FDA Adds AAMI Sterilization Guidance to Standards Database
FDA has recognized four AAMI sterilization documents in its Consensus Standards Database, including updated guidance on ethylene oxide usage.
FDA has recognized four AAMI sterilization documents in its Consensus Standards Database, including updated guidance on ethylene oxide usage.
Getinge acquired Healthmark Industries expanding the company's presence in the sterile reprocessing industry in the U.S.
The FDA is considering a master file pilot program for premarket approval holders whose approved devices are sterilized using radiation.
FDA has recognized four AAMI sterilization documents in its Consensus Standards Database, including updated guidance on ethylene oxide usage.
Englewood, Colo.-based UV-Concepts, Inc. announces the launch of the UV-C Enclosure, an automated no-touch UV-C enclosure designed to improve upon the existing standard of manual cleaning and disinfection of large portable medical equipment.
Read MoreThe U.S. FDA has alerted healthcare professionals, parents, and caregivers that there is a temporary shortage of a tracheostomy tube manufactured by Smiths Medical, the Bivona.
Read MoreThe FDA has announced steps to address potential medical device shortages due to the recent closure of a large sterilization facility in Illinois. Specifically, the agency is working to ensure that devices continue to be sterilized safely and that patients continue to have access to critical devices.
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