Federal regulators are warning medical device manufacturers that if they do not take actions to prevent the release of defective defibrillators onto the market, they may face new, more stringent regulations over their construction in the near future.
The FDA sent a letter to the medical device manufacturing community alerting them to the likelihood of regulatory changes if something is not done regarding widespread problems with external defibrillators. The industry has been beset by a series of recalls for the life-saving devices due to problems that have put patients’ lives at risk.
“The Food and Drug Administration (FDA) is notifying you of our concerns relating to serious adverse events noted in Medical Device Reports (MDRs) associated with the use of external defibrillators and a large number of recalls of external defibrillators,” the FDA wrote in its ‘Dear Industry’ letter. “As a result, FDA may, in the future, take regulatory steps to improve the current premarket and postmarket regulatory processes associated with external defibrillators.”
According to the FDA there were 68 external defibrillator recalls from January 1, 2005 to July 10, 2010, with the number of recalls growing each year. In 2005, there were nine recalls, but in 2009 there were 17. During the same time period, the FDA received more than 28,000 MDRs of defibrillator problems. That number, too, increased over the years from 4,210 reports in 2005 to 7,807 reports last year.
This year has also seen a number of major defibrillator recalls and other defibrillator developments. In February, Cardiac Sciences recalled about 12,200 automated external defibrillators (AEDs) because the units could fail when needed. That recall was later expanded to 280,000 units when the FDA warned that the defective components were widespread throughout the company’s products.
Defibtech also recalled 5,400 rechargeable defibrillator battery packs in June due to defects that could prevent them from providing power.
Medtronic’s Physio-Control Inc. subsidiary has had to make two major recalls of LIFEPAK defibrillators. In April a recall of the LIFEPAK 15 defibrillators was announced because the units could turn off and on by themselves. In July about 43,000 LIFEPAK 20 and LIFEPAK 20e units were recalled due to possible power failures.
The FDA says it has found that many of the external defibrillator problems may have been preventable, correctable and avoidable and says it has determined that there are a number of industry problems driving the recalls and complaints. The medical device industry has done poorly designing and manufacturing the devices, handling user complaints, conducting recalls and communicating with users of the devices, the FDA said in its letter.
The agency has urged medical device manufacturers to meet with federal regulators to hash out potential solutions to the problem. If that avenue of approach does not bring an increase in quality, the FDA is likely to institute industry-wide practices of its own making. That could mean that medical device manufacturers will find it much tougher in the future to get new external defibrillators approved and onto the market.
A workshop discussing external defibrillator innovation has been scheduled for December 15-16 and will be open to the public, the agency announced.