Collaborator Forum

Relevant Upcoming Events

• 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.
• FDA Public Advisory Committee Meetings on Pulse Oximeters – Virtual meeting of the CDRH Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee on February 2, 2024, from 9 a.m. to 6:30 p.m. Eastern Time (more info)

Collaborator Meetings

• Open Ox Data Repository Feedback Meeting, November 15, 2023 (Recording | Agenda & Minutes)
• Open Oximetry Project Collaborators Forum Meeting, October 12, 2023  (Recording | Agenda & Minutes) – The purpose of this meeting is to provide updates on emerging evidence and upcoming regulatory changes to improve pulse oximetry performance and equity.

• 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)

•  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

• New Paper from FDA Approach for improving the performance evaluation of pulse oximeter devices taking into considerationskin pigmentation, race and ethnicity
  • This draft is open for public comments by January 16, 2024
• 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

Visit our OpenOximetry Protocols Page

Regulatory Documents

• CDRH Takes Steps to Advance Further Discussions on Pulse Oximeters (11.2023)
• Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Health Care (Updated 10.2022)
• Diversity Plans to Improve Enrollment of Participants From Underrepresented Racial and Ethnic Populations in Clinical Trials; Draft Guidance for Industry (Updated 4.2022)
• Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry (Updated 11.2020)
• 2019 FDA General Wellness Guidance: Policy for Low Risk Devices (9.2019)
• Collection of Race and Ethnicity Data in Clinical Trials (Updated 9.2018)
• 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)
• ISO 80601-2-61:2017 Medical electrical equipment — Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
• 2013 FDA – Pulse Oximeters – Premarket notification submissions (510k): guidance for industry and FDA Administration Staff (3.2013)

Relevant Publications

Visit our Publications & Literature Review Page

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

Membership

How to Join (Coming Soon)

Organizations (Coming Soon)

List of Members

Job Opportunities

• UCSF – 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.
• FAS – Health Regulatory Specialist – The Federation of American Scientists (FAS) is seeking to hire a Health Regulatory Specialist to support dynamic and growing health equity portfolio. FAS works hand in hand with policymakers from across the federal government to develop and support policies and programs aimed at rapidly accelerating equitable medical products broadly accessible to patients across the United States. FAS has worked as a convener of ideas and stakeholders across the medical innovation pipeline to improve health equity from basic research to translational science to regulatory policy to post-market evaluation.