BOSTON — Although industry officials appeared to embrace proposed guidelines from the Heart Rhythm Society aimed at improving postmarket surveillance and the performance of implantable heart devices, the reaction of the Food and Drug Administration was more guarded during a Town Hall Meeting hosted by the society at its annual meeting.

“I was not particularly encouraged by the FDA's comments,” remarked Dr. Robert G. Hauser, a member of the Heart Rhythm Society (HRS) task force that drafted the proposed guidelines, and a senior consultant cardiologist at the Minneapolis Heart Institute.

The guideline's intent is to improve both the detection of device malfunctions and the communication of their clinical significance to physicians and patients. The guidelines were released in April; the society plans to publish the final recommendations in October.

Broadly speaking, the guidelines advocate improved transparency in the industry's postmarket monitoring and reporting of device malfunctions in pacemakers and implantable cardioverter defibrillators (ICDs) and their components; the establishment of new systems to identify malfunctioning devices more quickly; and a standard process of notification and communication from manufacturers to patients and physicians in the event of device malfunction.

More specifically, HRS recommends that the industry and the FDA abandon the term “recall”—replacing it with “advisory”—because it is misleading and can cause undue alarm in patients. “It frightens patients, and it is inaccurate,” said Dr. Hauser in an interview. “Until they get in to see the physician, they are under the impression that they have to have their device removed and returned to the manufacturer.”

But the suggestion met with FDA resistance. “Recall nomenclature is deeply embedded in FDA regulations and operations and cannot be changed quickly,” said the FDA's Dr. Bram D. Zuckerman, director of the division of cardiovascular devices in the Center for Devices and Radiological Health.

“They're reluctant because this terminology applies to all the medical devices they oversee,” Dr. Leslie A. Saxon, professor of medicine at University of Southern California, Los Angeles, said in an interview. But with roughly 200,000 ICDs falling under the “recall” terminology in the past 12–18 months, and driving an arguably inflated 20% explantation rate, the terminology deserves reconsideration.

For physicians, the guidelines suggest informing patients not only of device therapy's benefits and risks, but also about device and component performance and expected malfunction rates both at initial implantation and replacement.

Furthermore, physicians should consider, when appropriate, alternatives to device explantation, such as reprogramming or enhanced monitoring.

Physicians are also encouraged to enhance surveillance by obtaining patient or family consent for the return of all devices to the manufacturer after explantation—even when malfunction is not suspected—or, when this is not possible, to attempt postmortem device interrogation. The society also noted that physicians should be adequately compensated for their time and effort in the postmortem evaluation and reporting process, and that CPT codes should be set for these activities.

For manufacturers, the society recommended they set standards for device and component performance, and provide regular, unbiased reports on malfunction rates for each device in a user-friendly format that is easily accessible by physicians, health care givers, and patients.

The HRS recommendations also call for an independent advisory committee for industry, made up of medical experts in the field. Such a committee would meet regularly but also in response to specific malfunction reports, and would advise the industry on how to inform physicians and the public.

Manufacturers should communicate the committee findings on malfunctions and performance first to physicians and then directly to patients by using standard communication forms, said the HRS recommendation.

Direct communication to patients is a controversial idea, acknowledged Dr. Saxon, but it fits with the times. “It's an information age. People want to know and I don't blame them.”

Timothy S. Samsel, vice president of regulatory affairs for Medtronic Inc., said companies support the notion of an independent advisory panel but acknowledged that the panel's independence could be questioned because panelists would be compensated, would be asked to sign a contract of confidentiality, and could potentially have their advice ignored by the company.

“I think that would be a rare event,” commented Dr. Hauser. “If a group of experts makes a recommendation and the company decides to ignore it, they would be going down a separate path—and I don't think you would see that kind of thing happening.”

The FDA's Dr. Zuckerman says his agency has already begun to establish a postmarket advisory panel and has appointed Dr. William H. Maisel of Beth Israel Deaconess Medical Center, Boston, as chairman.

HRS also recommended that the FDA enhance its Manufacturer and User Facility Device Experience (MAUDE) database by devising a form that would allow for specific reporting on ICD/pacemaker events.

The proposed guidelines are available at www.hrsonline.org

Proposed ICD Guidelines Emphasize Transparency : Physicians of patients with implanted heart devices are asked to beef up their surveillance procedures.