Nursing home incident prompts new medical gas rule

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The Food and Drug Administration has proposed a new rule to make the contents of medical gas containers easier to identify. Serious incidents involving these containers, including one at a nursing home, spurred the FDA to take action.

Six years ago, four nursing home residents died in a gas mix-up at an Ohio facility where they were given nitrogen instead of oxygen due to a mislabeled tank. Between 1996 and 2006, the FDA received reports of medical gas mix-ups that resulted in at least 8 deaths and 18 serious injuries.

Injury or death has resulted from medical gas mix-ups caused by any of a number of factors. They include 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.

A 90-day public comment period on the proposed regulation will take place before FDA develops the final rule.

For more information, visit www.fda.gov/cder/dmpq/MedGas_QA_20060410.htm.