Late last year, we wrote that a then-new U.S. Food & Drug Administration (FDA) report on <"http://www.yourlawyer.com/practice_areas/defective_medical_devices">external defibrillators found that the devices malfunction far too often and that such malfunctions can prove fatal. The agency announced that it had launched an initiative aimed at facilitating the development of safer, more effective external defibrillators. Now, says The Associated Press (AP), the FDA is proposing stricter safety measures for the devices.
The proposal suggests that external defibrillator manufacturers submit additional information and also go through manufacturing inspections prior to releasing a new product, said the AP.
According to the FDA, some 300,000 Americans collapse each year when the heart stops pumping blood to the body (sudden cardiac arrest). These patients can die if normal rhythms are not restored quickly, with survival dependant on a rapid sequence of rescue events that can include the successful delivery of a high-energy shock from an external defibrillator. Automated external defibrillators (AEDs) are found in public settings and increasingly in homes, airports and office buildings. More complex external defibrillators are used in hospitals by trained health care professionals.
In the past five years, the FDAâ€™s Center for Devices and Radiological Health (CDRH) has received more than 28,000 medical device reports associated with the failures of external defibrillators. According to FDA data, from January 1, 2005 to July 10, 2010, there were 68 recalls of external defibrillators, exhibiting an increase from nine (in 2005) to 17 (in 2009, the last complete year for which data are available). During this period, the FDA received over 28,000 medical device reports, which also exhibited an increase from 4,210 (in 2005) to 7,807 (in 2009, the last complete year for which data are available). The FDA conducted multiple inspections of all external defibrillator manufacturers throughout this time period.
The proposed regulation is meant to minimize flaws in how the devices are designed and made and also involves the FDA seeking opinion from an expert panel on its recommendations, said the AP.
Today, defibrillators receive approval via an accelerated process that is meant for low-risk devicesâ€”the 510(k) systemâ€”that allows fast tracking for new products that are similar to products already on the market, explained the AP. Also, under current regulations, site inspections are only called for if a problem is suspected, said the AP, which noted that Philips Healthcare, Cardiac Science Corp., and Defibtech, among others, have petitioned the FDA to keep their devices approved at existing standards.
The FDA says that the increased measures are necessary because makers of AEDs have yet to correct problems that resulted in recalls of hundreds of thousands of devices, wrote the AP.
The new proposal calls for regular inspections and submitting more clinical data prior to introducing a new version of their devices, the standards currently in place for implantable defibrillators and heart valves, said the AP.
We previously wrote that many of the problems the FDA identified are preventable, correctable, and impact patient safety. The agency concluded that there are numerous problems with industry practices for designing and manufacturing defibrillators, handling user complaints, conducting recalls, and communicating with users.