|The total number of medical-device recalls in the third quarter of 2012 jumped by nearly 70% over the previous quarter. Image from SteriCycle ExpertRECALL report.|
There were 407 documented medical device recalls in the third quarter of 2012 compared with 242 recalls in the previous quarter. The number of recalls in Q3 2012 is the highest total in at least nine quarters, says Mike Rozembajgier, vice president of recalls for ExpertRECALL (Indianapolis). Approximately 26.5 million units were affected by the recalls in the third quarter of 2012; 40% of the companies named in the FDA Enforcement Reports had multiple products recalls. Class I recalls, the most serious type, saw a nearly threefold increase over the previous quarter. Class II recalls also saw a significant jump.
Interestingly, the total of medical devices affected by the recalls fell compared with the second quarter of 2012, in which 123.5 million units were recalled. “Certainly the dynamic nature of recalls gives you this level of unpredictability in terms of how it is going to occur,” Rozembajgier says.
Determining the reason behind the uptick in recalls is a subject worthy of debate, with increased scrutiny at FDA and growing supply-chain complexity each playing a role. Patient advocates and a number of politicians have criticized the 510(k) pathway, arguing that it does not prevent new medical devices from being based on faulty predicates.
“There is no doubt when we look at the trends that there is an increased [level of] scrutiny at the agency in a variety of different areas, and certainly medical device sees its share of oversight,” Rozembajgier says. In terms of other FDA-related sectors, there was also a significant increase in the number of recalls related to food and pharmaceuticals. “From a percentage-wise basis, med device actually had the lowest increase among those segments.”
Brian Buntz is the editor-at-large at UBM Canon's medical group. Follow him on Twitter at @brian_buntz.