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FDA Public Health Advisory: Medical Gas Mix-Ups Can Cause Death and Serious Injury

[PDF version of this document]

Gases for medical use are prescription drugs that must be carefully regulated and handled.

Adaptors should never be used and fittings never changed on medical gas containers. If a connection doesn't fit, it isn't supposed to fit. Contact the supplier immediately.

Store medical grade products separately from industrial grade products in well-defined areas.

Educate and train personnel who are directly responsible for handling medical gas to:

  • recognize medical gas labels
  • examine all labels carefully before hooking containers to the system.

Skilled and knowledgeable personnel should always check the container and connection prior to introducing gas into the system.

won't connect: don't connect

Patients have been injured - and some have died - because of medical gas mix-ups. This usually occurs when the wrong gas is forcibly connected to the oxygen supply system. Please promote the importance of properly handling medical gases.

  • Manufacturers who receive reports of death or serious injury associated with the use of medical gases are required by law to report these incidents to the FDA.
  • Hospitals, nursing homes, and other health care facilities should submit reports of such mix-ups (whether or not they resulted in a serious injury) to FDA's voluntary report system, MedWatch:

Phone - (800) FDA-1088
Fax -     (800) FDA-1078

Mail
MedWatch, Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20852-9787

US Food and Drug Administration

For more information, call 1-888-INFO-FDA or go to www.fda.gov/cder/dmpq/gases.htm

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FDA/Center for Drug Evaluation and Research
Last Updated: October 10, 2001
Originator: OTCOM/DLIS
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