研究评估了目前在乌干达不同地区有目的地选择的9所公立三级医院和5个研究实验室使用的设备。数据由专门从事生物医学工程的人员收集,采用混合方法,包括对指定卫生设施的卫生工作者进行清查和调查。结果:医院提供医疗设备1995件(85%),研究实验室提供医疗设备343件(15%),共2338件。平均而言,卫生设施中34%的医疗设备有缺陷,85.6%缺乏手册。讨论和结论:虽然创新的解决方案和捐赠的设备解决了资源受限环境的近期和长期目标,但我们的研究表明,围绕现有医疗设备存在一些问题,这些问题需要立即得到关注。
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引用次数: 3
Overview of Trending Medical Technologies 趋势医疗技术概述
Pub Date : 2022-03-01 DOI: 10.31354/globalce.v4i3.142
J. Nkurunziza, J. C. Udahemuka, Jean Baptise Dusenge, Francine Umutesi
Healthy population is regarded as the most valuable asset of any country. Unfortunately, the health challenges that hinder mankind's wellbeing are enormously increasing. Examples include but are not limited to: the diversity of emerging diseases afflicting the global population, the projected demographic growth of elderly people who need consistent monitoring, the deficiency in medical staff, the lower density of physicians, and the challenging geographical location of the population from healthcare providers. The mitigation of such health challenges calls for novel technologies to improve patient outcomes. In this article, seven emerging technologies, namely: Wearable Devices and Internet of Things, Artificial Intelligence, Blockchain Technology or Distributed Ledger Technology, Robotics Technology, Telehealth and Telemedicine, Big Data Technology and Nanomedicine have been highlighted. For each discussed technology, its historical background, development drivers, market status and trends, significance to healthcare, key player companies, and associated challenges have been presented. The information contained in this paper was collected from different journal articles, websites, reports, conference proceedings, and books. It was observed that though the technologies discussed in this article show growth at different rates, healthcare technology development and implementation are very promising in revolutionizing the health sector and improving the health of the population. Therefore, healthcare providers and countries are recommended to put in place Healthcare Technology Assessment Programs to help them collect data regarding the technology efficacy, relevance, safety, outcomes, and alternative technologies towards better planning for healthcare services improvement.
健康的人口被视为任何国家最宝贵的财富。不幸的是,阻碍人类福祉的健康挑战正在急剧增加。例子包括但不限于:影响全球人口的新发疾病的多样性、需要持续监测的预计老年人人口增长、医务人员不足、医生密度较低以及人口在医疗保健提供者处的地理位置具有挑战性。缓解这些健康挑战需要新技术来改善患者的治疗结果。本文重点介绍了可穿戴设备和物联网、人工智能、区块链技术或分布式账本技术、机器人技术、远程医疗和远程医疗、大数据技术和纳米医学等七大新兴技术。对于所讨论的每种技术,都介绍了其历史背景、开发驱动因素、市场现状和趋势、对医疗保健的重要性、主要参与者公司以及相关挑战。本文中包含的信息来自不同的期刊文章、网站、报告、会议记录和书籍。有人指出,虽然本文讨论的技术显示出不同的增长速度,但医疗保健技术的开发和实施在改革卫生部门和改善人口健康方面非常有希望。因此,建议医疗保健提供者和国家实施医疗保健技术评估计划,以帮助他们收集有关技术有效性、相关性、安全性、结果和替代技术的数据,从而更好地规划医疗保健服务的改进。
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引用次数: 1
Editor's Corner 编辑器的角落
Pub Date : 2021-06-01 DOI: 10.31354/globalce.v4i2.129
E. Sloane
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引用次数: 0
Editor's Corner 编辑器的角落
Pub Date : 2020-12-01 DOI: 10.31354/globalce.v3i2.115
D. Yadin
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引用次数: 0
Unravelling the magic of latent safety threats 揭开潜在安全威胁的神秘面纱
Pub Date : 2020-12-01 DOI: 10.31354/globalce.v3i2.116
D. Yadin
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.
根据ECRI年度“2020年十大卫生技术危害”报告,医疗和牙科诊所的无菌处理错误被列为第三大危害。其他专家也对消毒过程提出了类似的担忧。例如,世卫组织和国际医学和生物工程联合会临床工程司合作举办了一系列网络研讨会,与国际专家就COVID-19相关关键主题交流知识。最近的一次网络研讨会讨论了低收入和中等收入国家对COVID-19医疗设备进行去污和消毒的关键挑战。在网络研讨会期间,与会者询问了评估感染传播是否由用于抗击该疾病的技术工具传播的方法。如何安全、快速地对关键的救生呼吸设备进行消毒,并将其从一个病人转移到另一个病人?世卫组织/IFMBE网络研讨会指出,“工程师和感染控制专业人员似乎在不同的领域工作”。必须拆除这种孤岛,因为医疗技术在提供保健服务方面是不可或缺的。医疗设备的消毒和灭菌是医疗机构的关键问题,他们需要认真考虑社会技术系统的相互作用。年度“十大卫生技术危害”报告基于回顾性研究,但COVID-19安全管理需要处理实时数据的能力和专家的投入,以预测可能发生的风险以及如何部署计划以维持安全的医疗保健环境。
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引用次数: 0
Emerging Horizons of Clinical Engineering in Disaster Preparedness and Management 灾害准备和管理临床工程的新视野
Pub Date : 2020-06-30 DOI: 10.31354/globalce.v3i1.98
Fred W. Hosea
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.
全球灾难准备不足——2020年的全球COVID-19危机令人不安地突显出,在应对我们这个时代最具破坏性的医疗灾难时,医疗系统、政府、医疗行业、市场和医疗保健专业在许多方面存在危险的分散、毫无准备、资源不足、极其缓慢和不协调。尽管各州和联邦机构进行了大量的威胁分析研究,详细的流行病情景和模拟,尽管在9/11后的国际灾难准备方面花费了数十亿美元,并多次发出顶级警告,但世界各国政府、市场和医疗保健系统未能做好准备,也未能防止一场健康灾难爆发为一场多维灾难。跨部门的计划和能力的碎片化,加上政治决策的复杂化,显然要求机构参与者之间进行关键任务的重组,在全球范围内采用更加协调、综合和面向系统的专业方法,并积极培养公共卫生情报。出于以下原因,临床和生物医学工程师是最适合在这一迫切需要的转变中承担扩大和全面领导作用的卫生专业人员之一。
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引用次数: 2
Bedside communication and management of vital parameters and alarms in care-intensive environments: Simulation model development for the clinical effectiveness analysis of an innovative technology 护理密集型环境中重要参数和警报的床边通信和管理:创新技术临床有效性分析的仿真模型开发
Pub Date : 2020-05-29 DOI: 10.31354/GLOBALCE.V2I3.86
Immacolata De Rosa, A. Pepino, G. Giaconia, Mario Guarino
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.
背景和目的。2001年12月31日第7301号审议文件规定在康复病房的最低设备内安装声光信号呼叫系统。然而,传统的呼叫系统效率低下,因为它们基于以下错误的假设:患者和工作人员不动,信息源是静态的,援助是单向的。照顾病人需要不同的人,他们应该是动态的,应该能够交换信息。此外,大量的临床呼叫和警报可能是一个问题,因为一方面它们对满足病人的需要至关重要,但另一方面它们可能给医务人员带来压力和额外的工作量。事实上,他们有时会忽略一些电话,或者在非紧急请求上浪费大量时间。此外,识别警报和及时干预似乎在旅行中更加困难。一个理想的报警系统应该有100%的灵敏度和特异性。尽管如此,警报器被设计得极其敏感,但却牺牲了特殊性。报警疲劳是指由于报警次数过多而造成的工作过载,是目前临床实践中一个严重的安全问题,因为它涉及到患者的脱敏和报警丢失,有时甚至会导致患者死亡。材料和方法。因此,应评估适当的通知方法,包括移动无线技术的有效性:将患者、工作人员、数据、服务和医疗设备连接起来,简化通信和工作流程。分析了与工作人员之间、患者与护理人员之间以及护理密集环境中的警报和重要参数分配有关的若干问题,重点分析了一项创新技术的临床效果,以支持医院急诊部的活动。之后,我们用Simul8创建了一个仿真模型,这样数字孪生就可以在两种情况下再现直接和间接的活动:有和没有(假设和事实模型)技术的帮助。结果和结论。该模型提供了一组关键绩效指标(执行活动的数量、平均警报解决时间、等待时间),在这些指标上应用补偿聚合方法,在这两种情况下详细说明一个单一的最终分数。在现状模型中,这个分数是52.5分,在假设模型中是80分。因此,临床效果得到了证明。
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引用次数: 1
A Model for Priority Setting in Health Technology Innovation Policy 卫生技术创新政策优先事项设定模型
Pub Date : 2020-05-19 DOI: 10.31354/GLOBALCE.V2I3.84
J. Sharma, J. Bunders, T. Zuiderent-Jerak, B. Regeer
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
卫生技术评估侧重于对引进市场的卫生技术进行平等评价。这使得监管机构和创新治理被动地依赖于创新者为技术发展所采取的主动行动,从而使其成为供应驱动型。决策者的作用已经变成了评价已经开发出来的技术,而不是指导发展议程。这严重限制了确保卫生技术充分解决诸如疾病负担、贸易逆差和卫生不平等等重大问题的可能性。它将政府排除在早期共同塑造技术的角色之外,限制了政府的参与,以促进规模扩大或不扩大。这使得难以实现卫生技术治理实践,这些实践最大限度地有助于确保技术发展实际解决公众关注的问题。改变这种动态的框架的潜力是什么?证据如何在不落入监管者锁定或社会工程陷阱的情况下塑造技术发展议程?本研究提出的方法迈出了重要的第一步,朝着建立以证据为基础的框架,确定优先事项,以指导创新,特别是在卫生和社会部门
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引用次数: 4
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Global Clinical Engineering Journal
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