Medical Device Recalls Reach Historic Levels in 2018
The medical device and pharmaceutical industries saw an incredible spike in product recalls during the first three months of 2018, according to a report released by Stericycle Expert Solutions. In the first quarter of this year, there was a 126% increase in medical device recalls—the most since 2005. More than 208 million units were included in 343 separate recalls.
So what’s with this sudden increase?
According to Michael Good, vice president of marketing & sales operations for Stericycle Expert Solutions, “As with other types of products, there are many causes, but software appears to be a driving factor with imaging. The higher the level of complexity, the higher the chance that something can go wrong. That’s true of many industries we cover, including the medical device sector. Imaging leaders will need to keep these risks in mind as they continue to innovate.”
Software problems made up about 22.7% of device recalls and has been the leading cause for recalls for the 8th consecutive quarter.
“There are a number of different issues that led to software recalls, including software anomalies, false results, and network connection issues,” Good said. “No single root cause stands out, but it has been a consistent issue over several quarters. Labeling issues also can cover a large range of causes. For example, we saw recalls due to missing expiration dates, incorrect label for the product, and incorrect size marked, among other issues.”
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