Spike in medical device recalls expected in COVID-19 aftermath

Alia Paavola - Print  | 

While medical device recalls declined in the first quarter of 2020, a surge in product recalls is expected when the relaxed regulatory environment ends, according to medical waste disposal and compliance training company Stericycle.

Six things to know from the company's first-quarter 2020 recall insights report:

1. Medical device recalls in the first quarter of 2020 hit 260, a 6.1 percent decrease from the last quarter of 2019. 

2. For the 16th consecutive quarter, software issues were the top reason for recalls in the quarter ended March 31. Forty-eight recalls were attributed to software issues, followed by 42 recalls attributed to quality concerns and 34 recalls due to out-of-specification issues. 

3. The average first-quarter medical device recall affected 1,365,848 units, but this number includes a large recall that affected more than 314 million units. 

4. A lower recall rate is expected through this summer.

5. Despite the lower recall rate in the first quarter of 2020 and anticipated dip through the second quarter, a surge of recalls will follow when "the world goes back to normal and the FDA's emergency-use authorizations and enforcement-discretion ends," Stericlyle's report predicts.

6. A research letter published in JAMA Internal Medicine found that medical devices approved by priority review are twice as likely to be recalled and that devices that received approval by priority review are recalled 6.5 months sooner than other products after they hit the market, according to Stericycle. As a result, device recalls are expected to increase as many devices have received priority review amid the pandemic, according to the report.

"Anything that may have slipped through the cracks will be rectified," said Chris Harvey, director of recalls at Stericycle Expert Solutions. "What companies need to worry about is the reputational hit of a recall announced two months too late. Not to mention the fact that recalls will be harder to execute if consumers are still in a panic about COVID-19."

Access the full report here.

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