How To Prevent Parenteral Drug Shortages As Sterilizer Capacity Tightens
Sterility assurance expert urges check-and-adjust approach as ethylene oxide and gamma radiation sterilization capacity tightens, pointing to Bio-Process Systems Alliance’s plan for single-use system sterilization as a model.
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The EPA issued proposed regulations that would limit the use of EtO the same day the FDA launched a pilot program for alternative sterilization methods for medical devices.
A report from the Union for Concerned Scientists found that EtO facilities are often located in communities of color, low-income communities, and communities in which many residents are not proficient in English.
While a number of US states are taking actions that could potentially ban or limit ethylene oxide (EtO) sterilization plants in their communities, the FDA, industry and others are raising the alarm that such moves could lead to a shortage of medical devices critical to patients.