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Take a Look Before You Hook

June 1, 2006
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In the wake of recent tragedy, a report on the new FDA guidance on administering medical gases by Julie A. Braun, JD, LLM

Take a look before you hook
Preventing deaths and serious injuries from medical gas mix-ups Nursing homes and other healthcare facilities should be aware of the dangers caused by errors in administering medical gases. Some residents have been injured-and others have died-because of medical gas mix-ups; that is, the inappropriate administration of an industrial gas to a resident intended to receive a medical gas-for example, substituting industrial nitrogen for medical-grade oxygen. This usually occurs when the wrong gas is forcibly connected to the oxygen supply system. Although these types of misconnections are uncommon, the risk persists in most nursing homes-including yours. Readers are urged to take every opportunity to promote the importance of properly handling medical gases.

Courtesy of the Compressed Gas Association, www.cganet.com.
The Problem
Oxygen supply systems in healthcare facilities are equipped with gas-specific connectors that fit only the corresponding connectors on the cryogenic vessels in which oxygen is delivered. Cryogenic vessels are tubular containers used to hold materials stored at very low temperatures, such as medical gases. Among the organizations that have received reports of improper handling of medical gases resulting in death/injury is the United States Pharmacopeia (USP), the public standards-setting authority for all prescription and over-the-counter medicines, dietary supplements, and other healthcare products manufactured and sold in the United States. The USP sets the standards for medical gases, including those that address quality, strength, purity, packaging, labeling, and identification. Other organizations receiving reports include the Joint Commission on Accreditation of Healthcare Organizations, which released a Sentinel Event Alert, "Medical Gas Mix-Ups" (available at: www.jointcommission.org/SentinelEvents/SentinelEventAlert/sea_21.htm) and the Food and Drug Administration (FDA). Medical gases include oxygen, nitrogen, nitric oxide, nitrous oxide USP, carbon dioxide USP, helium USP, medical air USP, and combinations of these gases.

In March 2001, the FDA issued a guidance for nursing homes, hospitals, and other healthcare facilities containing specific recommendations for, among other things, the appropriate education and training of healthcare facility and medical gas manufacturer employees involved in handling medical gases and their containers (available at: www.fda.gov/cder/guidance/4341fnl.pdf). And in July 2001, the agency issued a public health advisory on the potential for injury from medical gas misconnections (available at: http://www.fda.gov/cdrh/safety/medical-gas-misconnect.html). Between 1996 and April 2004, the FDA received several reports of medical gas mix-ups resulting in at least 8 patient deaths and 18 serious patient injuries. Because nursing homes and hospitals are not required to report adverse events associated with medical gas mix-ups to the FDA, it is likely that the actual number of these events exceeds the number reported.

Reports received by the FDA involve two major types of medical gas storage containers: portable cryogenic containers and high-pressure medical gas cylinders. In the cases reviewed, deaths and/or injuries occurred when two sequential errors were made. First, a cryogenic vessel containing another gas was mistakenly identified as one containing oxygen. Second, the gas-specific connector on that particular cryogenic vessel was changed or misadapted. Consequently, the wrong gas was connected 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 a facility employee) did not know that the gas-specific connector is designed as a safeguard to prevent such mishaps.

The FDA's Solution