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Pulse Oximeters: Rarely Evaluated by Manufacturers Across Diverse Populations
- Researchers at the Johns Hopkins Bloomberg School of Public Health have recently uncovered a significant gap in compliance with the Food and Drug Administration’s (FDA) guidance on testing pulse oximeters across diverse skin tones.
- Only a modest number of manufacturers have adapted their testing protocols to include individuals with a range of skin pigmentations, despite an increase since the FDA issued its guidance in 2013.
- Pulse oximeters yield less accurate results for individuals with darker skin, and undetected low blood oxygen levels could lead to misdiagnosis and delayed treatment for vulnerable populations.
- While FDA’s guidance had some influence, the implementation to include diverse participant pools has been alarmingly slow.
- The responsibility of diversifying participant pools to enhance accuracy and promote greater patient safety falls on manufacturers and regulatory bodies.
- Addressing the complex issue of inherent biases in healthcare technology requires a sustained effort towards systemic change in the healthcare system.
- The ongoing COVID-19 pandemic makes it more pressing than ever to accurately test and validate the effectiveness of health technology devices across all demographic groups.
- Cultural competence is an ongoing challenge in medical technology development, and standardization of testing trials and clearer benchmarks regarding skin tone variation is necessary.
- The FDA’s updated draft guidance is an opportunity for stakeholders to engage in meaningful discourse, ensuring that pulse oximeters serve the entirety of the population effectively.
- Greater emphasis on inclusivity in medical testing and rigorous application of guidelines will be essential in bridging the gaps present in healthcare delivery and achieving equitable health outcomes for all.
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