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From Health Law Daily, November 18, 2016

FDA amends gas container manufacturing and labeling under pressure of safety concerns

By Bryant Storm, J.D.

Portable cryogenic medical gas containers must meet new manufacturing, labeling, naming, and color requirements under an FDA Final rule amending the current good manufacturing practice (CGMP) and labeling regulations regarding medical gases. The new requirements are designed to increase the likelihood that the contents of gas containers can be accurately identified and to reduce the risk of the incorrect gas being connected to a gas supply system or container. The Final rule also places oxygen and nitrogen on a list to conditionally exempt those gasses from certain labeling requirements. Additionally, the Final rule removes cyclopropane and ethylene from that list. The rule is effective January 17, 2017 (Final rule, 81 FR 81685,November 18, 2016).

Proposed rule. The publication of the Final rule follows a 2006 Proposed rule (71 FR 18039), which was issued in response to a number of incidents where medical gas containers holding a gas other than oxygen were accidently connected to a health care facility’s oxygen supply system. In those situations, the misidentification of the gas led to serious injuries and deaths. Additionally, the issuance of the Proposed rule was motivated by the FDA’s concern over reports of serious injuries related to the contamination of high-pressure medical gas cylinders with the residue of industrial cleaning solvents, which, the FDA indicated, was likely a result of inadequate cleaning when the cylinders were converted from industrial to medical use.

Gas containers. If cryogenic medical gas containers are manufactured without permanent gas use outlet connections, under the Final rule, they must have gas-specific use outlet connections that cannot be readily removed or replaced except by the manufacturer. The new labeling requirements mandate that portable cryogenic medical gas containers bear a 360 degree wraparound label identifying the contents of the container, and high-pressure. Additionally, medical gas cylinders are required to be colored on the shoulder of the container in the FDA-designated color or colors associated with the gas or gases held in the container. The labeling requirements are designed to ensure the contents of medical gas containers are identified accurately in order to reduce the likelihood of the wrong gas being connected to the wrong container.

MainStory: TopStory FinalRules FDCActNews GMPNews LabelingNews MDeviceNews SafetyNews

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