FOR IMMEDIATE RELEASE
September 28, 2006
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ADVAMED SUPPORTS FINAL 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 today following the release of the Heart Rhythm Society’s (HRS) final recommendations on performance policies for pacemakers and implantable cardioverter defibrillators (ICDs):
“AdvaMed is pleased that the Heart Rhythm Society has issued its final recommendations, and we commend the Society for taking the lead on this important work. AdvaMed is proud to have been actively engaged with HRS in the development of these recommendations, which will help ensure that important information on these lifesaving technologies is effectively communicated to physicians and their patients.”
“HRS’ final recommendations are largely in line with the draft recommendations they released in April, which AdvaMed strongly supported. In particular, we applaud 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. In fact, FDA’s own public opinion research indicates that people think the term ‘recall’ implies ‘serious, life-threatening risks requiring immediate action and stopping use,’ which is rarely the case when it comes to an implantable medical device.”
“Consistent with HRS’ recommendation that ICD/pacemaker companies issue standardized product performance reports, for several months the major manufacturers of these devices have been using standardized reporting guidelines developed by AdvaMed. We also support the recommendation that after explantation physicians and hospitals return all devices to the manufacturer for analysis and that greater use of remote monitoring technologies needs to be encouraged.”
“AdvaMed looks forward to working with HRS and other stakeholders in implementing these recommendations.”
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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.