Shah Aashka, Olson Michelle M, Maurice Joseph M
Carle Illinois College of Medicine, University of Illinois at Urbana-Champaign, Urbana, IL, United States.
Division of Colon & Rectal Surgery, Digestive Health, Carle Foundation Hospital, Urbana, IL, United States.
Surg Pract Sci. 2023 Feb 15;12:100158. doi: 10.1016/j.sipas.2023.100158. eCollection 2023 Mar.
Medical devices in the United States can be FDA approved either by the premarket notification (510(k)) or premarket approval process (PMA). Applications for PMA are more intensive than 510(k). This study aims to compare the recall rates of 510(k) and PMA General and Plastic Surgery (Surgery) devices and to educate physicians about potential flaws in the approval process.
This is a retrospective case study utilizing the public FDA Medical Device Recalls database. Inclusion criteria for this study includes devices approved by the Surgery Devices Panel via 510(k) or PMA in the United States between 11/2/2002- 11/9/2021.
Out of 8,985 devices, 81% of surgery devices were approved by 510(k) while 19% were approved by PMA. The recall rate for devices approved by PMA and 510(k) was 2.3% and 11.6% respectively ( < .01). 510(k) device recalls are 5.32 times more likely. The differences in severity of recall is also significant ( < .01). From 2002 to 2021, the percent of devices that were approved by 501(k) decreased ( < .01) but rate of recalls was consistent.
Surgical devices were overwhelmingly approved with 510(k) versus PMA. 510(k) applications are cheaper, faster, and less stringent. These factors may contribute to the disproportionate 510(k) approvals and the discrepancy in recall rates. Cardiology, Orthopedics, and Obstetrics and Gynecology have similar trends for devices that go through the 510(k) device approval pathway. Though the rate of 510(k) approvals in Surgery is decreasing, more must be done to ensure that the 510(k) process sufficiently minimizes potential patient risk.
美国的医疗器械可通过上市前通知（510(k)）或上市前批准程序（PMA）获得美国食品药品监督管理局（FDA）的批准。PMA申请比510(k)申请更为严格。本研究旨在比较510(k)和PMA普通外科及整形外科（外科）器械的召回率，并就批准过程中的潜在缺陷对医生进行教育。
这是一项利用FDA公开的医疗器械召回数据库进行的回顾性病例研究。本研究的纳入标准包括2002年11月2日至2021年11月9日期间在美国通过510(k)或PMA由外科器械小组批准的器械。
在8985件器械中，81%的外科器械通过510(k)批准，19%通过PMA批准。PMA和510(k)批准的器械召回率分别为2.3%和11.6%（P<0.01）。510(k)器械召回的可能性高5.32倍。召回严重程度的差异也很显著（P<0.01）。从2002年到2021年，501(k)批准的器械百分比下降（P<0.01），但召回率保持一致。
与PMA相比，绝大多数外科器械通过510(k)获得批准。510(k)申请成本更低、速度更快且要求更宽松。这些因素可能导致510(k)批准比例过高以及召回率存在差异。心脏病学、骨科以及妇产科在通过510(k)器械批准途径的器械方面有类似趋势。尽管外科领域510(k)批准率在下降，但仍需采取更多措施以确保510(k)程序充分降低潜在的患者风险。
