FDA Proposes Regulation to Prevent Medical Gas Mix-Ups

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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