Growth and development of transcutaneous monitoring in the U.S.A.--1978-1986

Surface blood gas monitoring is an invaluable clinical technique. It is, unfortunately, subject to many errors unless carefully carried out. This can be done by clinicians. Clinicians, however, cannot be responsible for the cumulative effects of changes in the electrodes made by manufacturers. Before a modified electrode is approved for use its accuracy under clinical conditions and at high arterial PO2 tensions has to be established. In America this has not and is not being done. The F.D.A. met in December, 1986, to consider this problem. Recommendations are expected to be published in 1987. In any new regulations similar but not identical requirements for accuracy should be demanded from pulse oximeters, as these devices have their own unique limitations under hyperoxic and hypoxic conditions.