Medical Gases Health Article

Definition

A medical gas is defined as one that is manufactured, packaged, and intended for administration to a patient in anesthesia, therapy, or diagnosis. Title 21 of the Code of Federal Regulations (CFR) designates medical gases as drugs, and mandates the Secretary of the Treasury and the Secretary of Health and Human Services to promulgate regulations for the efficient enforcement of the Federal Food, Drug, and Cosmetic Act (FDA)(drug portion of 21 CFR). Such other regulatory bodies as the Department of Transportation (DOT) and national organizations [e.g., the Compressed Gas Association (CGA) and the National Fire Protection Association (NFPA)] write regulations and standards for compressed gases. Medical gases are considered prescription drugs because their use as drugs is unsafe without the supervision of a licensed practitioner or by properly instructed emergency personnel. Regulations regarding the purity of these substances are established by the United States Pharmacopeia/National Formulary (USP/NF).

Purpose

Medical gases are used within hospital settings for many purposes. They include the following elements and compounds:

• Oxygen, used to provide supplemental oxygen to the respiratory system; in dentistry in combination with nitrous oxide; and as an emergency standby.
• Nitrous oxide, used as an anesthetic agent in surgery; mixed with oxygen to help patients relax during dental procedures; and in cryosurgery (the use of extreme cold to destroy tissue).
• Nitrogen, used to provide pneumatic pressure in medical equipment; to prevent combustion and other chemical reactions; and as a component of many gas mixtures.
• Carbon dioxide, used to inflate areas of the body for "keyhole" surgery (small incisions made to accommodate surgical instruments); mixed with air or oxygen to stimulate breathing; and in cryosurgery or testing tooth sensitivity in dentistry.
• Medical air, used in administering breathing treatments and as a mixing component for other respiratory gases.
• Helium, used in breathing mixtures for patients with impaired lung functions.

Since medical gases are the most frequently administered drugs in the United States, the FDA is attempting to heighten both consumer and industry awareness about this specialized category of regulated products. Such related delivery hardware as regulators and tubing is also regulated as medical devices.