Medical Gas Safety

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The FDA regulates medical gases, such as oxygen, as prescription drugs, and also the related delivery hardware, such as concentrators, tubing, and regulators, as medical devices. Because of increasing reports about occasional disasters involving medical gases, including some deaths, FDA is attempting to increase both consumer and industry awareness about this specialty area of regulated products. Medical gases are the most frequently administered drugs in the United States, and oxygen is the most common medical gas. For example, oxygen is usually administered at home to patients suffering from various respiratory conditions, such as emphysema. But in the last five years, FDA has received reports of deaths and "near hits" (events in which the mistake of administering the wrong gas or contaminated gas was found in time to prevent injury), which have been traced to human error. A patient died in a hospital after receiving argon, a gas with a variety of industrial uses, instead of oxygen. Because maintenance personnel were not properly trained, argon was inadvertently dispensed in the main oxygen supply. The FDA has received 16 reports of aluminum regulators (valves that control the flow of a gas) burning or exploding when used with oxygen cylinders. It is believed that the aluminum (rather than brass, which is preferred) in oxygen regulators was a major factor in both the ignition and severity of these fires, although experts say there could have been other contributing factors. Many materials, such as the metal in oxygen regulators or cylinders, that will not burn in air (which is only 21 percent oxygen) may burn in the presence of pure, high-pressure oxygen. Any lubricant added to medical gas apparatus in an attempt to make repairs can cause injuries and deaths. The FDA emphasizes the importance of having all at-home medical gas equipment properly installed and regularly maintained by professionals. Some patient manuals indicate that oxygen concentrators should be serviced every 9,000 hours, yet last year the FDA issued a warning letter citing a firm for waiting as long as 30,000 hours before servicing a unit. It's not easy to tell if a company has delivered the right gas, or if the oxygen cylinder is made with the safest material. There are actions consumers can take to protect themselves:

• Check that the label on each high-pressure cylinder or cryogenic vessel states for high-pressure cylinders, "Oxygen Compressed U.S.P.," or for liquid vessels, "Oxygen Refrigerated Liquid U.S.P." If the labels do not contain these drug names, do not use the product and call your supplier immediately.
• The high-pressure cylinders need to be secured in place, in an upright position, and in a well-ventilated area. Do not allow cylinders to be stored on their sides or loosely on the floor.
• Open cylinder valves slowly. Sudden opening can cause the valve seal or "O" ring to ignite and release dangerous gases.
• Oxygen concentrators must be located in a well-ventilated area and not in a closet, back room, or garage where they might mix exhaust fumes with the medical gas.
• Do not leave the unit turned on when not in use. A cannula (nose tubing) that is left in contact with a synthetic blanket, for example, could spark a fire.
• Oxygen concentrators are not user serviceable. If you detect a problem, contact your supplier immediately.
• If you are using an oxygen regulator that contains any aluminum, replace it with a regulator made of brass. Consult the manufacturer if you don't know what material the regulator is made of.
• If non-aluminum oxygen regulators are not available, contact the Center for Devices and Radiological Health, Office of Compliance, at 301-594-4659 for specific precautions when using aluminum regulators.

Medical gases are prescription drugs, and are thus under the scrutiny of the FDA's Center for Drug Evaluation and Research. To report a problem with a drug product, contact the FDA's MedWatch program at:
Telephone; 1-800-332-1088
Fax on 1-800-332-0178
Mail to:

MedWatch
Food and Drug Administration (HF-2)
5600 Fishers Lane
Rockville, MD
20852-9787

Website at http:/www.fda.gov/medwatch/

Glossary of Medical Gas Terminology: