Heart Rhythm Society publishes final recommendations for heart patients

WASHINGTON, September 28, 2006 -- The Heart Rhythm Society today issued final recommendations to provide heart patients with clearer, timelier and more consistent information about the recall process and the performance of pacemakers and implantable cardioverter defibrillators (ICDs). The recommendations also offer specific guidance to physicians, Food and Drug Administration (FDA) officials and members of Congress about performance issues and advisories for implantable cardiac devices. In addition, the final recommendations report also addresses international principles related to device performance.

The report will be published in the October issue of Heart Rhythm.

"This report offers the first comprehensive recommendations for the surveillance, analysis and performance reporting of pacemakers and ICDs," said Dwight Reynolds, MD, FHRS President of the Heart Rhythm Society. "These changes will help patients continue to have confidence and trust in these lifesaving treatments."

The overarching objectives of the recommendations include the following:

  • Greater transparency in the post-market surveillance, analysis and reporting of information;
  • The establishment of new systems to identify malfunctioning devices more quickly;
  • Standard notification and communication to physicians and patients from the manufacturer when a device malfunction is identified. Manufacturers, the FDA and physicians are encouraged to work together to prevent adverse events due to device malfunctions; and
  • The global scope of device performance issues; cooperation among industry, physicians, government authorities and national health care systems are necessary to reduce the risk of injuries and deaths due to device malfunctions.

"The next step is for the Heart Rhythm Society to work with Congress, regulators, industry, patients and other stakeholders to ensure that these recommendations will guide key policy decisions that will help heart patients," said Mark D. Carlson, MD, FHRS, Chairman of the Heart Rhythm Society Task Force on Device Performance Policies and Guidelines.

Specific recommendations for each of the key audiences include:

Physicians:

  • Should inform patients not only about the benefits and risks of devices, but also about the overall expected performance of devices, including potential malfunction rates.
  • Should 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.
  • Should consider the risks of explantation and re-implantation of a new device when considering with their patients how to respond to an advisory notice that a device malfunction has been identified.

Manufacturers:

  • Should use expanding wireless and remote monitoring technologies to identify abnormal devices earlier and automatically.
  • Should establish independent, standing committees of outside experts to analyze device performance reports and to recommend appropriate action.
  • Should communicate with physicians and patients directly using standard physician and patient communication forms to notify patients regarding potential malfunctions.

FDA:

  • Should use simple language to communicate important information about device malfunctions and eliminate the term "recall" in public communications.
  • Should enhance the existing databases to more readily identify devices that may pose a danger to patients.
  • Should establish a post-marketing surveillance advisory panel of independent expert advisors to assist FDA with this function.

Congress:

  • Should recognize the FDA needs the appropriate resources, funding and focus to perform post-market surveillance, analysis and reporting.

A 15-member task force of leading cardiac care providers and experts developed the guidelines with feedback from regulators at the FDA, representatives from industry and patient advocacy groups. Additional feedback was received from a public comment period that ended May 30, 2006.

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The guidelines have been officially endorsed by the American College of Cardiology Foundation, American Heart Association and an International Coalition of Pacing and Electrophysiology organizations, which includes the Asian-Pacific Cardiology Society, European Heart Rhythm Association, European Cardiac Arrhythmia Society and Latin American Society of Pacing and Electrophysiology.

The final guidelines are available online at http://www.hrsonline.org.

About the Heart Rhythm Society
The Heart Rhythm Society is the international leader in science, education and advocacy for cardiac arrhythmia professionals and patients, and the primary information resource on heart rhythm disorders. Its mission is to improve the care of patients by promoting research, education and optimal health care policies and standards. Incorporated in 1979 and based in Washington, DC, it has a membership of over 4,500 heart rhythm professionals in over 74 countries around the world.

EDITOR'S NOTE: To schedule an interview with Dr. Dwight Reynolds, please contact Rachael Lille Moore at 202-464-3476 or rmoore@hrsonline.org


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