The automated external defibrillator industry is about to get a bit of a jolt. In March, the Food and Drug Administration released a long-inthe- works proposed order that will toughen the procedure for getting the devices on the market after a number of high-profile recalls. It’s unclear exactly how this will affect AED-makers, but it could dramatically increase the money and time needed to commercialize the life-saving equipment.

Not everyone is happy about this. The fear is that the new regulations could, by making it harder and more expensive to commercialize devices, discourage innovation or raise the costs of AEDs. Pricier automated defibrillators, which already run between $1,000 and $2,500 per unit, could make it less likely that budget-strapped public facilities will have them on hand in an emergency.

“I hope the public won’t be confused by reports of device failures and think they shouldn’t be involved in helping to save a life,” says Mary Newman, the head of the Sudden Cardiac Arrest Foundation, which it should be noted is sponsored by AED manufacturers. “As it is, it’s an uphill battle for people to understand how simple these devices are to use.”

But the current, lighter regulations have risks, too. Consumer and patient safety advocates had long warned that AEDs, as life-supporting devices, ought to be held up to a higher regulatory standard, and that over the past decade hundreds of thousands of defective or potentially malfunctioning devices have been recalled — some which have even failed during resuscitation attempts in which the patient died.

“We don’t oppose these devices or their use,” says Dr. Michael Caroome, with Public Citizen, a watchdog group that has argued for the reclassification of the devices. “We think they should be appropriately studied and tested before marketing to protect the patients on whom they’re used.”

AED use in perspective
Thanks to a variety of state laws and health campaigns, you can now find AEDs in many public places, such as schools, airports and malls. They’re widespread, because sudden cardiac arrest, the condition they’re meant to counteract, is one of the country’s leading killers. According to the SCA Foundation, about 360,000 people in the U.S. experience SCA out of the hospital, and about 90 percent of them die.

SCA is usually caused by ventricular fibrillation, in which the heart’s lower chambers quiver erratically, causing the heart to stop pumping blood, according to the National Institutes of Health. Death occurs within three to five minutes; thus, quick intervention by bystanders is critical to survival.

This is where an AED comes in. The battery-powered system, which comes equipped with a pad electrode to put on the victim’s body, uses a computer to monitor heart rhythm. If it thinks the patient could benefit by the shock — generally for ventricular fibrillation or pulseless ventricular tachycardia — it either administers the jolt itself, or urges the responder to do so, according to the FDA.

While SCA is fairly common, AED use is not. A 2010 study in the Journal of the American College of Cardiology examined 13,700 out-of-hospital cardiac arrests, and found only 2.1 percent had an AED applied before the paramedics came. But when it is used, it can save lives. The same study found that AEDs helped bump up survival rates, going from about 9 percent with CPR alone to 24 percent with AED use and 38 percent if the AED delivered a shock. (The AED can instruct the user to perform CPR and skip the shock.)

New rules
On March 22, the FDA said it would require AEDs to be regulated as Class III devices, its highest-risk category, largely following recommendations it received from an advisory panel in January 2011. Previously, AEDs had been regulated as Class II, medium-risk devices (a category that includes most X-ray equipment). The reason is fairly convoluted — AEDs had a “predicate” or earlier device that was the basis for their regulation, which was a so-called pre-amendment device, meaning it came out before the FDA’s current device rules took shape in the 1970s. Thus, AEDs were grandfathered in as Class II products. But under congressional orders, the FDA has to look at AEDs and other grandfathered devices and either downgrade their classification or regulate them according to their “real” status — which is what the FDA is doing now.

Under the old rules, AED manufacturers needed only to obtain 510(k) clearance for their product and accessories, which typically just requires evidence that the device is “substantially equivalent” to another device already on the market. But now, if FDA’s proposed order goes into effect, manufacturers will have to get premarket approval, or PMA, a much more expensive and involved process.

Now, this doesn’t mean AEDs currently on the market will be pulled right away. According to the agency, companies will have a 15-month “enforcement discretion” period if they notify the FDA within 90 days of whenever the final rules are published.

Reasons for the rules
When the agency was still mulling over how to treat AEDs, manufacturers had asked the agency to keep them as Class II, but with “special controls.” These included testing to industry standards, certain labeling and guidance documents, and post market surveillance, according to the proposed rules.

But the FDA was not convinced.

“[The] 510(k) clearance process for these devices has failed to protect American consumers,” Dr. William Maisel, now the deputy director of the FDA’s Center for Devices and Radiological Health and formerly director of the medical device safety institute at Beth Israel Deaconess Medical Center, said in a speech before the House subcommittee on health a few years ago.

Of the nearly 1 million AEDs on the market at that time, one-fifth had been recalled by the FDA, mostly because of electrical or software problems, he testified. In a nearly 10-year period ending in 2005, AED-related device malfunctions were linked to hundreds of deaths. In total, there were 52 FDA recalls, he said.

“Although they’re relatively on their face simple devices, they are complex in terms of their hardware, their maintenance and their software, and so there’s lots of areas where things can go wrong with them,” Caroome, with Public Citizen, explains. “So when you look at reasons for some of the recalls, there can be failures at multiple levels.”

There have been devices at risk of voice prompt failures, where the computerized voice that instructs the user how to apply the AED doesn’t work properly. In another recall, which affected almost 10,000 AEDs, the devices could shut down during attempted resuscitation. There were others that wouldn’t give a shock when the patient’s rhythm required it, or it gave a shock when the patient’s rhythm was normal enough to sustain blood flow to the body, which could then be disrupted by a bad shock, Caroome says.

Perhaps a more common problem is that if the device is defective, the time spent trying to apply it is time that could have been spent trying CPR. “When you use the device you stopped CPR or chest compressions,” he says.

“There are always going to be some of these devices that are going to fail, just because of the nature of them,” Caroome adds. “But with appropriate testing this can be minimized.”

For its part, the FDA said the PMA rules would help improve patient safety. Medical device reports for AEDs doubled from 2005 to 2010, and were still increasing from 2011 to 2012. But this data-collecting, at least, could be better under the new rules. “Annual reporting (which occurs with PMA devices) would improve overall surveillance by providing denominator data for device distribution as well as current trend information on issues being followed by the manufacturer,” the agency said in the proposed order.

The agency also said in its analysis of recalls most were linked to purchasing and design controls. Plus, the company said it noted a “significant number of violative AED manufacturing facility inspections.” Thus, as part of the PMA process, companies would have to undergo a premarket review of quality-control procedures and preapproval inspections, as well as post market follow-up.

How big is the effect on AED manufacturers?

For the industry, then, the question is: how onerous are these changes? So far, it’s not exactly clear, but potentially the effect is quite large, as higher-risk devices take months longer, and millions of dollars more, to get approved for market.

“Generally, PMA approval imposes a significant time and financial commitment on companies seeking such approval,” AED-maker Philips Healthcare told DOTmed News in an e-mail. “The added costs associated could ultimately increase the cost to consumers, which is already significant given that AEDs are not reimbursed by insurance.”

Still, based on talks between the FDA and industry on March 21, Philips said it doesn’t believe the rules, if final, would interrupt its AED distribution in the U.S.

“Philips continues to review the proposed order, and remains committed to working with the FDA to ensure the best application of technology and clinical experience in support of AED performance and reliability,” the company said.

Brian Webster, the president and CEO of PhysioControl, an AED manufacturer that recently was bought by Bain Capital (of Romney fame) from Medtronic, said his company has “the most-robust quality system in the industry” and as a result is also “extremely confident” it can meet the new regulations.

“The move would level the playing field and require all AED manufacturers, including third-party suppliers, to adhere to the same high quality standards,” he said in a statement sent to DOTmed News. In any case, he said it was important to remember that “AEDs save lives and that device failures are extremely rare.”

“While it is the FDA’s position that defibrillator failures have risen, the number of devices in the market has grown exponentially and AED reliability continues to improve,” he added.

Other manufacturers, such as HeartSine and Zoll, did not respond to requests for comment by press time.

But some numbers will help put the debate into context. A Class II application, going from submission to final 510 (k) clearance, takes 138 days on average, according to Elisa Maldonado-Holmertz, VP of business development at Emergo Group, a company that consults with device manufacturers about regulations. For a Class III device, on average it’s 540 days.

“It’s a substantially longer timeframe for manufacturers to make it to market access,” Maldonado-Holmertz says. “That’s a significant difference.”

The costs are higher too. A 510(k) application is $4,950, whereas a PMA is $258,000. Potentially, though, AED makers could spend a lot more, depending on the burden of clinical evidence required.

For now, that’s not clear, either. In its comments, the agency suggested that most AED manufacturers already have enough data for devices out on the market. “In most cases, FDA believes the clinical data that has been submitted for AEDs in 510(k) applications will suffice as valid scientific evidence necessary to support a PMA,” the FDA said in the proposed order.

The agency did note, however, that a “small number” of companies would need “additional investigation to support approval.”

“In those circumstances, FDA will consider the least burdensome means of gathering information, and will consider whether reliance on post market controls can reduce the extent of data that would otherwise be required to show effectiveness,” the agency said. The agency also noted that one PMA application could cover all of a manufacturer’s models, according to a March Reuters report.

Still, if clinical trials are needed for at least upcoming, brand-new devices, they could be expensive, depending on how the new position is enforced. Previously, most AEDs only needed a usability study, Maldonado-Holmertz explains, such as whether a bystander could pull the device off the wall and use it safely. These typically had no more than 20 to 50 participants. But for a PMA, manufacturers could potentially require a large-scale true clinical trial to prove safety and efficacy. This would involve possibly 200 to 250 subjects.

The price difference is huge, too. Small usability studies tend to run from $20,000 to $800,000, depending on their complexity, Maldonado-Holmertz says. But true clinical PMA trials can cost upwards of $3 million.

Will the increased costs be a problem? “For researchers and AED manufacturers committed to driving innovation to help improve survival from SCA, some may find that it is only feasible to conduct research outside the U.S. given the regulations associated with Class III,” Philips said. “The resulting advanced technology may only be made available in markets outside the U.S. due to differing AED regulations in other geographies.”

But others aren’t so sure. Public Citizen’s Caroome is skeptical that being regulated as a Class III product will dry up the market, as some AED advocates or manufacturers have feared.

“That’s a common refrain you hear, that ‘Oh, these devices, we won’t be able to afford to do this,’” he says. “There are companies out there that will still be able to make these out there with appropriate testing. Using language out there to scare the public isn’t helpful.”

DOTmed Registered DMBN May 2013 - Defibrillators Companies

Names in boldface are Premium Listings.
Domestic
David Wakefield, Jet Medical Electronics, CA
Leslie Roberts, Altra Medical, FL
James Fowler, BioMed Techs Inc, FL
John Mantilla, Dimesan USA Inc, FL
Randy Lowers, L & R Services, FL
DOTmed Certified
Garret Purrington, Medical Equipment Dynamics, Inc., MA
DOTmed 100
John Gladstein, Medical Device Depot, MD
DOTmed Certified
Robert Schirano, Finger Lakes Medical Supply LLC, NY
Lawrence Maroney, Integris Equipment, NY
DOTmed Certified
Mark Taylor, Masterfit Medical , TN
DOTmed Certified
DOTmed 100
JORGE DELGADO, PRESTIGE EMS, TX

International
Pedro Pestana, Spacemedical, Portugal
Dan Kongsted, Cervius Medical, Denmark
Nitin Khalate, Multitech Medical Systems PVT.LTD, India
Norm Villeneuve, B.B.Products, Canada
Mehmet Er, TEPA, Inc., Turkey
Rodolfo Reyes Ingeniero, INNOVA MEDICAL, Mexico
Naveen Kangokar, Alvin Care Services UK Ltd, United Kingdom
Rick Meerkerk, Mediproma B.V., Netherlands