Medical Innovation Exchange

ethylene oxide

FDA CDRH Takes Additional Steps To Advance Innovation in Medical Device Sterilization

FDA CDRH Takes Additional Steps To Advance Innovation in Medical Device Sterilization     In response to safety concerns and proposed regulatory action related to industrial use of ethylene oxide (EtO), the FDA Center for Devices and Radiological Health (CDRH) is taking additional steps to advance innovation in medical device sterilization. CDRH has updated its Recognized …

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FDA CDRH Takes Additional Steps To Advance Innovation in Medical Device Sterilization

FDA CDRH Takes Additional Steps To Advance Innovation in Medical Device Sterilization     In response to safety concerns and proposed regulatory action related to industrial use of ethylene oxide (EtO), the FDA Center for Devices and Radiological Health (CDRH) is taking additional steps to advance innovation in medical device sterilization. CDRH has updated its Recognized …

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AdvaMed Warns EPA of Massive Interruption to Patient Care

AdvaMed Warns EPA of Massive Interruption to Patient Care     In comments filed with the Environment Protection Agency (EPA), industry association AdvaMed called for continued cooperation between the medical device industry and the EPA as the regulations covering medical device sterilization using ethylene oxide (EtO) move forward. AdvaMed said if the proposals are finalized as …

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CDRH Announces Radiation Sterilization Pilot Program

CDRH Announces Radiation Sterilization Pilot Program     On the heels of the EPA’s announcement of two new proposed rules to reduce ethylene oxide (EtO) emissions, Jeff Shuren, M.D., J.D., director of the FDA CDRH, announced a radiation sterilization master file pilot program for medical devices. The program is designed to help companies advance alternative and …

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EPA Announces Proposed Rules To Reduce Ethylene Oxide Exposure

EPA Announces Proposed Rules To Reduce Ethylene Oxide Exposure     On April 11, the Environmental Protection Agency (EPA) proposed new health protections to reduce exposure to Ethylene Oxide (EtO). These include a proposed rule regulating ethylene oxide (EtO) sterilizers of medical technology and other commercial uses through the National Emission Standards for Hazardous Air Pollutants …

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