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AED manufacturers get regulatory jolt

by Brendon Nafziger, DOTmed News Associate Editor | May 07, 2013
From the May 2013 issue of HealthCare Business News magazine

Names in boldface are Premium Listings.
Domestic
David Wakefield, Jet Medical Electronics, CA
Leslie Roberts, Altra Medical, FL
James Fowler, BioMed Techs Inc, FL

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John Mantilla, Dimesan USA Inc, FL
Randy Lowers, L & R Services, FL
DOTmed Certified
Garret Purrington, Medical Equipment Dynamics, Inc., MA
DOTmed 100
John Gladstein, Medical Device Depot, MD
DOTmed Certified
Robert Schirano, Finger Lakes Medical Supply LLC, NY
Lawrence Maroney, Integris Equipment, NY
DOTmed Certified
Mark Taylor, Masterfit Medical , TN
DOTmed Certified
DOTmed 100
JORGE DELGADO, PRESTIGE EMS, TX

International
Pedro Pestana, Spacemedical, Portugal
Dan Kongsted, Cervius Medical, Denmark
Nitin Khalate, Multitech Medical Systems PVT.LTD, India
Norm Villeneuve, B.B.Products, Canada
Mehmet Er, TEPA, Inc., Turkey
Rodolfo Reyes Ingeniero, INNOVA MEDICAL, Mexico
Naveen Kangokar, Alvin Care Services UK Ltd, United Kingdom
Rick Meerkerk, Mediproma B.V., Netherlands

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Richard Lazar

AED Reclassification – When Near Perfect is Not Enough for FDA

May 17, 2013 04:27

The FDA is proposing to reclassify AEDs as Class III medical devices. This change will require manufacturers to go through a much more time consuming and costly regulatory process before their AEDs can be sold. Why? According to the agency’s proposed rule, the primary purpose of reclassification is to reduce the risk of illness or injury resulting from AED failures. Yet, a study relied upon by the agency finds that AEDs work as intended during rescue attempts greater than 99% of the time. This is a clear example of the perfect as the enemy of the good (or even great) driving a regulatory action that will cost lives and money with very little public health benefit.

More on this can be found at:
www.readisys.com/aed-reclassification-when-near-perfect-is-not-enough-for-the-fda/

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