The U.S. Food and Drug Administration (FDA) has proposed tightening regulations over heart defibrillators after dozens of recalls, failures and deaths attributed to the malfunctioning medical device. There are about 2.4 million automated external defibrillators (AED) in public places in the U.S. They are found in newsrooms, airports, casinos, even churches. Using paddles that deliver an electrical jolt to the chest, an AED can re-establish a normal heart beat during a potentially fatal cardiac arrhythmia which, according to the American Heart Association, kills about 400,000 a year.
No one knows how many patients have died due to the malfunctioning devices, but the New York Times reports in one case a nurse was trying to help a patient in cardiac arrest when the defibrillator read “memory full” and it shut down. The patient died. In another instance the software showed an “equipment disabled” message. That patient also died.
The FDA reports that there have been 45,000 failures of defibrillator hardware and software since 2005, and manufacturers have had to recall AEDs 88 times. In order to improve that dismal record, the proposed order will require manufacturers to make available designs of the AEDs. The agency would also be given tighter controls on buying defibrillator components overseas. Dr. William Maisel with the Center for Devices and Radiological Health (CDRH) announced plants could also be inspected, although historically the FDA has not had the personnel to inspect plants overseas.
The FDA could have downgraded AEDs to a lower or moderate risk device (Class I or II), but an expert panel convened in October 2011 recommended AEDs remain Class III (highest-risk medical device) and required pre-market approval (PMA), higher degree of scrutiny than the current notification process.
One application for PMA approval would cost about $248,000 according to Dr. Maisel, but that would cover all models of AEDs made by the company. Dr. Maisel says the safety data has already been conducted by the companies so most will not have to do any additional clinical studies. The revamp of FDA safety oversight should be completed by 2014.
AEDs are known as “pre-amendment devices” which means that they were already in the marketplace before 1976 when the FDA began regulating medical devices. At that time there were 170 devices called Class III that were approved through the 510(k) notification process that were never required to submit PMAs. The FDA’s website says 19 medical devices are still waiting to be reclassified, including the high-risk metal hip joints with uncemented acetabular components as well as cemented acetabular components.
How do we know they are safe and effective?
The simple answer, which would surprise most patients and physicians, is that we do not know if the medical devices are safe and effective. A study published in the Archives of Internal Medicine in 2011 found nearly three-quarters of medical devices that caused injury or death from 2005 to 2009 had entered the market through the 510(k) process. Any changes in the 510(k) process, however, would also need to address the false notion that the PMA process leads to safer medical devices. That is not necessarily the case, with the Birmingham metal-on-metal hip implant marketed by Smith & Nephew being a prime example of a PMA-approved medical devices that has injured untold thousands of patients who have had to undergo revision surgeries and suffered other bone and tissue damage and disability as a result of cobalt and chromium poisoning and premature failure of the devices.