Although medical device recalls dropped 29% in Q3 2020 (and to a six-month low, for that matter), they are still on their way to beat the 2019 total. Why? Because the 2020 quarterly average is higher than last year. Stericycle’s Q3 Recall Index also notes that the recall data could be even higher, because it does not include unofficial recalls of products such as PPE, which are not necessarily recorded at the federal level.
Software continues to be the top reason for a recall (it has been the top issue for 17 out of the 18 past quarters), with 50 recalls during Q3, affecting nearly 5 million units of all recalled units. Meanwhile, quality came in second in terms of reason for a recall, but it impacted 6.2 million units. Nearly 87% of recalled products were distributed nationwide, and 55% of FDA-recalled products were globally distributed. And despite the pressures that the medtech industry faces as a result of COVID-19, their long-term focus should remain on managing the daily safety concerns related to medical devices, such as software, quality and cybersecurity issues, the Stericycle report states.
“We already see reports of cybersecurity concerns and software-related recalls, and the reality is we are still just learning the signs and potential impact of security threats. Effective responses to these challenges will be critical to the future of all medical IoT devices,” stated Lynn Tyler, partner at Barnes & Thornburg, LLP in the report.
Read MTI’s recent interview with Chris Harvey, vice president of crisis solutions at Stericycle Expert Solutions:
Medical Device Recall Activity at Highest Levels in Two Years, Is COVID-19 Responsible?