Collaborative Community
The Open Oximetry Project was created to improve the safety and accuracy of pulse oximeters in all populations, and we hope to build a community of stakeholders from diverse disciplines, geographies, industries, viewpoints and populations, to prevent duplication of efforts, share knowledge, and accelerate progress.
Announcement
Mark Your Calendar! December 2024The Open Oximetry Skin Color Diversity Subgroup will be hosting a virtual meeting on Tuesday, December 3rd, 2024. We will review and discuss a proposal for new ITA bins to reflect diversity more accurately in the global population. Please contact us here if you would like to be added to the meeting invite.
View detailsAbout
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. This process began in August 2022, and in January 2024 our Collaborative Community has been recognized by the FDA, Center for Devices and Radiological Health (CDRH).
For more information about our Collaborative Community, please review the charter here.
Membership in the Collaborative Community is open to all stakeholders, including individuals and organizations takes minutes to complete this short form to sign up.
You may also view our Individual Members List and our Institutional Members List
A list of organizational members is coming soon.
Membership
Both individuals and organizations are welcome to join, and membership is free. Please review the charter and sign-up via the link below.
Events
Here you can find past Open Oximetry events as well as other initiatives' events that we've been following.
Upcoming Events
- Tuesday, December 3rd, 2024 – Skin Color Diversity Subgroup
- Purpose: To review and discuss a proposal for new ITA bins to reflect diversity more accurately in the global population. Contact us here for the meeting invite!
Prior Collaborative Community Meetings
- October 1, 2024- OpenOx Data Review (Recording | Slides| Agenda & Minutes)
- The purpose to share preliminary results on 21 devices that have completed testing
- June 4, 2024- Stakeholder Consultation on Pulse Oximeters
- Welcome and introduction of the Open Oximetry project, consultation agenda, and meeting participants- Mike Ruffo, PATH
- Landscape of where we are and where we want to go. Introduction of problem statement, summary of the work to date – historical milestones and ongoing pulse oximeter research, including preliminary root cause findings, as available- Dr. Michael Lipnick, UCSF
- Panel discussion: Lessons learned from technical evaluations of tender processes. Practical insights and lessons learned from evaluating pulse oximeter tender processes (UNICEF, ICRC, UNOPS, WHO) -Moderator: Matthew Black, Unitaid
- Performance testing of pulse oximeters and findings and building third party testing capacity in LMICs- Dr. Michael Lipnick, UCSF and John Aleleu, Uganda National Drug Authority
- How updating pulse oximetry regulatory and technical guidelines can help save more lives – a country perspective– TIMCI Project, Kenya
- Panel discussion: Updating global requirements for pulse oximeters. Discussion on upcoming guideline updates/revisions and potential implications on global and national pulse oximeter performance requirements, procurement processes, and access (US FDA, ISO, UK MHRA)
- How will pulse oximeter guideline revisions impact LMICs? Findings from discussions with national government representatives and procurement from India, Kenya, Senegal and Tanzania – Matt Morio, PATH
- Next steps and closing remarks. Discussion and alignment on next steps and key actions. Presentations on the goals and priorities of the Lancet Global Health Oxygen Commission (Freddy Kitutu, Makerere University), Global Oxygen Alliance (Pablo Vega, Unitaid), and the OpenOx Collaborative Community (Fekir Negussie, UCSF)
- October 12, 2023 – Open Oximetry Project Collaborators Forum Meeting (Recording | Agenda & Minutes) – The purpose of this meeting was to provide updates on emerging evidence and upcoming regulatory changes to improve pulse oximetry performance and equity.
- March 14-15, 2023 – Open Oximetry and ISO WG10 Concurrent Meeting (Agenda & Minutes)
- 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 Convener), 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)
- 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)
- December 8, 2022 – Intro to the Community & Priority Setting (Slides | Recording | Agenda & Minutes)
- August 23, 2023 – Clinical Trials Subgroup Meeting 3 (Recording | Agenda & Minutes)
- May 25, 2023 – Clinical Trials Subgroup Meeting 2 (Recording | Slides)
- January 12, 2023- Clinical Trials Subgroup Meeting 1 (Agenda & Minutes)
- July 15, 2024 – Skin Color Diversity Subgroup Meeting 4 (Recording | Agenda & Minutes)
- Skin color scales: Are they a surrogate for colorimetry?, a presentation by Wim Verkruysse and Ellis Monk
- March 13, 2024 – Skin Color Quantification Subgroup Meeting 3 (Recording | Agenda & Minutes)
- MST Printing, a presentation by Wim Verkruysse and colleagues
- Why and How to Bin ITA, a presentation by Leo Shmuylovich and UCSF Hypoxia Lab
- May 8, 2023 – Skin Color Quantification Subgroup Meeting 2 (Recording | Agenda & Minutes)
- February 10, 2023 – Skin Color Quantification Subgroup Meeting 1 (Recording | Agenda & Minutes)
- October 31, 2024- Meeting 4 (Recording | Agenda & Minutes)
- July 8, 2024 – Meeting 3 (Recording | Agenda & Minutes)
- May 7, 2024- Meeting 2 (Recording | Agenda & Minutes)
- March 20, 2024 – Kickoff Meeting (Recording| Agenda & Minutes)
- November 15, 2023 – Open Ox Data Repository Feedback Meeting (Recording | Agenda & Minutes)
Other Meetings (Prior)
- June 11-13, 2024, Improving Access to Tools that Detect Severe Illness
- March 14, 2024 – The Use of Race and Ethnicity in Biomedical Research – Meeting 4 – Virtual meeting of the the Committee on the Use of Race and Ethnicity in Biomedical Research.
- February 2, 2024 – 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 (Agenda | Webcast Link | Executive Summary | More info)
- January 31, 2024 – The Use of Race and Ethnicity in Biomedical Research – Meeting 3 – Virtual meeting of the the Committee on the Use of Race and Ethnicity in Biomedical Research (Agenda | Link to event)
- November 29-30, 2023 – Workshop to Enhance Clinical Study Diversity – The U.S. Food and Drug Administration, in collaboration with the Clinical Trials Transformation Initiative (CTTI), convened a public workshop to solicit input on increasing the enrollment of historically underrepresented populations in clinical studies and encouraged clinical study participation that reflects the prevalence of the disease or condition among demographic subgroups.
- 2022 – 50 years after pulse oximetry was invented – SPIE Journal of Biomedical Optics Webinar Series
Resources
Misc Resources
- PATH Pulse Oximetry Primer (5.2024)
- FDA Pulse Oximetry Safety Communications, Public Hearings and Advisory Committees
- UK Equity in Medical Devices Independent Review Initiative
- Pulse Oximetry Clinical Trials
- 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)
Any questions or comments?
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