In a lawsuit filed against CVS, Walgreens, GE Healthcare and many other medical technology companies and sellers of pulse oximeters — devices that use light to measure oxygen saturation in the blood — Medtronic has been dismissed, the company said in a statement Monday.
Meanwhile, the U.S. Food and Drug Administration has been working to update its 2013 guidelines on pulse oximetry submissions; publication and public comment have been pushed back to fiscal year 2025.
WHY IT’S IMPORTANT
Medtronic, a medical device and technology company, was one of several defendants named in a lawsuit Roots Community Health Center filed in Alameda County Superior Court last year.
Passed during the COVID-19 epidemic, when the death rate among Black Americans was disproportionately high, Roots said in his report. announcement about the lawsuit that the company relied on pulse oximeters in its decisions to administer oxygen therapy to the swelling lines of patients coming to the hospital for medical care.
Roots asked the court to halt sales of “unreliable pulse oximeters” or require manufacturers and distributors of the defective devices to warn buyers about the dangerous flaws of their products.
“At least one of the FDA-approved Medtronic/Covidien pulse oximeters notes in the manual that comes with the pulse oximeter that dark skin pigment can cause inaccurate readings,” Roots said in the submit.
“The manual does not explain that measurements in people with dark skin may appear skewed to show that people with dark skin have more oxygen than they actually do, nor that dark skin pigmentation can interact with other conditions to cause or worsen inaccurate measurements. “
While Roots also alleged that Medtronic and other companies “knew or should have known” that statements not approved by the FDA were “false or misleading and would mislead or be likely to mislead consumers,” Roots agreed at that time to dismiss claims against Medtronic,” a company spokesperson said Healthcare IT news by email.
The spokesperson said Medtronic has recruited more “diverse participants” for its clinical trials, educated medical providers on the proper use of pulse oximetry and invested in technology improvements over the past two years.
THE BIG TREND
Research published in the New England Journal of Medicine In late 2020, it was discovered that pulse oximeters may be less accurate for Black patients, and since that time, many critics of pulse oximeters say the rapid adoption has caused the medical community and regulators to overlook how skin color can affect pulse reading.
According to critics at the Bloomberg School’s Johns Hopkins School of Medicine in Health Policy and Management, the FDA’s standards for pulse oximeters essentially ignored the functional racial disparity that has proven to be pervasive among photosensitive devices. The health policy academics argued earlier this year in journal articles and in their podcast series eliminate that pulse oximetry bias requires decisive regulatory action.
This was reported by the FDA’s Center for Devices and Radiological Health Healthcare IT news in July, it was announced that the 2013 revision of the pulse oximeter guidelines will be listed as a priority on the CDRH Guidance Agenda with the intention to issue it in fiscal year 2024, which ended on September 30.
“The FDA has engaged stakeholders, gathered input from ongoing clinical research to help inform our decisions and evaluated all available information regarding factors that may affect pulse oximeter accuracy and performance,” the spokesperson said at the time.
Two months after Congress joined his colleagues in criticizing him for missteps in medical devices, CDRH director Dr. However, Jeff Shuren will retire at the end of July.
Last week the FDA announced that Dr. Michelle Tarver, an ophthalmologist with a doctorate in epidemiology who has held several leadership positions at the FDA as a medical device regulator, would replace Shuren as permanent CDRH director.
We reached out to the FDA for an update on the dangling status of updated guidelines for pulse oximeters and asked about Tarver’s POV on pulse oximeters.
“The CDRH 2024 guidance agenda included guidance documents that CDRH intended to publish in fiscal year 2024,” the FDA spokesperson explained by email on Wednesday. “However, the Center is not bound by this list of topics nor is it required to issue every guidance document on the list.”
The spokesperson added, “The FDA has worked diligently to update its 2013 final guidance for pulse oximeters and is committed to issuing these new draft recommendations as soon as possible.”
“Updating these guidelines is a priority for CDRH.”
We’ve reached out to Roots about the Medtronic agreement and the status of the FDA’s pulse oximeter submission guidelines and will update this story if there is a statement.
ON THE RECORD
“Medtronic is pleased to announce that Roots Community Health has agreed to dismiss claims against the company regarding pulse oximeters,” Medtronic said in a statement.
“Medtronic looks forward to working with Roots, the FDA and other key stakeholders to ensure healthcare equity can be achieved through technology, educational efforts and partnerships.”
Andrea Fox is editor-in-chief of Healthcare IT News.
Email: afox@himss.org
Healthcare IT News is a HIMSS Media publication.