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.
Meetings
Upcoming Meetings
- Meeting 2 – Open Oximetry and ISO WG10 concurrent meeting (Agenda)
- When: March 14-15, 2023, from 0900-1700 PST
- Where: San Francisco, CA, USA and Zoom
- Registration: To attend virtually via Zoom: Register here | To attend in person in San Francisco, send us an e-mail (fekir.negussie AT ucsf.edu). Space to join the in-person meeting is limited.
Past Meetings
- Meeting 1 – Intro to the Community & Priority Setting (Virtual, Zoom), December 8, 2022 (Slides | Recording | Agenda & Minutes)
- Sub Group Meeting – Clinical Trials (Virtual, Zoom), January 12, 2023 (Agenda & Minutes)
- Sub Group Meeting – Skin Color Quantification (Virtual, Zoom), February 10, 2023 (Recording | Agenda & Minutes)
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
- 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Plans to Improve Enrollment of Participants From Underrepresented Racial and Ethnic Populations in Clinical Trials; Draft Guidance for Industry (Updated 4.2022)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
- Race, ethnicity, skin color and medical research
Relevant studies and initiatives
Community Members
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