过期的修复：种族偏见和脉搏血氧仪

The invention of pulse oximeters in the 1980s reshaped healthcare. While tracking blood oxygen content (commonly recognized as the “fifth vital sign”) once required a painful blood draw and time-delayed analysis, pulse oximeters deliver nearly instantaneous data by simply sending a pulse of light through the skin. Today, pulse oximeters today are ubiquitous: built into smartwatches, purchased at pharmacies for home health monitoring, and used by clinicians to inform treatment of everything from asthma to heart failure to COVID-19. Emerging algorithms are even incorporating pulse ox data to predict future illness.

有一个巨大的警告。脉搏血氧仪在医学上具有变革性，但存在种族偏见。这些设备在深色皮肤种群上的精确工作较少，因为黑色素是赋予皮肤色素的化学物质，会干扰光基脉搏OX的测量。这意味着深色皮肤的个体可以表现出正常的脉搏氧读数，但患有低氧血症或其他关键疾病。

但是，由于今天的法规不需要医疗设备评估的多样性，因此许多Pulse Ox制造商不会在各种人群上测试其设备。And because the Food and Drug Administration (FDA) has created streamlined pathways to approve new medical devices based on technology that is “substantially similar” to already-approved technology, the racial bias embedded in ‘80s-era pulse ox technology continues to pervade pulse oximeters on the market today.

Covid-19以毁灭性的方式说明了这个问题的后果。脉搏血氧仪中的嵌入式偏见明显地恶化了患者人群的结果已经受到COVID-19的影响不成比例的。研究表明，黑色共同19患者已经接受补充氧气的可能性降低了29％按时和three times as likely to suffer occult hypoxemiaduring the pandemic.

在健康创新生态系统中，类似的不平等持续存在。妇女遭受缺乏性意识的处方药剂量。少数民族越来越遭受biased health risk-assessment algorithms。儿童和身体类型不同的人遭受医疗设备不是为其身体特征而设计的。总体上，不平等会带来更大的发病率和死亡风险，并有助于激增国家医疗保健费用。

这不必是现状。如果健康利益相关者（包括患者拥护者，MedTech公司，临床医生，研究人员和政策制定者）​​进行了调整，以系统的评估和修复健康技术中的偏见，则可能会发生变化。

一个很好的例子是EGFR算法。这些算法用于评估肾脏功能，以前使用了错误的“校正因子”来说明患者种族。但是，这种纠正实际上与生物学现实无关，而不是更有效地治疗患者，而是增加disparities in care. Motivated by the data, advocacy and industry organizations issued broad recommendations to avoid using the eGFR calculation. Hospitals and medical systems listened, dropping eGFR from practice, and the National Institutes of Health (NIH) is现在可以投资研究替代计算。

作为一个社会，我们必须继续扎根于卫生技术的偏见，从开发进行测试到部署。

当我们开发新的医疗工具时，我们应该考虑所有最终需要它们的人群。

当我们测试工具时，我们应该严格评估亚组人群之间的结果，寻找可能因其在护理中的使用而变得更好或更糟的群体。

当我们部署技术时，我们需要准备好跟踪其大规模使用的结果。

Engineers, researchers, and clinicians can support these goals by designing medical devices with equity in mind. The UK just launched its循证收集过程on equity in medical devices, looking into the impacts of bias and ways to build more equitable solutions.FDA的会议回顾有关脉搏血氧饱和度的证据是审核技术在不同人群上的表现的开始。

Advocacy organizations can support these goals by providing input to ongoing policy processes. The Federation of American Scientists (FAS), alongside the University of Maryland Medical System,提交公众评论向FDA呼吁采取法规，以鼓励开发低偏见和无偏见工具。FAS也召集了关于脉搏血氧饱和度偏差的论坛为了检查偏见的后果，请为无偏见的脉搏血氧仪建立证据基础，并展望构建更公平的设备的方法。

“不伤害”,医学中心誓言变得ing exceedingly difficult in our technological age. Yet, with an evidence-based approach that ensures technologies equitably serve all groups in a population and works to correct them when they do not, we can come closer to achieving this age-old goal.