A model for technology assessment applied to pulse oximetry. The Technology Assessment Task Force of the Society of Critical Care Medicine.
OBJECTIVE
To test a model for the assessment of critical care technology. To develop practice guidelines for the use of pulse oximetry.


METHODS
A computer-assisted search of the English language literature and interviews with recognized experts in the field of pulse oximetry.


METHODS
Those studies that addressed one or more of the seven questions contained in our technology assessment template were analyzed. Study design was not a factor in article selection. However, the lack of well-designed clinical outcome studies was an important factor in determining the method of practice policy development we utilized.


METHODS
A focus person summarized the data from the selected studies that related to each of the seven assessment questions. The preliminary data summary developed by the focus person was further analyzed and refined by the task force and then sent to 16 expert reviewers for comment. These expert comments were considered by the task force, and this final consensus report was developed.


RESULTS
Pulse oximetry combines the principles of spectrophotometry and plethysmography to noninvasively measure oxygen saturation with a high degree of accuracy over the range of 80% to 100% saturation, assuming the device is being used according to the manufacturer's instructions and without any adverse operating conditions. The appropriate clinical uses of pulse oximetry fall into one of two broad categories: as a warning system based on continuous real-time measurement of arterial desaturation, or as an end-point for titration of therapeutic interventions. There are no published studies that allow for definitive, outcome-based conclusions concerning either the clinical impact or cost-benefit ratio of pulse oximetry.


CONCLUSIONS
The model developed for technology assessment proved to be appropriate for assessing pulse oximetry. The available data have allowed us to develop an evidence-based practice policy for the use of pulse oximetry in critical care. Critical care clinicians, researchers, and industry have a shared responsibility to provide valid outcome and efficacy studies of new technologies.
D014487:Centers for Medicare and Medicaid Services, U.S.; D003362:Cost-Benefit Analysis; D003422:Critical Care; D008962:Models, Theoretical; D010092:Oximetry / Q000191:economics; D013673:Technology Assessment, Biomedical / Q000379:methods*; D014481:United States; D014486:United States Food and Drug Administration