Defibrillation Leads Suspension Underscores Need for Guidelines
October 16, 2007 — In response to Medtronic’s decision to voluntarily suspend its Sprint Fidelis defibrillation leads, the Heart Rhythm Society (HRS) made a statement to underscore the importance of the society’s task force recommendations for the surveillance, analysis and performance reporting of pacemakers and implantable cardioverter defibrillators (ICDs).
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.
“Our guidelines are intended to help ensure transparency and promote cooperation among manufacturers, physicians, patients and the FDA,” said Bruce D. Lindsay, M.D., FHRS, president of the Heart Rhythm Society. “Adhering to the principles of these guidelines can help ensure the best patient care possible.”
The overarching objectives of the HRS 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.
Specific recommendations and more information are available online at: http://www.hrsonline.org/Policy/ClinicalGuidelines/HRS-Device-Perform-Recs.cfm.
For more information: www.HRSonline.org