The annual number of medtech recalls nearly doubled from 2003 to 2012, but FDA regulators are calling the skyrocketing figures a win.
There were 604 total recalls in 2003, compared with 1,190 in 2012. The number of Class I recalls, tied to product defects that the FDA says pose a risk of "serious adverse health consequences or death," increased more than 8-fold, from 7 in 2003 to 57 in 2012.
The analysis concluded that the rise in recalls was due to increased awareness among medical device makers of the types of device issues that merit recall action. Industry groups agreed.
"The increase in recalls reflected in the data can be attributed primarily to companies taking a more cautious, pro-active, patient-centric approach to quality, safety and reporting of events to FDA," medtech lobbying group AdvaMed spokeswoman Wanda Moebius told the Wall Street Journal.
The report spurred mixed reactions from medtech stakeholders, fueling arguments by groups that have been critical of the FDA’s review process for new devices. Others saw the report as a signal that the FDA is taking renewed interest in medtech recalls.
FDA maintained that the rising figures arise from agency efforts to spur more reporting from medical device manufacturers.
"Based on the data we have reviewed and our experience, we believe the increase is the result of increased awareness prompted by targeted interactions with industry and individual manufacturers," according to the FDA report. "Moreover, these interactions triggered efforts within industry to improve safety of devices, which are expected to improve device performance over time."