Class I Medical Device Recalls in Women’s Health: 2002 - 2016 [27G

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INTRODUCTION: Class I recalls are defined by the Food and Drug Administration (FDA) as the most serious type of recall where a medical device problem could lead to death or serious health problems. Understanding the factors leading to these events in women’s health may provide policy implications to improve medical device safety. METHODS: We performed a retrospective review of the FDA’s database for Class I device recalls in women’s health from 2002-2016. The reason for recall was defined as either a premarket (e.g. device design problems) or a postmarket (e.g. manufacturing problems) issue. RESULTS: 75 unique Class I recalls affecting more than 88,000 medical devices were identified from 2002-2016. Recalls included diagnostic assays for chlamydia/gonorrhea, a laparoscopic tissue morcellator, and surgical kits used in women’s health. 95% of recalls were due to postmarketing problems such as improper packaging and labeling. Only 5% of recalls were due to premarket issues (device or software design). In regards to the original approval pathway, 4% of recalled products were cleared via the 510K pathway, while 96% were essentially exempt from premarket approval by the FDA. No recalls were attributed to devices approved along the most stringent post-market approval pathway. The majority of recalls occurred after 2013 with 93% of total recalls occurring in 2014; this spike was attributed to sterility problems with surgical kits used in obstetrics and gynecological procedures. CONCLUSION: The majority of recalled devices in women’s health required minimal regulatory scrutiny prior to approval suggesting the need for continued postmarket vigilance.