I had recently had a gentleman in Denmark ask me what I thought about… “The use of oxygen concentrators with mild hyperbaric devices, has not yet been cleared by FDA (as I understand) and that selling this solution is considered illegal in most U.S states (as I understand). Europe and US not to be compared.”
My response went something like this… “Definitely Europe and US should not to be compared as the FDA has no ruling or jurisdiction outside of the United States. Now, when considering the United States and the legality of using an oxygen concentrator with a portable hyperbaric chamber, I think we should also consider the source of this question… Likely it was either an argument against portable chambers from someone attempting to secure their position with a hard chamber, or they are a manufacturer who can not sell o2 concentrators and they are in competition with resellers who do. The problem lies in that actual manufacturers of equipment can’t sell anything except what is FDA approved and ass the FDA has not approved the chamber with an o2 concentrator, they would be selling a modification to their FDA approval. Further, I would imagine that even if an o2 concentrator were approved, each different unit would require an additional FDA certificate as it would greatly change the design and specs of the overall medical device. Of course, portable hyperbaric chambers all have auxiliary ports designed for attaching oxygen equipment such as o2 concentrators; one would think that if connecting an o2 concentrator was such a big deal, the FDA would put the Kabash on such attachments at the design and approval level.
Now, since a licenced physician can prescribe off-label (outside of FDA approval) and a licensed physician is prescribing a portable hyperbaric chamber with an oxygen concentrator; where is the legality issue with selling those two devices to an end user? Personally, I don’t see it… and either do thousands of other end-users, physicians, and clinics where such practice takes place within the USA. I would think that if it really was an issue, then the FDA could come down hard on a lot of people as nobody is trying to hid e the practice of using an o2 concentrator with a hyperbaric chamber.
In conclusion, I believe there is no conflict in this activity as long a licensed physician is prescribing it. Further, I believe that anyone who attempts to use such an argument to dissuade an end user from such a device should focus on other issues such as research. If you are a manufacturer making such statements… grow up and realize that you are in manufacturing, not sales… quit trying to compete and just make stuff already!
Greg Harris - Hyperbaric Warrior