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SafetyAlerts
July 25, 2001

FDA Public Health Advisory:
Potential for Injury from Medical Gas 
Misconnections of Cryogenic Vessels

To: Hospital Administrators Directors, Respiratory Therapy
Risk Managers Nursing Home Administrators
Directors, Biomedical Engineering Home Health Care Agencies

 This advisory is to alert you to the potential for patient injury when cryogenic vessels containing medical gas are misconnected to oxygen delivery systems. Misconnections cause patients who should receive medical oxygen to receive another gas, such as nitrogen, instead. Over the past four years, FDA has received reports of seven deaths and fifteen injuries associated with medical gas misconnections that occurred in acute care and nursing home settings.

Nature of the Problem 

Oxygen supply systems in medical facilities are equipped with gas-specific connectors that fit only the corresponding connectors on the cryogenic vessels in which oxygen is delivered. In the cases we have reviewed, deaths and injuries occurred when two errors were made in sequence. First, a cryogenic vessel containing another gas was mistakenly identified as containing oxygen. Then, the gas-specific connector on this cryogenic vessel was changed or misadapted so that it could deliver the wrong gas to an oxygen-delivery system. In many of the reported incidents, the person connecting the vessel to the oxygen delivery system (either the delivery person or the facility employee) did not understand that the gas-specific connector was a safeguard designed to prevent such mishaps from occurring.

Recommendations 

We urge you to take every opportunity to promote proper handling of medical gases. Inform all personnel handling and using cryogenic vessels of these recommendations. To avoid possible injuries from misconnected medical gases, we recommend the following:

  • When connecting a cryogenic vessel, check the label carefully to ensure that it contains the appropriate gas for the intended application.
  • Never use adapters or change the connectors or fittings on cryogenic vessels. If a connector will not connect to the oxygen supply system, the contained gas is likely not oxygen and should not be used. Contact the gas supplier for further information and guidance.
  • Make sure that all personnel who will be handling medical gases are properly trained to understand the operations and connections of the medical gas system. Make sure that personnel are trained to examine and recognize medical gas labels.
  • If your facility receives both medical and industrial grade gases, store them separately.

Getting More Information

Further information regarding medical gas misconnections may be found at http://www.fda.gov/cder/guidance/4341fnl.htm. Should you have questions regarding this letter, please contact Paula Simenauer, Office of Surveillance and Biometrics (HFZ-510), 1350 Piccard Drive, Rockville, Maryland, 20850, by fax at 301-594-2968, or by e-mail at phann@cdrh.fda.gov. Additionally, a voice-mail message may be left at 301-594-0650 and your call will be returned as soon as possible.

Sincerely yours,

 

David W. Feigal, Jr., MD, MPH Janet Woodcock, MD
Director Director
Center for Devices and Radiological Health Center for Drug Evaluation and Research
Food and Drug Administration Food and Drug Administration
 
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