4729.70 Establishing and implementing medical gases safety program.
4729.70 Establishing and implementing medical gases safety program.
(A) As used in this section, “cryogenic vessel” means an insulated metal container in the form of a cylinder or other design used to hold gases that have been liquefied by extreme reductions in temperature.
(B) The state board of pharmacy shall establish and implement a medical gases safety program to ensure that cryogenic vessels containing medical gases meet the requirements of this section and are properly handled. The program applies only to cryogenic vessels that are portable and contain medical gases in a volume intended for use in administering direct treatment to one or more individuals. The program does not apply to cylinders or containers of other designs that contain medical gases that are only compressed.
(C) Each cryogenic vessel subject to this section shall meet the following requirements:
(1) The vessel shall be properly labeled according to the medical gas contained in the vessel.
(2) The vessel shall be color coded as follows:
(a) Air – yellow;
(b) Carbon dioxide – gray;
(c) Cyclopropane – orange;
(d) Helium – brown;
(e) Nitrogen – black;
(f) Nitrous oxide – blue;
(g) Oxygen – green. The colors specified in this division shall not be used for any medical gas other than those specified in this division.
(3) The color coding specified in division (C)(2) of this section shall be applied to the vessel by doing either of the following:
(a) Applying the appropriate color to the top six inches of the body of the vessel;
(b) Affixing a wrap to the vessel that encircles the vessel completely, has the identity of the contained gas printed completely or continuously around the wrap, and uses the appropriate color as the print or background for the identity of the gas.
(4) The vessel shall not have previously contained a gas that is not a medical gas.
(5) When the vessel is being reused for a medical gas other than the medical gas it previously contained, new labeling and color coding shall be applied to the vessel and all old labeling and color coding shall be completely removed.
(6) The connector between the vessel and the valve through which the medical gas is delivered shall be either of the following:
(a) A threaded or socket connection that is silver brazed or welded to the valve;
(b) A permanent and integral part of the valve.
(D) No person shall remove a connector between a cryogenic vessel subject to this section and the valve through which the medical gas is delivered from the vessel, replace the connector with another connector, or attach an adapter to the vessel or connector unless the person meets standards established by the board in rules adopted under this section. A person who violates this division is guilty of tampering with drugs pursuant to section 2925.24 of the Revised Code.
(E) All employees who are responsible for installing or changing the cryogenic vessels subject to this section shall be trained in the proper handling of medical gases and cryogenic vessels, including training in understanding the labeling of the vessels and recognizing the color coding required by this section.
(F) The board shall adopt rules to implement the medical gases safety program established pursuant to this section. The rules shall be adopted in accordance with Chapter 119. of the Revised Code. The board’s rules shall specify standards and procedures to be followed in ensuring that the individuals who modify existing cryogenic vessels for purposes of bringing the vessels into compliance with this section are qualified individuals. The board’s standards for being considered qualified shall include requirements for knowledge in proper safety precautions concerning medical gases, cryogenic vessels that contain medical gases, and devices through which medical gases are delivered from cryogenic vessels.
Effective Date: 03-15-2002