From the May 2014 issue of HealthCare Business News magazine


For device malfunctions that were associated with a death or serious injury, the rate of such incidents is estimated to have been cut by 45 percent for devices used by professionals and 56 percent for devices used by the public when comparing 2007 and 2008 to 2010 and 2011, according to Taylor’s analysis.

The review also found that of the 5,375 MRDs filed for Public Access Devices from 2007 to 2011, 4,471 of those MDR reports occurred during non-clinical use and did not involve patients. Of the nearly 17 percent of MDRs filed for events that occurred during clinical use, only 3.6 percent were associated with death or serious injury. “There’s no change that would warrant any kind of changing in the FDA stance on defibrillators,” Taylor says. “Certainly an argument that defibrillator quality is getting worse, so we need to take action, is not warranted.”


Preparing for tougher regulations
In comments submitted to the FDA in June, Paula Lank, vice president of regulatory and clinical affairs for Physio-Control, asked the agency to reconsider the tougher regulations. With the change to PMA appearing likely, Lank said the company has shifted to preparing for the changes.

“We’re taking this time to prepare and plan to comply with the final order, which we do believe will be PMA,” Lank says. “I think the indications from the FDA have not wavered.” Lank says the planning process includes assessing the current quality systems and identifying areas that need to be modified in order to comply with PMA regulations.

Physio-Control has also taken advantage of the pre-submission process, which allows manufacturers to send a formal request to the FDA to meet and discuss a proposed approach for PMA submissions. In general, PMA submissions require much more clinical evidence on the devices than 510(k) applications do, though the FDA has reached out to AED manufacturers to let them know that large-scale and costly clinical trials to prove safety and efficacy shouldn’t be necessary.

“They are handling our industry a little bit differently because of the extensive field experience and peer-reviewed scientific publications that support a number of the products on the market,” Lank says.

While the agency has suggested that most AED manufacturers already have enough data for devices out on the market, it noted in the proposed order that a “small number” of companies such as third party electrode manufacturers would need “additional investigation to support approval.”

One thing that Physio-Control hopes the FDA will reconsider is including companies that refurbish and resell AEDs as part of the more stringent regulatory pathway. “We have strongly encouraged the FDA to review and consider AED equipment resellers to be subject to PMA regulations,” Lank says.

May 2014 Magazine

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