Lipnick Michael S, Feiner John R, Au Paul, Bernstein Michael, Bickler Philip E
From the *Department of Anesthesia and Perioperative Care, University of California at San Francisco, San Francisco, California; and †Physio Monitor LLC., San Ramon, California.
Anesth Analg. 2016 Aug;123(2):338-45. doi: 10.1213/ANE.0000000000001300.
Universal access to pulse oximetry worldwide is often limited by cost and has substantial public health consequences. Low-cost pulse oximeters have become increasingly available with limited regulatory agency oversight. The accuracy of these devices often has not been validated, raising questions about performance.
The accuracy of 6 low-cost finger pulse oximeters during stable arterial oxygen saturations (SaO2) between 70% and 100% was evaluated in 22 healthy subjects. Oximeters tested were the Contec CMS50DL, Beijing Choice C20, Beijing Choice MD300C23, Starhealth SH-A3, Jumper FPD-500A, and Atlantean SB100 II. Inspired oxygen, nitrogen, and carbon dioxide partial pressures were monitored and adjusted via a partial rebreathing circuit to achieve 10 to 12 stable target SaO2 plateaus between 70% and 100% and PaCO2 values of 35 to 45 mm Hg. Comparisons of pulse oximeter readings (SpO2) with arterial SaO2 (by Radiometer ABL90 and OSM3) were used to calculate bias (SpO2 - SaO2) mean, precision (SD of the bias), and root mean square error (ARMS).
Pulse oximeter readings corresponding to 536 blood samples were analyzed. Four of the 6 oximeters tested showed large errors (up to -6.30% mean bias, precision 4.30%, 7.53 ARMS) in estimating saturation when SaO2 was reduced <80%, and half of the oximeters demonstrated large errors when estimating saturations between 80% and 90%. Two of the pulse oximeters tested (Contec CMS50DL and Beijing Choice C20) demonstrated ARMS of <3% at SaO2 between 70% and 100%, thereby meeting International Organization for Standardization (ISO) criteria for accuracy.
Many low-cost pulse oximeters sold to consumers demonstrate highly inaccurate readings. Unexpectedly, the accuracy of some low-cost pulse oximeters tested here performed similarly to more expensive, ISO-cleared units when measuring hypoxia in healthy subjects. None of those tested here met World Federation of Societies of Anaesthesiologists standards, and the ideal testing conditions do not necessarily translate these findings to the clinical setting. Nonetheless, further development of accurate, low-cost oximeters for use in clinical practice is feasible and, if pursued, could improve access to safe care, especially in low-income countries.
全球范围内普遍使用脉搏血氧仪常常受到成本限制，并产生重大的公共卫生影响。低成本脉搏血氧仪越来越容易获得，但监管机构的监督有限。这些设备的准确性往往未经验证，引发了对其性能的质疑。
在22名健康受试者中评估了6种低成本手指脉搏血氧仪在70%至100%的稳定动脉血氧饱和度（SaO2）期间的准确性。测试的血氧仪有康泰CMS50DL、北京卓瑞C20、北京卓瑞MD300C23、星创SH-A3、骏珀FPD-500A和亚特兰蒂斯SB100 II。通过部分重呼吸回路监测并调整吸入氧气、氮气和二氧化碳的分压，以在70%至100%之间实现10至12个稳定的目标SaO2平台期，且PaCO2值为35至45 mmHg。将脉搏血氧仪读数（SpO2）与动脉SaO2（通过雷度ABL90和OSM3）进行比较，以计算偏差（SpO2 - SaO2）均值、精密度（偏差的标准差）和均方根误差（ARMS）。
分析了与536份血样相对应的脉搏血氧仪读数。测试的6种血氧仪中有4种在SaO2降至<80%时估计饱和度时显示出较大误差（平均偏差高达-6.30%，精密度4.30%，ARMS 7.53），并且一半的血氧仪在估计80%至90%之间的饱和度时表现出较大误差。测试的两种脉搏血氧仪（康泰CMS50DL和北京卓瑞C20）在70%至100%的SaO2时ARMS<3%，从而符合国际标准化组织（ISO）的准确性标准。
许多售卖给消费者的低成本脉搏血氧仪显示出高度不准确的读数。出乎意料的是，这里测试的一些低成本脉搏血氧仪在测量健康受试者的低氧血症时，其准确性与更昂贵的、获得ISO认证的设备相似。这里测试的设备均未达到世界麻醉医师协会联合会的标准，并且理想的测试条件不一定能将这些结果转化到临床环境中。尽管如此，进一步开发用于临床实践的准确、低成本血氧仪是可行的，如果付诸实施，可能会改善安全护理的可及性，特别是在低收入国家。
