Medical Device Recalls Up 97% Since 2002: FDA Report

A report by government health officials indicates that the number of medical device recalls has nearly doubled over the past decade.  

The FDA’s Center for Devices and Radiological Health (CDRH) issued a Medical Device Recall Report earlier this month, summarizing data from the fiscal years 2003 through 2012. The report finds that the annual number of medical device recalls has increased 97% over that time, but notes that the increase may not be a bad thing.

“Concerted efforts to improve the quality and safety of medical devices on the part of both CDRH and the industry has resulted in greater numbers of recalls reported — and greater benefit for the public health,” the report states. “We attribute this increase to: enhanced awareness by device firms, including those that were cited for reporting violations; and specific CDRH efforts to improve medical device safety.”

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The report notes that the CDRH’s efforts have been focused on medical devices that historically have been linked to a high number of problems, including ventilators, infusion pumps, and external defibrillators. In recent years, the FDA has released additional industry guidance on how infusion pumps and defibrillators should be manufactured in order to reduce recalls and problems associated with those devices.

In April 2010, the FDA announced an infusion pump safety initiative aimed at improving manufacturing in that industry. The agency called for manufacturers to undergo more risk assessments before gaining approval for new or modified devices, and they had to submit more design and engineering information for premarket approval.

New guidelines for automated external defibrillators (AEDs) were announced a year ago, on March 25, 2013, following a number of deaths and more than 45,000 adverse event reports submitted to the FDA between 2005 and 2012.

The FDA first began looking at new standards for defibrillators in January 2011, after a string of AED recalls.

AEDs are portable electronic devices which jump-start a person’s heart in emergency situations after it has stopped beating. It re-establishes a normal heart rhythm through the means of electrical stimulation.

Many of the adverse event reports are connected to failure of the devices, such as battery failures or improper maintenance of the device. The adverse event reports have resulted in dozens of recalls by the manufactures, Physio-Control Inc., Zoll Medical Corp and Royal Philips Electronics NV.

The new report is part of a larger effort to eventually cut down on medical device recalls and increase the public health benefit of medical devices, CDRH states. The center indicates that over the last three years it has reduced the delay in announcing Class I medical device recalls by nine days.

Class I recalls are the most serious classification, meaning the FDA believes the problem could cause serious injury or death. However, it sometimes takes the agency months to announce that a class I recall has occurred after the manufacturer has sent letters to customers and doctors identifying the problem.


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