Heart Rhythm Society to Develop Guidelines on ICD Recalls

Task Force to Begin Drafting Recommendations

on Manufacturer Notification Standards

Jun 21, 2005, 01:00 ET from Heart Rhythm Society

    WASHINGTON, June 21 /PRNewswire/ -- The Heart Rhythm Society has formed a
 task force to begin drafting recommendations for uniform notification
 standards to inform physicians and patients about safety alerts and recalls of
 implantable cardioverter defibrillators (ICDs).  The Task Force on Device
 Performance will finalize the standards -- including recommendations for
 physicians on when to replace an ICD -- at a public policy conference in
 Washington in the fall. The meeting will include representation from the Food
 and Drug Administration (FDA), clinicians, media, manufacturers, and cardiac
 and patient organizations.
     "These new guidelines will focus on what is always our first priority:
 patient safety," says Anne B. Curtis, MD, president of the Heart Rhythm
 Society. "We're taking the lead in developing these guidelines, just as we've
 been the industry leader in establishing universal standards of care for heart
 rhythm disorders for 25 years."
     While the guidelines are being developed, Dr. Curtis says the Heart Rhythm
 Society concurs with the FDA in recommending that patients affected by recalls
 seek the medical advice of their heart rhythm specialists.
     "Patients need to discuss the variety of treatment options available with
 the heart rhythm specialist overseeing their care," she says. "Each patient is
 unique and the decision regarding ICD treatment based on recall information
 from the manufacturer and the FDA will depend on the patient's specific
 medical condition.
     "Despite recent device recalls, the benefits of sudden cardiac arrest
 prevention conveyed by the ICD, far outweigh the risk of device failure," she
     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. Headquartered in Washington, DC, the
 Society was incorporated in 1979, and has a membership of over 3,500
 physicians and associated professionals in over 65 countries around the world.

SOURCE Heart Rhythm Society