The UCSF Hypoxia Laboratory and UCSF Center for Health Equity in Surgery and Anesthesia (CHESA) are formally launching the Open Oximetry Project, a multi-year initiative to improve access to safe pulse oximeters worldwide, by sharing data and creating new standards and technologies for oximeter validation that better account for skin color.
This initiative will address domestic and international concerns over the accuracy of pulse oximeters, especially in patients with dark skin pigment. The project will characterize the magnitude and root cause of oximeter inaccuracy in dark skin pigment, augment performance standards to eliminate performance disparities, and disseminate performance data to promote manufacturer accountability, regulatory adherence, and consumer awareness.
The initiative includes laboratory-based research as well as a prospective, real-world study designed to quantify and understand errors in pulse oximetry in hospitalized patients in relation to their skin pigmentation. The initiative is driven by recent retrospective studies showing missed diagnosis of hypoxemia in patients with darker skin pigmentation and subsequent health and health care disparities.
“It is long overdue to see growing interest in this neglected topic,” said Michael Lipnick, MD, UCSF associate professor of clinical anesthesia. “We are excited to leverage some of the relatively unique resources we have here at UCSF at the intersection of health equity, pulse oximetry research and clinical studies, and share these not only with researchers and developers to accelerate their work, but also find ways to effectively share data with the public.”
The project is being launched with catalytic funding from the Gordon and Betty Moore Foundation, Patrick J. McGovern Foundation, Robert Wood Johnson Foundation, and funding support for the clinical trial component by the US Food and Drug Administration through the UCSF-Stanford Center of Excellence in Regulatory Sciences and Innovation (CERSI).
Led by the UCSF Hypoxia Lab and CHESA, the Open Oximetry Project is building a consortium of collaborators from multiple disciplines and geographies, who are dedicated to the sharing of ideas, resources and accelerating progress in this area.
Members of the Open Oximetry team introduced the project during the FDA's Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee virtual meeting on November 1.
The UCSF Hypoxia Lab is an independent, nonprofit research lab and testing facility based within the university. It was founded by John W. Severinghaus, MD, in 1958 and has been a leading center for the study of pulse oximetry and the effects of hypoxemia on humans for decades. The Hypoxia Lab is a global leader in oximeter testing for product development and clinical certification for leading manufacturers.
CHESA is one of six centers within the UCSF Institute for Global Health Sciences. Founded in 2020, CHESA is working toward increasing access to safe surgery and perioperative care worldwide.
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