Final Rule on Medical Gas CGMPs

[membership level=”0,4″][The content continues for paid members only.] Login or Subscribe [/membership][membership level=”1,5,6,7,8,9,10,11,12″][membership] FDA has published a final rule, initially proposed in 2006, amending its CGMP and labeling regulations regarding medical gases. FDA notes in its summary that the rule requires that “portable cryogenic medical gas containers not manufactured with permanent gas use outlet connections have gas-specific use outlet connections that cannot be readily removed or replaced except by the manufacturer.” FDA is also requiring that portable cryogenic medical gas containers and high-pressure medical gas cylinders meet certain labeling, naming, and color requirements. The requirements are intended to increase the likelihood that the contents of medical gas containers are accurately identified and reduce the likelihood of the wrong gas being connected to a gas supply system or container. The chief impetus for the rule was a number of incidents in which a medical gas container holding a gas other than oxygen was erroneously connected to a health care facility’s oxygen supply system, leading to serious injuries and deaths.
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