Pulse oximeters are a common monitoring tool for sedation dentists. However, their accuracy has come into question when used on patients with dark skin, causing the FDA to issue new guidelines.
By Michael D. Silverman, DMD, FIADFE, FACD, FICD, DICOI
An integral part of clinical practice, pulse oximeters have been considered the "gold standard" for arterial blood gas readings since the 1990s. However, they have been scrutinized for potentially providing inaccurate readings in patients with higher melanin levels. New research has led to significant clinical implications and pressure from a multistate coalition of 25 attorneys general and U.S. senators to encourage the Food and Drug Administration (FDA) to take action.
Although FDA officials initially projected the release of new pulse oximeter guidelines by September 30th last year, the draft guidance was issued on January 6th of this year.
Pulse Oximeter Concerns

In 2021, the FDA issued a safety communication regarding the accuracy of pulse oximeters, particularly among individuals with darker skin pigmentation.
This warning came after several studies showed that these devices tend to overestimate oxygen saturation levels in individuals with darker skin tones. Between 2020 and 2023, six out of seven systematic reviews identified that pulse oximeters often provided less accurate readings for "non-white" individuals.
This inaccuracy can have serious consequences, particularly in medical settings where real-time and accurate oxygenation levels are critical for decision-making. Overestimated oxygen saturation can result in delayed treatment, especially for patients at risk of hypoxia or respiratory distress.
New FDA Standards for Pulse Oximeters
One of the key discussions during the FDA advisory panel was whether prescription and over-the-counter pulse oximeters should adhere to the same regulatory standards. The panel discussed possible updates to clinical trial requirements that pulse oximeters be tested across a diverse range of skin tones, which has historically been overlooked in device development. Much of the existing medical technology, including pulse oximeters, has been validated on ethnically homogenous groups, leading to gaps in the accuracy of these devices on diverse populations.
The FDA just released draft guidance aimed at improving the accuracy and reliability of pulse oximeters titled "Pulse Oximeters for Medical Purposes: Non-Clinical and Clinical Performance Testing, Labeling, and Premarket Submission Recommendations."
This document highlights concerns over device performance, particularly among individuals with darker skin tones. The new recommendations emphasize the need for rigorous testing across diverse populations to address discrepancies and ensure accurate readings under various conditions.
Once finalized, this guidance will replace the 2013 standards, incorporating advances in technology and updated testing expectations. Manufacturers are urged to assess how factors like skin pigmentation, motion, and ambient light affect accuracy and to clearly disclose any limitations in product labeling. Public comments on the draft are open until March 7, 2025.
According to 2020 Census data, the U.S. is more multiracial and ethnically diverse than ever, making the issue of biased medical devices increasingly critical. Healthcare should reflect the diverse population it serves, including improving and developing technology that performs consistently. By modernizing these standards, the FDA encourages the development of safer, more effective devices that meet the needs of all patients.
Sedation Monitoring for Dark Skin Patients
The discussion about pulse oximeter accuracy also raises broader questions about how clinicians approach monitoring for hypoxia or sedation in patients with darker skin tones. Cyanosis, a bluish skin discoloration caused by a lack of oxygen, is a common clinical sign of hypoxia. However, cyanosis can be difficult to detect in patients with darker skin, as pigmented oral mucosa or nails may not reliably show early signs of oxygen deprivation. In such cases, reliance on pulse oximetry becomes even more critical, making any inaccuracies all the more dangerous.
The challenge lies in current standard clinical practices, as they do not always take into account the variability in skin pigmentation, which can delay the recognition of hypoxia and lead to worse outcomes for darker-skinned patients.
"For sedation monitoring, clinicians may need to employ additional strategies beyond pulse oximetry, such as more frequent arterial blood gas measurements or capnography (emphasis added), which monitors carbon dioxide levels and can provide indirect clues to oxygenation status."
Remember that pulse oximeter readings are only an "estimate" of blood oxygen saturation. It's best to treat the patient based on readings over time and consider the limitations of the device you are using when making a diagnosis or treatment decision.
Factors that can affect the accuracy of pulse oximeter readings include:
- Skin pigmentation
- Skin thickness
- Skin temperature
- Smoking
- Fingernail polish
- Poor circulation
- Using a finger clip vs. adhesive sensor
Improving Accuracy
Research is currently underway to address disparities in pulse oximeter performance. Duke University has completed clinical verification trials for a newly designed pulse oximeter called NiCO™, which utilizes advanced laser technology to provide direct readings instead of estimates.
Additionally, the Open Oximetry Project, led by the UCSF Hypoxia Lab at UC San Francisco’s Center for Health Equity in Surgery and Anesthesia, is collaborating with various initiatives and donors to develop reliable and accurate pulse oximeters suitable for all skin tones.
These efforts are also expected to prompt changes in manufacturing standards, ensuring that pulse oximeters are tested and validated across all skin pigments before regulatory agencies like the FDA grant approval.
Safe Sedation: Stay Vigilant
For the quality of healthcare in the United States to advance, it must evolve to meet the needs of an increasingly diverse population. Collaborative and innovative efforts to address the inaccuracy of pulse oximeters in individuals with higher melanin levels are moving the needle in the right direction. However, achieving equitable care across all patient populations is an ongoing commitment.
As sedation dentists, we must remain vigilant in our monitoring protocol and procedures. It's imperative to keep your dental team prepared to address the issue of inaccurate pulse oximeters, especially when monitoring patients with darker skin tones. By using additional monitoring strategies and approaching pulse oximeter readings with scrutiny, you can ensure that all patients, regardless of skin color, receive the highest standard of care.
Author: In addition to four decades of experience as a general dentist, Dr. Michael D. Silverman is a globally recognized lecturer, education, and patients’ rights advocate. His extensive dental background and entrepreneurial spirit led to the development of DOCS Education and RAMP – Results-Driven Advertising & Marketing Professionals. As the President of DOCS and RAMP, Dr. Silverman has taught over 30,000 dental professionals how to implement sedation and how to acquire new patients.
In November 2015, Dr. Silverman was inducted as a Fellow of the International College of Dentistry and, in 2020, as a Fellow of the American College of Dentistry in recognition of his exemplary professional accomplishments and devotion to improving the practice of dentistry.