Pruitt Zoe, Boxley Christian, Krevat Seth A, Sengupta Srijan, Ratwani Raj M, Fong Allan
MedStar Health National Center for Human Factors in Healthcare.
Georgetown University School of Medicine.
Patient Saf (Harrisbg). 2021;3(3):28-35. doi: 10.33940/data/2021.9.3. Epub 2021 Sep 17.
The Manufacturer and User Facility Device Experience (MAUDE) database houses medical device reports submitted to the U.S. Food and Drug Administration (FDA). In May 2020, the FDA released guidance about medical device reporting during a pandemic, anticipating delays in reporting and investigating events involving medical devices.
We aimed to understand how the COVID-19 pandemic impacted medical device reporting by analyzing reports in the MAUDE database that mention COVID-19.
From the 816,470 reports submitted between January 1 and July 31, 2020, 3,500 (0.43%) included phrases related to COVID-19. Of these reports, 4.8% (167/3,500) described adverse events during COVID-19 patients' treatment, and 90.3% (3,161 /3,500) described barriers manufacturers faced investigating malfunctioning devices during the pandemic. 4.9% (172/3,500) of reports were not related to COVID-19. Malfunctions were clinically significant in 85.8% (3,004/3,500) of reports.
Reports indicate challenges some manufacturers had when investigating medical devices during the pandemic. The pandemic made investigating implants uniquely difficult, as restrictions to person-to-person contact limited the type of care patients could receive. Because full-scale investigations into malfunctioning devices may be difficult to perform during the pandemic, safety issues may go unaddressed and result in future harm to patients.
The COVID-19 pandemic and the myriad of healthcare, travel, and shipping challenges it created impacted how manufacturers reported and investigated medical devices. At the current time, it is unclear how manufacturers will address delayed clinical management of implant devices and other uninvestigated malfunctions after the pandemic and how this will impact patient safety.
制造商和用户设施设备经验（MAUDE）数据库收录了提交给美国食品药品监督管理局（FDA）的医疗器械报告。2020年5月，FDA发布了关于大流行期间医疗器械报告的指南，预计涉及医疗器械的事件报告和调查会出现延迟。
我们旨在通过分析MAUDE数据库中提及COVID-19的报告，了解COVID-19大流行如何影响医疗器械报告。
在2020年1月1日至7月31日提交的816,470份报告中，有3500份（0.43%）包含与COVID-19相关的表述。在这些报告中，4.8%（167/3500）描述了COVID-19患者治疗期间的不良事件，90.3%（3161/3500）描述了制造商在大流行期间调查故障设备时面临的障碍。4.9%（172/3500）的报告与COVID-19无关。85.8%（3004/3500）的报告中的故障具有临床意义。
报告表明一些制造商在大流行期间调查医疗器械时面临挑战。大流行使植入物的调查格外困难，因为人际接触限制限制了患者可接受的护理类型。由于在大流行期间可能难以对故障设备进行全面调查，安全问题可能得不到解决，从而给患者带来未来的伤害。
COVID-19大流行及其带来的众多医疗、旅行和运输挑战影响了制造商报告和调查医疗器械的方式。目前尚不清楚制造商在大流行后将如何应对植入设备的临床管理延迟和其他未调查的故障，以及这将如何影响患者安全。
