Quality and Software Issues Remain Top Reasons for Medical Device Recalls
For the 14th quarter in a row, software was the leading reason for a medical device recall, according to Stericycle’s Q3 2019 Recall Index, which was released earlier this week. The following are some key takeaways.
- Device recalls increased 21.5%
- Number of units recalled
- Class I: 201,244,136
- Class II: 14,816,297
- Class III: 3,123,777
- Primary reason for recall
- Software issue: 54
- Quality issue: 34
- Device failure: 33
- Sterility, parts issue, or outside of specs: 20
The report also indicated some change in the types of recalls industry can expect moving forward, especially considering the shift to more home healthcare devices, products that integrate a mobile component, and the rise of artificial intelligence. “While we’ll certainly still see traditional recalls of medical devices, companies will be best served by thinking through what recall management means in 2020 and beyond, particularly as devices become smarter and more connected online,” the report stated.
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