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The Joint Commission on Accreditation of Healthcare Organizations in Oakbrook Terrace, IL, has issued a Sentinel Event Alert and the Food and Drug Administration (FDA) has issued an advisory to alert providers 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, the FDA has received reports of seven deaths and 15 injuries associated with medical gas misconnections that occurred in acute care and nursing home settings.
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 reviewed by the FDA, 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 delivery person or staff member) didn’t understand that the gas-specific connector was a safeguard designed to prevent such mishaps from occurring.
The FDA urges health care providers to do 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 additional information and guidance.
• Ensure 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 medical and industrial grade gases, store them separately.
Health care providers are required to report deaths and serious injuries associated with the use of medical devices, including devices used to deliver medical gases. The FDA also encourages providers to report other adverse events associated with the use of a medical gas. You can report these directly to the device or medical gas manufacturer. You can also report to MedWatch, the FDA’s voluntary reporting program. You may submit reports to MedWatch one of four ways:
You can find additional information regarding medical gas misconnections at www.fda.gov/cder/guidance/4341fnl.htm. The Joint Commission’s Sentinel Event Alert can be accessed at www.jcaho.org/edu_pub/sealert/sea21.html.