CGA’s M-1 Publication Guides Safe Use of Medical Gas Supply Systems at Health Care Facilities
August 12, 2020
CGA M-1, Standard for Medical Gas Supply Systems at Health Care Facilities (an American National Standard), provides requirements for the design, installation, maintenance, testing, and removal of compressed medical gas (CMG) supply systems at health care facilities.
This safety standard, published by the Compressed Gas Association (CGA), is referenced by the National Fire Protection Association in NFPA 55.
Compressed medical gases are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in human beings or animals. Medical gas supply systems deliver CMGs to piped distribution systems at health care facilities. Oxygen USP (United States Pharmacopeia) and medical air USP provide direct assistance for breathing and also assist in the delivery of medical treatment(s). Oxygen USP, medical air USP, and CMG mixtures are used in hyperbaric chambers. Nitrogen NF is used to operate power tools during patient care procedures.
CMGs are typically supplied to a medical gas piped distribution system by a cryogenic fluid central supply (either a permanently installed bulk supply system or permanently installed microbulk supply system), cylinders or containers connected to a manifold system, or a temporary supply system. Supplier-owned or health care facility-owned storage and control systems that supply CMG shall be installed and maintained in compliance with CGA M-1, applicable regulations, and the U.S. Food and Drug Administration (FDA) current good manufacturing practices (CGMP).
The system owner is responsible for compliance with CGMP. Title 21 (Food and Drugs) of the U.S. Code of Federal Regulations Parts 210-211 prohibits the adulteration of drugs. Introducing a drug product into a system that has not been installed in accordance with CGMP will adulterate the product.
The supplier of the CMG is responsible for ensuring that the system has been installed in compliance with CGMP prior to first filling of the system. Supplier and contractor personnel who work on supplier-owned equipment shall be able to provide documentation that demonstrates compliance with this standard.
CGA M-1 Aids Compliance with FDA, U.S. CFR, NFPA Regulations & Codes
CGA M-1 applies to all new or upgraded CMG supply systems at health care facilities. It provides detailed procedures to help designers, installers, and operators of CMG supply systems with compliance with the following national regulations and model codes:
- Federal Food, Drug, and Cosmetic Act, U.S. FDA;
- Title 21 of the U.S. Code of Federal Regulations (21 CFR) Parts 210 to 211;
- NFPA 55, Compressed Gases and Cryogenic Fluids Code, and
- NFPA 99, Health Care Facilities Code
CGA M-1 captures the requirements from these codes along with best practices to provide a comprehensive publication for the process of designing, locating, installing, commissioning, maintaining, testing, removing, and documenting work on a medical gas supply system.
This safety standard covers:
- Health hazards and safety considerations when dealing with CMGs;
- Applicable codes and standards that CMG supply systems must meet;
- Training and qualifying personnel to install CMG supply systems;
- Site selection and development;
- Equipment selection and installation;
- System commissioning, startup, initial fill, operation and maintenance;
- System decommissioning and removal, and;
The full Table of Contents may be downloaded for free from the CGA M-1 publication details page on the CGA portal.
For facilities that are solely intended for use in non-human applications (i.e., veterinary or pharmaceutical), the applicability of this standard is to be determined by the CMG system designer, authority having jurisdiction (AHJ), or other related parties based on facility requirements.
What’s New in the 4th Edition of CGA M-1
- A new section 6.2.4 (under section 6, Personnel) provides details for certifying installers of CMG supply systems.
- A new section 9.2.5 (under section 9, Equipment selection) gives more specific requirements for pressure relief devices.
- A new section 9.3 has more details about the design of storage vessels, vaporizers, and other parts of a CMG supply system.
- A new section 11.5 (under section 11, Equipment installation) lists and gives details for acceptable pipe joints.
- New informational appendices provide commentary and explanatory material for the requirements in CGA M-1: “A” addresses ventilation, “B” covers switching vaporizers, and “C” shows where to find NFPA 55 and NFPA 99 requirements for CMG supply systems.