A rule to make medical gas container contents more easily/readily identifiable is being proposed by the FDA. The aim is to prevent deaths and injuries as a result of mistakes (and contamination medical gas).

Several types of gases are administered to patients, either in health care facilities or at home. Oxygen is frequently given to patients with respiratory conditions, such as emphysema.

Cases of deaths and injuries have been reported which resulted from mistakes. These mistakes could have been caused because:

-- Mistaken administration of industrial gas to patients
-- Improper connection of industrial gas to medical oxygen supply systems
-- Contamination of cylinders with residues of industrial cleaning solvents

Over 8 deaths and 18 serious injuries have been reported over the last ten years in the USA.

Steven Galson, MD, Director, Center for Drug Evaluation and Research, said "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."

The proposal is that 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.

The proposed rule will supplement existing regulations, says the FDA.

Before the FDA develops the final rule, there is a 90-day period for public comment.