The Heart Rhythm Society should work with FDA and manufacturers to educate physicians on realistic expectations for ICD and pacemaker performance, according to participants at the Policy Conference on Pacemaker and ICD Performance.

Sponsored by FDA and the HRS, the Sept. 16 conference in Washington, D.C. was led by the Task Force on Device Performance (¹ Also see "“Passive” Adverse Event Data Inadequate, Say FDA/HRS Meeting Panelists" - Medtech Insight, 19 September, 2005., p. 3)

According to HRS, the conference was the first step in developing guidelines to improve the collection and communication of ICD and pacemaker postmarket performance information.

Michael Barber, MD/PhD, Penrose Hospital System, Colorado Springs, presented the results of a 37-physician national survey of attitudes toward implantable cardioverter defibrillator and pacemaker recalls.

The survey found a wide variety of opinions on when manufacturers should notify physicians about a potential problem with an ICD or pacemaker.

For example, 24% of respondents said they want to be notified of any potential malfunction with an expected failure rate of 0.02% or greater, while 21% said they would only want to be notified of a problem if it was expected to cause 0.1% or more devices to fail.

This wide variation in physicians' expectations of device reliability was also demonstrated in a 2004 survey of 162 members of the Heart Rhythm Society, conducted by William Maisel, MD, Harvard Medical School. Maisel is also a member of the Task Force on Device Performance and the chairman of FDA's Circulatory System Devices Advisory Panel.

"The physician that wants to be notified [of device problems affecting] one in 5,000 would really need to get a letter about every device he or she implants, and that's not realistic," Bruce Lindsay, MD, Washington University in St. Louis, observed.

Lindsay is a member of the independent panel created by Guidant to analyze the company's recent handling of ICD safety communications.

"One of the things I'd like to see come out of this meeting is a consensus of industry on 'what is the...expected failure rate' of [all ICDs and pacemakers]," Lindsay said. "If we look at the survey, the lack of consensus probably reflects that physicians don't understand that very well."

"We need a better sense of what the expected failure rate really is so that we can set up boundaries, and that would help us to then put in perspective these recall issues, and then physicians could decide whether they really need to change the device or not."

However, several conference participants argued that manufacturers and physicians would be unable to agree on a specific failure-rate threshold for triggering reports to physicians.

"Talking about a rate only is insufficient," St. Jude Medical Cardiac Rhythm Management, VP-Quality Assurance Gabe Kohanyi said.

He said physicians need detailed information about each case of device failure in order to "apply the right methodology to get the right answer."

Robert Myerburg, MD, University of Miami, suggested that FDA, manufacturers and physicians need to share more information about device issues, and that physicians need guidance on how to decide whether a device should be replaced. Myerburg is the chair of Guidant's independent panel (² Also see "Independent Panel Study Of Guidant Will Help Beyond ICDs – Panel Chair" - Medtech Insight, 5 September, 2005., p. 9).

"What we really have is three different repositories of information, with the technical information being held in the corporations, with the reporting event information being held at the FDA and the clinical information being held by physicians," Myerburg said.

"The problem with this is that there has been very poor communication, either on a structural basis because of the nature of how this information is being held or on a functional basis, because of the accessibility of this information."

"What we really need are practice guidelines based on information that is resting in two different other organizations," he said, referring to FDA and industry.

"In order for those guidelines to be developed, the physicians - who are usually the primary movers for making guidelines on what to do with information - need to understand the process."

Physicians Implanting ICDs, Pacers Need Education On Reliability – HRS Docs

More from Archive

More from Medtech Insight