Defibrillators need monitoring


Concerned that thousands of heart defibrillators were recalled last year, a group of doctors recommended widespread changes this week in the way the popular devices are tracked and monitored once they are implanted in patients.

The Heart Rhythm Society report culminates a nearly yearlong controversy that was prompted by the death of a Minnesota college student whose Guidant Corp. implantable cardioverter defibrillator, or ICD, short-circuited. After his doctors criticized the company for failing to warn the public, a chorus of clinicians and patients called for greater transparency in the way device malfunctions are reported.

"By having an improved system for device surveillance and by identifying problems, the overall effect will be improved performance that will ultimately save lives," said Dr. Anne Curtis, president of the Heart Rhythm Society, a group of doctors who implant pacemakers and ICDs.

The report, which is still in draft form, has been closely followed by the makers of implantable cardioverter defibrillators - Medtronic Inc., Guidant (now part of Boston Scientific Corp.) and St. Jude Medical Inc.

The report's recommendations call on manufacturers to form committees of outside experts to analyze device performance and recommend action; expand wireless and remote monitoring in patients so problems can be spotted earlier; communicate with patients directly about safety issues; and publish twice-yearly product performance reports.

The report comes after the recall of about 300,000 pacemakers and ICDs by Guidant. Seven deaths have been tied to faulty Guidant devices. Medtronic and St. Jude last year issued safety advisories for some models of their defibrillators.

Pacemakers manage a heartbeat that is too slow or irregular, while ICDs shock an errantly beating heart back into rhythm.

"This is a sound and constructive report whose recommendations can and must be implemented," said Jim Tobin, president and chief executive of Boston Scientific, which this month completed its $27 billion purchase of Guidant. "We clearly understand and acknowledge our need to do better in this area."

Many of the recommendations are already practiced by device makers. Medtronic, for example, has offered product performance reports to patients for more than 20 years, and Guidant has formed an independent panel to consider safety issues. All three manufacturers can remotely track their devices in patients.

It's too early to tell how the report will shake out in the marketplace, although the normally fast-growing ICD market has slowed considerably since the recalls. "There's not a whole lot of deviation here from what the companies are doing now," said Thomas Gunderson, an analyst at Piper Jaffray & Co.

The report also encourages the Food and Drug Administration, which regulates pacemakers and ICDs, to use simpler language when communicating safety issues; enhance its databases to better identify products with dangerous side effects; and to establish an independent panel to follow devices once they are implanted in patients.

The report also encourages Congress to provide the FDA with additional resources to fund post-market surveillance efforts.

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