Medical device recalls increased 126 percent in the first quarter of 2018, according to a new report from Stericycle Expert Solutions. More than 208 million units were included in 343 separate recalls. The average recall affected 607,000 units.
These statistics represent the medical device industry’s highest number of recalls since at least 2005, according to the report. So what caused this sharp increase? Radiology Business reached out to Michael Good, vice president of marketing & sales operations for Stericycle Expert Solutions, for more information.
“As with other types of products, there are many causes, but software appears to be a driving factor with imaging,” Good told Radiology Business. “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 issues were behind 78 recalls in the quarter, making them the No. 1 cause. Mislabeling issues were responsible for 73 recalls.
“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.”
Stericycle Expert Solutions has been publishing its Recall Index reports since 2012. Data is collected from several sources, including the Consumer Product Safety Commission and the FDA. More information is available at the company’s website.