CGMP Regulations – Medical Gas Mix-Ups

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The Food and Drug Administration (FDA) is very concerned about deaths and injuries from medical gas mix-ups.  For example, patients who were thought to be receiving medical grade oxygen have received a different gas (e.g., nitrogen) that had been mistakenly connected to the oxygen supply system.  Medical gas mix-ups have caused many deaths and serious injuries (for details, see Guidance for Hospitals, Nursing Homes, and Other Health Care Facilities: CDER Public Health Advisory (PDF – 19KB).  This web page provides educational materials you can use to help reduce these risks of medial gas mix-ups in your facilities.  It also provides other resources about medical gas mix-ups.

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