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Posted 22 March 2013 | By Alexander Gaffney, RAC,
US regulators have proposed a new rule that would require all automated external defibrillators (AEDs) to undergo the premarket approval (PMA) process for approval due to concerns that deficient or malfunctioning devices had been a contributing factor in the deaths of some patients.
The US Food and Drug Administration (FDA) has since 2011 been considering the reclassification of AEDs from their current Class II (Editor's note: the devices are actually Class III devices since 2003) device classification, which allows them to be marketed under a 510(k) premarket notification procedure with special controls, to designation that requires a PMA and clinical data to support the application.
That has led to a furious campaign by AED and firefighting groups, which have argued that the regulatory changes would raise the costs of the devices and thus make them less available to consumers.
A comment to FDA by the King County Fire Chief Association in March 2013, for example, notes that sudden cardiac arrest kills nearly 300,000 people each year-"the leading cause of death among adults."
"Early defibrillation is the only therapy to treat this dramatic emergency and widespread distribution of AEDs is the only reasonable strategy to accomplish rapid defibrillation." If anything, they added, it should be easier-not harder-to get the devices into the hands of more people.
And moving the devices into a more stringent category would make them harder to obtain, some say. Their rationale is that because a PMA requires more time and monetary resources to go through, device manufacturers will need to raise the prices of their devices. Others pointed to innovation in the devices, which have recently come to include more electronic functions to make them easier to use. If the device needed to go through the PMA process, these innovations would be scarcer and harder to come by, groups argued.
But that is just one side of the story, and regulators have hit back at that narrative, saying their concerns are rooted in faulty devices that have left some consumers dead after the devices malfunctioned in spectacular ways. A New York Times piece published on 22 March 2013 outlines one such case, in which an electronic AED displayed a message that its memory was full before shutting down. The patient the AED was intended to treat died soon thereafter, though it is not clear from the article whether the device would have saved the patient.
Neither is that event an isolated incident, The Times explained. FDA officials explained to the paper that since 2005, they have received 45,000 reports of the devices failing to operate or operating incorrectly, leading to 88 recalls in all.
Now, in recognition of those risks, FDA has released a new proposed regulation that would require the devices to be reclassified as Class III devices and thus require a PMA to obtain approval.
That action comes after a 2001 device classification panel recommended the agency reclassify the devices as Class III devices in light of their "lifesaving" status. FDA also said it found that "the problems with medical device reporting (MDR) systems and recalls indicate that having these devices regulated under 510(k) has not been successful."
FDA said that once the regulation is implemented, a company will be able to continue marketing AEDs without a PMA for 90 days, after which time it will need to have agency approval. However, the agency said it is also prepared to use its enforcement discretion to allow manufacturers that file a PMA within those 90 days to continue marketing its devices for an additional 12 months in recognition of AEDs' "widespread distribution" and contribution to public health-a potential nod to critics who voiced concern about the regulation's effects.
"The notification of the intent to file a PMA submission should include a list of all model numbers for which a manufacturer plans to seek marketing approval through its PMA," the agency explained. "Manufacturers should be able to collect additional scientific evidence, to the extent any is necessary, and prepare PMA submissions, in this [15 month enforcement discretion] time," it added.
The rule would become effective on the date of its final publication in the Federal Register. Comments are being accepted by FDA for the next 90 days.
Tags: Reclassify, Class III, medical device
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