Purpose: 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.
Keywords: 21st Century Cures Act; FDA; Medical device recall; health policy; medical device regulation; patient safety.
Copyright © 2016 American College of Radiology. Published by Elsevier Inc. All rights reserved.