AdvaMed Proposes Standard for CRM Performance Reports

Responding to increasing concern about the safety and reliability of cardiac rhythm management (CRM) devices, industry association AdvaMed (Washington, DC) has released a draft proposal for pulse-generator product performance reports. According to the association, the proposal is designed to “improve communications between the manufacturers of cardiac rhythm management devices and patients, providers, and the public.”

AdvaMed’s Ubl: Better understanding.

AdvaMed president and CEO Stephen J. Ubl commented that the proposal “will help ensure these key stakeholders have a better understanding of the performance of these lifesaving medical technologies.”

The proposed reporting format is based on a standard compiled by the International Organization for Standardization (ISO; Geneva), Cardiac Pacemakers–Part 2: Reporting of Clinical Performance of Populations of Pulse Generators or Leads (ISO 5841-2:2000). The AdvaMed proposal establishes specific definitions, procedures, and requirements for medtech companies to follow when issuing performance reports on such CRM devices as implantable cardioverter defibrillators and cardiac pacemakers. The reporting standard would enable device performance comparisons among the various CRM manufacturers.

To avoid confusion about what constitutes a problem with a CRM device, the standard seeks to establish “the most objective, feasible representation of device performance.” If further clarification or judgment is required regarding device performance, the standard would require manufacturers to disclose their techniques fully so that the goal of comparison among manufacturers can be practically achieved. If a manufacturer finds it cannot conform to the international standard, the company’s product performance report should clearly disclose the nonconformance.

The AdvaMed proposal was developed with the help of FDA and the Heart Rhythm Society (HRS; Washington, DC). Last September, HRS sponsored the Policy Conference on Pacemaker and ICD Performance, held in Washington, DC. The conference proceedings are available from the HRS Web site at www.hrsonline.org/positionDocs/HRS-device_conference.pdf. As a follow-up to the conference, HRS commissioned a task force to develop more-effective ways of gathering and disseminating information about CRM device performance. According to The New York Times, HRS plans to issue the report of its task force on May 2.

AdvaMed says that its member companies have begun preparing and evaluating reports based on the new format in consultation with various stakeholder groups. The draft of AdvaMed’s proposed Requirements for Uniform Reporting of Clinical Performance of Pulse Generators is available via the AdvaMed Web site at www.advamed.org/publicdocs/PPR_proposal_030306.pdf.

© 2006 Canon Communications LLC

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