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CGMP Regulations - Medical Gas Mix-Ups

   


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Labeling of Oxygen Gas Canister

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 dpapubs@fda.hhs.gov or call 301-796-3703.

 
Medical Gas Mix-up Alerts

 
Guidance and Standards

  • Guidances

  • U.S. Pharmacopeia.  Practitioner's Reporting News: Medical Gas Errors.  

  • NFPA 99, Standard for Health Care Facilities (PDF - 23KB)disclaimer icon:  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.

 

Page Last Updated: 04/10/2015
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