Society Releases Guidelines for CRM DevicesSociety Releases Guidelines for CRM Devices

Late last month, a 15-member task force of the Heart Rhythm Society (HRS; Washington, DC) released its draft recommendations on surveillance, analysis, and performance reporting for cardiac rhythm management (CRM) devices, including pacemakers and implantable cardioverter defibrillators (ICDs). The task force was convened last September following a conference on CRM devices that was attended by device manufacturers, physicians, and representatives from patient advocacy groups, HRS, and FDA.

The draft guidelines call for greater transparency in the postmarket surveillance, analysis, and reporting of device information; the establishment of new systems to more quickly identify malfunctioning devices; and the development of standardized procedures through which manufacturers can notify physicians and patients when a device malfunction is identified. The report also recommended that manufacturers, FDA, and physicians “work together to prevent adverse events due to device malfunctions.”

Specific recommendations detailed in the report focus on the following six areas.

• Device performance: Use of standardized device performance reports and more-thorough communications with patients.

• Surveillance: Use of new technologies and enhanced databases to monitor device performance.

• Data analysis: Establishment of committees of experts to expedite analysis.

• Common terminology: Use of identical terms to classify device malfunctions and communicate them to the public.

• Communications: Use of standardized notification procedures and a centralized system when device malfunctions are identified.

• Reimplantation: Physician consideration of risks of and alternatives to device reimplantation.

Referring to the guidelines as “an important step toward strengthening patient and physician knowledge, confidence, and trust,” HRS president Anne B. Curtis, MD, said, “We believe these suggested changes will ensure that patients continue to have access to these lifesaving treatments.”

Mark D. Carlson, MD, task force chairman and HRS treasurer said, “The recommendations and guidelines were necessary to address concerns about the safety, effectiveness, and postmarket surveillance of cardiac devices. We will continue to work with Congress, regulators, industry, patients, and other stakeholders to ensure these draft recommendations will guide important and necessary policy changes to benefit patients.”

Stephen Ubl, president and CEO of AdvaMed (Washington, DC), commended HRS on the guidelines and noted that the association “has been actively engaged in the development of these recommendations, providing input along with our ICD-pacemaker member companies and reviewing earlier drafts of the document. We are pleased that HRS has reviewed our suggestions and incorporated several of them into this latest draft.”

Likewise, the report has received a warm reception among manufacturers. James Tobin, president and CEO of Boston Scientific Corp. (Natick, MA), said, “This is a sound and constructive report whose recommendations can and must be implemented. Boston Scientific plans to implement all the recommendations that apply to manufacturers. In particular, we believe an industrywide, independent committee of outside experts should be established.”

Just days before HRS released the report, Boston Scientific finalized its $27 billion acquisition of Guidant Corp. (Indianapolis), which recalled nearly 300,000 CRM devices last year. The company's response to the situation—particularly its failure to notify physicians and patients in a timely manner—is generally acknowledged as the impetus for calls for greater postmarket scrutiny of device performance. Tobin said that implementing the HRS recommendations “will help ensure timely and transparent clinician communication and patient safety. We clearly understand and acknowledge our need to do better in this area.”

Other U.S. manufacturers of CRM devices—for which the worldwide market is growing at an annual rate of 20%—include market leader Medtronic Inc. (Minneapolis) and St. Jude Medical Inc. (St. Paul, MN). In response to the HRS report, Stephen Mahle, Medtronic's president of cardiac rhythm disease management, said, “Medtronic has routinely used outside medical advisers and other third-party experts to provide product quality, safety, and reliability assessments. We welcome these types of activities becoming standard practice for the entire industry.”

The report's cautionary tone regarding physician reimplantation following a manufacturer's report of CRM device failure was widely hailed as prudent and in keeping with current clinical research. Studies that have shown that removal can present a significant risk to patient safety and should only be considered if device failure would likely cause harm or death. Also well received was the recommendation that all CRM devices be returned to the manufacturer for postuse analysis, whether they failed or were removed for other reasons.

HRS is soliciting input from physicians, patients, regulatory agencies, and the general public on the CRM device guidelines through May 30. The final recommendations are expected in October.

The report, Draft Recommendations Report by the Heart Rhythm Society Task Force on Device Performance Policies and Guidelines, is available on the Web at www.hrsonline.org/uploadDocs/HRS_Device-Performance-Recommendations-Apr06.pdf.

© 2006 Canon Communications LLC

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