The recommendations also provide heart patients with clearer, timelier and more consistent information about the recall and advisory process.
"As the international leader in science, education and advocacy for cardiac arrhythmia professionals and patients, we believe these suggested changes will ensure that patients continue to have access to these lifesaving treatments," said Anne B. Curtis, M.D., President of the Heart Rhythm Society. "We believe these draft guidelines are an important step towards strengthening patient and physician knowledge, confidence and trust."
The draft guidelines call for: 1.) greater transparency in the post-market surveillance, analysis, and reporting of information 2.) the establishment of new systems to identify malfunctioning devices more quickly and 3) 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.
Select highlights from the recommendations include the following:
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 patients directly using standard 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 additional resources and funding to perform post-market surveillance, analysis and reporting.
Development of the guidelines began when the Heart Rhythm Society convened a policy conference last September 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 charged with the development of draft recommendations. Regulators from the FDA, representatives from industry, and patient advocacy groups were asked to provide feedback in the initial phases of crafting the document. The recommendations are the first such collaboration among these diverse groups.
"As part of our mission to improve the care of patients by promoting research, education and optimal health care policies and standards, the recommendations and guidelines were necessary to address concerns about the safety, effectiveness and post-market surveillance of cardiac devices," said Mark D. Carlson, M.D., task force chairman and Treasurer, Heart Rhythm Foundation. "The Heart Rhythm Society will continue to work with Congress, regulators, industry, patients and other stakeholders to ensure these draft recommendations will guide important and necessary policy changes to benefit patients."
Today's release signals the opening of a public comment period. Physicians, patients, regulators and the general public are encouraged to comment on the guidelines through May 30, 2006. Comments on the guidelines may be made online at http://www.hrsonline.org/members. To assess the international applicability of the proposed guidelines, the Heart Rhythm Society will also be receiving feedback from Coalition of Pacing and Electrophysiology, an organization representing heart rhythm societies worldwide.
The draft recommendations will also the subject of the Health Policy Town Hall Meeting at Heart Rhythm Society's annual scientific sessions, taking place in Boston on Wednesday, May 17, 2006. Representatives from the Society, FDA, industry and patient advocacy organizations will participate in a series of panels to discuss the proposed recommendations.
Final guidelines are expected to be published in the October issue of Heart Rhythm Journal.
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.