CGMP Regulations - Medical Gas Mix-Ups
Proper labeling of a medical oxygen canister
The Food and Drug Administration (FDA) is very concerned about deaths and injuries from medical gas mix-ups. For example, patients who were thought to be receiving medical grade oxygen have received a different gas (e.g., nitrogen) that had been mistakenly connected to the oxygen supply system. Medical gas mix-ups have caused many deaths and serious injuries (for details, see Guidance for Hospitals, Nursing Homes, and Other Health Care Facilities: CDER Public Health Advisory (PDF - 19KB). This web page provides educational materials you can use to help reduce these risks of medial gas mix-ups in your facilities. It also provides other resources about medical gas mix-ups.
Medical Gas Safety - FDA Educational Products
For information on obtaining the flier or poster, please email firstname.lastname@example.org or call 301-796-3703.
- Flier: CDER Public Health Advisory: Medical Gas Mix-Ups Can Cause Death and Serious Injury (PDF - 514KB) Optional format: HTML. This one-page, color flier is intended to alert people who handle medical gases about the hazards of mix-ups. Please feel free to copy and distribute this flier. Comments and suggestions are welcome.
- Poster: Medical Gas Mix-Ups: "Take a look before you hook."
Please feel free to download, print, and distribute this poster.
- Video Webcast: "Preventing Deaths and Serious Injuries from Medical Gas Mix-Ups." To view the webcast and read the transcript, go to the Center for Devices and Radiological Health's FDA Patient Safety News, Video Webcast Center, and scroll to Show #1: February 2002, on the bottom of the page.
Medical Gas Mix-up Alerts
- Center for Devices and Radiological Health (CDRH) Public Health Advisory: Potential for Injury from Medical Gas Misconnections of Cryogenic Vessels.
- Sentinel Event Alert. Issued by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) on medical gas mix-ups.
Guidance and Standards
U.S. Pharmacopeia. Practitioner's Reporting News: Medical Gas Errors.
NFPA 99, Standard for Health Care Facilities (PDF - 23KB): 23 From the National Fire Protection Association. This Tentative Interim Amendment (TIA) was issued in August 2000 and adds new sections to the NFPA 99, which is the NFPA's consensus standard for health care facilities. FDA does not require that you comply with NFPA standards, but your state of local government may do so.