The Association for the Advancement of Medical Instrumentation (AAMI) is reporting that medical device recalls nearly doubled between fiscal year (FY) 2003 and FY 2012, according to a new report from the Food and Drug Administration (FDA), which hailed the findings as a positive development.
The report, which the agency says is part of a broader effort to improve public health through the timely reporting of recalls, provides a number of details, including recall classification timelines, recalls by medical specialty, regulatory violations cited, and other information. Its release comes in the wake of a June 2011 report in which the Government Accountability Office recommended the agency enhance its oversight of medical device recalls.
“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,” the agency says in the report.
There were 1,190 recalls in FY 2012, representing a 97 percent increase over the FY 2003 total of 604, according to the report. The FDA categorizes recalls by three classes. A Class I recall covers situations in which use of or exposure to the suspect device would likely lead to serious injury or death. Class II recalls are not as dire, and Class III recalls are deemed the least serious, dealing with situations in which the use of or exposure to the device in question would likely not cause any injury.
Class II recalls increased the most—rising from 460 a decade ago to 1,043 in FY 2012. The total number of Class I recalls rose from seven to 57 in the same time period. The report says the joint efforts of the FDA and industry to fix devices that have had a history of problems, including ventilators, infusion pumps, and external defibrillators, have led to the increase. Meanwhile, the number of Class III recalls declined 35 percent, from 137 to 90.
The FDA report also highlights that the number of days between recall completion and the termination of a Class I recall has dropped dramatically. In FY 2009, it took 597 days; by FY 2012, it was 15 days. The agency’s Center for Devices and Radiological Health (CDRH) terminates Class I recalls, while district offices of the Office of Regulatory Affairs have the responsibility over Class II and III recalls.
Despite the increase in the number of recalls, the CDRH sees room for improvement. The most frequent causes of recalls are due to device design, software, and nonconforming material or component issues, and if the CDRH and industry were to work more closely together to address these issues, as many as 400 recalls could be prevented annually, according to the report.
An executive with AdvaMed, a trade association that represents device manufacturers, said the report underscores the industry’s commitment to patient safety.
“It is important to note that nowhere in its report does FDA indicate that the increase in recalls correlates to increased risk for patients,” says Janet Trunzo, senior executive vice president, technology and regulatory affairs, in an e-mailed statement. “As the agency notes in its report, industry and FDA are working together more and more to improve the quality and safety of medical devices, and this partnership will continue.”
She added that the numbers provided in the report need to be viewed in context, particularly as new and more complex technologies come on the market. “The increase in recalls reflected in the data can be attributed primarily to companies taking a more, aggressive, proactive, patient-centric approach to quality, safety, and reporting of events to FDA,” she says. “The overwhelming majority of devices perform as intended to save and improve lives, and our members are committed to improving that remarkable record of safety and reliability.”
To view the report, CLICK HERE.