FDA: Mandatory Heart Defibrillator Improvements Order Issued
The US Food and Drug Administration, through its Circulatory System Devices Panel, issued a proposed order aimed at helping manufacturers of heart related life-saving devices improve the reliability of a specific type of device, an automated external defibrillator (AED).
When finalized, the proposed order will require manufactures of these heart related life-saving devices to submit to a pre-market approval (PMA) process application.
AED’s are portable, electronic medical devices, that when used properly, reestablish the normal heart rhythm rate of a person suffering from a life-threatening cardiac arrhythmia. This is done through the use of electronic stimulation of the heart, and although these devices have saved many lives over the years, the US FDA has received more than 45,000 adverse event reports with regards to AED’s in the 8 years starting in 2005 to the present.
Several of the current manufacturers of these devices have conducted their own recalls associated with the failure of these devices, and the problems that the FDA is seeing appeared to be preventable and correctable, with the most common failure issues had been established as inadequate control of design and manufacturing of the components that may be purchased from other suppliers for products that attach to the main unit which the accessory manufacturer did not manufacture in the 1st place.
“Automated external defibrillators save lives,” said Dr. William Maisel, M.D., M.P.H., deputy director of science, and chief scientist at the FDA’s Center for Devices and Radiological Health. “However, the agency is concerned about the number of recalls and manufacturing problems that have been associated with these devices and we’re committed to working with manufacturers to address these issues.”
This proposed order, and the review process that follows, allows the agency to be spot on in their monitoring of these devices, and how they are designed and manufactured, improving this life-saving technology.
Safety and innovation act calls for the FDA to publish a proposed and final order to reclassify or call for PMA’s 48 pre-amendments device. The recommendation that AED’s remain as class III medical devices which require PMA’s came from the FDA circulatory system devices panel, and the proposed order was issued as part of the 515 program, and FDA regulatory body that ensures the appropriate regulation of class III. Amendments devices.
Clinical data that supports a products approval are required in all PMA applications, however, “if our proposed order is finalized, the FDA intends to focus its review of the premarket applications on the more problematic aspects of AED’s.” Added Dr. Maisel.
Comments on the proposed FDA order are open for 90 days, and if the proposed order is finalized, the FDA intends to exercise its enforcement discretion on those manufacturers that notify the FDA of their intentions to file a PMA in a timely manner for up to one year and a half.
A PMA normally reviews a medical device manufacturer’s quality systems information and inspection of its manufacturing facilities, in addition to clinical safety and effectiveness data, and once approved, these medical device manufacturers must submit annual reports of the devices performance, as well as any significant manufacturing changes made to the device.