Collaborative Community

<!DOCTYPE html> <html lang="en-US" > <head> <meta charset="UTF-8"> <meta name="viewport" content="width=device-width, initial-scale=1.0, viewport-fit=cover"> <meta name="author" content="openoximetry.org/"> <link rel="apple-touch-icon" sizes="57x57" href="https://openoximetry.org/wp-content/themes/oximetry/assets/favicons/apple-icon-57x57.png"> <link rel="apple-touch-icon" sizes="60x60" href="https://openoximetry.org/wp-content/themes/oximetry/assets/favicons/apple-icon-60x60.png"> <link rel="apple-touch-icon" sizes="72x72" href="https://openoximetry.org/wp-content/themes/oximetry/assets/favicons/apple-icon-72x72.png"> <link rel="apple-touch-icon" sizes="76x76" href="https://openoximetry.org/wp-content/themes/oximetry/assets/favicons/apple-icon-76x76.png"> <link rel="apple-touch-icon" sizes="114x114" href="https://openoximetry.org/wp-content/themes/oximetry/assets/favicons/apple-icon-114x114.png"> <link rel="apple-touch-icon" sizes="120x120" href="https://openoximetry.org/wp-content/themes/oximetry/assets/favicons/apple-icon-120x120.png"> <link rel="apple-touch-icon" sizes="144x144" href="https://openoximetry.org/wp-content/themes/oximetry/assets/favicons/apple-icon-144x144.png"> <link rel="apple-touch-icon" sizes="152x152" href="https://openoximetry.org/wp-content/themes/oximetry/assets/favicons/apple-icon-152x152.png"> <link rel="apple-touch-icon" sizes="180x180" href="https://openoximetry.org/wp-content/themes/oximetry/assets/favicons/apple-icon-180x180.png"> <link rel="icon" type="image/png" sizes="192x192" href="https://openoximetry.org/wp-content/themes/oximetry/assets/favicons/android-icon-192x192.png"> <link rel="icon" type="image/png" sizes="32x32" href="https://openoximetry.org/wp-content/themes/oximetry/assets/favicons/favicon-32x32.png"> <link rel="icon" type="image/png" sizes="96x96" href="https://openoximetry.org/wp-content/themes/oximetry/assets/favicons/favicon-96x96.png"> <link rel="icon" type="image/png" sizes="16x16" href="https://openoximetry.org/wp-content/themes/oximetry/assets/favicons/favicon-16x16.png"> <link rel="manifest" href="https://openoximetry.org/wp-content/themes/oximetry/assets/favicons/manifest.json"> <meta name="msapplication-TileColor" content="#afca26"> <meta name="msapplication-TileImage" content="https://openoximetry.org/wp-content/themes/oximetry/assets/favicons/ms-icon-144x144.png"> <meta name="theme-color" content="#000000"> <link rel="stylesheet" href="https://openoximetry.org/wp-content/themes/oximetry/build/ElasticPage.css?f0cff159"> <meta name='robots' content='index, follow, max-image-preview:large, max-snippet:-1, max-video-preview:-1' /> <style>img:is([sizes="auto" i], [sizes^="auto," i]) { contain-intrinsic-size: 3000px 1500px }</style> <title>Collaborative Community - OpenOximetry</title> <link rel="canonical" href="https://openoximetry.org/community/" /> <meta property="og:locale" content="en_US" /> <meta property="og:type" content="article" /> <meta property="og:title" content="Collaborative Community - OpenOximetry" /> <meta property="og:url" content="https://openoximetry.org/community/" /> <meta property="og:site_name" content="OpenOximetry" /> <meta property="article:modified_time" content="2025-02-21T03:31:50+00:00" /> <meta property="og:image" content="https://openoximetry.org/wp-content/uploads/2021/05/social-new-lqpvat.png" /> <meta property="og:image:width" content="1200" /> <meta property="og:image:height" content="630" /> <meta property="og:image:type" content="image/png" /> <meta name="twitter:card" content="summary_large_image" /> <script type="application/ld+json" class="yoast-schema-graph">{"@context":"https://schema.org","@graph":[{"@type":"WebPage","@id":"https://openoximetry.org/community/","url":"https://openoximetry.org/community/","name":"Collaborative Community - OpenOximetry","isPartOf":{"@id":"https://openoximetry.org/#website"},"datePublished":"2024-03-14T11:36:22+00:00","dateModified":"2025-02-21T03:31:50+00:00","breadcrumb":{"@id":"https://openoximetry.org/community/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https://openoximetry.org/community/"]}]},{"@type":"BreadcrumbList","@id":"https://openoximetry.org/community/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https://openoximetry.org/"},{"@type":"ListItem","position":2,"name":"Collaborative Community"}]},{"@type":"WebSite","@id":"https://openoximetry.org/#website","url":"https://openoximetry.org/","name":"OpenOximetry","description":"","potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https://openoximetry.org/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"}]}</script> <link rel="https://api.w.org/" href="https://openoximetry.org/wp-json/" /><link rel="alternate" title="JSON" type="application/json" href="https://openoximetry.org/wp-json/wp/v2/pages/2747" /><link rel="alternate" title="oEmbed (JSON)" type="application/json+oembed" href="https://openoximetry.org/wp-json/oembed/1.0/embed?url=https%3A%2F%2Fopenoximetry.org%2Fcommunity%2F" /> <link rel="alternate" title="oEmbed (XML)" type="text/xml+oembed" href="https://openoximetry.org/wp-json/oembed/1.0/embed?url=https%3A%2F%2Fopenoximetry.org%2Fcommunity%2F&format=xml" /> </head> <body class="page-template page-template-templates page-template-ElasticPage page-template-templatesElasticPage-php page page-id-2747 preload ElasticPage" data-jsmodule="Subpage"> <a href="#main_content" class="Subpage__link">Skip to content</a> <header class="Header" data-jsmodule="Header"> <div class="Header__sub"> <div class="sub__nav" data-id="2699" tabindex="-1"> <div class="row"> <div class="nav__group"> <div class="group__items"> <a href="https://openoximetry.org/study-protocols/" data-desc-id="2697" class="items__link">Protocols</a> <a href="https://openoximetry.org/infographic-builder/" data-desc-id="4151" class="items__link">Infographic Builder</a> <a href="https://openoximetry.org/diversity-toolkit/" data-desc-id="3239" class="items__link">Diversity Toolkit</a> <a href="https://openoximetry.org/skin-color-quantification/" data-desc-id="3240" class="items__link">Skin Color Quantification</a> <a href="https://openoximetry.org/publications/" data-desc-id="2696" class="items__link">Publications</a> <a href="https://openoximetry.org/faq/" data-desc-id="2911" class="items__link">Oximeter FAQ</a> </div> </div> </div> </div> </div> <div class="Header__content"> <div class="row"> <a href="https://openoximetry.org" aria-label="Go to homepage" class="content__logo"><img src="https://openoximetry.org/wp-content/themes/oximetry/assets/svg/logo.svg" alt="OpenOximetry logotype"/></a> <form class="content__search" method="GET" action="https://openoximetry.org/oximeters/"> <button type="button" class="search__button" aria-label="Start search" ><svg fill="none" xmlns="http://www.w3.org/2000/svg" viewBox="0 0 17 16"><path d="M7.152 13.255a5.926 5.926 0 100-11.852 5.926 5.926 0 000 11.852zM11.632 11.308l3.87 3.87" stroke="#283649" stroke-width="1.2" stroke-linecap="round" stroke-linejoin="round"/></svg></button> <input id="header_search_input" aria-label="Search" type="text" name="search" placeholder="Search" class="search__input OAI__read" value="" > </form> <nav class="content__nav"> <ul id="nav_header" class="nav__list"> <li class="list__item" > <a href="https://openoximetry.org/about/" class="item__link"> <span>About</span> </a> </li> <li class="list__item" > <a href="https://openoximetry.org/community/" class="item__link"> <span>Community</span> </a> </li> <li class="list__item" > <a href="https://openoximetry.org/oximeters/" class="item__link"> <span>Device Data</span> </a> </li> <li class="list__item" > <a href="https://openoximetry.org/data-repository/" class="item__link"> <span>Raw Data</span> </a> </li> <li class="list__item" data-id="2699" > <a href="#" class="item__link"> <span>Other</span> </a> </li> </ul> </nav> <div class="LanguageSelect LanguageSelect__color--black" data-jsmodule="LanguageSelect"> <button class="LanguageSelect__button" aria-label="Change language"> <span class="button__icon"><svg xmlns="http://www.w3.org/2000/svg" xml:space="preserve" style="enable-background:new 0 0 512 512" viewBox="0 0 512 512"><path fill="#052049" fill-opacity="0.5" stroke="unset" d="M145.44 214.85 131.52 256H96l59.58-160h41.09L256 256h-37.34l-13.92-41.15h-59.3zm52.29-23.55L176 126.59h-1.57l-21.73 64.7h45.06-.03z"/><path fill="#052049" fill-opacity="0.5" stroke="unset" d="M0 64C0 28.65 28.65 0 64 0h224c35.35 0 64 28.65 64 64v96h96c35.35 0 64 28.65 64 64v224c0 35.35-28.65 64-64 64H224c-35.35 0-64-28.65-64-64v-96H64c-35.35 0-64-28.65-64-64V64zm64-32c-17.67 0-32 14.33-32 32v224c0 17.67 14.33 32 32 32h224c17.67 0 32-14.33 32-32V64c0-17.67-14.33-32-32-32H64zm228.42 319.84c6.18 9.63 12.86 18.66 20.16 27.07-23.94 18.4-53.54 32.03-88.58 41.34 5.7 6.94 14.43 20.32 17.76 27.74 36-11.49 66.56-27.01 92.35-47.81 24.86 21.28 55.65 37.28 93.76 47.1 4.26-8.13 13.25-21.54 20.13-28.48-36-8.1-65.82-22.21-90.24-41.09 21.79-23.9 39.1-52.83 51.87-88.22H448V256h-96v33.5h24.48c-10.18 27.01-23.68 49.47-40.7 68.16-4.7-5.01-9.14-10.26-13.28-15.74a63.647 63.647 0 0 1-30.08 9.92z"/></svg></span> <span class="button__content notranslate">English</span> <span class="button__arrow"><svg xmlns="http://www.w3.org/2000/svg" fill="none" viewBox="0 0 10 6"><path fill="#052049" d="M8.586 0H1.414C.524 0 .077 1.077.707 1.707l3.586 3.586a1 1 0 0 0 1.414 0l3.586-3.586C9.923 1.077 9.477 0 8.586 0z" opacity=".5"/></svg></span> </button> <div class="LanguageSelect__wrapper" aria-hidden="true"> <div class="wrapper__content"> <ul class="content__list"> <li class="list__single"> <button data-g-lang-label="English" data-g-lang="en" class="single__button notranslate active" aria-label="Change language" >English</button> </li> <li class="list__single"> <button data-g-lang-label="Español" data-g-lang="es" class="single__button notranslate " aria-label="Change language" >Español</button> </li> <li class="list__single"> <button data-g-lang-label="Français" data-g-lang="fr" class="single__button notranslate " aria-label="Change language" >Français</button> </li> <li class="list__single"> <button data-g-lang-label="Português" data-g-lang="pt" class="single__button notranslate " aria-label="Change language" >Português</button> </li> </ul> </div> </div> </div> <button id="hamburger" class="content__hamburger" aria-label="Show/hide mobile menu"> <div class="hamburger-box"> <div class="hamburger-inner"></div> </div> </button> </div> </div> </header> <main id="main_content" class="ElasticPage"> <section class="IconTitle"> <div class="row"> <div class="IconTitle__row"> <div class="image-wrapper image-wrapper--svg row__icon"> <div class="asset"> <picture class="lazy-load-item asset-loaded" data-alt="image19-sra896" data-iesrc="https://openoximetry.org/wp-content/uploads/2024/03/image19-sra896.svg" data-loaded="true" > <source srcset="https://openoximetry.org/wp-content/uploads/2024/03/image19-sra896.svg" sizes="100vw"> <img alt="image19-sra896"> </picture> </div> </div> <h1 class="row__content">Collaborative Community</h1> </div> <p class="IconTitle__description">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. </p> </div> </section> <div class="ElasticPage__box"> <div class="StickySubNav StickySubNav--theme-2" data-jsmodule="StickySubNav" data-id="67b8a662d3f7e"> <ul id="2747_67b8a662d3f7e_page_nav" class="StickySubNav__content"> <li class="content__item"> <a href="#about" class="item__link " > <span class="link__content">About</span> </a> </li> <li class="content__item"> <a href="#events" class="item__link " > <span class="link__content">Events</span> </a> </li> <li class="content__item"> <a href="#resources" class="item__link " > <span class="link__content">Resources</span> </a> </li> </ul> </div> <section class="AnnouncementBox"> <div class="row"> <div class="AnnouncementBox__wrapper"> <div class="wrapper__content"> <h2 class="content__heading">Announcement</h2> <span class="content__label">All notes and recordings from previous calls are located below. Please check back for upcoming events or register to receive e-mail updates.</span> <a href="https://openoximetry.org/community/#events" class="content__button Button Button--orange-3 Button--size__large"> View details </a> </div> <div class="image-wrapper image-wrapper--svg wrapper__image"> <div class="asset"> <picture class="lazy-load-item" data-alt="image-1-ojynju" data-iesrc="https://openoximetry.org/wp-content/uploads/2024/02/image-1-ojynju.svg" > <source srcset="https://openoximetry.org/wp-content/uploads/2024/02/image-1-ojynju.svg" sizes="100vw"> </picture> </div> </div> </div> </div> </section> <section id="about" tabindex="-1" class="AboutWithBox" data-bg-color="white"> <div class="AboutWithBox__content"> <div class="row"> <div class="content__header"> <h2 class="header__heading">About</h2> </div> <div class="content__row"> <div class="row__content"><h3>The Open Oximetry Project was created to improve the safety and accuracy of pulse oximeters in all populations.</h3> <p>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 <a href="https://www.fda.gov/about-fda/cdrh-strategic-priorities-and-updates/collaborative-communities-addressing-health-care-challenges-together" target="_blank" rel="noopener">FDA, Center for Devices and Radiological Health (CDRH)</a>.</p> <p>For more information about our Collaborative Community, please review the <a href="https://docs.google.com/document/d/1Fv88gdAReD0XqFAPsu4KVE8vfXFmN4CrSouz_hu2w_4/edit?usp=sharing" target="_blank" rel="noopener">charter here</a>.</p> <p>Membership in the Collaborative Community is open to all stakeholders, including individuals and organizations takes minutes to complete this short form to sign up.</p> <p>You may also view our <a href="https://docs.google.com/spreadsheets/d/1DVfwI567qvGFqXvMRx_w4pKpYWjU6bt78yFBqBpaHWc/edit#gid=303613047" target="_blank" rel="noopener">Individual Members List</a> and our <a href="https://docs.google.com/spreadsheets/d/1DVfwI567qvGFqXvMRx_w4pKpYWjU6bt78yFBqBpaHWc/edit#gid=1677801749" target="_blank" rel="noopener">Institutional Members List</a></p> <p>A list of organizational members is coming soon.</p> </div> <div class="row__box"> <div class="image-wrapper image-wrapper--svg box__image"> <div class="asset"> <picture class="lazy-load-item" data-alt="image-1-5lrw8j" data-iesrc="https://openoximetry.org/wp-content/uploads/2024/03/image-1-5lrw8j.svg" > <source srcset="https://openoximetry.org/wp-content/uploads/2024/03/image-1-5lrw8j.svg" sizes="100vw"> </picture> </div> </div> <h3 class="box__heading">Membership</h3> <div class="box__description"><p>Both individuals and organizations are welcome to join, and membership is free. Please review <a href="https://docs.google.com/document/d/1Fv88gdAReD0XqFAPsu4KVE8vfXFmN4CrSouz_hu2w_4/edit?usp=sharing" target="_blank" rel="noopener">the charter</a> and sign-up via the link below.</p> </div> <a href="https://docs.google.com/forms/d/e/1FAIpQLSdblE4bcQkaCVtDYIa7ABtBFZQkRAbojnrrHfnIgRv0La1C9Q/viewform" aria-label="Sign Up - open link in new tab" target="_blank" class="box__button Button Button--orange-3 Button--size__large"> Sign Up </a> </div> </div> </div> </div> </section> <section id="events" tabindex="-1" class="EventsAccordions" data-jsmodule="EventsAccordions"> <div class="row"> <div class="EventsAccordions__header"> <h2 class="header__heading">Events</h2> <p class="header__description">Here you can find past Open Oximetry events as well as other initiatives' events that we've been following. </p> </div> <div class="EventsAccordions__groups"> <div class="groups__single"> <div class="single__row"> <span class="row__label">Upcoming Events</span> <button data-label-1="Collapse" data-label-2="Expand" aria-label="Expand" class="row__button"> <span>Collapse</span> <span>Expand</span> </button> </div> <div class="single__wrapper" aria-hidden="true"> <div class="wrapper__content"> <div class="content__accordion"> <button class="accordion__button" aria-label="Expand/collapse"> <span class="button__label">TBD</span> <span class="button__icon"> <img src="https://openoximetry.org/wp-content/themes/oximetry/assets/svg/icon-accordion-expand.svg" alt="icon-accordion-expand"/> <img src="https://openoximetry.org/wp-content/themes/oximetry/assets/svg/icon-accordion-collapse.svg" alt="icon-accordion-collapse"/> </span> </button> <div class="accordion__wrapper" aria-hidden="true"> <div class="wrapper__text"><p>TBD</p> </div> </div> </div> </div> </div> </div> <div class="groups__single"> <div class="single__row"> <span class="row__label">Prior Collaborative Community Meetings </span> <button data-label-1="Collapse" data-label-2="Expand" aria-label="Expand" class="row__button"> <span>Collapse</span> <span>Expand</span> </button> </div> <div class="single__wrapper" aria-hidden="true"> <div class="wrapper__content"> <div class="content__accordion"> <button class="accordion__button" aria-label="Expand/collapse"> <span class="button__label">General</span> <span class="button__icon"> <img src="https://openoximetry.org/wp-content/themes/oximetry/assets/svg/icon-accordion-expand.svg" alt="icon-accordion-expand"/> <img src="https://openoximetry.org/wp-content/themes/oximetry/assets/svg/icon-accordion-collapse.svg" alt="icon-accordion-collapse"/> </span> </button> <div class="accordion__wrapper" aria-hidden="true"> <div class="wrapper__text"><ul> <li>February 19, 2025- <strong>Discussion on ISO 80601-2-61 and the latest FDA guidance</strong> (<a href="https://youtu.be/dbwoas6ec1Y" target="_blank" rel="noopener">Recording</a> | <a href="https://docs.google.com/document/d/13fBNLUnDVe36FOURVwemOM-vP6AY2OBuGjMKo4oFsJo/edit?tab=t.0" target="_blank" rel="noopener">Agenda & Minutes</a>)</li> <li>October 1, 2024- <strong>OpenOx Data Review </strong>(<a href="https://youtu.be/uhG-ws0u31A" target="_blank" rel="noopener">Recording</a> | <a href="https://docs.google.com/presentation/d/1VKj8lVzLXcV5NrSWA-BMbtIaz94Bg-bhrSvCFueUIbY/edit#slide=id.g2f9236a9b0a_0_8" target="_blank" rel="noopener">Slides</a>| <a href="https://docs.google.com/document/d/19-Eg-6NHoImWkaq7gtWQkatzazd17Io3Fu9MTiOZhfE/edit" target="_blank" rel="noopener">Agenda & Minutes</a>) <ul> <li>The purpose to share preliminary results on 21 devices that have completed testing</li> </ul> </li> <li>June 4, 2024- <strong>Stakeholder Consultation on Pulse Oximeters</strong> <ul> <li><a href="https://youtu.be/EeiUGk6cxEY" target="_blank" rel="noopener"><strong>Welcome and introduction</strong></a> of the Open Oximetry project, consultation agenda, and meeting participants- Mike Ruffo, PATH</li> <li><a href="https://youtu.be/GwQjFwBOlLk" target="_blank" rel="noopener"><strong>Landscape of where we are and where we want to go</strong></a>. Introduction of problem statement, summary of the work to date – historical milestones and ongoing pulse oximeter research, including preliminary root cause findings, as available- <a href="https://docs.google.com/presentation/d/1rh77q1lEduu8m6feTPOjr0027gEB2lFsQyTKIK1kiW8/edit#slide=id.g1647cd4a99e_0_106" target="_blank" rel="noopener">Dr. Michael Lipnick, UCSF</a></li> <li><strong><a href="https://youtu.be/Ev23CubQ_vg" target="_blank" rel="noopener">Panel discussion: Lessons learned from technical evaluations of tender processes</a>.</strong> Practical insights and lessons learned from evaluating pulse oximeter tender processes (<a href="https://docs.google.com/presentation/d/1-v8TwuJLAxvSly1zcm5vbbeKdpC_HdFk/edit#slide=id.p1" target="_blank" rel="noopener">UNICEF</a>, ICRC, UNOPS, WHO) -Moderator: Matthew Black, Unitaid</li> <li><a href="https://youtu.be/NOxveY4_yh8" target="_blank" rel="noopener"><strong>Performance testing of pulse oximeters and findings and building third party testing capacity in LMICs-</strong></a> <a href="https://docs.google.com/presentation/d/1bWVreTx7jkgjovnnMBgkHVlWU3MEPwgwrZMAdsXpHbc/edit#slide=id.g2e1a4983303_0_0" target="_blank" rel="noopener">Dr. Michael Lipnick, UCSF</a> and John Aleleu, Uganda National Drug Authority</li> <li><a href="https://youtu.be/mKsBjs8PMrY" target="_blank" rel="noopener"><strong>How updating pulse oximetry regulatory and technical guidelines can help save more lives – a country perspective</strong></a>– TIMCI Project, Kenya</li> <li><a href="https://youtu.be/zSl5OWkOyck" target="_blank" rel="noopener"><strong>Panel discussion: Updating global requirements for pulse oximeters.</strong></a> Discussion on upcoming guideline updates/revisions and potential implications on global and national pulse oximeter performance requirements, procurement processes, and access (<a href="https://docs.google.com/presentation/d/1dvmW7t0LUjADHpn2xcWhZQcjkmokcDOb/edit#slide=id.p1" target="_blank" rel="noopener">US FDA</a>, <a href="https://docs.google.com/presentation/d/1rE2dVkw7b_eq57itp5M9jjS6RyFfJHP1/edit#slide=id.p1" target="_blank" rel="noopener">ISO</a>, UK MHRA)</li> <li><a href="https://youtu.be/NJWj_Cov1tg" target="_blank" rel="noopener"><strong>How will pulse oximeter guideline revisions impact LMICs?</strong></a> Findings from discussions with national government representatives and procurement from India, Kenya, Senegal and Tanzania – Matt Morio, PATH</li> <li><a href="https://youtu.be/2MqyMdrSZfs" target="_blank" rel="noopener"><strong>Next steps and closing remarks.</strong></a> Discussion and alignment on next steps and key actions. Presentations on the goals and priorities of the Lancet Global Health Oxygen Commission <a href="https://drive.google.com/file/d/1D9cU8e_vh0c3jJtJkA_lZdywYhBI6Sv4/view" target="_blank" rel="noopener">(Freddy Kitutu, Makerere University)</a>, Global Oxygen Alliance (Pablo Vega, Unitaid), and the OpenOx Collaborative Community <a href="https://docs.google.com/presentation/d/122rjyu-zuXf6QVY-sNbXpWFH-DRRv8GwzcUyFHeRT2k/edit#slide=id.g272cda29777_0_673" target="_blank" rel="noopener">(Fekir Negussie, UCSF)</a></li> </ul> </li> </ul> <p> </p> <ul> <li>October 12, 2023 – <strong>Open Oximetry Project Collaborators Forum Meeting</strong> (<a href="https://youtu.be/f7iRx2eCJ5o" target="_blank" rel="noopener">Recording</a> | <a href="https://docs.google.com/document/d/1sK_qf7lZ_w-9dLRkm6sFODMBEL2Geh0ZohEvTRwyfq4/edit" target="_blank" rel="noopener">Agenda & Minutes</a>) – The purpose of this meeting was to provide updates on emerging evidence and upcoming regulatory changes to improve pulse oximetry performance and equity.</li> </ul> <p> </p> <ul> <li>March 14-15, 2023 – <strong>Open Oximetry and ISO WG10 Concurrent Meeting </strong>(<a href="https://docs.google.com/document/d/1cuejmHiXTLuN9obUP0vnRQMrd75nvxzq/edit?usp=sharing&ouid=104622584959359647854&rtpof=true&sd=true" target="_blank" rel="noopener">Agenda & Minutes</a>) <ul> <li><a href="https://www.youtube.com/watch?v=9mDB0sDED-Q" target="_blank" rel="noopener">Welcome, Overview, and Goals for the Pulse Oximetry Forum</a> – Dr. Mike Lipnick (UCSF), Dr. Odi Ehie (UCSF), Dr. James Lee (FDA), Bob Kopotic (IEC/ISO Convener), Dr. Sandy Weininger (FDA)</li> <li><a href="https://www.youtube.com/watch?v=nJ3dfoCBnjk" target="_blank" rel="noopener">Real World Challenges in Pulse Oximetry</a> – 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)</li> <li><a href="https://www.youtube.com/watch?v=Riif9YZaBow" target="_blank" rel="noopener">Confounding Factors in Pulse Oximeter Performance and Discussion</a> – Dr. Philip Bickler (UCSF), Mike Bernstein (Physiomonitor), Dr. Ellis Monk (Harvard University), Dr. Mark Ansermino (University of British Columbia)</li> <li><a href="https://www.youtube.com/watch?v=JonQQ2xP0RA" target="_blank" rel="noopener">Strengths and Shortcomings of Controlled Desaturation Studies</a> – Bob Kopotic (IEC/ISO co-Convenor), Paul Batchelder (Clinimark physiology laboratories), Dr. John Feiner (UCSF), Dr. Bunmi Okunlola (NYU), David Macleod</li> <li><a href="https://www.youtube.com/watch?v=0SenoYgVZq4" target="_blank" rel="noopener">Statistical Analyses and Sample Size for Controlled Desaturation Study Design</a> – Dr. John Feiner (UCSF), Dr. Gene Pennello (FDA), David Milkes (Medtronic and ISO)</li> <li><a href="https://www.youtube.com/watch?v=BeE92ORkwj4" target="_blank" rel="noopener">Open Forum</a> – Dr. Zach Vesoulisch (Washington University), Dr. François Lellouche (Laval University)</li> <li><a href="https://www.youtube.com/watch?v=UQvpEtzVwUI" target="_blank" rel="noopener">Optimized Skin Color Quantification Techniques and Discussion</a> – 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)</li> <li><a href="https://youtu.be/bt10VPb8NVM" target="_blank" rel="noopener">How to Account for Challenging Clinical Scenarios and Potential Roles for Phantom in vitro Testing</a> – 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)</li> <li><a href="https://www.youtube.com/watch?v=9pryIxegCjE" target="_blank" rel="noopener">Open Forum</a>– Gauri Singh (Lifebox)</li> <li><a href="https://www.youtube.com/watch?v=7QYU3mFfNPY" target="_blank" rel="noopener">Opportunities to Utilize Standards for Improving Communication of Device Performance and Day 2 Review</a> – Dr. Mike Lipnick (UCSF)</li> </ul> </li> </ul> <p> </p> <ul> <li>December 8, 2022 – <strong>Intro to the Community & Priority Setting</strong> (<a href="https://docs.google.com/presentation/d/e/2PACX-1vS_KS65DACZDHK2TNJM1nOBVEmlf36x1pDNBIsZEYqu2LV8_EyL0m4zHQ_S7voTiH0XMCPnv1Sw1eX1/pub?start=false&loop=false&delayms=3000" target="_blank" rel="noopener">Slides</a> | <a href="https://youtu.be/zXmRL_pg4ds" target="_blank" rel="noopener">Recording</a> | <a href="https://docs.google.com/document/d/1mKygIUuVdp9aRQqiyFgxhDI0Dlg1r3lI31iYapJS6uY/edit" target="_blank" rel="noopener">Agenda & Minutes</a>)</li> </ul> <p> </p> </div> </div> </div> <div class="content__accordion"> <button class="accordion__button" aria-label="Expand/collapse"> <span class="button__label">Clinical Trials </span> <span class="button__icon"> <img src="https://openoximetry.org/wp-content/themes/oximetry/assets/svg/icon-accordion-expand.svg" alt="icon-accordion-expand"/> <img src="https://openoximetry.org/wp-content/themes/oximetry/assets/svg/icon-accordion-collapse.svg" alt="icon-accordion-collapse"/> </span> </button> <div class="accordion__wrapper" aria-hidden="true"> <div class="wrapper__text"><ul> <li>August 23, 2023 – <strong>Clinical Trials Subgroup Meeting 3</strong> (<a href="https://youtu.be/LB-Go4wOubs" target="_blank" rel="noopener">Recording</a> | <a href="https://docs.google.com/document/d/1uDHwy83FSlkMYeugnGvfhXQ501sbYe8QIfLjjPRlefo/edit" target="_blank" rel="noopener">Agenda & Minutes</a>)</li> <li>May 25, 2023 – <strong>Clinical Trials Subgroup Meeting 2</strong> (<a href="https://youtu.be/l05lz3cXyYU" target="_blank" rel="noopener">Recording</a> | Slides)</li> <li>January 12, 2023- <strong>Clinical Trials Subgroup Meeting 1</strong> (<a href="https://docs.google.com/document/d/1uDHwy83FSlkMYeugnGvfhXQ501sbYe8QIfLjjPRlefo/edit" target="_blank" rel="noopener">Agenda & Minutes</a>)</li> </ul> </div> </div> </div> <div class="content__accordion"> <button class="accordion__button" aria-label="Expand/collapse"> <span class="button__label">Skin Color Diversity </span> <span class="button__icon"> <img src="https://openoximetry.org/wp-content/themes/oximetry/assets/svg/icon-accordion-expand.svg" alt="icon-accordion-expand"/> <img src="https://openoximetry.org/wp-content/themes/oximetry/assets/svg/icon-accordion-collapse.svg" alt="icon-accordion-collapse"/> </span> </button> <div class="accordion__wrapper" aria-hidden="true"> <div class="wrapper__text"><ul> <li>December 3rd, 2024 –<strong> Skin Color Diversity Subgroup Meeting 5</strong> (<a href="https://youtu.be/1bVtAoW8hFk" target="_blank" rel="noopener">Recording</a> | <a href="https://docs.google.com/document/d/1NExZ5DGNUAODavuVLkeg8QIDdYhzBVEZfO8u95u34fk/edit?tab=t.0" target="_blank" rel="noopener">Agenda & Minutes</a>)</li> <li>July 15, 2024 – <strong>Skin Color Diversity Subgroup Meeting 4</strong> (<a href="https://youtu.be/6qaoFpJ7sb8" target="_blank" rel="noopener">Recording</a> | <a href="https://docs.google.com/document/d/1NExZ5DGNUAODavuVLkeg8QIDdYhzBVEZfO8u95u34fk/edit" target="_blank" rel="noopener">Agenda & Minutes</a>) <ul> <li><a href="https://ucsfonline-my.sharepoint.com/:b:/g/personal/lily_ortiz_ucsf_edu/Ea5vxheMYN9GhY7nuHUGYycBi-tLDSbVF47iXFxOh69AsA?e=nSUh5b">Skin color scales: Are they a surrogate for colorimetry?</a>, a presentation by Wim Verkruysse and Ellis Monk</li> </ul> </li> <li>March 13, 2024 – <strong>Skin Color Quantification Subgroup Meeting 3 </strong>(<a href="https://youtu.be/6ELI__1XcbI" target="_blank" rel="noopener">Recording</a> | <a href="https://docs.google.com/document/d/1NExZ5DGNUAODavuVLkeg8QIDdYhzBVEZfO8u95u34fk/edit" target="_blank" rel="noopener">Agenda & Minutes</a>) <ul> <li><a href="https://ucsfonline-my.sharepoint.com/:b:/g/personal/lily_ortiz_ucsf_edu/EWE4eXFERWVOu7QBVEBohwsBpYRnd7Tt0vZyCekZli35lw?e=ZXCn4K" target="_blank" rel="noopener">MST Printing</a>, a presentation by Wim Verkruysse and colleagues</li> <li><a href="https://docs.google.com/presentation/d/1Y7RNRJiowMSlkN8agcpeot4agn2tCUyAk-oIoUX1_So/edit?usp=sharing" target="_blank" rel="noopener">Why and How to Bin ITA</a>, a presentation by Leo Shmuylovich and UCSF Hypoxia Lab</li> </ul> </li> <li>May 8, 2023 – <strong>Skin Color Quantification Subgroup Meeting</strong> <strong>2</strong> (<a href="https://www.youtube.com/watch?v=5xid_0BRy-4" target="_blank" rel="noopener">Recording</a> | <a href="https://docs.google.com/document/d/1NExZ5DGNUAODavuVLkeg8QIDdYhzBVEZfO8u95u34fk/edit" target="_blank" rel="noopener">Agenda & Minutes</a>)</li> <li>February 10, 2023 – <strong>Skin Color Quantification Subgroup Meeting 1</strong> (<a href="https://www.youtube.com/watch?v=4_j5PPyk9oY" target="_blank" rel="noopener">Recording</a> | <a href="https://docs.google.com/document/d/1NExZ5DGNUAODavuVLkeg8QIDdYhzBVEZfO8u95u34fk/edit?usp=sharing" target="_blank" rel="noopener">Agenda & Minutes</a></li> </ul> </div> </div> </div> <div class="content__accordion"> <button class="accordion__button" aria-label="Expand/collapse"> <span class="button__label">Education & Comms </span> <span class="button__icon"> <img src="https://openoximetry.org/wp-content/themes/oximetry/assets/svg/icon-accordion-expand.svg" alt="icon-accordion-expand"/> <img src="https://openoximetry.org/wp-content/themes/oximetry/assets/svg/icon-accordion-collapse.svg" alt="icon-accordion-collapse"/> </span> </button> <div class="accordion__wrapper" aria-hidden="true"> <div class="wrapper__text"><ul> <li>October 31, 2024- <strong>Meeting 4</strong> (<a href="https://youtu.be/lYRAh7NQTwQ">Recording</a> | <a href="https://docs.google.com/document/d/1Ptwnvv9VKq229b5wdHtOeUnPzQrWsLOGod46N4FfGmU/edit?tab=t.0">Agenda & Minutes</a>)</li> <li>July 8, 2024 – <strong>Meeting 3</strong> (<a href="https://youtu.be/1NmMPec1kqc" target="_blank" rel="noopener">Recording</a> | <a href="https://docs.google.com/document/d/1Ptwnvv9VKq229b5wdHtOeUnPzQrWsLOGod46N4FfGmU/edit" target="_blank" rel="noopener">Agenda & Minutes</a>)</li> <li>May 7, 2024- <strong>Meeting 2</strong> (<a href="https://www.youtube.com/watch?v=hCxxPx5OZm8">Recording</a> | <a href="https://docs.google.com/document/d/1Ptwnvv9VKq229b5wdHtOeUnPzQrWsLOGod46N4FfGmU/edit">Agenda & Minutes</a>)</li> <li>March 20, 2024 – <strong>Kickoff Meeting</strong> (<a href="https://youtu.be/frauIlp0ZVM" target="_blank" rel="noopener">Recording</a>| <a href="https://docs.google.com/document/d/1Ptwnvv9VKq229b5wdHtOeUnPzQrWsLOGod46N4FfGmU/edit" target="_blank" rel="noopener">Agenda & Minutes</a>)</li> </ul> </div> </div> </div> <div class="content__accordion"> <button class="accordion__button" aria-label="Expand/collapse"> <span class="button__label">Data Sharing</span> <span class="button__icon"> <img src="https://openoximetry.org/wp-content/themes/oximetry/assets/svg/icon-accordion-expand.svg" alt="icon-accordion-expand"/> <img src="https://openoximetry.org/wp-content/themes/oximetry/assets/svg/icon-accordion-collapse.svg" alt="icon-accordion-collapse"/> </span> </button> <div class="accordion__wrapper" aria-hidden="true"> <div class="wrapper__text"><ul> <li>November 15, 2023 – <strong>Open Ox Data Repository Feedback Meeting</strong> (<a href="https://youtu.be/AUr--NgNCag" target="_blank" rel="noopener">Recording</a> | <a href="https://docs.google.com/document/d/1p6A73C4xtyjPpWLIaepdIv3IqekaLubCjlByWalT42E/edit?pli=1" target="_blank" rel="noopener">Agenda & Minutes</a>)</li> </ul> </div> </div> </div> </div> </div> </div> <div class="groups__single"> <div class="single__row"> <span class="row__label">Other Meetings (Prior)</span> <button data-label-1="Collapse" data-label-2="Expand" aria-label="Expand" class="row__button"> <span>Collapse</span> <span>Expand</span> </button> </div> <div class="single__wrapper" aria-hidden="true"> <div class="wrapper__content"> <div class="content__accordion"> <button class="accordion__button" aria-label="Expand/collapse"> <span class="button__label">View All</span> <span class="button__icon"> <img src="https://openoximetry.org/wp-content/themes/oximetry/assets/svg/icon-accordion-expand.svg" alt="icon-accordion-expand"/> <img src="https://openoximetry.org/wp-content/themes/oximetry/assets/svg/icon-accordion-collapse.svg" alt="icon-accordion-collapse"/> </span> </button> <div class="accordion__wrapper" aria-hidden="true"> <div class="wrapper__text"><ul> <li>June 11-13, 2024, Improving Access to Tools that Detect Severe Illness</li> <li>March 14, 2024 – <a href="https://www.nationalacademies.org/event/41882_03-2024_the-use-of-race-and-ethnicity-in-biomedical-research-meeting-4" target="_blank" rel="noopener"><strong>The Use of Race and Ethnicity in Biomedical Research</strong></a> – Meeting 4 – Virtual meeting of the the Committee on the Use of Race and Ethnicity in Biomedical Research.</li> <li>February 2, 2024 – <strong>FDA Public Advisory Committee Meetings on Pulse Oximeters</strong> – Virtual meeting of the CDRH Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee (<a href="https://www.fda.gov/media/175825/download" target="_blank" rel="noopener">Agenda</a> | <a href="https://www.fda.gov/media/175266/download" target="_blank" rel="noopener">Webcast Link</a> | <a href="https://www.fda.gov/media/175828/download" target="_blank" rel="noopener">Executive Summary</a> | <a href="https://www.fda.gov/medical-devices/medical-devices-news-and-events/cdrh-takes-steps-advance-further-discussions-pulse-oximeters" target="_blank" rel="noopener">More info</a>)</li> <li>January 31, 2024 – <strong>The Use of Race and Ethnicity in Biomedical Research</strong> – Meeting 3 – Virtual meeting of the the Committee on the Use of Race and Ethnicity in Biomedical Research (<a href="https://www.nationalacademies.org/documents/embed/link/LF2255DA3DD1C41C0A42D3BEF0989ACAECE3053A6A9B/file/DF68F050764919C10EC63630ABEF15B9ACF683BC72AD?noSaveAs=1" target="_blank" rel="noopener">Agenda</a> | <a href="https://www.nationalacademies.org/event/41676_01-2024_the-use-of-race-and-ethnicity-in-biomedical-research-meeting-3" target="_blank" rel="noopener">Link to event</a>)</li> <li>November 29-30, 2023 – <strong>Workshop to Enhance Clinical Study Diversity – </strong>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.</li> <li>2022 – <a href="https://www.spiedigitallibrary.org/jbo-hot-topics-webinar-series?videoId=6317093124112&SSO=1" target="_blank" rel="noopener"><strong>50 years after pulse oximetry was invented</strong> – SPIE Journal of Biomedical Optics Webinar Series</a></li> </ul> </div> </div> </div> </div> </div> </div> </div> </div> </section> <section id="resources" tabindex="-1" class="LinksGroupSection" data-bg-color="white"> <div class="LinksGroupSection__content"> <div class="row"> <div class="content__header"> <h2 class="header__heading">Resources</h2> </div> <div class="content__grid"> <div class="grid__single" style="background-color: rgba(255,226,162,0.7)"> <div class="image-wrapper image-wrapper--svg single__icon"> <div class="asset"> <picture class="lazy-load-item" data-alt="image-3-7qq6bx" data-iesrc="https://openoximetry.org/wp-content/uploads/2024/03/image-3-7qq6bx.svg" > <source srcset="https://openoximetry.org/wp-content/uploads/2024/03/image-3-7qq6bx.svg" sizes="100vw"> </picture> </div> </div> <a href="https://openoximetry.org/study-protocols/" class="single__link">Protocols</a> </div> <div class="grid__single" style="background-color: rgba(123,139,233,0.3)"> <div class="image-wrapper image-wrapper--svg single__icon"> <div class="asset"> <picture class="lazy-load-item" data-alt="image-4-mm26kr" data-iesrc="https://openoximetry.org/wp-content/uploads/2024/03/image-4-mm26kr.svg" > <source srcset="https://openoximetry.org/wp-content/uploads/2024/03/image-4-mm26kr.svg" sizes="100vw"> </picture> </div> </div> <a href="https://openoximetry.org/publications/" class="single__link">Publications</a> </div> <div class="grid__single" style="background-color: rgba(0,163,255,0.3)"> <div class="image-wrapper image-wrapper--svg single__icon"> <div class="asset"> <picture class="lazy-load-item" data-alt="image-5-odatah" data-iesrc="https://openoximetry.org/wp-content/uploads/2024/03/image-5-odatah.svg" > <source srcset="https://openoximetry.org/wp-content/uploads/2024/03/image-5-odatah.svg" sizes="100vw"> </picture> </div> </div> <a href="https://openoximetry.org/publications/?category=regulations" class="single__link">Regulations & Standards</a> </div> <div class="grid__single" style="background-color: rgba(110,164,0,0.3)"> <div class="image-wrapper image-wrapper--svg single__icon"> <div class="asset"> <picture class="lazy-load-item" data-alt="image-6-onwxw2" data-iesrc="https://openoximetry.org/wp-content/uploads/2024/03/image-6-onwxw2.svg" > <source srcset="https://openoximetry.org/wp-content/uploads/2024/03/image-6-onwxw2.svg" sizes="100vw"> </picture> </div> </div> <a href="https://openoximetry.org/diversity-toolkit/" class="single__link">Diversity Toolkit </a> </div> </div> <div class="content__row"> <div class="image-wrapper image-wrapper--svg row__image"> <div class="asset"> <picture class="lazy-load-item" data-alt="image-2-g2jvei" data-iesrc="https://openoximetry.org/wp-content/uploads/2024/03/image-2-g2jvei.svg" > <source srcset="https://openoximetry.org/wp-content/uploads/2024/03/image-2-g2jvei.svg" sizes="100vw"> </picture> </div> </div> <div class="row__content"><h3>Misc Resources</h3> <ul> <li><a href="https://www.path.org/our-impact/resources/pulse-oximetry-primer/">PATH Pulse Oximetry Primer (5.2024)</a></li> <li><a href="https://www.fda.gov/medical-devices/safety-communications/pulse-oximeter-accuracy-and-limitations-fda-safety-communication" target="_blank" rel="noopener">FDA Pulse Oximetry Safety Communications, Public Hearings and Advisory Committees</a></li> <li><a href="https://www.gov.uk/government/groups/equity-in-medical-devices-independent-review" target="_blank" rel="noopener">UK Equity in Medical Devices Independent Review Initiative</a></li> <li><a href="https://clinicaltrials.gov/ct2/results?cond=oximeter%2C+oximetry&term=skin&cntry=&state=&city=&dist=" target="_blank" rel="noopener">Pulse Oximetry Clinical Trials</a></li> <li><a href="https://www.fda.gov/medical-devices/medical-devices-news-and-events/cdrh-takes-steps-advance-further-discussions-pulse-oximeters">CDRH Takes Steps to Advance Further Discussions on Pulse Oximeters (11.2023)</a></li> <li class="text-center content-title"><a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/select-updates-breakthrough-devices-program-guidance-reducing-disparities-health-and-health-care" target="_blank" rel="noopener">Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Health Care (Updated 10.2022)</a></li> <li class="text-center content-title"><a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/diversity-plans-improve-enrollment-participants-underrepresented-racial-and-ethnic-populations" target="_blank" rel="noopener">Diversity Plans to Improve Enrollment of Participants From Underrepresented Racial and Ethnic Populations in Clinical Trials; Draft Guidance for Industry (Updated 4.2022)</a></li> <li class="text-center content-title"><a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enhancing-diversity-clinical-trial-populations-eligibility-criteria-enrollment-practices-and-trial" target="_blank" rel="noopener">Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry (Updated 11.2020)</a></li> <li><a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/general-wellness-policy-low-risk-devices">2019 FDA General Wellness Guidance: Policy for Low Risk Devices (9.2019)</a></li> <li class="text-center content-title"><a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/collection-race-and-ethnicity-data-clinical-trials" target="_blank" rel="noopener">Collection of Race and Ethnicity Data in Clinical Trials (Updated 9.2018)</a></li> <li class="text-center content-title"><a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/evaluation-sex-specific-data-medical-device-clinical-studies-guidance-industry-and-food-and-drug" target="_blank" rel="noopener">Evaluation of Sex-Specific Data in Medical Device Clinical Studies – Guidance for Industry and Food and Drug Administration Staff (Updated 2.2018)</a></li> <li class="text-center content-title"><a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/evaluation-and-reporting-age-race-and-ethnicity-specific-data-medical-device-clinical-studies" target="_blank" rel="noopener">Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device Clinical Studies (Updated 2.2018)</a></li> </ul> </div> </div> </div> </div> </section> <section class="BlueContactBox BlueContactBox__type--4"> <div class="row"> <div class="BlueContactBox__content"> <p class="content__label">Any questions or comments? </p> <a href="https://openoximetry.org/contact/" aria-label="Contact Us - open link in new tab" target="_blank" class="Button Button--orange-3 Button--size__large"> Contact Us </a> </div> </div> </section> </div> </main> <footer class="Footer" data-endpoint="https://openoximetry.org/wp-admin/admin-ajax.php"> <div class="row"> <div class="Footer__col Footer__col--1"> <ul id="nav_footer_menu" class="Footer__menu"> <li class="menu__item"> <a href="https://openoximetry.org/about/" class="item__link">About</a> </li> <li class="menu__item"> <a href="https://openoximetry.org/contact/" class="item__link">Contact</a> </li> <li class="menu__item"> <a href="https://opencriticalcare.org/terms/" aria-label="Copyright - open link in new tab" target="_blank" class="item__link">Copyright</a> </li> <li class="menu__item"> <a href="https://opencriticalcare.org/terms/" aria-label="Terms of Use - open link in new tab" target="_blank" class="item__link">Terms of Use</a> </li> <li class="menu__item"> <a href="https://twitter.com/opencritcareorg" aria-label="Twitter - open link in new tab" target="_blank" class="item__link">Twitter</a> </li> </ul> <div class="Footer__description"> <p>Disclaimer: This site is a collaborative effort by representatives of multiple institutions, and this site and the information herein are intended and designed for educational purposes only. It is the responsibility of the user to ensure that all information contained herein is current and accurate, and the creators and hosts of this site make no claims or warranties as to the currency, accuracy, or suitability of this information for any purpose. Any reference to specific equipment, pharmaceuticals, or other medical devices on this site is not meant as an endorsement of such items, and you should consult manufacturers’ documentation prior using any such items that may be referenced within this site. The use of any information on this site is undertaken solely at your own risk, and the creators and hosts of this site shall not be liable for any damages, losses, or other injury caused by the use of any information on this site, nor for any reliance on the accuracy or reliability of such information.</p> </div> </div> <div class="Footer__col Footer__col--2"> <div class="col__logos"> <span class="logos__heading">Supporters</span> <div class="logos__layout"> <a href="https://www.moore.org/initiative-strategy-detail?initiativeId=diagnostic-excellence" aria-label=" - open link in new tab" class="layout__logo" target="_blank"> <div class="image-wrapper equalHeight "> <div class="asset" style="padding-bottom: 43.3360927152%"> <picture class="lazy-load-item" data-alt="moore-logo-FINAL-NEG-oi0gfu" data-iesrc="https://openoximetry.org/wp-content/uploads/2022/08/moore-logo-FINAL-NEG-oi0gfu.png" > <source srcset=" https://openoximetry.org/wp-content/uploads/2022/08/moore-logo-FINAL-NEG-oi0gfu.png 2416w, https://openoximetry.org/wp-content/uploads/2022/08/moore-logo-FINAL-NEG-oi0gfu-1920x832.png 1920w, https://openoximetry.org/wp-content/uploads/2022/08/moore-logo-FINAL-NEG-oi0gfu-1600x693.png 1600w, https://openoximetry.org/wp-content/uploads/2022/08/moore-logo-FINAL-NEG-oi0gfu-1280x555.png 1280w, https://openoximetry.org/wp-content/uploads/2022/08/moore-logo-FINAL-NEG-oi0gfu-1024x444.png 1024w, https://openoximetry.org/wp-content/uploads/2022/08/moore-logo-FINAL-NEG-oi0gfu-768x333.png 768w, https://openoximetry.org/wp-content/uploads/2022/08/moore-logo-FINAL-NEG-oi0gfu-480x208.png 480w, https://openoximetry.org/wp-content/uploads/2022/08/moore-logo-FINAL-NEG-oi0gfu-340x147.png 340w, https://openoximetry.org/wp-content/uploads/2022/08/moore-logo-FINAL-NEG-oi0gfu-240x104.png 240w, " sizes="100vw"> </picture> </div> </div> </a> <div class="layout__logo"> <div class="image-wrapper equalHeight "> <div class="asset" style="padding-bottom: 70.3%"> <picture class="lazy-load-item" data-alt="rwjf-logo-white-padded-sqe1gb" data-iesrc="https://openoximetry.org/wp-content/uploads/2022/12/rwjf-logo-white-padded-sqe1gb.png" > <source srcset=" https://openoximetry.org/wp-content/uploads/2022/12/rwjf-logo-white-padded-sqe1gb.png 1000w, https://openoximetry.org/wp-content/uploads/2022/12/rwjf-logo-white-padded-sqe1gb-768x540.png 768w, https://openoximetry.org/wp-content/uploads/2022/12/rwjf-logo-white-padded-sqe1gb-480x337.png 480w, https://openoximetry.org/wp-content/uploads/2022/12/rwjf-logo-white-padded-sqe1gb-340x239.png 340w, https://openoximetry.org/wp-content/uploads/2022/12/rwjf-logo-white-padded-sqe1gb-240x169.png 240w, " sizes="100vw"> </picture> </div> </div> </div> <a href="https://www.mcgovern.org/" aria-label=" - open link in new tab" class="layout__logo" target="_blank"> <div class="image-wrapper equalHeight "> <div class="asset" style="padding-bottom: 33.9442231076%"> <picture class="lazy-load-item" data-alt="PJMF-LOGO-HORIZONTAL_Blue-on-Transparent-yx8rr8" data-iesrc="https://openoximetry.org/wp-content/uploads/2022/08/PJMF-LOGO-HORIZONTAL_Blue-on-Transparent-yx8rr8.png" > <source srcset=" https://openoximetry.org/wp-content/uploads/2022/08/PJMF-LOGO-HORIZONTAL_Blue-on-Transparent-yx8rr8.png 1255w, https://openoximetry.org/wp-content/uploads/2022/08/PJMF-LOGO-HORIZONTAL_Blue-on-Transparent-yx8rr8-1024x348.png 1024w, https://openoximetry.org/wp-content/uploads/2022/08/PJMF-LOGO-HORIZONTAL_Blue-on-Transparent-yx8rr8-768x261.png 768w, https://openoximetry.org/wp-content/uploads/2022/08/PJMF-LOGO-HORIZONTAL_Blue-on-Transparent-yx8rr8-480x163.png 480w, https://openoximetry.org/wp-content/uploads/2022/08/PJMF-LOGO-HORIZONTAL_Blue-on-Transparent-yx8rr8-340x115.png 340w, https://openoximetry.org/wp-content/uploads/2022/08/PJMF-LOGO-HORIZONTAL_Blue-on-Transparent-yx8rr8-240x81.png 240w, " sizes="100vw"> </picture> </div> </div> </a> <div class="layout__logo"> <div class="image-wrapper equalHeight "> <div class="asset" style="padding-bottom: 31.0416666667%"> <picture class="lazy-load-item" data-alt="usaid-6ih6h6-480x149-0d0auq" data-iesrc="https://openoximetry.org/wp-content/uploads/2021/08/usaid-6ih6h6-480x149-0d0auq.png" > <source srcset=" https://openoximetry.org/wp-content/uploads/2021/08/usaid-6ih6h6-480x149-0d0auq.png 480w, https://openoximetry.org/wp-content/uploads/2021/08/usaid-6ih6h6-480x149-0d0auq-480x149.png 480w, https://openoximetry.org/wp-content/uploads/2021/08/usaid-6ih6h6-480x149-0d0auq-340x106.png 340w, https://openoximetry.org/wp-content/uploads/2021/08/usaid-6ih6h6-480x149-0d0auq-240x75.png 240w, " sizes="100vw"> </picture> </div> </div> </div> <div class="layout__logo"> <div class="image-wrapper equalHeight "> <div class="asset" style="padding-bottom: 38.3631713555%"> <picture class="lazy-load-item" data-alt="thumbnail_PATH_Logo_Color-x2k92a-xqiv6e" data-iesrc="https://openoximetry.org/wp-content/uploads/2024/09/thumbnail_PATH_Logo_Color-x2k92a-xqiv6e.png" > <source srcset=" https://openoximetry.org/wp-content/uploads/2024/09/thumbnail_PATH_Logo_Color-x2k92a-xqiv6e.png 391w, https://openoximetry.org/wp-content/uploads/2024/09/thumbnail_PATH_Logo_Color-x2k92a-xqiv6e-340x130.png 340w, https://openoximetry.org/wp-content/uploads/2024/09/thumbnail_PATH_Logo_Color-x2k92a-xqiv6e-240x92.png 240w, " sizes="100vw"> </picture> </div> </div> </div> <div class="layout__logo"> <div class="image-wrapper equalHeight "> <div class="asset" style="padding-bottom: 24.8484848485%"> <picture class="lazy-load-item" data-alt="unitaid-logo-1qcyl0-cfz3jh" data-iesrc="https://openoximetry.org/wp-content/uploads/2024/09/unitaid-logo-1qcyl0-cfz3jh.png" > <source srcset=" https://openoximetry.org/wp-content/uploads/2024/09/unitaid-logo-1qcyl0-cfz3jh.png 330w, https://openoximetry.org/wp-content/uploads/2024/09/unitaid-logo-1qcyl0-cfz3jh-240x60.png 240w, " sizes="100vw"> </picture> </div> </div> </div> <div class="layout__logo"> <div class="image-wrapper equalHeight "> <div class="asset" style="padding-bottom: 31.4705882353%"> <picture class="lazy-load-item" data-alt="logo-star-t7j7a4-340x107-jtzb5k" data-iesrc="https://openoximetry.org/wp-content/uploads/2021/11/logo-star-t7j7a4-340x107-jtzb5k.png" > <source srcset=" https://openoximetry.org/wp-content/uploads/2021/11/logo-star-t7j7a4-340x107-jtzb5k.png 340w, https://openoximetry.org/wp-content/uploads/2021/11/logo-star-t7j7a4-340x107-jtzb5k-340x107.png 340w, https://openoximetry.org/wp-content/uploads/2021/11/logo-star-t7j7a4-340x107-jtzb5k-240x76.png 240w, " sizes="100vw"> </picture> </div> </div> </div> <a href="http://www.hypoxialab.com" aria-label="hypoxia lab - open link in new tab" class="layout__logo" target="_blank"> <div class="image-wrapper equalHeight "> <div class="asset" style="padding-bottom: 31.3479623824%"> <picture class="lazy-load-item" data-alt="hypoxialab-white-f9fwtp" data-iesrc="https://openoximetry.org/wp-content/uploads/2021/11/hypoxialab-white-f9fwtp.png" > <source srcset=" https://openoximetry.org/wp-content/uploads/2021/11/hypoxialab-white-f9fwtp.png 957w, https://openoximetry.org/wp-content/uploads/2021/11/hypoxialab-white-f9fwtp-768x241.png 768w, https://openoximetry.org/wp-content/uploads/2021/11/hypoxialab-white-f9fwtp-480x150.png 480w, https://openoximetry.org/wp-content/uploads/2021/11/hypoxialab-white-f9fwtp-340x107.png 340w, https://openoximetry.org/wp-content/uploads/2021/11/hypoxialab-white-f9fwtp-240x75.png 240w, " sizes="100vw"> </picture> </div> </div> </a> </div> </div> <div class="GoogleTranslate" data-jsmodule="GoogleTranslate"> <p class="GoogleTranslate__label">Translate this page</p> <div id="google_translations_footer" class="GoogleTranslate__content notranslate"></div> </div> </div> </div> </footer> <section class="MobileMenu" data-jsmodule="MobileMenu"> <div class="MobileMenu__content" tabindex="-1"> <div class="content__langs"> <button aria-label="Select language" class="langs__single notranslate active" data-g-lang="en">English</button> <button aria-label="Select language" class="langs__single notranslate " data-g-lang="es">Español</button> <button aria-label="Select language" class="langs__single notranslate " data-g-lang="fr">Français</button> <button aria-label="Select language" class="langs__single notranslate " data-g-lang="pt">Português</button> </div> <ul id="nav_mobile_menu" class="content__nav"> <li> <a href="https://openoximetry.org/about/" >About</a> </li> <li> <a href="https://openoximetry.org/community/" >Community</a> </li> <li> <a href="https://openoximetry.org/oximeters/" >Device Data</a> </li> <li> <a href="https://openoximetry.org/data-repository/" >Raw Data</a> </li> <li> <a href="https://openoximetry.org/study-protocols/" >Protocols</a> </li> <li> <a href="https://openoximetry.org/infographic-builder/" >Infographic Builder</a> </li> <li> <a href="https://openoximetry.org/publications/" >Publications</a> </li> <li> <a href="https://openoximetry.org/diversity-toolkit/" >Diversity Toolkit</a> </li> <li> <a href="https://openoximetry.org/skin-color-quantification/" >Skin Color Quantification</a> </li> <li> <a href="https://openoximetry.org/faq/" >FAQ</a> </li> </ul> <form class="SearchInputRow" method="GET" action="https://openoximetry.org/oximeters/"> <input aria-label="Search by manufacturer, model or keyword" type="text" name="search" value="" placeholder="Search by manufacturer, model or keyword"> <button aria-label="Start search"><svg fill="none" xmlns="http://www.w3.org/2000/svg" viewBox="0 0 17 16"><path d="M7.152 13.255a5.926 5.926 0 100-11.852 5.926 5.926 0 000 11.852zM11.632 11.308l3.87 3.87" stroke="#283649" stroke-width="1.2" stroke-linecap="round" stroke-linejoin="round"/></svg></button> </form> </div> </section> <section id="modal-healthy-human-performance-tests" class="ModalSection"> <div class="ModalSection__content"> <div class="content__header"> <h2 class="header__heading">Healthy Human Performance Tests</h2> <button class="header__close" aria-label="Close modal"><img src="https://openoximetry.org/wp-content/themes/oximetry/assets/svg/close-cookie.svg" alt="close-cookie"/></button> </div> <div class="content__text"><p>To meet 2017 ISO standards (80601-2-61) or 2013 <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/pulse-oximeters-premarket-notification-submissions-510ks-guidance-industry-and-food-and-drug" target="_blank" rel="noopener">FDA guideline</a> adherence for clinical use, pulse oximeter performance must be tested in healthy humans in a laboratory setting. Independent device testing for the Open Oximetry Project follows <a href="https://docs.google.com/document/d/1bpVzZg9M0StLoyB_iF07V8at0h8lQhDyYnNCoSMVZQU/edit" target="_blank" rel="noopener">our protocol consistent with ISO and FDA</a>. Only devices labeled as ‘verified’ or ‘failed’ have been independently tested by the Open Oximetry Project.<br /> All other devices listed show data from manufacturers or published literature and have not been confirmed by the Open Oximetry team. Scoring criteria will be modified based on evolving data on this topic. See the table below for scoring criteria for this category:</p> </div> <div class="content__table"> <div class="table__grid table__grid--col-0-heading" style="grid-template-columns: repeat( 4, minmax(160px, 1fr) );"> <div class="grid__cell grid__cell--header grid__cell--col-0">Score</div> <div class="grid__cell grid__cell--header grid__cell--col-1">Root mean square error (Arms) composite all skin colors & all perfusions tested 2022 FDA/ISO <span>(manufacturer* or independent testing)</span></div> <div class="grid__cell grid__cell--header grid__cell--col-2">Skin color</div> <div class="grid__cell grid__cell--header grid__cell--col-3">Perfusion</div> <div class="grid__cell grid__cell--content grid__cell--col-0 grid__cell--row-0" >No Data</div> <div class="grid__cell grid__cell--content grid__cell--col-1 grid__cell--row-0" >No Data</div> <div class="grid__cell grid__cell--content grid__cell--col-2 grid__cell--row-0" ></div> <div class="grid__cell grid__cell--content grid__cell--col-3 grid__cell--row-0" ></div> <div class="grid__cell grid__cell--content grid__cell--col-0 grid__cell--row-1" >1 (red)</div> <div class="grid__cell grid__cell--content grid__cell--col-1 grid__cell--row-1" >>4%</div> <div class="grid__cell grid__cell--content grid__cell--col-2 grid__cell--row-1" ></div> <div class="grid__cell grid__cell--content grid__cell--col-3 grid__cell--row-1" ></div> <div class="grid__cell grid__cell--content grid__cell--col-0 grid__cell--row-2" >2 (red)</div> <div class="grid__cell grid__cell--content grid__cell--col-1 grid__cell--row-2" ><4%</div> <div class="grid__cell grid__cell--content grid__cell--col-2 grid__cell--row-2" >AND/OR Data suggesting Arms for dark skin color of >4%</div> <div class="grid__cell grid__cell--content grid__cell--col-3 grid__cell--row-2" >AND/OR Data suggesting Arms for PI<1 in dark or light skin color of >4%</div> <div class="grid__cell grid__cell--content grid__cell--col-0 grid__cell--row-3" >3 (yellow)</div> <div class="grid__cell grid__cell--content grid__cell--col-1 grid__cell--row-3" ><4%</div> <div class="grid__cell grid__cell--content grid__cell--col-2 grid__cell--row-3" >AND/OR Data suggesting Arms for dark skin color of 3-4%</div> <div class="grid__cell grid__cell--content grid__cell--col-3 grid__cell--row-3" >AND/OR Data suggesting Arms for PI<1 in dark or light skin color of 3-4%</div> <div class="grid__cell grid__cell--content grid__cell--col-0 grid__cell--row-4" >4 (green)</div> <div class="grid__cell grid__cell--content grid__cell--col-1 grid__cell--row-4" ><3%</div> <div class="grid__cell grid__cell--content grid__cell--col-2 grid__cell--row-4" >AND No data for or against performance problems in darker skin colors</div> <div class="grid__cell grid__cell--content grid__cell--col-3 grid__cell--row-4" >AND No data for or against performance problems in low perfusion</div> <div class="grid__cell grid__cell--content grid__cell--col-0 grid__cell--row-5" >5 (green)</div> <div class="grid__cell grid__cell--content grid__cell--col-1 grid__cell--row-5" ><3%</div> <div class="grid__cell grid__cell--content grid__cell--col-2 grid__cell--row-5" >AND Extended testing beyond ISO/FDA recommendations Criteria TBD April 2023</div> <div class="grid__cell grid__cell--content grid__cell--col-3 grid__cell--row-5" >AND Extended testing beyond ISO/FDA recommendations Criteria TBD April 2023</div> </div> <span class="table__caption">* only independently tested devices by OpenOximetry (Hypoxia Lab and Clinimark Lab) get labeled as ‘verified’</span> </div> </div> </section> <script src="https://openoximetry.org/wp-content/themes/oximetry/build/ElasticPage.js?f0cff159"></script> </body> </html>

CINXE.COM

Collaborative Community - OpenOximetry