In what is good news for the medical device industry, a recall consultancy firm’s study reports that the medical device industry has experienced its lowest number of medical device recalls since 2012.
Recalls of Medical Devices Down
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There were 275 recalls of devices from 148 different companies, according to the 15-page report prepared by Stericycle. The report was based on data obtained from several government agencies including the U.S. Food and Drug Administration.
According to the report, more than half of the recalls, 57%, took place within the United States and just one other country. Twenty-eight percent of the companies involved in recalls this past quarter—which ended June 30—had two or more products recalled. Seven percent of the companies involved had five or more recalls.
An analysis reported earlier this year from the FDA and cited in the news release noted that device recalls over the past decade have more than doubled, with software-related recalls being the most common type of product or device recall.
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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