Distributors must comply with CGA publication C-9.
Over the last five years, the medical gases industry reached a consensus agreement with both the United States Pharmacopeia (USP) and the Food and Drug Administration (FDA) on color coding of medical cylinders. This article will examine the status of that initiative, along with some recommendations on medical gas cylinder color coding.
For more than ten years now, the FDA has been pushing for a regulatory change to require a standardized color code for medical cylinders. Recently, USP proposed a change to the medical gas monographs that would have ushered in a version of standardized color coding for medical gas cylinders. Through proactive work on behalf of the industry by both GAWDA and CGA, the FDA and USP have all agreed that the color code requirements contained in CGA publication C-9 shall be the standard for color coding of medical gas cylinders. This is a significant accomplishment, as it allows the industry to remain self-regulating in this area. However, it also creates a requirement for the entire industry to come into compliance with this standard.
|Medical cylinders that do not comply with the CGA color code standard should not be filled, regardless of the ownership of the cylinder.|
Unfortunately, there are still many firms, some GAWDA members, that have not fully complied with this standard. Additionally, some companies have interpreted this requirement as being applicable only to their cylinder fleet, and currently exempt customer-owned cylinders that they fill from meeting this color code requirement. During a number of 2007 site audits performed by B&R around the industry, we observed a virtual rainbow of colors still being used for medical gas cylinders. In our opinion, this is an unacceptable lack of progress, and can only lead to FDA increasing the level of regulation and enforcement in our industry.
The industry must be prepared to voluntarily and proactively make changes to address identified concerns over product safety or quality. When we propose our consensus standards as a reasonable compliance requirement, and the authorities agree, then the companies that comprise the industry must implement the voluntary actions needed to comply with our consensus standard. Otherwise the FDA will ultimately come to the conclusion that the only way to accomplish any change in the medical gas industry is through more regulation and stricter enforcement.
With regard to color coding, it appears that a change is on the horizon. As of press time, some of the major gas producers have, or soon will, implement a policy that all medical gas cylinders they fill must meet CGA C-9 color code requirements, including customer-owned cylinders. In our opinion, this is a very positive step in the right direction. We strongly encourage all GAWDA members to implement the same policy in their business. Medical cylinders that do not comply with the CGA color code standard should not be filled, regardless of the ownership of the cylinder.
Ultimately, it is more cost-effective for gas manufacturing firms to adopt a consensus standard and then implement a process to self-police compliance to that standard than to force FDA’s hand into adopting new regulatory requirements and then turn their field inspectors loose on our industry like they did in the mid to late ’90s.
A copy of the CGA publication C-9 can be obtained at www.cganet.com, or by calling CGA at (703) 788-2700.
|Meet the Author
GAWDA Medical Gases Consultant J. Robert Yeoman is president & CEO of B&R Compliance Associates LLC in Lehigh Valley, Pennsylvania. Members can reach him at (610) 868-7183 and at email@example.com.