Community

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
  • 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Plans to Improve Enrollment of Participants From Underrepresented Racial and Ethnic Populations in Clinical Trials; Draft Guidance for Industry (Updated 4.2022)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