FDA Proposes Tighter Regulations on Emergency Defibrillators

The U.S. Food and Drug Administration (FDA) is proposing tighter regulations on emergency defibrillators. The agency has been inundated with reports of failures of the devices – some 45,000 over the past seven years – and is submitting proposals that would require manufacturers to provide proof that their devices are safe and effective before they are allowed on to the market.

There has been a great uptick in the number of automated emergency defibrillators in public venues. They are commonly seen at gyms, airports, restaurants, and shopping malls.

The deputy director of the FDA’s center for devices and radiological health told Reuters there were 88 recalls of defibrillators from 2005 to 2012. The deputy director would not speculate how many deaths may have been prevented if the medical devices had not been defective, but stated that there have been enough reports of failure for the FDA to take action on the matter.

The deputy director said that many of the problems with the defibrillators are due to the design or manufacture of the devices. He also raised concerns that there is insufficient control over the suppliers of the components that go into the manufacture of the devices. He said the initial focus of the FDA would be on these areas.

The FDA proposals would also require that manufacturers keep the agency up-to-date on inspection reports and any changes made to the devices. Once the proposals are final, companies will have 15 months to gather and complete the information required by the FDA.

One CEO of a defibrillator manufacturer suggested that the high failure rate reports might be skewed due to the large increase of the devices on the market. He questioned the accuracy and the methodology of gathering the statistics.

The Jacksonville medical device product liability attorneys at Farah & Farah watch the progress of these stringent regulations with great interest. If you believe you or a loved one has been injured due to a defective medical device, call us at (800) 533-3555 or contact us online. We can determine if you have a case and what your legal options are.

Badges