W.T. Workman, BS, MS, CAsP, CHT-Admin, FAsMA, FUHM
On August 8, 2000, the US Food and Drug Administration (FDA) cleared the first of eight low-pressure, portable fabric hyperbaric oxygen therapy (HBOT) chambers, based upon the Gamow Bag, which was developed for the treatment of acute mountain sickness. Since then, these types of hyperbaric chambers have become endemic.
When I learned of the FDA’s decision, I called the FDA’s Deputy Director of Compliance for devices at the time and stated that the FDA has just opened Pandora’s Box.
At the time, I did not appreciate how prophetic that statement was. Why should anyone worry about the fact that there are a lot of inflatable “altitude sickness” hyperbaric chambers … read more