Pub Date : 2024-04-01DOI: 10.1097/jce.0000000000000639
Michael Levin-Epstein
{"title":"FDA Issues New Medical Device Guidance","authors":"Michael Levin-Epstein","doi":"10.1097/jce.0000000000000639","DOIUrl":"https://doi.org/10.1097/jce.0000000000000639","url":null,"abstract":"","PeriodicalId":77198,"journal":{"name":"Journal of clinical engineering","volume":"11 8","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140352503","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}
Pub Date : 2024-04-01DOI: 10.1097/jce.0000000000000635
Zhuang Chen, Frank E. Block
Medical device supply chain shortages have the potential to negatively impact patient care when patients and caregivers are unable to obtain the medical devices they need. The US Food and Drug Administration (FDA), specifically the Center for Devices and Radiological Health, received expanded authorities requiring medical device manufacturers to notify the FDA of any interruption or discontinuance of medical devices during or in advance of a public health emergency. The clinical community, in particular, healthcare technology managers, can provide additional information and perspective to the FDA by voluntarily reporting any device availability concerns. This will provide the FDA with more data about the current supply chain landscape and drive communication about the issue. Ultimately, improved information sharing will help ensure devices are available when and where they are needed to protect the health of the nation's patients and healthcare workers into the future.
当患者和护理人员无法获得所需的医疗器械时，医疗器械供应链的短缺有可能对患者护理产生负面影响。美国食品和药物管理局 (FDA)，特别是器械和放射卫生中心，获得了更大的授权，要求医疗器械制造商在公共卫生突发事件期间或之前通知 FDA 任何医疗器械的中断或中止。临床社区，特别是医疗保健技术经理，可以通过自愿报告任何设备可用性问题，向食品及药物管理局提供更多信息和观点。这将为 FDA 提供更多有关当前供应链状况的数据，并推动有关该问题的沟通。最终，改善信息共享将有助于确保在需要的时间和地点提供设备，从而在未来保护全国患者和医护人员的健康。
{"title":"Building Medical Device Supply Chain Resilience With the US Food and Drug Administration","authors":"Zhuang Chen, Frank E. Block","doi":"10.1097/jce.0000000000000635","DOIUrl":"https://doi.org/10.1097/jce.0000000000000635","url":null,"abstract":"Medical device supply chain shortages have the potential to negatively impact patient care when patients and caregivers are unable to obtain the medical devices they need. The US Food and Drug Administration (FDA), specifically the Center for Devices and Radiological Health, received expanded authorities requiring medical device manufacturers to notify the FDA of any interruption or discontinuance of medical devices during or in advance of a public health emergency. The clinical community, in particular, healthcare technology managers, can provide additional information and perspective to the FDA by voluntarily reporting any device availability concerns. This will provide the FDA with more data about the current supply chain landscape and drive communication about the issue. Ultimately, improved information sharing will help ensure devices are available when and where they are needed to protect the health of the nation's patients and healthcare workers into the future.","PeriodicalId":77198,"journal":{"name":"Journal of clinical engineering","volume":"18 11","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140354503","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}
Pub Date : 2024-04-01DOI: 10.1097/jce.0000000000000644
Binseng Wang, Torgeir Rui, Scott Skinner, Morgan Ayers-Comegys, Jason Gibson, Steve Williams
It has been long assumed that medical equipment deteriorates gradually with time (also known as wear-out or aging) like industrial equipment or human beings. An analysis of approximately 342 000 pieces of medical equipment managed for 30+ years by a single service provider shows this hypothesis is not always true. Some equipment will exhibit aging, whereas others can be deployed until a catastrophic event occurs and replacement is preferable than repair considering costs, downtimes, and/or technical/clinical innovations. Such knowledge can help to determine the best maintenance strategy for each type or even brand/model of equipment, as well as to optimize replacement planning, instead of blindly following recommendations made by manufacturers and/or age-based replacements often suggested by consultants. The first of this series of 3 articles presents the aging impact on maintenance, whereas the second one analyzes the impact on equipment lifespan. The final article reviews the root causes of aging and presents a simple, intuitive aging model that can be used for both maintenance and replacement plannings without having to analyze individual equipment types or individual brands and models in a comprehensive manner.
{"title":"Medical Equipment Aging","authors":"Binseng Wang, Torgeir Rui, Scott Skinner, Morgan Ayers-Comegys, Jason Gibson, Steve Williams","doi":"10.1097/jce.0000000000000644","DOIUrl":"https://doi.org/10.1097/jce.0000000000000644","url":null,"abstract":"It has been long assumed that medical equipment deteriorates gradually with time (also known as wear-out or aging) like industrial equipment or human beings. An analysis of approximately 342 000 pieces of medical equipment managed for 30+ years by a single service provider shows this hypothesis is not always true. Some equipment will exhibit aging, whereas others can be deployed until a catastrophic event occurs and replacement is preferable than repair considering costs, downtimes, and/or technical/clinical innovations. Such knowledge can help to determine the best maintenance strategy for each type or even brand/model of equipment, as well as to optimize replacement planning, instead of blindly following recommendations made by manufacturers and/or age-based replacements often suggested by consultants. The first of this series of 3 articles presents the aging impact on maintenance, whereas the second one analyzes the impact on equipment lifespan. The final article reviews the root causes of aging and presents a simple, intuitive aging model that can be used for both maintenance and replacement plannings without having to analyze individual equipment types or individual brands and models in a comprehensive manner.","PeriodicalId":77198,"journal":{"name":"Journal of clinical engineering","volume":"4 10","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140355090","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}
Pub Date : 2024-01-01DOI: 10.1097/jce.0000000000000630
{"title":"German Federal Institute Issues Warning About Counterfeiters","authors":"","doi":"10.1097/jce.0000000000000630","DOIUrl":"https://doi.org/10.1097/jce.0000000000000630","url":null,"abstract":"","PeriodicalId":77198,"journal":{"name":"Journal of clinical engineering","volume":"12 9","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139125805","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}
Pub Date : 2024-01-01DOI: 10.1097/jce.0000000000000620
Anna Shirazyan
The Food and Drug Administration (FDA) conducts postmarket review of medical devices as a part of its mission to protect patient safety and ensure product safety and effectiveness. Medical device reports (MDRs) are one way the FDA receives information on adverse events involving medical devices. Medical device reports can be submitted by manufacturers, importers, user facilities, and the public. User facilities are required to report device-related adverse events that resulted in a serious injury or death. In addition, user facilities are encouraged to submit voluntary medical reports where a device problem has the potential for patient harm. The FDA receives MDRs from user facilities through the MedWatch and Medical Product Safety Network programs. When reporters include detailed background information in their reports, they can directly contribute to meaningful action. Health technology management personnel, including clinical engineers, have unique insights into medical device problems and can provide valuable background information in MDRs. The highlighted examples hereinafter illustrate 2 cases where more detailed information included in MDRs was essential and contributed to a class I recall of a medical device.
美国食品和药物管理局（FDA）对医疗器械进行上市后审查是其保护患者安全、确保产品安全和有效性任务的一部分。医疗器械报告 (MDR) 是 FDA 接收医疗器械不良事件信息的一种方式。医疗器械报告可由制造商、进口商、用户机构和公众提交。用户机构必须报告导致严重伤害或死亡的与器械有关的不良事件。此外，如果器械问题有可能对病人造成伤害，我们鼓励用户机构自愿提交医疗报告。FDA 通过 MedWatch 和医疗产品安全网络计划接收来自用户机构的 MDR。如果报告人在报告中提供详细的背景信息，就能直接促进采取有意义的行动。卫生技术管理人员，包括临床工程师，对医疗器械问题有独特的见解，可以在 MDR 中提供有价值的背景信息。以下重点举例说明了两个案例，在这两个案例中，MDR 中包含的更多详细信息至关重要，并促成了医疗器械的 I 类召回。
{"title":"Analysis of Medical Device Reports That Contributed to a Class I Recall","authors":"Anna Shirazyan","doi":"10.1097/jce.0000000000000620","DOIUrl":"https://doi.org/10.1097/jce.0000000000000620","url":null,"abstract":"The Food and Drug Administration (FDA) conducts postmarket review of medical devices as a part of its mission to protect patient safety and ensure product safety and effectiveness. Medical device reports (MDRs) are one way the FDA receives information on adverse events involving medical devices. Medical device reports can be submitted by manufacturers, importers, user facilities, and the public. User facilities are required to report device-related adverse events that resulted in a serious injury or death. In addition, user facilities are encouraged to submit voluntary medical reports where a device problem has the potential for patient harm. The FDA receives MDRs from user facilities through the MedWatch and Medical Product Safety Network programs. When reporters include detailed background information in their reports, they can directly contribute to meaningful action. Health technology management personnel, including clinical engineers, have unique insights into medical device problems and can provide valuable background information in MDRs. The highlighted examples hereinafter illustrate 2 cases where more detailed information included in MDRs was essential and contributed to a class I recall of a medical device.","PeriodicalId":77198,"journal":{"name":"Journal of clinical engineering","volume":"51 18","pages":"22 - 24"},"PeriodicalIF":0.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139126487","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}
Pub Date : 2024-01-01DOI: 10.1097/jce.0000000000000629
{"title":"GlobalData Emphasizes Balancing Innovation and Accessibility in Advanced Medical Devices","authors":"","doi":"10.1097/jce.0000000000000629","DOIUrl":"https://doi.org/10.1097/jce.0000000000000629","url":null,"abstract":"","PeriodicalId":77198,"journal":{"name":"Journal of clinical engineering","volume":"14 7","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139127105","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}
Pub Date : 2024-01-01DOI: 10.1097/JCE.0000000000000624
{"title":"The Application of ISO 11138-7 for Industrial Ethylene Oxide Sterilization Qualification","authors":"","doi":"10.1097/JCE.0000000000000624","DOIUrl":"https://doi.org/10.1097/JCE.0000000000000624","url":null,"abstract":"","PeriodicalId":77198,"journal":{"name":"Journal of clinical engineering","volume":"38 8","pages":"15 - 17"},"PeriodicalIF":0.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139125663","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}
Pub Date : 2024-01-01DOI: 10.1097/JCE.0000000000000621
Ignacio M. Marolla
Given the need to acquire magnetic resonance imaging equipment through public tender, and to objectify the decision-making process, which takes into account multiple variables, a mathematical model has been developed based on the use of the analytic hierarchy process multicriteria analysis method, the linear weighting method, and the use of indicators to compare offers. For this purpose, a hierarchy of evaluating criteria to aid in selection processes has been defined and compared by a multidisciplinary team consisting of engineers, medical imaging specialists, lawyers, and economists who collaboratively developed and obtained a criteria prioritization scheme. Within this scheme, suppliers' offers were evaluated through indicators and then weighted accordingly to obtain a numerical ranking. The method has turned out to be applicable in evaluating and selecting highly complex biomedical technology and provides a hierarchical ranking of offers based on a numerical priority that considers multiple criteria. In the fast-growing market of medical technology, this method improves evaluative processes that depend on multiple criteria and helps institutions reduce risk when making decisions.
{"title":"Methodology for the Evaluation and Selection of High-Complexity Medical Equipment","authors":"Ignacio M. Marolla","doi":"10.1097/JCE.0000000000000621","DOIUrl":"https://doi.org/10.1097/JCE.0000000000000621","url":null,"abstract":"Given the need to acquire magnetic resonance imaging equipment through public tender, and to objectify the decision-making process, which takes into account multiple variables, a mathematical model has been developed based on the use of the analytic hierarchy process multicriteria analysis method, the linear weighting method, and the use of indicators to compare offers. For this purpose, a hierarchy of evaluating criteria to aid in selection processes has been defined and compared by a multidisciplinary team consisting of engineers, medical imaging specialists, lawyers, and economists who collaboratively developed and obtained a criteria prioritization scheme. Within this scheme, suppliers' offers were evaluated through indicators and then weighted accordingly to obtain a numerical ranking. The method has turned out to be applicable in evaluating and selecting highly complex biomedical technology and provides a hierarchical ranking of offers based on a numerical priority that considers multiple criteria. In the fast-growing market of medical technology, this method improves evaluative processes that depend on multiple criteria and helps institutions reduce risk when making decisions.","PeriodicalId":77198,"journal":{"name":"Journal of clinical engineering","volume":"17 11","pages":"25 - 29"},"PeriodicalIF":0.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139126312","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}
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