WASHINGTON--The Food and Drug Administration has issued a proposed rule designed to make the contents of medical gas containers more identifiable and prevent dangerous gas mix-ups.

Since 1996, the FDA said it has received reports of inadvertent use of incorrect medical gas or use of contaminated medical gas that resulted in at least eight deaths and 18 serious injuries.

According to the FDA, a gas mix-up is caused by one of several factors, including mistaken administration of industrial gas to patients, improper connection of industrial gases to medical oxygen supply systems and contamination of medical gas cylinders with residues of industrial cleaning solvents.

"By issuing this proposal, FDA is heightening consumer and industry awareness about this specialty area of regulated products. Greater understanding of the possible problems associated with the use of medical gases and the steps we can take to eliminate them will only lead to safer use of these products," said Steven Galson, director of the Center for Drug Evaluation and Research.

The regulation, which would apply to medical gas manufacturers and distributors, will require that certain portable medical gas containers:

• have gas use outlet connections (used to connect these containers to gas supply systems) that cannot be readily removed;
• be identified by labels that wrap all the way around the tops of these containers;
• have high-pressure medical gas cylinders painted according to a standard color-coding system that corresponds to the gases stored in them; and
• be dedicated to medical use and not converted from industrial use.

There is a 90-day public comment period on the proposed regulation before FDA develops the final rule.

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