The level of compliance burden, as described earlier in this document, would likely be lower per operation for companies that are not classified as industrial gas producers or welding suppliers. Home health service and equipment rental companies do not fill or distribute containers of portable cryogenic medical gases to hospitals or nursing homes. To the agency`s knowledge, the only cryogenic medical gas containers these companies would fill would be small cryogenic containers intended for use at home by individual patients. As discussed earlier in this document, these means of containment are not subject to the requirements proposed in this rule for portable containers of cryogenic medical gases. These proposed requirements represent the majority of the total estimated burden of compliance costs. While most industrial gas producers have been classified as small according to the SBA criteria, it is assumed that all or almost all of these producers would provide cryogenic gas filling services and therefore bear a greater share of the compliance burden. An alternative to silver brazing, which would also meet the proposed requirement, would be to lock the gas outlet ports on portable cryogenic medical gas containers to the valve bodies of these containers using multiple valves or interlocks. These valves or interlocks cost about $10 to $15 each. The FDA estimates that at most $2 to $3 in additional labor costs would be required to attach each valve or interlock.
Accordingly, FDA estimates that the total cost of proposed compliance with section 211.94(e)(3) from the use of valves or interlocks would be between $12 and $18 per cryogenic container. Assuming a current compliance rate of 90% (275,625 containers), the total cost of this option to industry is not expected to exceed approximately $551,000 ([306,250-275,625] x $18). High-pressure medical gas containers are used to store gases at relatively high ambient pressures and temperatures. These containers have a tubular design and are made of steel or aluminum. Between 1996 and April 2004, the FDA received several reports of serious injuries attributable to high-pressure medical gas cylinders contaminated with residues of industrial cleaning solvents, most likely as a result of improper cleaning during the conversion of cylinders from industrial to medical use. Initial print page 18041. There have also been incidents where industrial gases in high-pressure cylinders have been mistakenly identified for medical purposes and their contents have been improperly administered to patients, resulting in injury and death. Examples of incidents involving high-pressure medical gas cylinders are described in the following sections. Medical gases, like other medicines, must have a marketing authorisation (marketing licence) to be sold. The marketing authorisation defines the quality specifications, when a gas can be used and how it is to be administered to a patient.
For the treatment of the patient, all medical gases must be supplied with the appropriate marketing authorization. (Answer 5) The FDA acknowledges comments that certain over-the-counter uses of medical air are medically appropriate and, therefore, that the “prescription only” warning in § 201.161(a)(1)(i) as amended by this rule is not appropriate for medical air. The FDA is not finalizing the proposal to include medical air in the list of gases in section 201.161, and the question of what constitutes an appropriate warning for medical air is still being considered by the FDA. In §211.94(e)(3) of the proposed rule, the FDA proposed to require that portable cryogenic medical gas containers not manufactured with permanent gas outlet fittings have specific gas outlet fittings that can only be removed or replaced by the manufacturer. The FDA is in the process of finalizing this provision (renumbered § 211.94(e)(1)) with some minor changes that are explained in this document. Some medical facilities may use on-site gas production systems. When these systems are used, they must meet the requirements for the production of medical gases, including GMP and site quality management system compliance. In accordance with section 201.328(a)(2), the 360° wraparound label required by section 201.328(a)(1) or a separate label in conspicuous type must contain the words “For medical use”, “Medical gas” or a similar phrase indicating that the gas is intended for medical use. Finally, in accordance with §211.94(e)(2), the circumferential label must be affixed to the container in such a way that it does not interfere with other marks and cannot be worn or detached accidentally under normal conditions of use, and the circumferential label must be reasonably resistant to light and durable when exposed to atmospheric conditions. and hardly soluble in water.
Medical gases are generally classified as prescription drugs under sections 201(g)(1) and 503(b)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 321(g)(1) and 353(b)(1)) (although oxygen may be dispensed without a prescription for certain uses specified in Section 576(b)(2) of the FD&C Act (21 U.S.C. 360ddd-1(b)(2)). and are regulated under Section 501(a)(2)(B) of the FD&C Act (21 U.S.C.).