Devices

Class 3 Device Changes Up Recall Risk: Study

David McFarland

— 1 min read
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Researchers from the University of Missouri-Kansas City and other facilities say post-approval modifications to Class 3 medical devices approved through the premarket approval (PMA) supplement process are associated with an increased risk of device recall. The study, published by JAMA Network Open, says an “increase of one supplement per year, on average, was associated with a 28% increased risk of any recall and a 32% increased risk of Class 1 recall.”

Secondary findings worth mentioning, the authors say, are:

  • the median time until first recall was less than two years from the original device approval;
  • cardiovascular devices had 3.5 times the risk of a Class 1 recall; and
  • device design flaws caused nearly 30% of recalls and over half of Class 1 recalls.

“Physician awareness, improved preapproval testing, and post-market surveillance strategies should be used to mitigate risks to patient safety and public health,” the authors conclude.

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