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Medical Devices

医疗设备

FDA updates guidance on pulse ox devices used in healthcare

FDA更新用于医疗保健的pulse ox设备指南

The U.S. Food and Drug Administration has published updated draft recommendations to help improve the performance of pulse oximeters across skin tones.

美国食品和药物管理局发布了最新的建议草案，以帮助改善脉搏血氧仪在不同肤色下的性能。

By

签字人

Andrea Fox

安德烈福克斯

January 07, 2025

2025年1月7日

11:23 AM

11： 上午23点

Grace Cary/Getty Images

格雷斯·卡里/盖蒂图片

The U.S. Food and Drug Administration is seeking public comment on new recommendations for nonclinical and clinical performance testing to support premarket submissions for pulse oximeters for medical purposes. These include devices with a function that estimates the amount of oxygen in arterial blood and pulse rate..

美国食品和药物管理局正在就非临床和临床性能测试的新建议征求公众意见，以支持用于医疗目的的脉搏血氧仪上市前提交。这些设备具有估计动脉血中氧气量和脉搏率的功能。。

WHY IT MATTERS

为什么它很重要

During the COVID-19 pandemic, medical researchers and clinicians gathered evidence that pulse oximeters did not always provide accurate readings for darker skin tones.

在新型冠状病毒肺炎大流行期间，医学研究人员和临床医生收集到的证据表明，脉搏血氧仪并不总是能为较深的肤色提供准确的读数。

In 2023, the FDA

2023年，FDA

issued a warning about potential risks

发出潜在风险警告

of inaccuracy under certain circumstances and said it became aware that pulse oximeters could be less accurate in people with dark skin pigmentation. The agency then scheduled public meetings last year to reassess its existing pulse oximetry guidance.

在某些情况下不准确，并表示已经意识到脉搏血氧仪在深色皮肤色素沉着的人群中可能不太准确。该机构随后安排了去年的公开会议，以重新评估其现有的脉搏血氧仪指南。

The new

新的

proposed update

提议的更新

, posted on its website, sharpens recommendations for gathering real-world and laboratory clinical data to evaluate device performance accuracy across the range of skin pigmentations, using both subjective and objective methods to standardize evaluations of pulse oximeter products used in healthcare delivery..

，发布在其网站上，提出了收集真实世界和实验室临床数据的建议，以评估各种皮肤色素沉着的设备性能准确性，并使用主观和客观方法对医疗保健中使用的脉搏血氧仪产品进行标准化评估。。

The guidance, Pulse Oximeters for Medical Purposes – Non-Clinical and Clinical Performance Testing, Labeling and Premarket Submission Recommendations, suggests new performance information in product labeling and applies only to certain pulse oximeters used primarily for medical purposes in hospital settings or doctors’ offices, FDA said in a statement Monday..

FDA周一在一份声明中表示，该指南《医用脉搏血氧仪-非临床和临床性能测试、标签和上市前提交建议》在产品标签中提出了新的性能信息，仅适用于某些主要用于医院或医生办公室医疗目的的脉搏血氧仪。。

Some pulse oximeters that are currently marketed may meet the updated performance criteria without the need for significant hardware or software modifications, the agency explained.

该机构解释说，目前市场上销售的一些脉搏血氧仪可能符合更新的性能标准，而无需对硬件或软件进行重大修改。

If a sponsor of such a device submits only 'updated labeling to reflect the collection of clinical data that demonstrates comparable performance across skin pigmentations without device modifications,' the agency said it would provide an expeditious review within 30 days 'to help ensure the public has prompt access to safe and accurate pulse oximeters.'.

如果这种设备的赞助商只提交“更新的标签，以反映临床数据的收集，这些数据在没有设备修改的情况下显示出皮肤色素沉着的可比性能”，该机构表示，将在30天内提供快速审查，“以帮助确保公众迅速获得安全准确的脉搏血氧仪。”。

The updated pulse ox guidance does not apply to general wellness products or sporting/aviation products the FDA does not review or evaluate before being made available to the public, the FDA noted.

FDA指出，更新后的pulse ox指南不适用于一般健康产品或运动/航空产品，FDA在向公众提供之前不会对其进行审查或评估。

Comments received by March 10 will be considered before the agency begins work on the final version of the guidance, it said.

该机构表示，在3月10日之前收到的意见将在该机构开始制定指导意见的最终版本之前得到考虑。

THE LARGER TREND

更大的趋势

Research published in the

研究发表在

New England Journal of Medicine

新英格兰医学杂志

in 2020 showed that, after comparing measurements of arterial oxygen saturation with pulse oximetry, Black patients were

2020年的研究表明，在将动脉血氧饱和度测量值与脉搏血氧仪进行比较后，黑人患者

three times as likely

可能性是原来的三倍

to have occult hypoxemia than white patients.

比白人患者有隐匿性低氧血症。

Johns Hopkins School of Medicine has been drawing attention to FDA’s medical device regulation of pulse oximeters, critical of how the agency handled its 510(k) review process in getting these products to the medical, consumer and other industry markets and

约翰·霍普金斯医学院（Johns Hopkins School of Medicine）一直在提请人们注意美国食品和药物管理局（FDA）对脉搏血氧仪的医疗器械监管，批评该机构如何处理其510（k）审查过程，将这些产品推向医疗、消费者和其他行业市场，以及

calling out the agency's reaction time

说出机构的反应时间

.

.

In response, a spokesperson for FDA told

作为回应，FDA发言人告诉

Healthcare IT News

医疗保健IT新闻

in July that it was still engaging stakeholders and gathering input from clinical researchers to inform the update. Previously, the FDA said on its Center for Devices and Radiological Health Guidance Agenda that revisiting pulse ox guidance was a priority and intended to publish updates in FY 2024..

7月，它仍在吸引利益相关者，并收集临床研究人员的意见，以告知最新情况。此前，美国食品和药物管理局（FDA）在其设备和放射健康指导中心议程上表示，重新审视pulse ox指南是一项优先事项，并打算在2024财年发布更新。。

In a lawsuit filed to

在提交给

halt the sale of flawed pulse oximeters

停止销售有缺陷的脉搏血氧仪

by the Roots Community Health Center in Oakland, California, the healthcare organization called it a striking example of how systemic racism can drive healthcare and population health outcomes.

加利福尼亚州奥克兰的根社区健康中心（Roots Community Health Center）将其称为系统性种族主义如何推动医疗保健和人口健康结果的一个突出例子。

According to the American Heart Association, heart disease death rates are also

根据美国心脏协会的数据，心脏病死亡率也是

highest among Black Americans

美国黑人中最高

, and racial bias inherent in light-sensing and other technologies could be potential links to the demographic's elevated risks.

，而光感应和其他技术固有的种族偏见可能与人口风险升高有关。

Medtronic announced in October that it was

美敦力在10月份宣布

dismissed from the federal lawsuit

被联邦诉讼驳回

filed against CVS, Walgreens, GE Healthcare and many other medical technology companies. A company spokesperson said that Medtronic has been improving the diversity of its clinical studies, educating medical providers on the proper use of pulse oximetry and investing in technology improvements over the last two years. .

针对CVS、Walgreens、GE Healthcare和许多其他医疗技术公司提起诉讼。一位公司发言人表示，美敦力在过去两年中一直在改善其临床研究的多样性，教育医疗提供者正确使用脉搏血氧仪，并投资于技术改进。。

'We are pleased that Medtronic, which holds a dominant share in the pulse oximeter market, has agreed to prioritize patient safety by providing labels and brochures alerting their California hospital customers of the potential flawed readings for people with darker skin pigmentation,' Roots stated by email after the announcement. .

“我们很高兴美敦力在脉搏血氧仪市场占据主导地位，它同意优先考虑患者安全，提供标签和宣传册，提醒加州医院的客户，皮肤色素沉着较深的人可能存在缺陷的读数，”罗茨在宣布后通过电子邮件表示。。

ON THE RECORD

记录在案

'This draft guidance is aligned with the FDA’s broader commitment to helping facilitate the development of high-quality, safe, and effective medical devices,' said Dr. Michelle Tarver, FDA's CDRH director, in a statement. 'Our draft recommendations are based on the best available science to help address concerns of disparate performance of pulse oximeters based on an individual’s skin pigmentation.'.

FDA CDRH主任米歇尔·塔弗（MichelleTarver）博士在一份声明中说，这份指南草案与FDA更广泛的承诺相一致，即帮助开发高质量、安全和有效的医疗器械我们的建议草案基于现有的最佳科学，以帮助解决基于个人皮肤色素沉着的脉搏血氧仪不同性能的担忧。”。

Andrea Fox is senior editor of Healthcare IT News.

AndreaFox是《医疗保健IT新闻》的高级编辑。

Email:

电子邮件：

afox@himss.org

afox@himss.org

Healthcare IT News is a HIMSS Media publication.

医疗保健IT新闻是HIMSS的媒体出版物。

Topics:

主题：

Clinical

临床

,

,

Compliance & Legal

合规与法律

,

,

Government & Policy

政府与政策

,

,

Medical Devices

医疗设备

,

,

Population Health

人口健康

More regional news

更多地区新闻

NeuroFlow acquires, integrates Intermountain's behavioral health analytics model

NeuroFlow收购并整合了Intermountain的行为健康分析模型

By

签字人

Mike Miliard

迈克·台球

January 07, 2025

2025年1月7日

Explore the intersection of healthcare and agentic AI

探索医疗保健和代理人工智能的交叉点

January 07, 2025

2025年1月7日

2025 forecast: Telehealth will boost panel size and enable more delegation

2025年预测：远程医疗将扩大小组规模，并使更多的授权成为可能

By

签字人

Bill Siwicki

比尔·西维奇

January 06, 2025

2025年1月6日

The U.S. Food and Drug Administration is seeking public comment on new recommendations for nonclinical and clinical performance testing to support premarket submissions for pulse oximeters for medical purposes. These include devices with a function that estimates the amount of oxygen in arterial blood and pulse rate..

美国食品和药物管理局正在就非临床和临床性能测试的新建议征求公众意见，以支持用于医疗目的的脉搏血氧仪上市前提交。这些设备具有估计动脉血中氧气量和脉搏率的功能。。

WHY IT MATTERS

为什么它很重要

During the COVID-19 pandemic, medical researchers and clinicians gathered evidence that pulse oximeters did not always provide accurate readings for darker skin tones.

在新型冠状病毒肺炎大流行期间，医学研究人员和临床医生收集到的证据表明，脉搏血氧仪并不总是能为较深的肤色提供准确的读数。

In 2023, the FDA

2023年，FDA

issued a warning about potential risks

发出潜在风险警告

of inaccuracy under certain circumstances and said it became aware that pulse oximeters could be less accurate in people with dark skin pigmentation. The agency then scheduled public meetings last year to reassess its existing pulse oximetry guidance.

在某些情况下不准确，并表示已经意识到脉搏血氧仪在深色皮肤色素沉着的人群中可能不太准确。该机构随后安排了去年的公开会议，以重新评估其现有的脉搏血氧仪指南。

The new

新的

proposed update

提议的更新

, posted on its website, sharpens recommendations for gathering real-world and laboratory clinical data to evaluate device performance accuracy across the range of skin pigmentations, using both subjective and objective methods to standardize evaluations of pulse oximeter products used in healthcare delivery..

，发布在其网站上，提出了收集真实世界和实验室临床数据的建议，以评估各种皮肤色素沉着的设备性能准确性，并使用主观和客观方法对医疗保健中使用的脉搏血氧仪产品进行标准化评估。。

The guidance, Pulse Oximeters for Medical Purposes – Non-Clinical and Clinical Performance Testing, Labeling and Premarket Submission Recommendations, suggests new performance information in product labeling and applies only to certain pulse oximeters used primarily for medical purposes in hospital settings or doctors’ offices, FDA said in a statement Monday..

FDA周一在一份声明中表示，该指南《医用脉搏血氧仪-非临床和临床性能测试、标签和上市前提交建议》在产品标签中提出了新的性能信息，仅适用于某些主要用于医院或医生办公室医疗目的的脉搏血氧仪。。

Some pulse oximeters that are currently marketed may meet the updated performance criteria without the need for significant hardware or software modifications, the agency explained.

该机构解释说，目前市场上销售的一些脉搏血氧仪可能符合更新的性能标准，而无需对硬件或软件进行重大修改。

If a sponsor of such a device submits only 'updated labeling to reflect the collection of clinical data that demonstrates comparable performance across skin pigmentations without device modifications,' the agency said it would provide an expeditious review within 30 days 'to help ensure the public has prompt access to safe and accurate pulse oximeters.'.

如果这种设备的赞助商只提交“更新的标签，以反映临床数据的收集，这些数据在没有设备修改的情况下显示出皮肤色素沉着的可比性能”，该机构表示，将在30天内提供快速审查，“以帮助确保公众迅速获得安全准确的脉搏血氧仪。”。

The updated pulse ox guidance does not apply to general wellness products or sporting/aviation products the FDA does not review or evaluate before being made available to the public, the FDA noted.

FDA指出，更新后的pulse ox指南不适用于一般健康产品或运动/航空产品，FDA在向公众提供之前不会对其进行审查或评估。

Comments received by March 10 will be considered before the agency begins work on the final version of the guidance, it said.

该机构表示，在3月10日之前收到的意见将在该机构开始制定指导意见的最终版本之前得到考虑。

THE LARGER TREND

更大的趋势

Research published in the

研究发表在

New England Journal of Medicine

新英格兰医学杂志

in 2020 showed that, after comparing measurements of arterial oxygen saturation with pulse oximetry, Black patients were

2020年的研究表明，在将动脉血氧饱和度测量值与脉搏血氧仪进行比较后，黑人患者

three times as likely

可能性是原来的三倍

to have occult hypoxemia than white patients.

比白人患者有隐匿性低氧血症。

Johns Hopkins School of Medicine has been drawing attention to FDA’s medical device regulation of pulse oximeters, critical of how the agency handled its 510(k) review process in getting these products to the medical, consumer and other industry markets and

约翰·霍普金斯医学院（Johns Hopkins School of Medicine）一直在提请人们注意美国食品和药物管理局（FDA）对脉搏血氧仪的医疗器械监管，批评该机构如何处理其510（k）审查过程，将这些产品推向医疗、消费者和其他行业市场，以及

calling out the agency's reaction time

说出机构的反应时间

.

.

In response, a spokesperson for FDA told

作为回应，FDA发言人告诉

Healthcare IT News

医疗保健IT新闻

in July that it was still engaging stakeholders and gathering input from clinical researchers to inform the update. Previously, the FDA said on its Center for Devices and Radiological Health Guidance Agenda that revisiting pulse ox guidance was a priority and intended to publish updates in FY 2024..

7月，它仍在吸引利益相关者，并收集临床研究人员的意见，以告知最新情况。此前，美国食品和药物管理局（FDA）在其设备和放射健康指导中心议程上表示，重新审视pulse ox指南是一项优先事项，并打算在2024财年发布更新。。

In a lawsuit filed to

在提交给

halt the sale of flawed pulse oximeters

停止销售有缺陷的脉搏血氧仪

by the Roots Community Health Center in Oakland, California, the healthcare organization called it a striking example of how systemic racism can drive healthcare and population health outcomes.

加利福尼亚州奥克兰的根社区健康中心（Roots Community Health Center）将其称为系统性种族主义如何推动医疗保健和人口健康结果的一个突出例子。

According to the American Heart Association, heart disease death rates are also

根据美国心脏协会的数据，心脏病死亡率也是

highest among Black Americans

美国黑人中最高

, and racial bias inherent in light-sensing and other technologies could be potential links to the demographic's elevated risks.

，而光感应和其他技术固有的种族偏见可能与人口风险升高有关。

Medtronic announced in October that it was

美敦力在10月份宣布

dismissed from the federal lawsuit

被联邦诉讼驳回

filed against CVS, Walgreens, GE Healthcare and many other medical technology companies. A company spokesperson said that Medtronic has been improving the diversity of its clinical studies, educating medical providers on the proper use of pulse oximetry and investing in technology improvements over the last two years. .

针对CVS、Walgreens、GE Healthcare和许多其他医疗技术公司提起诉讼。一位公司发言人表示，美敦力在过去两年中一直在改善其临床研究的多样性，教育医疗提供者正确使用脉搏血氧仪，并投资于技术改进。。

'We are pleased that Medtronic, which holds a dominant share in the pulse oximeter market, has agreed to prioritize patient safety by providing labels and brochures alerting their California hospital customers of the potential flawed readings for people with darker skin pigmentation,' Roots stated by email after the announcement. .

“我们很高兴美敦力在脉搏血氧仪市场占据主导地位，它同意优先考虑患者安全，提供标签和宣传册，提醒加州医院的客户，皮肤色素沉着较深的人可能存在缺陷的读数，”罗茨在宣布后通过电子邮件表示。。

ON THE RECORD

记录在案

'This draft guidance is aligned with the FDA’s broader commitment to helping facilitate the development of high-quality, safe, and effective medical devices,' said Dr. Michelle Tarver, FDA's CDRH director, in a statement. 'Our draft recommendations are based on the best available science to help address concerns of disparate performance of pulse oximeters based on an individual’s skin pigmentation.'.

FDA CDRH主任米歇尔·塔弗（MichelleTarver）博士在一份声明中说，这份指南草案与FDA更广泛的承诺相一致，即帮助开发高质量、安全和有效的医疗器械我们的建议草案基于现有的最佳科学，以帮助解决基于个人皮肤色素沉着的脉搏血氧仪不同性能的担忧。”。

Andrea Fox is senior editor of Healthcare IT News.

AndreaFox是《医疗保健IT新闻》的高级编辑。

Email:

电子邮件：

afox@himss.org

afox@himss.org

Healthcare IT News is a HIMSS Media publication.

医疗保健IT新闻是HIMSS的媒体出版物。