Heart Rhythm Society to Develop
Guidelines on ICD Recalls
Task Force To Begin Drafting Recommendations On Manufacturer Notification Standards
WASHINGTON, June 21, 2005 -- 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 concludes.
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.
Heart Rhythm Society |
