The draft offers specific recommendations to industry, FDA, Congress and physicians for the surveillance, analysis and performance reporting of cardiac devices. The recommendations provide patients with clearer, timelier and more consistent information about the recalls and advisories of cardiac devices. This is the first time comprehensive guidelines have been developed to help physicians make critical decisions about responding to advisories.
What: A telephone briefing to announce the Heart Rhythm Society’s draft policy recommendations for pacemaker and implantable cardioverter defibrillator (ICD) performance.
Who: Telebriefing participants include:
When: Wednesday, April 26, 2006 10:00 AM ET
RSVP: Contact Rebecca Leaf at 202-745-5051, firstname.lastname@example.org / to receive the confirmation code.
This telebriefing is for credentialed media only.
Call-in telephone number: (866) 550-6338 (a confirmation code is needed to enter the call) Call-in replay information: (888) 203-1112 (passcode 6630214) from 2:00 p.m. ET on 4/26/06 until 11:59 p.m. ET on 4/30/06
History: In September, 2005, the Heart Rhythm Society convened a policy conference to discuss issues related to the performance of pacemakers and ICDs. As a result of that meeting, the Society assembled a 15-member task force of leading cardiac care providers and experts who were charged with the development of draft guideline recommendations. Additionally, the Task Force worked with regulators from the Food and Drug Administration (FDA) as well as representatives from industry, to solicit feedback in the initial phases of drafting the guidelines. This is the first such collaboration among these diverse groups.
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 4,300 heart rhythm professionals in over 65 countries around the world.
Last reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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