Performance evaluation of contemporary spirometers.

A comprehensive evaluation of 62 spirometers from 37 different sources was performed using a two-part protocol: calibrated syringe, and dynamic waveform testing. All testing was done with ambient air. Calibrated syringe testing examined the ability of the spirometers to accurately measure the output of a 3 L calibrating syringe under varying conditions. The accuracy, FVC volume linearity, and stability of each spirometer was determined from these data. All but five of 42 spirometers accurately measured a 3 L calibrating syringe to within +/- 3 percent. Dynamic waveform testing consisted of introducing 24 standard waveforms into the spirometer from a computer-controlled air pump. The values of FVC, FEV1, and FEF25-75% were compared to the actual values for each waveform to determine a performance rating. Only 35 (56.5 percent) of the spirometers performed acceptably when measuring the 24 standard waveforms. Nine (14.5 percent) were marginal and 18 (29.0 percent) were unacceptable. Fifty-nine (95 percent) of the 62 spirometers were computerized. Software errors were found in 25 percent of the computerized systems evaluated. Although using a 3 L syringe for quality control purposes is essential, simple testing of spirometers with a 3 L calibrating syringe for validation purposes was inadequate to assess spirometer performance when compared to dynamic waveform testing. Dynamic waveform testing is essential to accurately measure and validate acceptability of spirometer system performance.