Medical Device Daily

TheHeart Rhythm Society (Washington) yesterday released its long-awaited recommendations concerning the surveillance, analysis and performance reporting of pacemakers and implantable cardioverter defibrillators.

The guidelines – in proposed form, with the society now seeking public comment on them before issuing its final report – are the result of, and a distillation of, feedback that the society received at a meeting last September (Medical Device Daily, Sept. 20, 2005).

Overall, the guidelines offer no large surprises, since they propose more aggressive and more consistent communication to patients concerning the potential malfunctions of these devices – initiatives being loudly called for at various levels, from litigiously-prone patients who claim to have been injured to members of Congress.

The guidelines lay out “recommendations“ for improving communication to patients concerning the potential risks of the implantable devices that have received so much adverse publicity over the past year, due to recalls, reports of malfunctions and a flurry of follow-on lawsuits that these problems have attracted.

Ann Curtis, MD, president of the Heart Rhythm Society, said, “As the international leader in science, education and advocacy for cardiac arrhythmia professionals and patients, we believe these suggested changes will ensure that patients continue to have access to these lifesaving treatments. We believe these draft guidelines are an important step towards strengthening patient and physician knowledge, confidence and trust.“

“Important step“ may be the operative wording here, since the society says it has no role in mandating the guidelines or seeing that they are mandated by government.

As to whether they will be translated to more than recommendations by the FDA, or other governmental regulators, a society spokesperson said, “That's for them to decide.“

Following the September meeting, the society assembled a 15-member task force of what it called “leading cardiac care providers“ and other experts who were then charged with developing the draft recommendations.

The society said that regulators from the FDA, representatives from industry and patient advocacy groups were then asked to provide feedback in the initial phases of crafting the document. “The recommendations are the first such collaboration among these diverse groups,“ the society said in a statement bannering release of the guidelines.

Overall, the draft guidelines call for greater transparency in the postmarket surveillance, analysis and reporting of information, the establishment of new systems to identify malfunctioning devices more quickly and standard notification and communication to physicians and patients from the manufacturer when a device malfunction is identified. Perhaps one of the most cogent recommendations of the guidelines is that the term “recall“ be deleted from the language that is used to describe any action subsequent to determination of a device problem and public notification.

The word has been used in such a way as to cause confusion, the society spokesperson told MDD, the most graphic instance being the “recall“ of devices that are implanted, though it is rather obvious that not all of the devices will be explanted and returned.

The society recommendation is that the FDA needs to use “simple language to communicate important information about device malfunctions.“

It specifically recommends changing “the term 'Class I Recall“ to “Class I Advisory Notice' or 'Class I Safety Alert.' Class I advisory notices would signify when device replacement should be considered because malfunctions could result in death or significant harm. The term 'Class II and III Recalls' (non life-threatening malfunctions) should also be changed to 'advisory notices or safety alerts.'“

“Manufacturers, the FDA, and physicians are encouraged to work together to prevent adverse events due to device malfunctions,“ the society's statement said.

Interestingly, the society does not recommend “attempting to classify the types of malfunctions that would automatically trigger a notification or advisory.“ Rather, it simply says about the “threshold for action“ that “Single adverse events that could cause death or serious injuries in patients merit notification of physicians and patients.“

Mark Carlson, MD, task force chairman and treasurer of the Heart Rhythm Foundation, said, “As part of our mission to improve the care of patients by promoting research, education and optimal healthcare policies and standards, the recommendations and guidelines were necessary to address concerns about the safety, effectiveness and post- market surveillance of cardiac devices. The Heart Rhythm Society will continue to work with Congress, regulators, industry, patients and other stakeholders to ensure these draft recommendations will guide important and necessary policy changes to benefit patients.“

The society said it will also be receiving feedback from Coalition of Pacing and Electrophysiology , an organization representing heart rhythm societies worldwide.

The draft recommendations will also the subject of the Health Policy Town Hall Meeting at the society's annual scientific sessions May 17 in Boston. Representatives from the society, the FDA, industry and patient advocacy organizations will participate in a series of panel discussions concerning the proposed recommendations.

Final guidelines are expected to be published in the October issue of Heart Rhythm Journal.