Feeding the Loop: AEDs, Feedback & Federal Regulations

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Prompt response to cardiac arrest is critical; seconds lost reduce the chances for patient recovery. While other rescue procedures like CPR do help and buy rescuers time, when a shock is needed, it’s imperative for the equipment to work well and, in some cases, provide rescuers with feedback.

Automated external defibrillation (AED) saves lives when applied correctly, and as not every responder is a medical professional, efforts to improve AED safety, utility and responsiveness have lead manufacturers to develop real-time feedback to responders. These can include directions and assistance regarding depth and timing of CPR compressions and information on patient condition.

The devices themselves read the victim’s heart rhythm and some models use this information to work independently of rescuer efforts. The directions for use being simply to apply the pads correctly, press a button and step back. Fully automated models are intended to better provide assistance when the first responder to the arrest isn’t a medical professional.

However, things can and do go wrong with AEDs. And, when they do, appropriate responses to those errors are important to avoid history repeating with another patient.

Federal involvement

Recently, the U.S. Food and Drug Administration (FDA) strengthened regulations surrounding preapproval of AEDs and their components.  These regulations would make premarket approval (PMA) for AEDs and accessories mandatory. Once in effect, manufacturers are required to provide assurance of quality and safety of devices by providing quality systems information and to allow the FDA to inspect manufacturing facilities. “Reviewing PMAs will allow the FDA to more closely monitor manufacturers’ Quality System design practices and manufacturing changes that have contributed to recalls and adverse events associated with AEDs,” says William H. Maisel, MD, MPH, of the FDA. Maisel is the chief scientist and deputy center director for science at FDA's Center for Devices and Radiological Health based in Washington, D.C.

Maisel notes that the requirement to submit the new PMAs does extend to currently marketed—and previously approved—devices. "Each manufacturer of a currently marketed AED device was required to submit a notice of intent to file a PMA within 90 days of the effective date of FDA’s order for any device that it intends to continue to distribute.  After submitting an intent to file, the manufacturer must submit its PMA within 18 months of the effective date of the FDA’s order,” he says.

Maisel stresses that by and large, AEDs are safe. These new regulations, like the recalls prompted by reported device failures are intended to make available devices even safer, “FDA believes that consumers should have confidence in using AEDs that are in public places. Through the manufacturers’ quality systems and the FDA’s recall process, most problems with AEDs are found before the device is ever used,” he says. This should, in turn, reduce the number of reported device failures.

Between 2005 and 2011, around 72,000 AED device failures were reported to the FDA’s MAUDE (Manufacturer and User Facility Device Experience) database, leading to 111 manufacturer recalls of devices ( www.FDA.gov, 2015). As part of the new regulations, Maisel says that “Class III devices (including AEDs) that were put into commercial distribution after September 24, 2014, are subject to Unique Device Identification (UDI) requirements.  One of the primary anticipated benefits of the UDI System is that it will allow more accurate reporting, reviewing and analyzing of adverse event reports so that devices that have performance concerns can be identified and corrected more quickly. In addition, it is intended to enhance analysis of devices on the market by providing a standard and clear way to document device use in electronic health records, clinical information systems, and registries.”

This should improve reports to MAUDE and similar databases maintained by the manufacturer. Reporting to the FDA is mandatory when the patient dies, particularly if the device is considered to be at fault. Communication of reporting requirements to groups and individuals using or maintaining AEDs is important, as not everyone who uses or maintains AEDs is clear to whom they should report failures. But, reporting is key to improving problems with devices as quickly as possible.

According to Maisel, AEDs are subject to “tracking regulation (21 CFR part 821), which requires