FDA safety alerts for automated external defibrillators occur ...( essential to achieve the best possible ...),Health

essential to achieve the best possible clinical outcomes. Device manufacturers and the federal government should allocate the funds required to make this effort successful. Initial steps should be guided by knowledge that many advisory AEDs remain in service and have not been appropriately evaluated. Additional measures to accurately track those who purchase and use these devices are needed. Subsequent measures will require the best efforts of health care professionals, regulators, manufacturers, and the public working collaboratively to develop a transparent, rigorous, and systematic approach using the best practices of evidence-based medicine in postmarketing surveillance. From these efforts, guidelines for monitoring, communicating, and performance should be established. During cardiac arrest, when each minute really matters for survival, all stakeholders share the duty of ensuring the highest possible standards of AED reliability." (JAMA. 2006;296:700-702. Available pre-embargo to the media at www.jamamedia.org)

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Contact: Bonnie Prescott
617-667-7306
JAMA and Archives Journals
8-Aug-2006

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