FDA Considers Reclassifying AEDs, Costs Expected to Rise


There’s little argument that automated external defibrillators (AEDs) save lives and their success in restoring life during sudden cardiac arrest (SCA) has been well documented.

The U.S. Food and Drug Administration (FDA) is currently looking at reclassifying AEDs as Class III medical devices that will have to go through extensive and costly scientific pre-market approval. Experts in emergency medical service say that extra step with thwart AED innovation, drive up costs of the equipment and ultimately reduce their availability to SCA patients for early defibrillation.

The FDA announced that is pushing to issue the ruling for AEDs by the end of 2012 and EMS professional are now urging providers to let regulators know how they feel about the proposed change and the adverse affect it will have on patients.

Health care providers and AED manufacturers are encouraging those who use AEDs and those who believe in their value as widespread lifesaving tools to let the FDA know how they feel through a letter campaign.

Several organizations and manufacturers have developed form letters expressing concern about the proposed changes and the chilling effect they’ll have on positive patient outcomes that are already only about eight percent for SCA patients.

The FDA is deep in the process of making a decision on the rule and many say it’s critical they hear from as many people as possible to have AEDs remain as Class II devices as they have for more than 20 years and flow to the market place through the 510(k) process.

Below is a sample letter that can be sent to the FDA to show support for keeping AEDs readily available and allowing innovations to make it to the market place without extensive and unnecessary regulations.

The FDA is only accepting comments by postal service or fax and they can be sent to the following address and telephone number. It is important for appropriate routing that you reference Docket Number: FDA-2009-M-0101. The mailing address is below, and if you wish to fax your letter of support please send to: 301-827-6870

Sample letter of support:

Food and Drug Administration
Division of Dockets Management (HFA-305)
Docket Number: FDA 2009-M-101
5630 Fishers Lane, Room 1061
Rockville, MA 20852

To US Food & Drug Administration:

Early defibrillation is the definitive treatment for sudden cardiac arrest (SCA), which claims nearly 300,000 lives in the United States per year.

Widespread distribution of automated external defibrillators (AEDs) is overwhelmingly advocated by the medical community and legislators as a strategy for achieving early defibrillation. Even with the growing availability of AEDs in the US and highly successful early defibrillation programs throughout the country, the current national SCA survival rate is less than 8% largely because without AEDs early defibrillation doesn’t happen in time. In order to improve the national survival rate and help restore more lives, we must continue to drive widespread access to AEDs.

It is my understanding that the FDA is considering classifying AEDs as class III, requiring pre-market approval (PMA). I am writing to express my concern that this increased regulation of AEDs will limit innovation and public access to these devices, both highly negative results. Over several decades, hundreds of peer-reviewed studies have already demonstrated that AEDs are safe and effective and that early defibrillation saves lives.

There is no guarantee, and little likelihood that requiring AEDs to go through the PMA process will lead to an increase in AED safety and effectiveness. To the contrary, these additional regulations will likely stifle innovation and new, improved technology will be delayed, or may not even be pursued in the US due to regulatory costs and time-to-market considerations under the PMA process.

Furthermore, AEDs will become more expensive to purchase and maintain as a direct result of expenses associated with increased regulatory requirements. Communities, public entities such as schools and police forces, companies, including small businesses, and non-profit organizations, are among the primary groups that provide the funds to purchase and maintain public access AEDs for which there is no insurance reimbursement.

Moreover, to the extent individuals can now afford to have AEDs in their homes, this additional source of AED availability will surely diminish or disappear altogether. As prices rise, fewer AEDs will be purchased and deployed which limits public access AED availability when they are critically needed to help save lives. Without public access AEDs the average time to defibrillation will likely increase, which then could decrease survival in the US associated with SCA.

Robust AED safety and performance standards already exist that capture over 20 years of hard-won clinical, regulatory, and industry experience. These AED-specific standards are the foundation for securing consistent performance as they drive implementation of best practices across the industry. Perhaps focusing on broader support and continuous improvement of these standards would help achieve even improved product performance, while maximizing access to life-saving AEDs.

I urge FDA to consider alternative pathways that ensure the safety and effectiveness of AEDs, but at the same time continue to support efforts to drive widespread access to early defibrillation. For the hundreds of thousands of Americans who unexpectedly suffer an SCA each year, we cannot afford to further decrease the odds that an AED will be available when needed to help restore their lives.

Those who are motivated to do so are encouraged to take the above sample letter, sign it and send it to the FDA to help the agency make a decision based on feedback from the providers in the field
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