ICD safety: Convene panels, change term ‘recall’

The Heart Rhythm Society has released draft recommendations on performance policies.

An expert panel convened by the Heart Rhythm Society has released draft recommendations on how best to measure performance of implantable cardioverter defibrillators and pacemakers and how best to handle recalls.

“While the life-saving benefits of pacemakers and ICDs have been confirmed by numerous clinical trials, recent events have raised questions about the effectiveness of current systems and processes for post-marketing surveillance of these devices,” Anne B. Curtis, MD, president of the Heart Rhythm Society and professor of medicine at the University of Florida, said during a conference call.

Curtis said a key recommendation of the Heart Rhythm Society is that the FDA and representatives from industry establish standing committees of outside experts to analyze device performance and recommend appropriate action.

The FDA has already revised the rules of its Circulatory System Devices advisory committee to perform this role, and Curtis said industry representatives were “receptive” to the idea of creating their own panels.

The second key recommendation is the elimination of the term “recall,” Curtis said.

“The problem with the term ‘recall’ is that it creates the alarm that a recalled device cannot be left in. That’s not true. In fact there are often more risks involved with extracting a device and reimplanting another than there would be if the device was simply left in and closely monitored. So we recommend instead using the term ‘safety alert’ or ‘advisory,’” Curtis said.

Comment period

The draft recommendations from the Heart Rhythm Society are the latest in a series of steps that the professional organization has taken in response to controversy following the actions of device companies such as Guidant in communicating problems with their own ICDs.

In September, a policy conference was convened in Washington D.C. The Heart Rhythm Society then assembled a 15-member task force to draft the recommendations that were released on April 26, 2006.

The draft release launched a comment period, which was scheduled to conclude on May 30, 2006. The Heart Rhythm Society also planned to discuss the recommendations at their annual scientific sessions in Boston in a town hall format.

“Ultimately these recommendations are expected to improve patient confidence in these devices and ensure that these life saving technologies will be safe, effective and available to people who need them,” Curtis said.

The draft recommendations make suggestions for physicians, manufacturers, the FDA and Congress.

For physicians, the society recommends that clinicians inform patients not only about the benefits and risk of devices, but also about the overall expected performance, including potential malfunction rates.

Physicians should also return all devices after explant to the manufacturer for analysis, whether the replacement is routine or because of a malfunction.

Finally, a physician should consider the risks of explantation and re-implantation of a new device when considering with their patients how to respond to an advisory notice that a device malfunction has been identified.

Curtis said the number of unnecessary explants due to device recalls has not been reliably measured. “However, we are aware from some surveys that have been done that physicians ranged from changing out a large number of devices to changing out a few, and some were erring on the side of changing out a lot,” Curtis said. – by Jeremy Moore

For more information:

• A draft copy of the recommendations can be found at www.hrsonline.com.