About Open Oximetry
Many patients around the world do not have access to safe pulse oximeters.
There are many reasons for this such as high purchase costs and supply chain limitations. However, there are additional less obvious barriers to safe oximetry which include inadequate device testing standards, limited public access to device testing data, and fraudulent or misleading claims by some manufacturers. There are also additional challenges inherent to the design of many oximeters, such as the impact of dark skin pigmentation, low perfusion and severe anemia on performance, which have been incompletely characterized in the public domain and are not adequately accounted for in current regulatory standards.
Founded at UCSF’s Center for Health Equity in Surgery and Anesthesia (CHESA) and the UCSF Hypoxia Lab, the Open Oximetry project was created to improve the safety and precision of pulse oximeters in all populations as these devices have been found to be less accurate in people with darker skin tone. The Open Oximetry Project has organically grown into a hub for bringing together oximetry experts, engineers, academic researchers, clinicians, community members, manufacturers, and regulatory bodies from all geographies and backgrounds. We hope to continue to invite and hold space for diverse voices to work in partnership to tackle these issues.
This open community of collaborators are not only trying to understand the challenges with pulse oximeters but also identify solutions and work with regulatory bodies to set standards that can improve equity in access to reliable pulse oximeters globally. Though we may not have definitive answers yet as to why this problem is occurring and how to fix it, we have made progress in forming a large community of people interested in solving this problem, and we are committed to learning and finding ways to improve the project and its impact.
It is our hope that by building this Collaborators’ Community of stakeholders from diverse disciplines, geographies, industries, viewpoints, and populations, we may prevent duplication of efforts, share knowledge, and accelerate progress. We have also made our research protocols and resources publicly available, and plan to create an open-source data repository to share data from our studies in healthy human and in critical care settings. In our collaboration with global regulatory bodies and aid agencies, we are striving to help improve standards on procurement and device validation that bridge the disparities between high income and low- and middle-income countries for equitable access to reliable pulse oximeters.
We are dedicated to ensuring the outcome of our work will benefit communities who are disproportionally disadvantaged by challenges in pulse oximeters and while we are on this journey, we would love to hear from you if you have any questions or ideas that can help us address this problem in a meaningful and equitable way.
- Lab Testing on Humans to determine which existing oximeters work and which don’t and to develop new protocols that better validate device performance
- Performance Data Dissemination via OpenOximetry.org to help those buying and using oximeters to know which devices are safe
- Real World Human Studies to characterize how and why some oximeters perform well in a lab setting but not in some patients in the clinical setting (The FDA funded EquiOx Study begins enrollment July 25, 2022 – more information coming soon on our Study Protocols page)
- Bring together a consortium of stakeholders from diverse institutions, disciplines and settings to share ideas and data to help improve oximetry performance and equity
- Develop new laboratory based techniques (both in vivo and in vitro) to better predict oximeter performance in clinical settings across the spectrum of patient factors including skin pigment and low perfusion; this includes improved, standardized techniques for skin pigment quantification and novel mechanisms for raw oximeter signal analysis
- Analyze large, diverse datasets to provide insights that will help develop accurate, low-cost oximeters that perform safely in all patients; this will start the the Hypoxia Labs historical dataset of 1000s of patients
- Raise the bar for performance standards for oximeter certification that adequately account for the effects of skin pigment, perfusion and other factors known or hypothesized to impact performance (Okunlola et al, Respiratory Care Journal, November 2021)
- Provide pragmatic performance reviews for oximeters on the market, including not only validations of accuracy but also assessments of important implementation factors such as lifetime costs
- Create an open access online data repository for oximeter raw performance data that can be used by researchers and industry to inform better product development; the database will contain lab and clinical trial data from multiple groups collaborating on the Open Oximetry Project and will be available to anyone
If you or your organization is interested in collaborating with the Open Oximetry Project, please email us.
- The Gordon and Betty Moore Foundation and Robert Wood Johnson Foundation have provided catalytic funding to support our lab-based research.
- The Patrick J. McGovern Foundation has provided catalytic funding to support creation of our open access data repository.
- The US FDA has provided funding via the UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (CERSI) to support our prospective clinical studies
- The USAID-STAR Sustaining Technical and Analytic Resources (STAR) Project supported creation of the OpenOximetry.org beta website as part of the COVID19 Global Goods Project
- The UCSF Hypoxia Lab funded testing for the initial oximeters loaded into the database
Michael Lipnick, MD
UCSF OpenOximetry Project PI, Center for Health Equity in Surgery and Anesthesia
Michael Lipnick is an Associate Professor in the Department of Anesthesia at UCSF and based clinically at San Francisco General Hospital. He is an investigator in the UCSF Hypoxia Lab and co-Director of the UCSF Center for Health Equity in Surgery and Anesthesia. His research interests include health disparities, ARDS and hypoxia tolerance. His recent funding has supported investigations of performance of inexpensive pulse oximeters as well development of novel in vitro oximeter performance validation devices.
Kelvin Moore Jr.
UCSF School of Medicine
Kelvin Moore Jr. is a UCSF Medical Student and Research Assistant in the Hypoxia Lab. With career interests in anesthesiology and an overarching passion for implementing health equity, he believes that working on OpenOximetry is an excellent opportunity to propel his interests as well as contribute to a canon of work that highlights and addresses the disparate medical conditions seen domestically and globally. Prior to his appointment with the Hypoxia Lab, he served as a Clinical Research Coordinator at the Zuckerberg San Francisco General Hospital and the San Francisco AIDS Foundation. He holds two Bachelor of Arts in Public Health and Biology from Brown University.
Phil Bickler, MD, PhD
UCSF Hypoxia Lab PI
Phil Bickler is Professor of Anesthesia at UCSF and Director of the UCSF Hypoxia Lab. Dr. Bickler joined Dr. Severinghaus as a research fellow in 1986 and has directed the laboratory since Dr. Severinghaus’ retirement in the early 1990’s. In addition to the Hypoxia Lab, Dr. Bickler directs a basic science laboratory that is involved in studying how neurons adapt to oxygen deprivation. He also oversees high altitude protocols, clinical projects investigating regional and cerebral oximetry during neurosurgery, and a pilot study examining the effects of acute hypoxia and pre-conditioning on cognition. He has published over 80 peer reviewed studies.
Mr. Batchelder attended the University Of Chicago Pritzker School Of Medicine Respiratory Therapy Program and is currently Chief Clinical Officer of Clinimark. From 1991 to 2005 he was the Head of Clinical Research for Datex-Ohmeda and GE Healthcare, where he established and directed the Louisville laboratories and managed medical affairs.
He is a member of the University of Colorado Medical School, Division of Pulmonary Sciences and Critical Care Medicine Research Board. He is also a member of the ASTM Pulse Oximetry Working Group where he functioned as Designated United States Expert and representative to the International Standards Organization. He was actively involved in the development of the current International Standard for Pulse Oximetry (9919).
Carolyn Hendrickson, MD
UCSF EquiOx Study Site PI
Dr. Hendrickson is a pulmonary and critical care medicine subspecialist with an expertise and research focus in acute lung injury and acute respiratory distress syndrome (ARDS), the most common life-threatening manifestation of COVID-19 disease. She is the medical director of the Medical Intensive Care Unit at Zuckerberg San Francisco General Hospital. During the first two years of the pandemic, this safety-net hospital for our county cared for approximately half of all ICU patients with COVID-19 disease in San Francisco and Dr. Hendrickson served as the physician lead to establish and run the COVID ICU. She is currently the site PI for the Open Oximetry EquiOx Study for the FDA.
Physio Monitor LLC
Mike Bernstein is an engineer with extensive experience in pulse oximeter device development and validation. For nearly 40 years he has worked for leading oximeter manufacturers to develop and improve pulse oximeter technologies. He is the collaborating lead engineer for the UCSF Hypoxia Lab and has also served as a collaborator and advisor for Lifebox.
John Feiner, MD
UCSF Hypoxia Lab
John Feiner if Professor of Anesthesiology at UCSF and a co-investigator in the UCSF Hypoxia Lab. Dr. Feiner joined Dr. Severinghaus in the Hypoxia Lab in 1992 and has been participating in the study of pulse oximeters since that time. He is responsible for data acquisition, programming, and data analysis. He provides expertise in mathematical modeling, data acquisition programming, human studies, and respiratory physiology.
Bunmi Okunlola, MD
UCSF Center for Health Equity in Surgery and Anesthesia
Bunmi Okunlola is a Clinical Instructor of Anesthesia at NYU and member of the UCSF Hypoxia Lab research team. After completing her medical training and anesthesia residency at Mount Sinai in New York, Bunmi joined the CHESA team in 2020 as a Global Health Equity Fellow. During her Fellowship year she was based at Zuckerberg San Francisco General Hospital, and her projects included development of a Health Equity Curriculum for residents in multiple perioperative departments. Bunmi also led a research project focusing on equity in pulse oximetry.
UCSF School of Medicine
Isabella is a senior medical student at the University of California San Francisco with interests in anesthesia and global health equity. Isabella has been a key contributor to building the oximetry database and FAQs. She is also a research associate in the Hypoxia Lab where she has been actively studying the performance of inexpensive oximeters.
Christine Kuo, MD
UCSD Anesthesia Fellow
Christine Kuo is an anesthesia resident at the UCSF Anesthesia Residency Program. Dr. Kuo is interested in the intersection between technology and health equity and has been an active collaborator in the Hypoxia Lab and the UCSF Center for Health Equity in Surgery and Anesthesia. Dr. Kuo is currently developing protocols for in vitro oximeter validation and new protocols for in vivo skin pigment quantification for oximeter performance studies.
Caroline Hughes, BS
Hypoxia Lab CRC
Deleree Schornack, BS
Hypoxia Lab CRC
Odi Ehie, MD
UCSF Anesthesia, Vice Chair Diversity, Equity and Inclusion
I am a pediatric anesthesiologist whose interests include Diversity, Equity and Inclusion, Global Health, as well as Education. As a UCSF Teachers Scholar in 2020, I started a diversity curriculum for anesthesia and surgery residents, and I have held a teaching position as a UCSF Bridges coach from 2017 to 2021 for the School of Medicine thus providing a foundation in the Differences Matter Initiative. I joined the UC Berkeley / UCSF Joint Medical Program in 2021 as the Head of Clinical Skills Curriculum.
After graduating from the University of Wisconsin-Madison School of Medicine and Public Health, I completed my anesthesia residency program at New York University Langone Medical Center. I later completed my pediatric anesthesia fellowship at Stanford Lucile Packard Children’s Hospital where I focused on Global Health Education in Vietnam. Not only do I currently serve as the site co-director in Vietnam for the Health Volunteer Overseas / Society of Education in Anesthesia (SEA-HVO) Travel Fellowship, but I also serve as Designee Chair of the SEA Global Health Outreach Committee. I am currently the Chair for the California Society of Anesthesiologists Committee of Justice, Equity, Diversity, and Inclusion, and I am the Vice Chair of the Diversity, Equity, and Inclusion within the Department of Anesthesia and Perioperative Care.
Ellis Monk, PhD
Associate Professor of Sociology, Harvard, Visiting Faculty Researcher at Google
His research interests include: race/ethnicity in comparative perspective, colorism, health, race/ethnicity & technology (e.g., artificial intelligence, machine learning, and computer vision), sociology of the body, social psychology, and theory. He is a recent recipient of an NIH Director's New Innovator Award, which will support research on race, skin tone, and pulse oximetry.
Leo Shmuylovich, MD, PhD
Assistant Professor of Medicine, Radiology, Physics and Biomedical Engineering, Washington University of Saint Louis
Leo Shmuylovich is an Assistant Professor of Medicine, Radiology, Physics, and Biomedical Engineering in the Division of Dermatology at Washington University of Saint Louis. His research interests include developing low-cost optical imaging devices that are globally accessible, developing methods to quantify skin mechanical and optical properties, and interrogating disease with thermal and short wave infrared imaging. He was a 2021 recipient of the NIH Director's Early Independence Award, which supports his work to develop novel infrared imaging modalities that objectively assess skin disease at both large and small scales and across diverse skin types
Fekir Negussie, MPH
Fekir Negussie oversees the implementation of multiple programs at the UCSF Center for Health Equity in Surgery and Anesthesia, including the Open Oximetry Project. Fekir is a Global Health professional with experience supporting programs in the U.S and overseas. Her background includes quantitative and qualitative research, project management and capacity building.
Bob Kopotic, RN, RRT, MSN
IEC/ISO co-Convenor for Oximeter Device Standards, Joint Working Groups 5 & 10
Bob is a dual licensed clinician, Registered Nurse and Respiratory Therapist, with advanced degrees in bioengineering, clinical care and physiology from UC San Diego and the Emory University. I am a currently employed by Edwards Lifesciences as a Director of Clinical Affairs for R&D Critical Care team. While Edwards does not manufacture a pulse oximeter, my prior industry employers included 4 pulse oximeter manufacturers. Regarding ISO, I am the Co-convener for the ISO standards related to Oximetry devices (with responsibility for three 80601-2 oximeter standards) and remain busy advising AAMI, IEC and ISO on blood pressure, critical care and ventilatory support devices as well as issues of cybersecurity. Owing to recognition for improving clinical care and medical devices, I was inducted into the Sigma Theta Tau International Honor Society of Nursing (ΣΘΤ) and the AARC inducted him as a fellow (FAARC), as did the Association for the Advancement of Medical Instrumentation (AAMIF).