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Software complications are the leading cause that medical device recalls reached historic levels in the first quarter of 2018.
According to a report by Stericycle’s Recall Index, recalls impacted 343 devices, an increase of 126% in the first three months of 2018.
Medical device software was the primary factor for recalls accounting for 23% of all recalls, according to the data. Device software problems have been the leading factor in recalls since the start of 2016.
“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,” FDA attorney Bethany Hills told FierceHealthcare.
More than 208 million devices were impacted by recalls of all causes at the beginning of 2018, exceeding the total number of recalled devices in 2017.
Read more at FierceHealthcare.com.
Editorial photo credit: Paolo Bona / Shutterstock.com
