Draft recommendations from the Heart Rhythm Society would increase the clarity and amount of information industry gives FDA, physicians and patients on pacemaker and implantable cardioverter defibrillator (ICD) performance.

In an April 26 report, the society recommends changes across six broad areas, ranging from the need for regular reports on device performance to improvements in the way companies analyze and act on potentially life-threatening device defects.

"Ultimately," the society says, "the draft recommendations are expected to improve patient confidence in these devices and ensure that these lifesaving technologies will be safe, effective and available to people who need them."

The draft recommendations were developed by a Heart Rhythm Society task force consisting of 15 physicians, including Mark Carlson, Case Western Reserve University; Bruce Wilkoff, Cleveland Clinic; and William Maisel, Harvard University. The group was formed last October to address issues raised at a policy conference on heart device safety held by HRS and FDA (¹ 'The Gray Sheet' Oct. 17, 2005, In Brief).

The first recommendation urges companies to establish standards of performance for each of their heart devices. The companies should publish reports on actual product performance twice a year, focusing on helping physicians make clinical decisions. The latter recommendation previously appeared in a document drafted by AdvaMed's ICD/pacemaker working group, which includes representatives from Guidant, Medtronic, St. Jude and Biotronik (² Also see "AdvaMed Posts Guidelines For Pacemaker And ICD Performance Reports" - Medtech Insight, 27 March, 2006., p. 4).

The society also recommends that companies establish independent, standing committees of outside experts to analyze the device performance reports and recommend action when appropriate. The committees would meet regularly, "as well as on an ad hoc basis and quickly" whenever a life-threatening device defect is discovered.

This recommendation seems to address the problems experienced by Guidant in its handling of a rare defect associated with the Prizm 2 DR ICD. Although the company fixed the defect in 2002, it did not notify patients and physicians about the issue until after the March 2005 death of a young man implanted with the device ³ Also see "ICD/Pacer Advisory Standards Should Be Developed – FDA Panel Chair" - Medtech Insight, 30 May, 2005., p. 5). The publicity surrounding the death and subsequent recalls by Guidant and other manufacturers was the impetus for the Heart Rhythm Society's current efforts to improve postmarket surveillance and reporting.

The society recommends that manufacturers develop wireless and remote monitoring technologies to identify abnormal devices as early as possible. And when they need to tell physicians and patients about potential problems, companies should use standardized "Device Advisory Notice" forms, samples of which are provided in the report.

Equally ambitious are the society's proposals for FDA, which would change the way the agency obtains and communicates device performance information. The group recommends that FDA design a specialized form for people to use in reporting adverse events related to heart rhythm management devices. Companies and healthcare practitioners now report ICD and pacemaker events on the same generic form used for all types of medical devices.

The society also suggests that FDA's adverse event database, called "MAUDE," be enhanced to link reports in the database with findings from the manufacturers' evaluations of malfunctioning devices. The draft further recommends that FDA use "simple language" to communicate information about device malfunctions, eliminating the term "Class I recall" and replacing it with "Class I Advisory Notice" or "Class I Safety Alert."

Acknowledging FDA's limited budget, the authors urge Congress to "provide the FDA with the additional resources and funding that are needed to perform more thorough post-market surveillance, analysis and reporting." Heart Rhythm Society members plan to meet with Congressional legislators who oversee the agency, according to the group.

The chief recommendation for physicians is that they return all pacemakers and ICDs to manufacturers after explantation, regardless of the reason for removal. The society says physicians should be encouraged to remove devices after a patient dies, and get compensation for post mortem evaluation of devices and reporting of device adverse events.

Comments on the draft are due May 30, with final guidelines expected to be published in October.

- Matthew Perrone

Heart Rhythm Society Calls On Industry, FDA To Overhaul Device Surveillance

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