Medical device recalls reached record highs in the first three months of 2018 thanks to software complications that are likely to continue with the proliferation of high-tech devices.
Device recalls increased 126% in the first quarter of 2018. At 343 recalls, it was the highest number in a single quarter since 2005, according to a report by Stericycle’s Recall Index (PDF), which tracks recall data across several industries.
Software was the biggest driver of medical device recalls in the first quarter, accounting for 23% of all recalls. Software issues have been the leading factor in device recalls each quarter since the beginning of 2016.
Bethany Hills, an attorney at Mintz Levin in New York who chairs the firm's FDA practice, says the rapid increase is not totally unexpected. Medical device software is becoming increasingly complex, with analytics that provide a higher level of clinical decision support.
"The more complex the software, the more likely it is that the developers did not account for all variables in the clinical environment, increasing the risk of bugs and errors," she told FierceHealthcare. "This risk increases further if the device manufacturer outsources software development because integration of outside software and the inability to quickly modify the code can lead to additional errors slipping through the cracks."
All told, more than 208 million devices were recalled in the beginning of the year, more than the total number of recalled devices in all of 2017. There doesn’t appear to be one singular reason for the startling uptick, making it difficult to pinpoint an underlying trend.