FDA updates guidelines for Pulse Ox devices used in healthcare
The U.S. Food and Drug Administration is seeking public comment on new recommendations for non-clinical and clinical performance testing to support pre-market submissions for medical-grade pulse oximeters. These include devices with a function that estimates the amount of oxygen in the arterial blood and the heart rate.
WHY IT’S IMPORTANT
During the COVID-19 pandemic, medical researchers and physicians gathered evidence that pulse oximeters did not always provide accurate readings for darker skin tones.
In 2023, the FDA warned of possible risks of inaccuracy under certain conditions and said it became aware that pulse oximeters could be less accurate in people with darker skin pigmentation. The agency then scheduled public meetings last year to reassess existing pulse oximetry guidelines.
The new one proposed updateposted on its website, strengthens recommendations for collecting real-world and laboratory clinical data to evaluate the accuracy of device performance across the range of skin pigmentations and to use both subjective and objective methods to improve evaluations of pulse oximeter products used in the healthcare are used to standardize.
The guidance, Pulse Oximeters for Medical Purposes – Non-Clinical and Clinical Performance Testing, Labeling and Premarket Submission Recommendations, suggests new performance information in product labeling and applies only to certain pulse oximeters used primarily for medical purposes in hospitals or physician offices . The FDA reported this in a statement on Monday.
Some pulse oximeters currently on the market may meet the updated performance criteria without requiring significant hardware or software modifications, the agency explains.
If a sponsor of such a device submits only “updated labeling to reflect the collection of clinical data demonstrating comparable performance in skin pigmentations without modifications to the device,” the agency said it would provide an expedited review within 30 days “to ensure ensure the public has quick access to safe and accurate pulse oximeters.”
The updated Pulse Ox guidelines do not apply to general wellness products or sports/aerospace products that the FDA does not review or evaluate before making them available to the public, the FDA noted.
Comments received by March 10 will be considered before the agency begins work on the final version of the guidance, the agency said.
THE BIG TREND
Research published in the New England Journal of Medicine in 2020, after comparing arterial oxygen saturation measurements with pulse oximetry, black patients were found to be three times more likely to have occult hypoxemia than white patients.
The Johns Hopkins School of Medicine has drawn attention to the FDA’s regulation of pulse oximeters in the medical device field, criticizing the agency’s handling of its 510(k) review process to place these products in the medical, consumer and other industrial markets, and called for the agency’s response to be timely.
In response, an FDA spokesperson said Healthcare IT news in July that it was still engaging stakeholders and gathering input from clinical researchers to inform the update. Previously, the FDA said in its Center for Devices and Radiological Health Guidance Agenda that revising the pulse ox guidelines was a priority and intended to issue updates in FY 2024.
In a lawsuit filed with stop selling defective pulse oximeters by Roots Community Health Center in Oakland, California, the health care organization called it a striking example of how systemic racism can impact health care and public health outcomes.
According to the American Heart Association, mortality rates for cardiovascular disease are also the same highest among black Americansand racial biases inherent in light sensors and other technologies may have potential links to the demographic group’s increased risks.
Medtronic announced in October that it had been excluded from the federal lawsuit filed against CVS, Walgreens, GE Healthcare and many other medical technology companies. A company spokesperson said that over the past two years, Medtronic has improved the diversity of its clinical trials, educated medical providers on the appropriate use of pulse oximetry and invested in technology improvements.
“We are pleased that Medtronic, which has a dominant share of the pulse oximeter market, has agreed to prioritize patient safety by providing labels and brochures alerting their hospital customers in California to the potential measurement deficiencies for people with dark skin pigmentation” , said Roots. email after the announcement.
ON THE RECORD
“This draft guidance is consistent with the FDA’s broader commitment to help facilitate the development of high-quality, safe and effective medical devices,” said Dr. Michelle Tarver, FDA director at CDRH, said in a statement. “Our draft recommendations are based on the best available science to address concerns about the disparate performance of pulse oximeters based on an individual’s skin pigmentation.”
Andrea Fox is editor-in-chief of Healthcare IT News.
Email: afox@himss.org
Healthcare IT News is a HIMSS Media publication.