The performance of 11 fingertip pulse oximeters during hypoxemia in healthy human participants with varied, quantified skin pigmentResearch in context
Summary: Background: Fingertip pulse oximeters are widely available, inexpensive, and commonly used to make clinical decisions in many settings. Device performance is largely unregulated and poorly characterised, especially in people with dark skin pigmentation. Methods: Eleven popular fingertip pu...
| Main Authors: | , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Elsevier
2024-04-01
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| Series: | EBioMedicine |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2352396424000860 |
| _version_ | 1797214899316719616 |
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| author | Gregory Leeb Isabella Auchus Tyler Law Philip Bickler John Feiner Shamsudini Hashi Ellis Monk Elizabeth Igaga Michael Bernstein Yu Celine Chou Caroline Hughes Deleree Schornack Jenna Lester Kelvin Moore, Jr. Olubunmi Okunlola Jana Fernandez Leonid Shmuylovich Michael Lipnick |
| author_facet | Gregory Leeb Isabella Auchus Tyler Law Philip Bickler John Feiner Shamsudini Hashi Ellis Monk Elizabeth Igaga Michael Bernstein Yu Celine Chou Caroline Hughes Deleree Schornack Jenna Lester Kelvin Moore, Jr. Olubunmi Okunlola Jana Fernandez Leonid Shmuylovich Michael Lipnick |
| author_sort | Gregory Leeb |
| collection | DOAJ |
| description | Summary: Background: Fingertip pulse oximeters are widely available, inexpensive, and commonly used to make clinical decisions in many settings. Device performance is largely unregulated and poorly characterised, especially in people with dark skin pigmentation. Methods: Eleven popular fingertip pulse oximeters were evaluated using the US Food and Drug Administration (FDA) Guidance (2013) and International Organization for Standardization Standards (ISO, 2017) in 34 healthy humans with diverse skin pigmentation utilising a controlled desaturation study with arterial oxygen saturation (SaO 2) plateaus between 70% and 100%. Skin pigmentation was assessed subjectively using a perceived Fitzpatrick Scale (pFP) and objectively using the individual typology angle (ITA) via spectrophotometry at nine anatomical sites. Findings: Five of 11 devices had a root mean square error (ARMS) > 3%, falling outside the acceptable FDA performance range. Nine devices demonstrated worse performance in participants in the darkest skin pigmentation category compared with those in the lightest category. A commonly used subjective skin colour scale frequently miscategorised participants as being darkly pigmented when compared to objective quantification of skin pigment by ITA. Interpretation: Fingertip pulse oximeters have variable performance, frequently not meeting regulatory requirements for clinical use, and occasionally contradicting claims made by manufacturers. Most devices showed a trend toward worse performance in participants with darker skin pigment. Regulatory standards do not adequately account for the impact of skin pigmentation on device performance. We recommend that the pFP and other non-standardised subjective skin colour scales should no longer be used for defining diversity of skin pigmentation. Reliable methods for characterising skin pigmentation to improve diversity and equitable performance of pulse oximeters are needed. Funding: This study was conducted as part of the Open Oximetry Project funded by the Gordon and Betty Moore Foundation, Patrick J McGovern Foundation, and Robert Wood Johnson Foundation. The UCSF Hypoxia Research Laboratory receives funding from multiple industry sponsors to test the sponsors' devices for the purposes of product development and regulatory performance testing. Data in this paper do not include sponsor's study devices. All data were collected from devices procured by the Hypoxia Research Laboratory for the purposes of independent research. No company provided any direct funding for this study, participated in study design or analysis, or was involved in analysing data or writing the manuscript. None of the authors own stock or equity interests in any pulse oximeter companies. Dr Ellis Monk's time utilised for data analysis, reviewing and editing was funded by grant number: DP2MH132941. |
| first_indexed | 2024-04-24T11:21:30Z |
| format | Article |
| id | doaj.art-7e437b39c26b4f1cb25a2dcbb6c4906f |
| institution | Directory Open Access Journal |
| issn | 2352-3964 |
| language | English |
| last_indexed | 2024-04-24T11:21:30Z |
| publishDate | 2024-04-01 |
| publisher | Elsevier |
| record_format | Article |
| series | EBioMedicine |
| spelling | doaj.art-7e437b39c26b4f1cb25a2dcbb6c4906f2024-04-11T04:41:26ZengElsevierEBioMedicine2352-39642024-04-01102105051The performance of 11 fingertip pulse oximeters during hypoxemia in healthy human participants with varied, quantified skin pigmentResearch in contextGregory Leeb0Isabella Auchus1Tyler Law2Philip Bickler3John Feiner4Shamsudini Hashi5Ellis Monk6Elizabeth Igaga7Michael Bernstein8Yu Celine Chou9Caroline Hughes10Deleree Schornack11Jenna Lester12Kelvin Moore, Jr.13Olubunmi Okunlola14Jana Fernandez15Leonid Shmuylovich16Michael Lipnick17Department of Anesthesia, University of California, San Francisco, USADepartment of Anesthesia, University of California, San Francisco, USA; Corresponding author. Department of Anesthesia and Perioperative Care, University of California San Francisco, 1001 Potrero Avenue, Bld 5, Rm 3C38, San Francisco, CA, 94122, USA.Department of Anesthesia, University of California, San Francisco, USADepartment of Anesthesia, University of California, San Francisco, USADepartment of Anesthesia, University of California, San Francisco, USADepartment of Anesthesia, University of California, San Francisco, USADepartment of Sociology, Harvard University, USADepartment of Anesthesia, College of Health Sciences, Makerere University, UgandaPhysio Monitor, LLC, San Ramon, CA, USADepartment of Anesthesia, University of California, San Francisco, USADepartment of Anesthesia, University of California, San Francisco, USADepartment of Anesthesia, University of California, San Francisco, USADepartment of Dermatology, University of California, San Francisco, USAUniversity of California, San Francisco School of Medicine, USADepartment of Anesthesia, New York University Langone Hospital Brooklyn, USADepartment of Anesthesia, University of California, San Francisco, USADepartment of Dermatology, Washington University in St. Louis, USA; Corresponding author. Division of Dermatology in the Department of Medicine, Washington University in Saint Louis, MSC 8123-29-10014, 660 South Euclid Avenue, Saint Louis, MO, 63108, USA.Department of Anesthesia, University of California, San Francisco, USA; University of California, San Francisco Institute for Global Health Sciences, USASummary: Background: Fingertip pulse oximeters are widely available, inexpensive, and commonly used to make clinical decisions in many settings. Device performance is largely unregulated and poorly characterised, especially in people with dark skin pigmentation. Methods: Eleven popular fingertip pulse oximeters were evaluated using the US Food and Drug Administration (FDA) Guidance (2013) and International Organization for Standardization Standards (ISO, 2017) in 34 healthy humans with diverse skin pigmentation utilising a controlled desaturation study with arterial oxygen saturation (SaO 2) plateaus between 70% and 100%. Skin pigmentation was assessed subjectively using a perceived Fitzpatrick Scale (pFP) and objectively using the individual typology angle (ITA) via spectrophotometry at nine anatomical sites. Findings: Five of 11 devices had a root mean square error (ARMS) > 3%, falling outside the acceptable FDA performance range. Nine devices demonstrated worse performance in participants in the darkest skin pigmentation category compared with those in the lightest category. A commonly used subjective skin colour scale frequently miscategorised participants as being darkly pigmented when compared to objective quantification of skin pigment by ITA. Interpretation: Fingertip pulse oximeters have variable performance, frequently not meeting regulatory requirements for clinical use, and occasionally contradicting claims made by manufacturers. Most devices showed a trend toward worse performance in participants with darker skin pigment. Regulatory standards do not adequately account for the impact of skin pigmentation on device performance. We recommend that the pFP and other non-standardised subjective skin colour scales should no longer be used for defining diversity of skin pigmentation. Reliable methods for characterising skin pigmentation to improve diversity and equitable performance of pulse oximeters are needed. Funding: This study was conducted as part of the Open Oximetry Project funded by the Gordon and Betty Moore Foundation, Patrick J McGovern Foundation, and Robert Wood Johnson Foundation. The UCSF Hypoxia Research Laboratory receives funding from multiple industry sponsors to test the sponsors' devices for the purposes of product development and regulatory performance testing. Data in this paper do not include sponsor's study devices. All data were collected from devices procured by the Hypoxia Research Laboratory for the purposes of independent research. No company provided any direct funding for this study, participated in study design or analysis, or was involved in analysing data or writing the manuscript. None of the authors own stock or equity interests in any pulse oximeter companies. Dr Ellis Monk's time utilised for data analysis, reviewing and editing was funded by grant number: DP2MH132941.http://www.sciencedirect.com/science/article/pii/S2352396424000860Pulse oximeterSkin pigmentationMedical devicesLow-cost oximeter |
| spellingShingle | Gregory Leeb Isabella Auchus Tyler Law Philip Bickler John Feiner Shamsudini Hashi Ellis Monk Elizabeth Igaga Michael Bernstein Yu Celine Chou Caroline Hughes Deleree Schornack Jenna Lester Kelvin Moore, Jr. Olubunmi Okunlola Jana Fernandez Leonid Shmuylovich Michael Lipnick The performance of 11 fingertip pulse oximeters during hypoxemia in healthy human participants with varied, quantified skin pigmentResearch in context EBioMedicine Pulse oximeter Skin pigmentation Medical devices Low-cost oximeter |
| title | The performance of 11 fingertip pulse oximeters during hypoxemia in healthy human participants with varied, quantified skin pigmentResearch in context |
| title_full | The performance of 11 fingertip pulse oximeters during hypoxemia in healthy human participants with varied, quantified skin pigmentResearch in context |
| title_fullStr | The performance of 11 fingertip pulse oximeters during hypoxemia in healthy human participants with varied, quantified skin pigmentResearch in context |
| title_full_unstemmed | The performance of 11 fingertip pulse oximeters during hypoxemia in healthy human participants with varied, quantified skin pigmentResearch in context |
| title_short | The performance of 11 fingertip pulse oximeters during hypoxemia in healthy human participants with varied, quantified skin pigmentResearch in context |
| title_sort | performance of 11 fingertip pulse oximeters during hypoxemia in healthy human participants with varied quantified skin pigmentresearch in context |
| topic | Pulse oximeter Skin pigmentation Medical devices Low-cost oximeter |
| url | http://www.sciencedirect.com/science/article/pii/S2352396424000860 |
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