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OXYGEN 93% SAFETY AND EFFICACY ISSUES WILL BE ADDRESSED BY A SUBCMTE

Executive Summary

OXYGEN 93% SAFETY AND EFFICACY ISSUES WILL BE ADDRESSED BY A SUBCMTE. of the FDA Anesthetic & Life Support Drugs Cmte. The full cmte. recommended referring the subject to a subcmte. at a meeting in Washington on April 11. Hesitant about making any recommendations to FDA without further deliberation on these questions, the cmte. appointed a subcmte. to further research 93% oxygen. Summarizing, Cmte. Chairman Gerald Gronert, MD, Mayo Clinic, said: "My feeling is that the cmte. feels that it's a mistake to introduce a new kind of oxygen for a variety of reasons but I don't see that there's any real basis for this . . . There's at least one member of our cmte. who feels it would be perfectly legitimate to use this type of oxygen and that it would be unlikely to lead to any problems in the bulk of all our anesthetic users. So what I see is a variety of opinion; and I, for one, would like more information and I wonder if the cmte. [would like] to settle this question over a longer period of time." FDAer Patricia Russell, MD, presented to the cmte. a set of questions on the use of 93% oxygen. The key issue was whether there are specific clinical situations in which the use of 93% +/- 3% oxygen would not be a suitable alternative to 99% + oxygen. In her presentation, Russell stated that with 93% oxygen there is a variance of 3% and that the concentration of oxygen is flow dependent. The largest other component in the mixture is argon in a concentration of 8%. Though generators for 93% oxygen have been available for home use for at least 20 years, Russell noted that it has only been in the past year that the USP approved a petition for the manufacture of 93% oxygen for civilian hospital use. Joseph Arnaudo, from FDA's Center for Devices, noted that 93% oxygen (which he said averages about 12 cents a gallon) represents a "considerable" savings over liquid oxygen. Amortized over a period of two years for a large facility, Arnaudo said that the cost of 93% oxygen was less than liquid oxygen by a factor of 10. In their comments on the safety and efficacy of 93% oxygen, cmte. members expressed considerable apprehension about the large degree of variability associated with it. Cmte. member Robert Merin, MD, University of Texas, commented, "I think the big problem that we all see is that there's so much variability . . . I don't see any problem with a guaranteed 92% or 93% oxygen."
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