The Accuracy of 6 Inexpensive Pulse Oximeters Not Cleared by the Food and Drug Administration: The Possible Global Public Health Implications
The Accuracy of 6 Inexpensive Pulse Oximeters Not Cleared by the Food and Drug Administration: The Possible Global Public Health Implications
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DOI：
10.1213/ane.0000000000001300
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发表时间：
2016-08-01
影响因子：
5.7
通讯作者：
Bickler, Philip E.
中科院分区：
文献类型：
--
作者：
Lipnick, Michael S.;Feiner, John R.;Bickler, Philip E.
背景：脉搏血氧仪在全球范围内的普及通常受到成本的限制，并具有重大的公共卫生后果。低成本脉搏血氧仪已经变得越来越可用，而监管机构的监督有限。这些设备的准确性往往没有得到验证，提出了有关performance.METHODS的问题：6个低成本的手指脉搏血氧饱和度在稳定的动脉血氧饱和度（Sao（2））在70%和100%之间的准确性进行了评估，在22名健康受试者。受试血氧仪为Contec CMS 50 DL、Beijing Choice C20、Beijing Choice MD 300C 23、Starhealth SH-A3、Jumper FPD-500 A和Acutean SB 100 II。通过部分再呼吸回路监测和调节吸入的氧气、氮气和二氧化碳分压，以达到10 - 12个稳定的目标Sao 2平台（70%-100%）和Paco（2）值（35 - 45 mm Hg）。将脉搏血氧饱和度（Spo（2））与动脉血氧饱和度（Sao（2））（分别用Radiometer ABL 90和OSM 3测量）进行比较，计算偏倚（Spo（2）- Sao（2））均值、精密度（偏倚的SD）和均方根误差（ARMS）。当Sao 2降低时，测试的6个血氧仪中有4个显示出估计饱和度的较大误差（平均偏倚高达-6.30%，精密度4.30%，7.53 ARMS
BACKGROUND: 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.METHODS: The accuracy of 6 low-cost finger pulse oximeters during stable arterial oxygen saturations (Sao(2)) 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 Paco(2) values of 35 to 45 mm Hg. Comparisons of pulse oximeter readings (Spo(2)) with arterial Sao(2) (by Radiometer ABL90 and OSM3) were used to calculate bias (Spo(2) - Sao(2)) mean, precision (SD of the bias), and root mean square error (ARMS).RESULTS: 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