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Pulse Oximeter Regulation in the USA

Malvina Eydelman, MD

Director

Office of Ophthalmic, Anesthesia, Respiratory, ENT, & Dental Devices

Food and Drug Administration (FDA)

USA

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Pulse Oximeters

Medical Devices – Class 2 (moderate risk):

Pulse Oximeters for medical purposes

Reviewed by the FDA through 510(k) pathway
Undergo clinical testing to confirm their accuracy
Used to monitor (i.e., trending or spot checking) oxygen saturation levels of patients
Recognized Consensus Standards

1-139 ISO 80601-2-61 Particular requirements for basic safety and essential performance of pulse oximeter equipment

FDA Guidance (2013)

Pulse Oximeters - Premarket Notification Submissions [510(k)s]: Guidance for Industry and Food and Drug Administration Staff (2013)

Pulse Oximeters for non-medical purposes:

Intended for general wellness or sporting/aviation

Not intended for medical purposes

Often sold directly to consumers in stores or online
See FDA’s guidance document General Wellness: Policy for Low-Risk Devices

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Background

COVID-19 pandemic 🡪 increased awareness of the importance of pulse oximetry
In December 2020, Sjoding et al. reported that Black ICU patients had approximately three times the rate of occult hypoxemia compared to white patients
2020-present: increased awareness, interest and related research studies

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FDA Actions

Transparent communication with stakeholders

Safety communication (2/19/21, 6/21/22, 9/15/22, 11/16/23)
Consumer update (2/19/21)
Website (11/16/23)

Held two Advisory Committee meetings

(11/1/22, 02/02/24)

Funded two real world Prospective Clinical Studies at CERSI centers

Adult: 05/02/22- present

Pulse Oximeter Errors in Adult Hospitalized Patients with Varying Skin Pigmentation (CERSI-UCSF)

Pediatric: 08/25/22 – present

Accuracy of Pulse Oximeters in Children (CERSI- Stanford)

Published discussion paper

Proposed approach to improve the evaluation of pulse oximeter accuracy taking into consideration differences in pigmentation, race and ethnicity (11/16/23)

Joined OpenOximetry Collaborative Community

(01/17/24)

Updating Pulse Oximetry Guidance

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Pigmentation, Race and Ethnicity Considerations

Range of skin pigmentation
2 darkly pigmented individuals

Proposed updates to guidance

2013 guidance

Inclusive and equitable representation
Best method(s) to capture race and ethnicity diversity in pigmentation
Reliable and accurate subjective and objective pigmentation assessments
Best anatomical locations to capture pigmentation relevant for pulse oximeter performance
Proposed acceptance criteria for non-disparate performance

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Proposed Pigmentation Assessment

Recruitment

Evaluate Monk Skin Tone (MST) at forehead (10 MST Values)

Maximize participants from diverse racial and ethnic groups
Divide values into 3 MST cohorts (MST 1-4, MST 5-7, MST 8-10)

≥25% in each cohort

Sensor Site Measurement

Measure objective Individual Typology Angle (ITA) at emitter sensor site for non-disparate performance analyses

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Proposed Acceptance Criteria: �Non-disparate Performance

Across ITA and MST, the estimate of the maximum difference in SpO₂ bias* is

< 1.5% for SaO₂ > 85%

< 3.5% for 70% ≤ SaO₂ ≤ 85%

*Where SpO₂ bias is the mean of the difference D (where D = SpO₂- SaO₂)

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Anticipated Impact

Promote innovation of accurate pulse oximeters that perform equitably across entire range of skin pigmentation, accounting for race and ethnicity.

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Next Steps

Incorporate knowledge gained from CERSI real-world studies (anticipated completion in FY24)
Update pulse oximeter guidance
Continue to collaborate, collect and analyze feedback from global stakeholders

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