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 )

•  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)

Open for Community Feedback

• 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
  • List of devices independently being reviewed for testing
• Skin color quantification for pulse oximeter human study protocol
• Real world clinical study of pulse oximeter performance in critically-ill adults and pediatric patients
  • RedCap Data Dictionary
  • Full list of data variables with definitions
• 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

• Link to compilation of pulse oximeter performance publications

• Race, ethnicity, skin color and medical research
  • Race, ancestry, and medical Research
  • Historical aspects of race and medicine: the case of J. Marion Sims
  • Race, ancestry, and reporting in medical journals
  • Examining how race, ethnicity, and ancestry data are used in biomedical 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

Job opportunities

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.

Clinical Research Coordinator

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 Clinical Research Coordinator. We are undertaking prospective studies in the hospital and research laboratory settings to characterize the potential impact of skin pigment on accuracy or pulse oximetry.  The Clinical Research Coordinator will carry out the needed tasks as part of ongoing and future clinical and translational research projects to better understand bias in pulse oximetry in vulnerable populations in the San Francisco Bay Area. For more information on the position and to apply, visit the UCSF job portal.

Postdoctoral Researcher 

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 motivated postdoctoral researcher to work on a funded project at the UCSF Hypoxia Lab (hypoxialab.org) related to improving pulse oximeter performance in certain clinical scenarios including dark skin pigment and low perfusion states. Our lab has done seminal work to help identify limitations in current oximetry technology, and we are now embarking to solve these challenges. The Postdoctoral researcher will work closely with our multidisciplinary team to develop new validation protocols for use on human study subject testing, develop new in vitro testing devices to validate existing and new technologies, and collect data on performance of new and emerging clinical devices as part of the OpenOximetry.org project. This is a 1 year postdoctoral program, with possibility of extension for an additional year. To apply, please send a CV, cover letter, one manuscript (published or unpublishsed), and the contact information for 2 references to fekir.negussie AT ucsf.edu