Journal of clinical engineering最新文献_第3页

FDA Facilitates Expand Adoption of Vaporized Hydrogen Peroxide for Medical Device Sterilization 美国食品和药物管理局推动扩大采用蒸发过氧化氢进行医疗器械灭菌

Journal of clinical engineering Pub Date : 2024-04-01 DOI: 10.1097/jce.0000000000000634

Michael Levin-Epstein

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Building Medical Device Supply Chain Resilience With the US Food and Drug Administration 与美国食品和药物管理局共建医疗器械供应链复原力

Journal of clinical engineering Pub Date : 2024-04-01 DOI: 10.1097/jce.0000000000000635

Zhuang Chen, Frank E. Block

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Medical Equipment Aging 医疗设备老化

Journal of clinical engineering Pub Date : 2024-04-01 DOI: 10.1097/jce.0000000000000644

Binseng Wang, Torgeir Rui, Scott Skinner, Morgan Ayers-Comegys, Jason Gibson, Steve Williams

{"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}

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ACCE News ACCE 新闻

Journal of clinical engineering Pub Date : 2024-04-01 DOI: 10.1097/jce.0000000000000638

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German Federal Institute Issues Warning About Counterfeiters 德国联邦研究所发布关于假冒者的警告

Journal of clinical engineering Pub Date : 2024-01-01 DOI: 10.1097/jce.0000000000000630

引用次数: 0

Analysis of Medical Device Reports That Contributed to a Class I Recall 导致一级召回的医疗器械报告分析

Journal of clinical engineering Pub Date : 2024-01-01 DOI: 10.1097/jce.0000000000000620

Anna Shirazyan

{"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}

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GlobalData Emphasizes Balancing Innovation and Accessibility in Advanced Medical Devices GlobalData 强调先进医疗设备的创新性与可及性之间的平衡

Journal of clinical engineering Pub Date : 2024-01-01 DOI: 10.1097/jce.0000000000000629

引用次数: 0

InfoBionic Receives FDA 510(k) Clearance for Next-Generation MoMe ARC Solution InfoBionic 下一代 MoMe ARC 解决方案获得 FDA 510(k) 许可

Journal of clinical engineering Pub Date : 2024-01-01 DOI: 10.1097/jce.0000000000000628

Michael Levin-Epstein

引用次数: 0

The Application of ISO 11138-7 for Industrial Ethylene Oxide Sterilization Qualification ISO 11138-7 在工业用环氧乙烷灭菌鉴定中的应用

Journal of clinical engineering Pub Date : 2024-01-01 DOI: 10.1097/JCE.0000000000000624

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Methodology for the Evaluation and Selection of High-Complexity Medical Equipment 评估和选择高复杂性医疗设备的方法

Journal of clinical engineering Pub Date : 2024-01-01 DOI: 10.1097/JCE.0000000000000621

Ignacio M. Marolla

{"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}

引用次数: 0