The Heart Rhythm Society's Draft Guidelines on the Surveillance, Analysis, and Performance Reporting of Pacemakers and ICDs

What prompted the need to create these recommendations? The Heart Rhythm Society is the international leader for cardiac arrhythmia professionals and patients. As part of our mission to improve the care of patients by promoting optimal healthcare policies and standards, we believed it was necessary to develop a set of recommendations and guidelines to address concerns that have been raised about the safety, effectiveness and post-market surveillance of cardiac devices. Change to the current system is needed to ensure continued access to life-saving treatments and to enhance public knowledge, confidence and trust in these therapies.

These draft recommendations involve the participation of the FDA, Congress, CMS, physicians, industry, etc. Once the public comment period ends on May 30th, what will be the next step? How will those public considerations be used, and what process will be used to make sure all parties involved are in agreement? The Heart Rhythm Society believes it is crucial to solicit input from physicians, patients, regulators and the general public; therefore, we are making this draft available for a public comment period until May 30th, 2006. We strongly encourage those who are interested to submit comments online at our website at www.hrsonline.org/members. The draft recommendations will also be the focus of the Health Policy Town Hall Meeting at Heart Rhythm Society's annual scientific sessions, taking place in Boston on Wednesday, May 17, 2006 from 1 pm to 4 pm. Representatives from the Society, FDA, industry and patient advocacy organizations will participate in a series of panels to discuss the proposed recommendations, and there will also be a question and answer period for attendees. At the close of the public comment period, the Task Force will review the feedback submitted and re-evaluate the draft recommendations in light of the comments we receive. The final guidelines are expected to be published in the October edition of the Heart Rhythm journal.

How do these proposed recommendations differ from the current policies on device recall notification? According to the draft recommendations, if a malfunction occurs in a device, how soon will others (such as the FDA, physicians, and patients) be notified? The proposed recommendations differ quite a bit from current policies, and these are outlined in the section on terminology and thresholds for action regarding device recalls and advisory notices. Specifically, we are recommending that both FDA and manufacturers use identical terminology to both classify device malfunctions and communicate that to the public in a timely manner. The task force did not make a recommendation on the event rate for this notice that would trigger notification that is up to FDA, manufacturers and additional stakeholders to implement.

These recommendations bring to the forefront issues such as post-mortem interrogation of devices and getting patient families involved to make sure devices are returned to the manufacturer. Is this the first time issues like this have been addressed? Why was it important to include this? This is the first time these issues have been addressed in a comprehensive way by the Heart Rhythm Society, as well as by other key audiences, including regulators, patient groups and members of industry. The recommendation is important for several reasons. Currently, the vast majority of devices are not returned to the manufacturer after a patient dies. Legally, the device belongs to the patient, and the device cannot be returned to the manufacturer without prior consent from the patient or the patient's family. This is why the task force has recommended that physicians should educate patients and their families about the value of returning the devices, before a patient even receives an implanted device. It is important that every adverse event related to patients with these devices be evaluated independently. Outside panels to evaluate these situations should also be convened quickly.

Once the final guidelines are published in October 2006, what will be the next step? Do you think they will be difficult to monitor or enforce? How will these guidelines effect and help patients worldwide? Since the Society's members are healthcare practitioners, it would be inappropriate for the organization to assume any role in enforcing or regulating the guidelines that have been set forth in this draft. However, the Heart Rhythm Society is committed to advocating for changes to the post-market surveillance system as we have outlined. We have pledged to continue our efforts to improve device surveillance and patient and physician communication regarding device performance, and we look forward to continuing our collaborative efforts with the FDA and industry to encourage adoption of these recommendations. The Society will also be working with Congress to examine what, if any, legislation is needed to speed adoption of our recommendations and to ensure Congress provides the FDA the necessary resources to protect patient safety through the post-market surveillance system. In addition, to assess the international applicability of the proposed guidelines, the Heart Rhythm Society will also be receiving feedback from the Coalition of Organizations of Pacing and Electrophysiology (COPE), an organization representing heart rhythm societies worldwide.