During the first quarter of 2012, medical device recalls rose more than 160%, affecting more than five times as many units than the previous quarter. According to the U.S. Food and Drug Administration (“FDA”) Enforcement Reports, almost 82,000,000 individual units were recalled—a whopping 508% increase over the previous quarter. Ironically, this five-quarter high follows an unprecedented 2011 fourth-quarter low in device recalls. Products subject to recent recalls include alcohol prep pads, catheters, needles and latex gloves.
Notably, about 1/3 of companies that faced recalls in the first quarter of 2012 were implicated in more than one recall event. Mr. Rozembajgier, as vice president of recalls at Stericycle ExpertRECALL, observed that “what is troublesome is the dramatic increase in units affected by the recalls and continued number of repeat offenders. It’s scary to think about given the increasing number of devices that American patients rely on to maintain and improve their health. Consumer and patient safety should be the number-one priority for every manufacturer, distributor, retailer, doctor’s office and healthcare facility.”
Mr. Rozembajgier reiterated the general sentiment that device companies should do everything within their power to minimize safety concerns that ultimately necessitate recalls. “Similarly, any business or individual within a supply chain, whether a distributor or a doctor, should keep close tabs on the products they hand to ensure that potential safety concerns are identified early and reported to the manufacturer and the regulator agency.” While Mr. Rozembajgier’s recommendations may appear laborious and costly for device manufacturers at first blush, the costs and frustration of implementing such a monitoring system may pale in comparison to what is required should the device line need to be recalled.