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【medical-news】美国心律协会有关安装起博器的建
WASHINGTON, September 28, 2006 -- The Heart Rhythm Society today issued final recommendations to provide heart patients with clearer, timelier and more consistent information about the recall process and the performance of pacemakers and implantable cardioverter defibrillators (ICDs). The recommendations also offer specific guidance to physicians, Food and Drug Administration (FDA) officials and members of Congress about performance issues and advisories for implantable cardiac devices. In addition, the final recommendations report also addresses international principles related to device performance.
The report will be published in the October issue of Heart Rhythm.
"This report offers the first comprehensive recommendations for the surveillance, analysis and performance reporting of pacemakers and ICDs," said Dwight Reynolds, MD, FHRS President of the Heart Rhythm Society. "These changes will help patients continue to have confidence and trust in these lifesaving treatments."
The overarching objectives of the recommendations include the following:
◎Greater transparency in the post-market surveillance, analysis and reporting of information;
◎The establishment of new systems to identify malfunctioning devices more quickly;
Standard notification and communication to physicians and patients from the manufacturer when a device malfunction is identified. Manufacturers, the FDA and physicians are encouraged to work together to prevent adverse events due to device malfunctions; and
◎The global scope of device performance issues; cooperation among industry, physicians, government authorities and national health care systems are necessary to reduce the risk of injuries and deaths due to device malfunctions.
"The next step is for the Heart Rhythm Society to work with Congress, regulators, industry, patients and other stakeholders to ensure that these recommendations will guide key policy decisions that will help heart patients," said Mark D. Carlson, MD, FHRS, Chairman of the Heart Rhythm Society Task Force on Device Performance Policies and Guidelines.
Specific recommendations for each of the key audiences include:
Physicians:
◎Should inform patients not only about the benefits and risks of devices, but also about the overall expected performance of devices, including potential malfunction rates.
◎Should return all malfunctioning devices after explant to the manufacturer for analysis whether the replacement is routine or because of a malfunction. This will lead to more timely identification of potential malfunctions and a better understanding of the true 'denominator' for a particular device.
◎Should consider the risks of explantation and re-implantation of a new device when considering with their patients how to respond to an advisory notice that a device malfunction has been identified.
Manufacturers:
◎Should use expanding wireless and remote monitoring technologies to identify abnormal devices earlier and automatically.
◎Should establish independent, standing committees of outside experts to analyze device performance reports and to recommend appropriate action.
◎Should communicate with physicians and patients directly using standard physician and patient communication forms to notify patients regarding potential malfunctions.
FDA:
◎Should use simple language to communicate important information about device malfunctions and eliminate the term "recall" in public communications.
◎Should enhance the existing databases to more readily identify devices that may pose a danger to patients.
◎Should establish a post-marketing surveillance advisory panel of independent expert advisors to assist FDA with this function.
Congress:
◎Should recognize the FDA needs the appropriate resources, funding and focus to perform post-market surveillance, analysis and reporting.
A 15-member task force of leading cardiac care providers and experts developed the guidelines with feedback from regulators at the FDA, representatives from industry and patient advocacy groups. Additional feedback was received from a public comment period that ended May 30, 2006. 认领！好几天了终于领到了一篇，真不容易啊！哈哈。
尽管明天还有很多手术，后天还有空翻译。嘿嘿。 这两天忙死了，忙里偷闲翻出来，且水平有限，质量不高，敬请批评：）
Heart Rhythm Society publishes final recommendations for heart patients
美国心律协会为心脏病患者出版最终建议
WASHINGTON, September 28, 2006 -- The Heart Rhythm Society today issued final recommendations to provide heart patients with clearer, timelier and more consistent information about the recall process and the performance of pacemakers and implantable cardioverter defibrillators (ICDs). The recommendations also offer specific guidance to physicians, Food and Drug Administration (FDA) officials and members of Congress about performance issues and advisories for implantable cardiac devices. In addition, the final recommendations report also addresses international principles related to device performance.
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作者:admin@医学,生命科学 2011-01-24 05:34
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