Washington, DC - Industry, government regulators, and clinicians don't communicate with each other clearly, completely, or often enough, suggest preliminary recommendations for implantable-device-performance surveillance and reporting that were released yesterday by the Heart Rhythm Society (HRS) [1,2].

The draft document, developed by the HRS with the American College of Cardiology, contains the latest in a series of recommendations [3,4] intended to repair an apparently defective system for how device companies and the US Food and Drug Administration track and respond to malfunctions in pacemakers and especially implantable cardioverter defibrillators (ICDs). The system seemed to crash last year after a highly publicized recall of Guidant ICDs with potentially fatal design flaws, a problem the company was aware of as it continued to sell the devices [5]. As extensively covered by heartwire, Guidant and the FDA were broadly criticized for not promptly informing clinicians and the public.

The different proposals overlap somewhat, but in general the HRS document extends the earlier, broader recommendations by specifying procedural changes and new responsibilities for industry, the government, and clinicians, even providing sample standardized physician-advisory and patient-notification forms.

In my opinion, this is about reestablishing transparency and trust.

Among the document's major recommendations, implantable-device manufacturers would intensify their monitoring for malfunctions and promptly inform clinicians and the FDA of any issues that might compromise patient safety. Afterward, the companies would also directly give patients the same information.

Clearer communication was a major theme of the HRS document, which entreats industry and the FDA to use the same terminology consistently to classify device problems and communicate to the public. For its part, the FDA would revamp and simplify its language for classifying actions related to device problems. In particular, the document states, the word "recall" should be eliminated to avoid confusion among physicians and patients over the severity of individual device problems.

Clinicians and patients may incorrectly interpret a "recall" as a directive to explant potentially faulty devices, a procedure that entails some risk, observed HRS president Dr Anne B Curtis (University of South Florida, Tampa). Less urgent words might substitute for the traditional one. "By getting rid of the term recall and using the term safety alert or advisory, we want to get physicians and patients to look at what the details are and enable them to do a careful assessment of the risk of a malfunction vs the risk of changing it out," she said at a press conference held to publicly introduce the draft document. "I have felt all along that this was going to be a key recommendation of the Heart Rhythm Society guidelines."

The current system is heavily dependent on industry to detect and report device-performance problems.

Greater physician input to the process is also important to making it work, Curtis observed. "The current system is heavily dependent on industry to detect and report device-performance problems," she said. "Physicians are not involved systematically in determining if and when a device safety concern exists or the response to a safety concern." The companies should therefore establish "independent standing committees of outside experts" to analyze device-performance data and recommend any needed actions, the document states. Also, the FDA would set up a similar brain trust or appropriately extend the Circulatory System Devices Panel's mandate to include postmarketing evaluation of ICD performance.

Finally, the document recommends standards physicians can follow for their patients with devices identified with a potential malfunction. The risks of explanting and replacing ICDs vary among both patients and the experience of clinicians who would perform the procedure and must be balanced with the device's likely clinical benefit, Curtis said. "We recommend that physicians seriously consider replacing the device or lead if failure of the device could result in patient death or serious harm and if the risk of replacement is not substantially greater than the risk of device failure," she said. "Alternatively, observation is recommended in situations of low patient risk."

The HRS document addresses the primary issue in the public debate about ICDs and their reliability, according to one of its authors, Dr Bruce L Wilkoff (Cleveland Clinic, OH). "The core problem is, do we trust the therapy? If we don't trust the therapy, we'll never implement the therapy," he told heartwire. Should a 1% or 2% chance of device malfunction keep patients from avoiding a 10%-to-15% chance of sudden death? "That would be a tragedy. . . . In my opinion, this is about reestablishing transparency and trust."

A public comment period on the draft recommendations extends until May 30, 2006. Comments can be submitted through the HRS website.