New FDA Proposal Requires Medical Device Makers to Test Products on Diverse Patient Populations
Makers of Medical Devices Must Gather Extra Data to Show Efficacy for Patients of Color
The Food and Drug Administration (FDA) has released a new proposal that requires manufacturers of medical devices that measure oxygen levels in the blood to gather extra data to show that their products work for patients of color. The proposal applies to pulse oximeters, which are clip-on devices used in hospitals and medical clinics to ensure patients are getting enough oxygen.
Background:
Pulse oximeters use a non-invasive technique to measure the amount of oxygen in a patient’s blood by shining light through the skin. However, several studies have suggested that darker skin pigmentation can sometimes throw off the accuracy of readings. In 2021, the FDA warned doctors about potential inaccuracies with oximeters after a study found that they tend to overestimate Black patients’ oxygen levels, which could lead to delays in getting treatment and increased risks of death.
New Proposal:
The FDA’s draft recommendations aim to address these concerns by requiring manufacturers to conduct larger studies with more diverse patient populations. Specifically, the proposal requires:
- Enrolling at least 150 patients of different skin tones in clinical studies
- Including at least 25% of patients with darker skin complexion in each study, up from 15% previously
- Evaluating pigmentation of every study participant using at least two different methods, one based on a researcher’s evaluation and another based on scientific, light-based measurement of melanin levels in the skin
Key Takeaways:
- The FDA’s proposal applies to professional oximeters used in hospitals, doctor’s offices, and other medical settings, not over-the-counter oximeters
- The proposal is a draft and open for public comment for 60 days
- The FDA expects to see new diversity data from manufacturers when requesting changes or updates to older oximeters
Conclusion:
The FDA’s proposal is a step towards ensuring that medical devices are tested and validated for diverse patient populations, which is crucial for improving healthcare outcomes and reducing health disparities. By requiring manufacturers to gather extra data, the FDA is taking a proactive approach to address the potential biases in medical technology.
Frequently Asked Questions:
Q: What type of devices are affected by the FDA’s proposal?
A: The proposal applies to professional oximeters used in hospitals, doctor’s offices, and other medical settings.
Q: What is the purpose of the proposal?
A: The proposal aims to ensure that medical devices are tested and validated for diverse patient populations, reducing the risk of inaccurate readings and improving healthcare outcomes.
Q: How long is the public comment period for the proposal?
A: The public comment period is 60 days.
Q: What is the next step after the public comment period?
A: The FDA will begin working on a final version of the proposal after the public comment period.
