This Friday, the U.S. Food and Drug Administration (FDA) will hold a committee panel hearing to discuss future research into a potential link between errors in pulse oximeter performance and patients’ skin pigmentation, race and ethnicity. Pulse oximeters are essential tools used during anesthesia and surgery to monitor a patient’s blood oxygen saturation levels, but they have been reported to give inaccurate readings in people with darker skin tones. Accurate readings are fundamental to minimizing complications during and after surgery.
The American Society of Anesthesiologists (ASA) has provided recommendations to the FDA with critical insights in response to the agency’s discussion paper on the topic, acknowledging previous studies that link pulse oximeter performance errors to darker skin tones and supporting the need for further research. In response to the FDA’s request for other considerations that may contribute to pulse oximeter errors in darker skin tones and impact clinical outcomes, ASA provided several factors that should be further examined, including incorrect use of the device during surgery and patient conditions such as blood-related diseases and heart problems. ASA’s full comments can be found in this comment letter.
Jeffrey Feldman, M.D., a member of ASA’s Committee on Equipment & Facilities, will attend and participate in the hearing as a temporary member of the panel and is available to discuss the issue, including:
- How the FDA’s decisions will impact patient care,
- ASA's key recommendations for enhancing the accuracy and reliability of pulse oximeters,
- How skin pigmentation may influence pulse oximeter readings and the imposed risks for patients of color, and
- The importance of avoiding actions that might undermine confidence in current technology.
The hearing will be live-streamed from 9:30 a.m. to 6 p.m. EST on Friday, Feb. 2, here.
RSS