This guidance is intended to alert hospitals, nursing homes, and other health care facilities to the hazards of medical gas mix-ups. The Food and Drug Administration (FDA) has received reports during the past 4 years from hospitals and nursing homes involving 7 deaths and 15 injuries to patients who were thought to be receiving medical grade oxygen, but were receiving a different gas (e.g., nitrogen) that had been mistakenly connected to the oxygen supply system. This guidance makes recommendations that will help hospitals, nursing homes, and other health care facilities avoid the tragedies that result from medical gas mix-ups.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.