FDA advised to rethink recall language on heart devices

The wording of agency warnings was inflammatory and led to risky replacements of malfunctioning defibrillators, some doctors say.

By Kevin B. O’Reilly — Posted Nov. 6, 2006

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The Food and Drug Administration should stop using the word "recall" when telling the public about serious problems with implantable cardiac defibrillators and pacemakers, according to a report the Heart Rhythm Society released this fall.

The group's study, which the American College of Cardiology Foundation and the American Heart Assn. endorsed, also calls for the FDA and device makers to provide greater transparency and better postmarket monitoring.

The evaluation is an outgrowth of a policy conference the Heart Rhythm Society, an organization of cardiac electrophysiologists, held on the heels of a string of FDA heart-device recalls last year. One of these recalled devices, the Guidant Ventak Prizm 2 DR Model 1861 defibrillator, short-circuited and failed to send a lifesaving shock to Joshua Oukrup, a Minnesota 21-year-old with hypertrophic cardiomyopathy. The man died while bicycling.

The task force of 14 physicians and a nurse who authored the report concluded that the public would be served better by using terms such as "safety alert" or "safety advisory" instead of "recall" because, they said, many patients and some doctors mistakenly believe that a recalled heart device must be replaced.

The word "recall" is "inflammatory not just for patients but for physicians," said Dwight Reynolds, MD, Heart Rhythm Society president and chief of the cardiovascular section at the University of Oklahoma Health Sciences Center. "If you think about the Ford Pinto when you hear the word 'recall,' it's hard to sleep when you've got that in your chest."

Dr. Reynolds added that "some physicians made the decision to explant all the devices that came under advisory because they were termed Class I recalls. That, quite frankly, was a bad decision."

Explantation risks are great, doctors say, especially if a patient has not received lifesaving shock therapy or is not dependent on the device. An April 26 Journal of the American Medical Association study found that complications occurred in 8.1% of replacements for Canadian patients in 2004 and 2005. Nearly 6% of the patients had major complications requiring reoperation, and two died from infection.

In a statement responding to the HRS report, the FDA said it had "taken steps to explain the current terminology to the public and physicians," but the agency has said it wants to maintain a consistent taxonomy across all products it regulates -- from drugs to devices -- and that it could not legally use different wording.

Peter Reichertz, a partner at Sheppard, Mullin, Richter & Hampton LLP and an expert on the FDA, said that although the Federal Food, Drug and Cosmetic Act may limit agency officials, they could find some flexibility.

"I don't think anyone ... would object to them calling it something besides a recall," he said. The FDA "is being a little persnickety when they say they couldn't be more specific and get out a better description."

The HRS report also says:

  • The FDA should revamp its Manufacturer and User Device Experience database better to track problems specific to heart devices.
  • Device makers should issue semiannual plain-language reports available in print and online, standardize communications with physicians and patients, appoint independent expert panels regularly to assess problems and further develop wireless remote device monitoring.
  • Doctors should talk with patients about the need to explant devices after they die to check for problems.
  • Physicians and patients should carefully weigh risks and benefits of device replacement after a recall.

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External links

Recommendations from the Heart Rhythm Society Task Force on Device Performance Policies and Guidelines (link)

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