Medical Device Recalls Hit 2-Year High in Q2 2012

The number of medical device products affected by recalls hit an eight-quarter high in the second quarter of 2012, exceeding 100 million units for the first time in nearly two years.

Though the 242 medical device recalls reported last quarter were down more than more than 12% from the previous quarter, 50% more units were affected, according to Stericylce ExpertRECALL (Indianapolis), a company that offers recall services to medical device manufacturers.

Perhaps most striking is the fact that of the 140 medical device companies affected by recalls in the 90-day period, one-third faced multiple recalls.

It’s a reminder that recalls can happen to any company—especially as more and more medical device manufacturers turn to outsourcing, says Mike Rozembajgier, president of recalls for ExpertRECALL.

“I think that the increase in outsourcing increases the complexity of the supply chain, and only adds to the complexity of putting appropriate quality systems in place,” Rozembajgier says.

In all, 123.5 million units were affected by recalls in the second quarter of this year. Year over year, the number of recalls rose 4% and the number of units affected increased eight fold.

Of all second-quarter recalls, three affected more than 10 million units. Class I recalls, for dangerous or defective products that could result in serious health problems or death, increased to 7% of all recalls, from 4% the previous quarter. Two-thirds of the medical device recalls in the second quarter affected customers in the United States and at least one other country.

For device makers, Rozembajgier emphasizes the importance of having recall plans in place in advance. Thanks to social media, the public is more aware of recalls than it was 20 or 30 years ago, he says, so how companies handle recalls can have a big impact on their reputations. And regulators are likely to keep a closer eye on the industry going forward.

“We can count on FDA to increase the scrutiny on the medical device industry,” Rozembajgier says.
 

—Jamie Hartford is the associate editor of MD+DI. Follow her on Twitter @readMED.

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