CDRH says it is uncertain why there has been an increase in Class 1 medical device recalls over the past four years. Speaking to a Regulatory Affairs Professionals Society conference session in Seattle in October, CDRH Division of Risk Management Operations director Ann Ferriter said Class 1 recalls have increased from an average of 25 before 2008 to 50 and 57 such recalls in 2011 and 2012, respectively.
“We have seen a large increase in Class 1 recalls between 2008 and 2012,” she said. “Our analysts are looking at why this is. We have had the same standard of ‘reasonable probability of serious health consequences or death.’ So we are going back through our old data so that we can understand whether that standard has been upheld consistently or perhaps 10 years ago we were less likely to classify something as Class 1... but we haven’t changed our standard at all.”
75% of all recalls fall into Cardiovascular, Chemistry, General Surgery, General Hospital, Orthopedics, and Radiology medical specialty areas, according to Ferriter. Recently, the most frequently seen recalls involve radiology and cardiovascular devices, she said, with a large spike in radiology following press reports about CT scans and accidental radiation overdosing that has caused more vigilance from radiology firms. “We expect that trend to level out,” she said.
A CDRH “root cause” analysis of previous recalls shows that 49% are related to design controls, Ferriter told the RAPS session. “Go back to CFR 820.30 and see what is in the quality system design controls you can do better to prevent these design control-related recalls,” she said. “Dig deep into why these recalls are happening. What we would like to see is more recalls prevented early, perhaps through better design validation and better testing.” Other root cause categories include material/components (19%), process controls (15%), packaging/labeling (11%), and change control (6%).
Additionally, Ferriter said the Center has seen an uptick with software-related recalls. “Firms really struggle with releasing high-quality software,” she said. “Perhaps there needs to be better testing or better validation, and maybe more involvement with clinical people upfront in the design of the software so you get the right algorithms. We have also seen an increase in component-related recalls. We are concerned that your supplier controls are not as rigorous as they could be, and we would like to see that level back down.”