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UrduThis 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 and Patrick J. McGovern 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 will be introducing 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.
About UCSF Health: UCSF Health is recognized worldwide for its innovative patient care, reflecting the latest medical knowledge, advanced technologies and pioneering research. It includes the flagship UCSF Medical Center, which is ranked among the top 10 hospitals nationwide, as well as UCSF Benioff Children’s Hospitals, with campuses in San Francisco and Oakland, Langley Porter Psychiatric Hospital and Clinics, UCSF Benioff Children’s Physicians and the UCSF Faculty Practice. These hospitals serve as the academic medical center of the University of California, San Francisco, which is world-renowned for its graduate-level health sciences education and biomedical research. UCSF Health has affiliations with hospitals and health organizations throughout the Bay Area. Visit https://ucsfhealth.org. Follow UCSF Health on Facebook or on Twitter.
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