FOR IMMEDIATE RELEASE
April 28, 2006
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ADVAMED COMMENDS HRS’ RECOMMENDATIONS ON ICD/PACEMAKER PERFORMANCE COMMUNICATIONS
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WASHINGTON, D.C. – AdvaMed President and CEO Stephen J. Ubl issued the following statement following the release of the Heart Rhythm Society’s (HRS) draft recommendations on performance policies for pacemakers and implantable cardioverter defibrillators (ICDs):
“AdvaMed commends the Heart Rhythm Society for its work in developing these draft recommendations, which will help ensure that important information on these lifesaving technologies is effectively communicated to physicians and their patients. At HRS’ request, AdvaMed 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.
The Association is particularly encouraged by HRS’ call for FDA to cease use of the term ‘recall’ in its public communications involving device malfunctions, as the term is often inappropriate and routinely misunderstood, especially as regards to implanted devices. Regarding HRS’ recommendation that ICD/pacemaker companies issue standardized product performance reports, AdvaMed proposed a standardized reporting format in February. The major ICD/pacemaker companies have already begun using this template and are eager for feedback from stakeholders.
We also support the recommendation that physicians and hospitals return all devices to the manufacturer for analysis after explantation. Explanted devices contain a wealth of information that manufacturers need to assess overall device performance and to design the next generation of lifesaving technologies. Lastly, AdvaMed agrees that greater use of remote monitoring technologies needs to be encouraged and will work with HRS and other stakeholders to promote this issue.
AdvaMed plans to submit comments on the HRS draft recommendations by the May 30 deadline. We look forward to continuing to work with HRS, FDA and others to improve communications surrounding these vital medical technologies.”
AdvaMed member companies produce the medical devices, diagnostic products and health information systems that are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. Our members produce nearly 90 percent of the health care technology purchased annually in the United States and more than 50 percent purchased annually around the world. AdvaMed members range from the largest to the smallest medical technology innovators and companies.
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