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Healio
Issue: November 2006
November 01, 2006
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HRS offers final word on ICDs, pacemakers

Society recommends that the FDA take out the term ‘recall’ in public communications.

Issue: November 2006

The Heart Rhythm Society wants to provide clearer, timelier and more consistent information about the recall process and performance of pacemakers and implantable cardioverter defibrillators with its final recommendations.

The overarching goals of the new recommendations, formulated by a 15-member task force in collaboration with Centers for Medicare and Medicaid Services and the FDA, include greater transparency in post market surveillance, the analysis and reporting of information; establishment of new systems to identify malfunctioning devices more quickly and standard notification and communication to physicians and patients from the manufacturer when a device malfunction is identified.

“It puts forward recommendations on how to deal with device dysfunction, which is critical, but it also sets a new level of interaction between a physician organization – HRS – the CMS and the FDA that is really unprecedented,” said Douglas P. Zipes, MD, the American College of Cardiology liaison on the task force. Industry was involved and contributed to the recommendations as well, Zipes said. The public provided additional feedback during a public comment period that ended May 30, 2006.

The guidelines are available online and published in the October issue of Heart Rhythm.

Specifically for doctors

The HRS suggests physicians should do three things:

  • Inform patients not only about the benefits and risks of devices, but also about the overall expected performance of devices, including potential malfunction rates.
  • Return all malfunctioning devices after explant to the manufacturer for analysis whether the replacement is routine or because of a malfunction. This will lead to more timely identification of potential malfunctions and a better understanding of the true denominator for a particular device.
  • Consider the risks of explantation and reimplantation of a new device when considering with patients how to respond to an advisory notice that a device malfunction has been identified.

“The biggest Achilles heel in what we do is the lack of post market surveillance, and part of that is our fault because we do not pursue the potential of device failure and this needs to be done,” said Zipes, section editor of the Electrophysiology and Arrhythmia Disorders section of Cardiology Today.

The HRS provided specific recommendations for the FDA, Congress and manufacturers, too. Among its recommendations for the FDA, the society recommends the agency use simple language to communicate information about device malfunctions and eliminate the term “recall” in public communications.

“The FDA has already implemented one of the HRS’ key recommendations by expanding the charge of our standing cardiac advisory device panel beyond premarket issues to address device post market safety and effectiveness,” the FDA said in a statement. “Additionally, we are in the process of implementing other key HRS recommendations, some of which can yield results relatively soon, with others being implemented and showing results over a longer term.”

The ACC Foundation, American Heart Association and an international coalition of electrophysiology organizations endorsed the guidelines. – by Judith Rusk

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