FDA Publishes New Final Rule for Medical Gas Containers
GAWDA's FDA and Medical Gases Consultant Thomas L. Badstubner has alerted GAWDA members to a new final rule for medical gas containers.
Badstubner issued the following memo:
On Friday, Nov. 18, 2016, the FDA published a Final Rule regarding “Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements.”
This rule will change the regulations to, among other things, require similar provisions as CGA SB-26 (tamper-proof connections on portable cryogenic containers, 360 degree wrap-around labeling, color codes, etc. You can see the official text here. Let me know if you would like an annotated copy in PDF format.
The FDA has accepted many of our suggestions from 2006 in developing the Final Rule, but there are a few surprises. For example, the agency has specifically exempted medical air from the requirements. So far, we can see no good reason for the exemption. The agency has also mentioned validated cylinder cleaning in the final rule and this may/may not become significant. As we better understand the agency’s thinking, I will keep you informed.
This article is just to give you a heads-up that this compliance issue will need attention over the next several months. The rule gives us 180 days to comply. Since CGA SB-26 has been published for sixteen years, you are likely in substantial compliance with most of the details and we will be working with the Compressed Gas Association to get clarity from the agency where needed. We may be asked to contact our congressional representatives, as we have in the past, to get the agency’s attention.
In the meantime, please take the following Four Critical Action Steps outlined here.
1) Get SB-26. Go to cganet.com and download the latest version of CGA SB-26. This publication, and all CGA publications, are free to GAWDA members who participate in the GAWDA/CGA Safety Program. Otherwise the cost is only $5.
2) Make sure all of your liquid containers are compliant with the simple requirements in SB-26. (Tamper-Proof connections, etc.) See the appendix for examples of acceptable and not acceptable portable cryogenic container connections.
3) Train Pumpers. Be certain that your cryogenic container filling personnel and supervisors understand the critical elements of CGA SB-26 that apply to them. Contact firstname.lastname@example.org for a sample quiz and answer key for identifying acceptable portable cryogenic container outlet connections.
a) Medical portable cryogenic container outlet valves must be fitted with tamper-proof connections
b) Industrial portable cryogenic container outlet valves must be fitted with tamper-evident or tamper-proof connections. This includes (N2O, CO2, Ar, N2, O2).
c) Cryogenic containers should be labeled according to CGA C-7, Guide to Classification and Labeling of Compressed Gases, including the 360-degree wraparound label.
4) Train Drivers. Be sure your drivers understand the critical elements of CGA SB-26 that apply to them:
a) How to recognize medical versus industrial containers. The label is the primary identification for medical gases. The 360-degree wraparound tape and other measures are secondary identification techniques.
b) Never use an adapter to connect a cylinder/container to a customer system.
c) Never change an outlet connection.
Advise email@example.com if you have any questions. Click here to see this memo in full and photos of acceptable and unacceptable examples.