The number of medical device recalls jumped from 604 in FY 2003 to 1,190 in FY 2012. Additionally, the number of Class I and Class II recalls increased over the same time period. Class I recalls accounted for one percent of all recalls in FY 2003 and grew to 5 percent of all recalls in FY 2012. Class II recalls made up 76 percent of recalls in FY 2003 and 87.6 percent of recalls in FY 2012.
Part of the increase in Class I recalls can be attributed to the CDRH’s increased efforts to improve quality and safety of radiological devices, according to the report. The CDRH focused on devices with high-volume adverse event reports, such as automated external defibrillators, ventilators and infusion pumps. These devices accounted for approximately 30 percent of all Class I recalls in the study period.
The most common cause of recalls from FY 2010 to FY 2012 was device and software design failures (36 percent), followed by faulty material or component (26 percent), errors in process control (17 percent) and errors in packaging and labeling (13 percent).
The report notes the increase in recalls is also in part be due to improved awareness and reporting by device manufacturers.
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