March 25, 2013
Defibrillator Danger: FDA Recommends New Safety, Efficiency Regulations
Brett Smith for redOrbit.com - Your Universe Online
Although they have been credited with saving thousands of lives, the US Food and Drug Administration (FDA) has recommended new regulations for automated external defibrillators (AED), including the requirement that the devices must meet federal approval before hitting the market.
"[The] FDA is not questioning the clinical utility of AEDs," said FDA spokesman Dr. William Maisel in a statement on Friday. "These devices are critically important and serve a very important public health need.”
“The importance of early defibrillation for patients who are suffering from cardiac arrest is well-established,” he added.
AEDs can be found in workplaces, schools and restaurants across the country. They are designed to electrically jump-start the heart after it has gone into arrest and are supposed to be used only by properly trained individuals.
FDA officials said their new proposal would require manufacturers to submit evidence showing their devices are safe and efficient in order to be approved for or to remain on the market. The FDA rules would also necessitate that manufacturers provide inspection reports and submit details to the FDA of any changes made to the device.
"Today's action does not require the removal or replacement of AEDs that are in distribution. Patients and the public should have confidence in these devices, and we encourage people to use them under the appropriate circumstances," Maisel said.
He noted that it would be difficult to determine how many deaths defective devices have caused as the patients may have died due to cardiac arrest anyway. However, Maisel said there were enough problems with devices to warrant action by the federal government.
"Tens of thousands of adverse events is too many. We think 88 recalls are too many," Maisel said. “So, by calling for pre-market approval we can focus our attention on the types of problems that have been observed and our expectation is that we will observe an improvement in the reliability over time with these devices.”
Stories of AED malfunctions range from software problems to power failures to component failures.
The FDA said the new proposals are based on recommendations by its Circulatory System Devices Panel, which said AEDs should be a Class III medical device, requiring pre-market approval.
Many of the device´s makers stand by their AEDS and say they have been expecting this announcement for some time. Device maker Physio-Control's chief executive, Brian Webster, said the increasing number of device failures could be due to their increasing prevalence.
"While it is the FDA's position that defibrillator failures have risen over the past several years, the number of devices in the market has grown dramatically over that same time period," he told Reuters. "An evaluation of the number of defibrillator malfunctions must include the number of devices deployed to accurately assess whether the failure rate is increasing or actually decreasing."
Rachel Bloom-Baglin of Philips also told Reuters that while the company has not yet seen the official written proposal, they have been in discussions with the FDA regarding their AEDs. She said the company believes more federal oversight would not result in an interruption of device or parts supply.