The U.S. Food and Drug Administration (FDA) posts consumer information about the most serious medical devices recalls. The FDA notes on their medical device webpage that these products are on the list because they could cause serious health problems or death.
The FDA released a report yesterday indicating that the number of medical device recalls increased by ninety-seven percent between 2003 and 2012. This review was prompted by the Recall Process Improvement initiative begun in 2010 and also undertaken to address concerns raised by the Government Accountability Office over the FDA’s oversight of medical device recalls.
The broader initiative of the FDA is to optimize public health by issuing timely and effective recalls, reducing their number and frequency and streamlining the process. This report issued yesterday is part of that ongoing effort. The FDA attributes the rise during this period to enhanced awareness and reporting by device firms that were cited with 806 reporting violations. Increases were also seen as resulting from specific safety initiatives from the FDA’s Center for Devices and Radiological Health from manufacturers of radiology devices. Historically, high numbers of device problems have been associated with ventilators, infusion pumps and external defibrillators. The number of Class 1 recalls increased partially due to increased efforts by the FDA in these areas. The FDA notes in the report that the most frequent cause of recalls are related to device design, software or non-conforming materials or components. By working jointly with the industry in these specific areas, the FDA projects that as many as 400 recalls can be prevented per year.
The report concludes that the increase is the result of targeted interactions by the FDA with industry and individual manufacturers , including working together, and should be seen as a sign of progress toward the broader initiative of optimizing the public health.