Miami, FL - The implantable-device industry in general, and Guidant Corp in particular, should strengthen postmarket surveillance of their products, actively pursue any potential device-related problems, and be completely open with clinicians and the public about safety issues, concluded a Guidant-commissioned panel in a report issued March 20, 2006 [1].

In July 2005, the company asked Dr Robert J Myerburg (University of Miami, FL) to lead a team of experts in exploring events and corporate practices that led to a highly publicized series of implantable-cardioverter defibrillator (ICD) recalls stemming from discovery of potentially life-threatening flaws in some of the devices. The panel also was to recommend any needed fixes to how the company handles safety issues and the reporting of device-related events.

As detailed by heartwire, Guidant was roundly criticized for apparently failing to be open with clinicians about the identified problems and then allowing some potentially faulty ICDs to be implanted in patients before the US Food and Drug Administration encouraged it to implement a recall. The saga had a dampening effect on the company's planned purchase by Johnson & Johnson, later supplanted by an ultimately successful bid from Boston Scientific.

"From the outset, the panel members were determined that the analysis and recommendations in the report would be neither a whitewash nor a witch hunt, but rather a search for and honest appraisal of the facts," according to Myerburg, quoted in a press released issued by the panel. "The result is a product that we believe will help Guidant resolve the problems that emerged during the past year. These recommendations also may also be useful to others in the industry—to the ultimate benefit of patients and physicians."

Also in the release, Dr David W Feigal (Arizona State University, Tempe), a member of the panel, which included engineers and ethicists in addition to cardiac electrophysiologists, said, "We should not lose sight of the fact that these devices already perform at a very high level of reliability and provide great benefit. Guidant asked the panel to make recommendations to deal with special circumstances where low-frequency failures need to be communicated so that doctors and patients can make informed decisions about care. The challenges posed by such circumstances are not unique to Guidant; every manufacturer faces the same kind of problems." Feigal is a former director of the FDA's Center for Devices and Radiologic Health.

The panel's report included the following recommendations to Guidant:

• Establish a "committee of experts" to advise on how the company evaluates product performance and risk, responses to device failures and other events, and its reporting to physicians and the public.
• Hire a physician charged with overseeing safety issues and participating in their communication both inside and outside the company.
• Make safety concerns more prominent in the postmarket data-collection process and promote better communication among company management, "with specific attention to postmarket product performance, patient safety issues, and communication policies."
• Ensure that Guidant "implement and enforce policies of transparency of information regarding product performance and health-hazard risk both to physicians and the general public as new information is emerging."
• "Develop processes to identify and act on even a single event when it is associated with risk of death or serious injury, has a suspected or defined basis for the malfunction or failure, and is likely to be systematic and to occur in other patients."
• Lower the threshold for considering whether shipments of potentially involved devices should be halted and those already on hospital shelves retrieved.

In a statement issued by Guidant, Myerburg said, "The company now has an opportunity to transform a painful experience into a benefit for itself and others in its industry that must confront similar problems." The statement also quotes CEO James M Cornelius as stating Guidant's intention to take the panel's advice. "We are already working closely with Boston Scientific to ensure a smooth transition of these recommendations following the completion of the pending merger."