{"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":null,"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":0.0000,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of clinical engineering","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1097/jce.0000000000000635","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0
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.
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。