Chicago, IL - The complex implantable devices for correcting heart rhythm inevitably sometimes malfunction, but more consistent and complete reporting of the problems would improve patient safety and society's trust in the manufacturers, according to a commentary in the August 24/31, 2005 issue of the Journal of the American Medical Association [1].

The article, by Dr William H Maisel (Beth Israel Deaconess Medical Center, Boston, MA), proposes a series of changes to the system by which device manufactures report device malfunctions to physicians, patients, and the public, changes he suggests could potentially have spared all involved parties some grief over the past year. Maisel, who has been following the subject for years [2], is currently chair of the Circulatory System Medical Devices Advisory Panel that reports to the US Food and Drug Administration.

Ironically, consumers can learn more about the safety of the car they intend to purchase than they can about the reliability of their potentially life-saving ICD.

As covered by heartwire, Guidant has been criticized for failure to give timely public notification of potentially life-threatening problems in models of its implantable cardioverter-defibrillators (ICDs) and for then knowingly allowing some of the possibly faulty devices to be implanted in patients. After the public learned of these events, the company recalled thousands of its devices in use worldwide.

Although Guidant has attracted the lion's share of recent attention, the other ICD companies in the US have issued advisories or physician notifications about device malfunctions involving "close to 141 000" units in 2005 alone, according to Maisel. Device failures should therefore be kept in perspective: what modern ICDs accomplish for patients is "a truly remarkable technological accomplishment," and it shouldn't be surprising that the devices occasionally malfunction, he writes.

It's appropriate for us to have high expectations for a pretty low failure rate.

On the other hand, "there's no reason why any of these data should be hidden from view," according to Dr Harlan Krumholz (Yale University School of Medicine, New Haven, CT). Although expectations for ICDs should be "calibrated," he told heartwire, "it's appropriate for us to have high expectations for a pretty low failure rate. It's up to the engineers and manufacturers to design these devices so it's very unusual, virtually unheard of, for them to fail. If that's not possible, then we need to have an open discussion about it."

Maisel proposes a number of changes to the current device-failure notification process, measures that could help keep device reliability in perspective, enhance patient safety, and improve the entire landscape of ICD development and marketing:

• "Manufacturers should annually publish detailed data on device reliability." This should be required by law but also distinguish between minor non-life-threatening problems and major malfunctions that could prevent delivery of appropriate therapy, Maisel writes. "Ironically, consumers can learn more about the safety of the car they intend to purchase than they can about the reliability of their potentially life-saving ICD." Because physicians and patients would be able to comparison-shop when selecting an ICD, he predicts, market pressures would encourage manufacturers to develop "safer and more reliable devices."

Physicians and patients should be educated to have a more realistic expectation of device reliability.

• "Manufacturers should publicly report every confirmed device malfunction." Although companies are now compelled to report potentially injurious device malfunctions to the FDA, whether they also tell physicians, patients, or the public is left to their discretion. Because such complete reporting can potentially threaten their revenues, Maisel observes, there is an inherent conflict of interest that discourages such broad notification.
• "Physicians and patients should be educated to have a more realistic expectation of device reliability." More complete and accurate reporting of device problems would teach everyone—including physicians, who tend to underestimate ICD malfunction rates—how much to expect from the devices.
• "Patients should be directly notified about safety issues." The idea that patients won't understand the issues related to any problems with their devices that emerge is outdated, according to Maisel. "Modern patients are knowledgeable, informed, and proactive, and they have the right to know about malfunctions or potential defects affecting their implantable device." Ideally, he writes, physicians would be notified first so they have the opportunity to contact their patients, who could then be informed directly.
• "National physician and medical-device organizations must provide guidance to physicians, patients, regulators, and industry." Even expert physicians vary in their standards for how and when device problems should be reported, he writes. Therefore, evidence-based guidelines should be developed by organizations with a stake in the matter. The Heart Rhythm Society (HRS) has formed a task force on device performance that is planning a policy conference for September 2005 to address that very issue, writes Maisel, a member of the HRS Health Policy Committee.

The companies that get into trouble are the ones that try to hide information.

• "When you read these suggestions, they seem so reasonable that you can't imagine they haven't already been implemented," Krumholz said. "We need to make sure there's full disclosure and penalties for lack of disclosure." As for the revenue concerns that ICD manufacturers may have about completely reporting all problems, "the companies that get into trouble are the ones that try to hide information," he observes. "If they do well by the patients, their own bottom lines will do well."

Last month, heartwire reported that electrophysiologist Dr Robert J Myerburg (University of Miami, FL) had accepted Guidant's invitation to select and lead an independent panel to explore and make recommendations on how to improve monitoring and reporting of events in patients with implanted devices.