The ability to electrically jumpstart the heart into its normal rhythm has led Automated External Defibrillators to become some of the most vital medical devices available. But these items, which can actually sense when an individual has experienced a cardiac arrhythmia, are not without their errors. Recalls by the dozens have been issued, and from 2005 to 2012, the Food and Drug Administration was the recipient of a whopping 45,000 reports in which an adverse event purportedly occurred.
These issues typically take place when there exists a lack of quality control over the third-party components which make up the device. There have also been instances where errors with manufacturing or product design have led to their share of problems.
Because of this, the FDA has proposed regulations that would impose additional restrictions on the makers of AEDs. Specifically, anyone attempting to gain approval of such a device would have to submit something called a pre-market approval application, or PMA. This means that the safety of an AED, especially in terms of those issues which tend to lead to adversity, must be proved through clinical trials. A company must also take pains to demonstrate quality control at the manufacturing level and submit to a plant inspection.
The move comes as the result of a recommendation from the FDA’s Circulatory Systems Devices Panel. Once a 90 comment period has expired, the FDA will make its final decision on the matter.