This is an archived document and is no longer current information.
July 20, 2001
|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.
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.
Reporting Adverse Events to FDA
The Safe Medical Devices Act of 1990 (SMDA) requires hospitals and other user facilities to report deaths and serious injuries associated with the use of medical devices, including devices used to deliver medical gases. We request that you follow the procedures established by your facility for such mandatory reporting.
We also encourage you 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: online at http://www.accessdata.fda.gov/scripts/medwatch/ by telephone at 1-800-FDA-1088; by FAX at 1-800-FDA-0178; or by mail to MedWatch, Food and Drug Administration, HF-2, 5600 Fishers Lane, Rockville, MD 20857.
Getting More Information
If you have questions about this Notification, please contact FDA's Division of of Small Manufacturers, International and Consumer Assistance (DSMICA) by e-mail at firstname.lastname@example.org or by phone at 1-800-638-2041 or 301-796-7100
FDA Medical Device Public Health Notifications are available on the Internet. You can also be notified through email each time a new Public Health Notification is added to our web page. To subscribe, visit: http://service.govdelivery.com/service/subscribe.html?code=USFDA_39.
|David W. Feigal, Jr., MD, MPH||Janet Woodcock, MD|
|Center for Devices and Radiological Health||Center for Drug Evaluation and Research|
|Food and Drug Administration||Food and Drug Administration|