Representatives of implantable defibrillator and pacemaker manufacturers are recommending that companies standardize their product performance reports and present data in a way that is more useful to physicians.

The "Proposal for Uniform CRM Product Performance Reporting" recommends that cardiac rhythm management firms separate information on devices that malfunctioned from that of devices that stopped working due to normal battery depletion.

The report was drafted by AdvaMed's ICD/Pacemaker working group, which includes representatives from Guidant, Medtronic, St. Jude and Biotronik. AdvaMed is currently accepting comments on the document, which it posted on its website the week of March 13.

Because the authors of the proposal are also in regulatory positions at the companies it addresses, many of the recommended changes to reporting have already been implemented. The most recent product performance reports from Guidant and Medtronic, for example, present data as outlined in the proposal.

Tim Samsel, Medtronic VP-CRM regulatory affairs, chaired the group that drafted the recommendations and said they primarily grew out of comments made last September at a conference sponsored by FDA and the Heart Rhythm Society. An HRS task force is working separately to develop guidelines for communicating device risks to physicians (¹ 'The Gray Sheet' Oct. 17, 2005, In Brief).

"We wanted to be responsive to some of the feedback we heard in September," said Samsel. "And the two major themes we focused on here in this proposal were to both standardize the definitions and approach the CRM manufacturers use for product performance reporting of pacemakers and ICDs, and to extend it in some important ways that clinicians have indicated would be valuable to them in evaluating their patients."

The AdvaMed document is based on ISO 5841-2:2000, the international standard on reporting clinical performance of pulse generators and leads. According to the recommendations, companies should present data on device survival in two distinct formats: "all-cause device survival curves" and "malfunction free survival curves."

The "all-cause device survival curve" represents a composite of device problems, including "normal battery depletion, malfunction with compromised therapy, and malfunction without compromised therapy." The "malfunction free survival curve" reflects only malfunctions, with and without compromised therapy.

The document instructs companies to report performance information separately for each of their device models. Companies should update reports at least twice a year, according to the proposal.

Additionally, the draft advises companies to consider adjusting their calculations on device performance to reflect the fact that many malfunctions go unreported - for instance when a patient dies and the device is not returned to the company.

Samsel admitted that Medtronic has never adjusted for the underreporting of device malfunctions, saying that the creation of reliable adjustment factors is a "complicated question."

"We believe the majority of devices that are suspected of malfunctioning are returned to the manufacturers and are therefore tested and incorporated into the product performance report," Samsel said. "But of course not all devices are returned, so there is a certain amount of unknown."

Samsel said the AdvaMed reporting recommendations will probably overlap with those being developed by the Heart Rhythm Society. They also echo points made in a report released March 20 by an independent panel commissioned by Guidant to assess its postmarket monitoring practices.

Jeffrey Secunda, AdvaMed VP-technology and regulatory affairs said that while industry is changing how it reports product performance, it is still the physician's responsibility to communicate the meaning of the data to patients.

"The company has an obligation to inform, but the physicians are in a much better position both because of their knowledge but also their relationship with the patient to make sure the patient understands the nature of the information," Secunda said.

AdvaMed Posts Guidelines For Pacemaker And ICD Performance Reports

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