New Guidance Aims to Enhance Device Performance and Patient Care
The U.S. Food and Drug Administration (FDA) has recently unveiled draft guidance aimed at improving the accuracy and performance of pulse oximeters across various skin pigmentations. These vital medical devices, which estimate blood oxygen levels, have shown discrepancies in accuracy between individuals with lighter and darker skin tones.
To address these concerns, the FDA has proposed new recommendations for manufacturers on gathering clinical data and improving clinical study design and validation efforts. The goal is to ensure that pulse oximeters perform accurately across the spectrum of skin pigmentations.
Dr. Michelle Tarver, director of the FDA’s Center for Devices and Radiological Health, emphasized that the draft guidance aligns with the FDA’s broader commitment to facilitating the development of high-quality, safe, and effective medical devices. The recommendations are based on the best available scientific evidence to tackle disparities in pulse oximeter performance based on skin pigmentation.
Key elements of the FDA’s draft recommendations include:
1. Gathering clinical data to evaluate device performance accuracy across skin pigmentations.
2. Increasing the number of clinical study participants.
3. Using both subjective and objective methods to assess skin tone and device performance.
4. Including prominent labeling statements for devices that demonstrate comparable performance across diverse skin pigmentations.
The FDA anticipates that some currently marketed pulse oximeters may meet the updated performance criteria without significant modifications. In such cases, the agency intends to review submissions expeditiously to ensure prompt public access to safe and accurate devices.
The draft guidance applies to certain pulse oximeters intended for medical purposes, primarily used in hospital settings or doctors’ offices. It does not apply to general wellness or sporting/aviation products that are not reviewed by the FDA.
To enhance transparency, the FDA has proposed creating a publicly available webpage identifying FDA-cleared pulse oximeters for medical purposes that demonstrate comparable performance across skin pigmentations.
The agency developed these recommendations after considering various data sources, including controlled laboratory testing, real-world performance data, and feedback from scientists, clinicians, and manufacturers. The FDA also conducted two advisory committee meetings and issued a discussion paper on the topic.
Additionally, the FDA partnered with academic institutions to conduct prospective clinical studies on pulse oximeter accuracy in adults and pediatric patients with varying skin pigmentation. These studies informed the agency’s proposed approach to capturing and measuring skin pigmentation.
The FDA is now seeking public comments on the draft guidance within 60 days of publication. After reviewing all comments, the agency will finalize the guidance.
Commentary by SuppBase columnist Alice Winters:
The FDA’s recent draft guidance on pulse oximeters marks a significant step forward in addressing a crucial issue in medical device accuracy and healthcare equity. This move underscores the growing recognition of how medical technologies can inadvertently perpetuate racial disparities in healthcare outcomes.
The core of this guidance revolves around the alarming discrepancies in pulse oximeter accuracy between individuals with lighter and darker skin tones. This isn’t just a matter of slight variations; inaccurate readings can lead to delayed or missed diagnoses, potentially putting lives at risk. The COVID-19 pandemic brought this issue into sharp focus, as pulse oximeters became a frontline tool for monitoring patients’ oxygen levels.
What’s particularly noteworthy about the FDA’s approach is its comprehensive nature. By recommending increased diversity in clinical study participants and the use of both subjective and objective methods to assess skin tone, the agency is pushing for a more robust and representative evaluation process. The Monk Skin Tone Scale and the individual typology angle calculation are excellent choices for standardizing skin tone assessment, providing a more nuanced approach than the outdated Fitzpatrick scale.
However, the real challenge lies in implementation. While the FDA’s intentions are commendable, the success of these guidelines will depend on manufacturers’ willingness to invest in new clinical studies and potentially redesign their devices. The agency’s promise of expedited review for devices meeting the new criteria is a smart move, providing an incentive for quick adoption.
It’s also worth noting that this guidance only applies to medical-grade pulse oximeters. The vast array of consumer-grade devices flooding the market during the pandemic remains largely unregulated. This creates a two-tiered system where medical professionals might have access to more accurate devices, while the general public continues to rely on potentially less accurate consumer products.
The proposed public webpage listing FDA-cleared devices that meet the new standards is an excellent step towards transparency. However, it will be crucial to educate healthcare providers and the public about the importance of choosing devices from this list.
Looking ahead, this guidance could serve as a template for addressing similar issues in other medical devices. From skin cancer detection algorithms to facial recognition in medical imaging, many technologies have shown biases related to skin color. The FDA’s approach here – combining rigorous scientific standards with an awareness of diversity – could be applied more broadly across the medical technology landscape.
In conclusion, while this guidance is a significant step forward, it’s just the beginning. The medical community, device manufacturers, and regulatory bodies must continue to work together to ensure that all medical technologies perform equally well for all patients, regardless of their skin color. Only then can we truly claim to be providing equitable, high-quality healthcare for all.
