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Heart Rhythm Society publishes final recommendations for heart patients

cisions 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 resour
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Contact: Rachael Lille Moore
rmoore@HRSonline.org
202-464-3476
GYMR
28-Sep-2006


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