Community
The Open Oximetry Project was created to improve the safety and accuracy of pulse oximeters in all populations. We recognize that many teams and sectors around the world are working on these issues and hope to build a Collaborators' Community of stakeholders from diverse disciplines, geographies, industries, viewpoints and populations, to prevent duplication of efforts, share knowledge, and accelerate progress.
Relevant Upcoming Events
Patient Engagement Advisory Committee Meeting, September 6, 2023
Advisory committees provide independent expert advice to the FDA on broad scientific topics or on certain products to help the agency make sound decisions based on the available science. Advisory committees make non-binding recommendations to the FDA, which generally follows the recommendations but is not legally bound to do so. Please see, “Advisory Committees Give FDA Critical Advice and the Public a Voice,” for more information.
2-Day Virtual Public Workshop to Enhance Clinical Study Diversity, November 29 and 30, 2023 from 10 am- 2 pm ET
The U.S. Food and Drug Administration, in collaboration with the Clinical Trials Transformation Initiative (CTTI), is convening a public workshop to solicit input on increasing the enrollment of historically underrepresented populations in clinical studies and encouraging clinical study participation that reflects the prevalence of the disease or condition among demographic subgroups. Additional information about the public workshop along with registration details will follow in advance of the workshop. Subscribe here for further updates.
Collaborators’ Community Meetings
- Intro to the Community & Priority Setting, December 8, 2022 (Slides | Recording | Agenda & Minutes)
- Sub Group Meetings
- Clinical Trials, January 12, 2023 (Agenda & Minutes)
- Skin Color Quantification, February 10, 2023 (Recording | Agenda & Minutes)
- Skin Color Quantification, May 8, 2023 (Recording | Agenda & Minutes)
- Clinical Trials, May 25, 2023 (Recording | Slides )
- Clinical Trials, August 23, 2023 (Recording | Agenda & Minutes)
- Sub Group Meetings
- Open Oximetry and ISO WG10 concurrent meeting, March 14-15, 2023 (Agenda & Minutes)
- Day 1:
- Welcome, Overview, and Goals for the Pulse Oximetry Forum – Dr. Mike Lipnick (UCSF), Dr. Odi Ehie (UCSF), Dr. James Lee (FDA), Bob Kopotic (IEC/ISO co-Convenor), Dr. Sandy Weininger (FDA)
- Real World Challenges in Pulse Oximetry – Dr. Elizabeth Igaga (Makerere University), Dr. Michael Sjoding (University of Michigan), Dr. Carolyn Hendrickson (UCSF), Dr. Desiree Conrad (Standford University), Dr. Louise Mulroy (Medicines and Healthcare Products Regulatory Agency)
- Confounding Factors in Pulse Oximeter Performance and Discussion- Dr. Philip Bickler (UCSF), Mike Bernstein (Physiomonitor), Dr. Ellis Monk (Harvard University), Dr. Mark Ansermino (University of British Columbia)
- Strengths and Shortcomings of Controlled Desaturation Studies– Bob Kopotic (IEC/ISO co-Convenor), Paul Batchelder (Clinimark physiology laboratories), Dr. John Feiner (UCSF), Dr. Bunmi Okunlola (NYU), David Macleod
- Statistical Analyses and Sample Size for Controlled Desaturation Study Design– Dr. John Feiner (UCSF), Dr. Gene Pennello (FDA), David Milkes (Medtronic and ISO)
- Open Forum- Dr. Zach Vesoulisch (Washington University), Dr. François Lellouche (Laval University)
- Day 2:
- Optimized Skin Color Quantification Techniques and Discussion– Dr. Jenna Lester (UCSF), Dr. Ellis Monk (Harvard University), Dr. Leo Shmuylovich (Washington University), Dr. Sandhya Vasudevan (FDA), Dr. Wim Verkruijsse (Philips Research), Dr. Adia Benton (Northwestern University) and Dr. Amy Moran-Thomas (MIT)
- How to Account for Challenging Clinical Scenarios and Potential Roles for Phantom in vitro Testing– Dr. Sandy Weininger (FDA), Mike Bernstein (Physiomonitor), Dr. Chetan Patel (Temple University), Dr. Josh Pfeffer (FDA), Dr. Geoff Mathews and Dr. Veronica Hickson (The Electrode Company)
- Open Forum– Gauri Singh (Lifebox)
- Opportunities to Utilize Standards for Improving Communication of Device Performance and Day 2 Review– Dr. Mike Lipnick (UCSF)
- Day 1:
Open for Community Feedback
- Open Oximetry Data Sharing Agreement (use comment feature or email us)
- UNICEF Target Product Profile/Tender (use Feedback Form)
- Real world clinical study of pulse oximeter performance in critically-ill adults and pediatric patients
- RedCap Data Dictionary (Updated 10.2022)
- Full list of data variables with definitions (Updated 10.2022)
Resources
Protocols
- Laboratory-based, controlled hypoxemia pulse oximeter human study protocol
- Skin color quantification for pulse oximeter human study protocol
- Real world clinical study of pulse oximeter performance in critically-ill adults and pediatric patients
- Lab based in vitro studies (coming soon)
- How to capture raw PPG signal
Regulatory Documents
- 2013 FDA – Pulse Oximeters – Premarket notification submissions (510k): guidance for industry and FDA Administration Staff (March 2013)
- ISO 80601-2-61:2017 Medical electrical equipment — Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
- Diversity Plans to Improve Enrollment of Participants From Underrepresented Racial and Ethnic Populations in Clinical Trials; Draft Guidance for Industry (Updated 4.2022)
- Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Health Care (Updated 10.2022)
- Collection of Race and Ethnicity Data in Clinical Trials (Updated 9.2018)
- Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry (Updated 11.2020)
- Evaluation of Sex-Specific Data in Medical Device Clinical Studies – Guidance for Industry and Food and Drug Administration Staff (Updated 2.2018)
- Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device Clinical Studies (Updated 2.2018)
Relevant Publications
- Expanded Retrospective: Pulse Oximeter
- Link to compilation of pulse oximeter performance publications
- Race, ethnicity, skin color and medical research
Relevant studies and initiatives
- FDA Pulse Oximetry Safety Communications, public hearings and advisory committees
- UK Equity in medical devices independent review initiative
- Clinical Trials
- JBO Hot Topics Webinar
Job opportunities
Administrative Assistant for Center for Health Equity in Surgery and Anesthesia– Work Study Student
We are seeking a work study student for an administrative assistant position for a maximum of 20hr/week at Mission Hall to support The Open Oximetry and other closely related projects. The student will work in collaboration with key faculty and staff members in CHESA.
Health Disparities Data Analyst
The UCSF Department of Anesthesia, Hypoxia Lab (hypoxialab.org) and the Center for Health Equity in Surgery and Anesthesia (chesa.ucsf.edu) are seeking a full-time Data Analyst for a period of 12 months. The Data Analyst will support several studies in the hospital and human research laboratory to characterize the potential impact of skin pigment on accuracy of pulse oximetry and other medical diagnostic and health care wearables that may be affected. We are collecting vast amounts of diagnostics data, some using novel data collection methods. As part of the project we will be setting up robust data collection systems in the lab and the hospital settings as well as creating and managing an open access data repository for diagnostics device data. For more information on the position and to apply, visit the UCSF job portal.
Community Members
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