The use of advanced monitoring technologies in four key aspects of EtO sterilization can yield substantial business and regulatory benefits. Paul J. Sordellini, Frank R. Bonanni, and Gregory A.
In 2000, the FDA began to view and regulate all companies reprocessing single-use medical devices in the same way it viewed and regulated original equipment manufacturers (OEMs). Before returning ...
As a toxicologist, I have followed the Environmental Protection Agency’s work on ethylene oxide (EtO) closely, and am concerned about how the recent article titled “A Dirty Business: How the medical ...
New AST BOAZ EtO Reclamation System integrates with Picarro EtO Monitoring Systems to reduce EtO usage and costs while ensuring regulatory compliance SANTA CLARA, Calif., Jan. 30, 2025 /CNW/ -- ...
The Environmental Protection Agency’s proposed new rule meant to limit exposure of ethylene oxide to workers in sterilization plants has medical device manufacturers worried about potential delays and ...
The medical device sterilization industry has faced increasing scrutiny over the past 10 years, due to a series of sentinel events and resulting personal injury suits surrounding its use of the ...
Sterilization Global Sterilization: Making the Standards Standard The new harmonized documents may hold the key to sterilization standards, but critical changes are in store for manufacturers. Robert ...
The Environmental Protection Agency (EPA) finalized tighter standards and enhanced worker protections Thursday for medical sterilization facilities that use the colorless gas ethylene oxide (EtO), ...
1. The use of ethylene oxide is critical for the sterilization of medical equipment, which protects patients against infection and the transmission of disease. The continued utilization of ethylene ...
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