Overview of Class I Device Recalls in Diagnostic Radiology, 2002-2015

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• 作者：Comeron W. Ghobadi ; MD^a ; ^{Comeron.Ghobadi@uchospitals.edu" class="auth_mail" title="E-mail the corresponding author} ; Emily L. Hayman ; MD^b ; Shuai Xu ; MD ; MSc^c
• 关键词：Medical device recall ; FDA ; health policy ; patient safety ; 21st Century Cures Act ; medical device regulation
• 刊名：Journal of the American College of Radiology
• 出版年：2016
• 出版时间：June 2016
• 年：2016
• 卷：13
• 期：6
• 页码：638-643
• 全文大小：263 K

文摘

To assess class I radiological device recalls using the FDA medical device recall database and provide a detailed analysis, including recall trends, regulatory changes, and policy implications for the future.

Methods

This institutional review board-exempt study utilized the FDA Center for Devices and Radiological Health database for class I diagnostic radiological device recalls from November 1, 2002 to July 12, 2015. Recall characteristics, as well as market entry data, were collected for each device.

Results

Thirteen class I radiological device recalls were identified, with 12 of them occurring after 2011. SPECT nuclear medicine systems were the most common, followed by fluoroscopic x-ray and MRI systems. Eleven of the recalls were attributed to premarket-related issues. One recall event occurred in response to the death of a patient during a nuclear scan. Twelve of the devices were cleared under the 510(k) pathway. A median of 213 devices (range: 2 to 12,968) were recalled per event, and all but two devices had a worldwide distribution at the time of recall.

Conclusions

We found that policy changes to the FDA were temporally related to class I radiological recall events. Additionally, class I radiological device recalls share characteristics: device modality, reason for recall, market entry, and product distribution. These recalls have broad implications and highlight the need for continued regulatory oversight as imaging technologies continue to advance.