Heart Rhythm Society Urges Tougher Post-Market Device Surveillance

WASHINGTON -- The Heart Rhythm Society said today that the FDA should tighten up post-market surveillance of pacemakers and implantable cardioverter defibrillators (ICD).

The society would also have the agency ditch the word "recall" as not sufficiently specific when the FDA issues warnings about heart devices.

In addition, the society recommended that device manufactures use wireless technology for more consistent monitoring of devices, with the goal of earlier identification of problems.

All these were included in the final recommendations on pacemaker and ICD performance and safety from a society task force, which were released today on the society's Web site and will be published in the October issue of Heart Rhythm.

The recommendations are the culmination of a process that started a year ago when the society and the FDA co-hosted a daylong meeting on the performance and safety of pacemakers and ICDs.

The impetus for that meeting was a series of FDA "recalls" of pacemakers and ICDs, which began in June 2005 and continued throughout the year.

The recommendations, the society said, were intended to improve cooperation among the FDA, device manufacturers, and physicians, while at the same time making it easier to track results of post-market surveillance with the ultimate goal of speeding the reporting of safety and performance information.

Right now the FDA uses the term recall even when a device malfunction would not warrant explantation, the Society said. The Society suggested substituting "advisory notice" or "safety alert" for the word recall.

The FDA responded almost immediately with a statement posted on its Web site that thanked the Heart Rhythm Society for its suggestions, signaling that the agency was inclined to implement the recommendations.

The Task Force on Device Performance Policies and Guidelines worked for a year to craft new recommendations that also include specific advice for physicians, device manufacturers, and Congress. The recommendations were endorsed by the American College of Cardiology Foundation, the American Heart Association, and the International Coalition of Pacing and Electrophysiology Organizations.

The society said the FDA should:

• Simplify language when communicating with the public about device malfunctions and eliminate the term "recall" in public communications.
• Enhance the existing post-market surveillance databases to more readily identify devices that may pose a danger to patients.
• Establish a post-market surveillance advisory panel of independent experts to assist the FDA with its post-market activities.

The FDA said it has already acted on the third recommendation by expanding the "charge of our standing cardiac advisory device panel beyond pre-market issues to address device post-market safety and effectiveness."

The agency said that members of this enhanced "post-market panel have already provided feedback to FDA on internal evaluations associated with cardiac rhythm device malfunctions."

Changes at the FDA are likely to be expensive, so the Heart Rhythm Society called on Congress to increase FDA funding for post-market surveillance, analysis, and reporting.

Turning to device manufactures, the society said that in addition to wireless monitoring, the companies "should establish independent, standing committees of outside experts to analyze device performance reports and to recommend appropriate action."

Addressing physicians, the society said they should not only inform patients about the benefits and risks of devices, "but also about the overall expected performance of devices, including potential malfunction rates."

Other recommendations for physicians:

• Return all malfunctioning devices after explant to the manufacturer "whether the replacement is routine or because of a malfunction."
• Consider the risks of both explantation and re-implantation of a new device when counseling patients about how to respond to notices about device malfunctions.