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FDA Considers New Rules for Manufacturing External Defibrillators

Home | Articles | FDA Considers New Rules for Manufacturing External Defibrillators

Sometimes the medical devices that save people’s lives can also cause unnecessary injuries or deaths to patients. Recently, the FDA has issued an astonishing number of recalls for external defibrillators. The recalls follow a series of incidents with use of some external defibrillators, which are produced by various medical device companies. The FDA now warns that if manufacturers do not create further safeguards to prevent the making and selling of these defective defibrillators, they could face increased regulations in the near future.

Recent Recalls

Based on information from the Food and Drug Administration (FDA), the number of external defibrillator recalls has steadily increased from 2005 to 2010. There were 68 total recalls during this period, but the number almost doubled from nine issued in 2005 to 17 issued in 2009. The recalls were based on over 28,000 Medical Device Reports (MDRs) that were filed with the FDA during the five-year timeframe. This number also rose from around 4,200 in 2005 to about 7,800 in 2009.

The final number of defibrillator recalls for 2010 is not yet known, but multiple medical device manufacturers are currently under FDA scrutiny for producing defective medical device products this past year. Cardiac Sciences had to recall about 12,200 automated external defibrillators (AEDs) for failing to work when needed. Defibtech issued a recall for 5,400 rechargeable defibrillator battery packs because they did not supply power to the defibrillators. Physio-Control Inc., a subsidiary of Medtronic, also made two LIFEPAK defibrillator recalls, totaling 43,000 devices, for malfunctioning power sources.

The increasing number of external defibrillator recalls in the last five years compelled the FDA to issue a “Dear Industry” letter to all medical device manufacturers in late 2010. In the letter, the FDA noted their concerns with recent recalls, including that some problems may have been preventable. The letter also warned that the FDA is considering further regulations regarding the manufacture, sale and use of these devices.

Next Steps

For the FDA, the next step is to meet with external defibrillator manufacturers to discuss device issues that could be avoided and potential solutions to their defects, such as better design. For the medical device makers producing defective defibrillators, the next step is to work with the FDA to increase product quality in the face of potential further regulations. If you or your loved one was injured by a defective external defibrillator or other medical device, take the next step by contacting a Rhode Island attorney experienced in medical malpractice and defective products to discuss your legal rights and options.