MDDI_Medical Device & Diagnostic Industry

MDDI, July 2016

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What's Behind Medtech's Medical device recalls hit an all-time high in 2014, and nearly a third of manufacturers experience multiple recalls for similar reasons. Joshua R. Dix, suRaJ RamachanDRan, anD DaRin s. oppEnhEimER s ince the release of the 1970 Cooper Committee Report docu- menting thousands of deaths and serious injuries related to the use of medical devices, FDA has taken a focused approach in its microscopic tracking of medical device adverse events and recalls. The agency's efforts culminated in the October 2014 issuance of the guid- ance Distinguishing Medical Device Recalls from Medical Device Enhance- ments. As advancements in technology have provided FDA with greater resources to compile and communicate data to industry and consum- ers alike, reports of events like those first demonstrated in the Cooper Report have become more frequent and progressively alarming. At the end of 2006, FDA communicated a staggering set of data to the medical device community. A calendar year's worth of agency data was conclusive in attributing 116,000 injuries, 96,000 malfunctions, and 4500 deaths to the use—or, in this case, misuse—of medical devices. 1 Further analysis released in 2012 in the Medical Device Recall Report FY 2003 to FY 2012 reported a 97% increase in recalls from fiscal year (FY) 2003 (604 total) to FY 2012 (1190 total). Recent analysis conducted for this article used CDRH's recall reposi- tory to collect data and evaluate trends in both voluntary and involun- tary recalls established between January 2010 and December 2015. The product of this evaluation demonstrates an average of approximately 2600 recalls annually, according to ongoing analysis of medical device recalls provided by Blue Lynx Consulting (Figure 1). The data also speci- fies a progressive yearly occurrence rate, with trending indicating an upward swing in the following root causes as identified by the agency: device design, software controls, and production controls. Recalls 20 | July 2016 Figure 1. There were an average of approximately 2600 medical device recalls each year from 2010 through 2014. Annual Recalls 3000 2250 1500 750 0 Medical Device Recalls by Year 2010–2014 2010 2770 2715 2656 2823 2239 2011 2012 2013 2014

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