Advisory Committee Urges FDA to Raise Standards for Pulse Oximeters

Pulse Oximeter inaccuracies contributed to deaths among Black Americans during the COVID-19 pandemic, the panel believes.

A panel of scientific experts is recommending U.S. regulators focus on improving the accuracy of pulse oximeters, which have been shown to be prone to inaccurate readings when monitoring patients with dark skin, which may have contributed to a number of deaths during the COVID-19 pandemic and in other medical emergencies.

The FDA’s Anesthesiology and Respiratory Therapy Devices advisory panel met Tuesday and offered recommendations to the agency (Youtube), but did not formally take up a vote regarding pulse oximeter device regulation or treatment standards.

Pulse oximeters are used to measure oxygen levels in the blood. They are usually placed on the fingertip, and tend to be small and inexpensive medical devices. While they are mostly used in hospitals, medical clinics and doctor’s offices, pulse oximeters are increasingly sold on the retail market to consumers as well.

Problems with pulse oximeters gained public attention during the coronavirus pandemic. Prior research has shown the devices are less accurate on patients with more melanin in their skin, which impacts Black patients and other individuals with darker skin color.

Did You Know?

AT&T Data Breach Impacts Millions of Customers

More than 73 million customers of AT&T may have had their names, addresses, phone numbers, Social Security numbers and other information released on the dark web due to a massive AT&T data breach. Lawsuits are being pursued to obtain financial compensation.

Learn More

Reports have highlighted inaccurate readings among people of color, and suggest that the problems contributed to increased deaths during the pandemic, as people of color were not receiving timely treatment due to flawed readings.

The panel, largely composed of white, male doctors, issued recommendations that focused on improving the accuracy standards and called for doctors using the devices to be aware of potential inaccuracies when making treatment decisions for patients based on pulse oximeter readings. However, the panel fell short of specific regulations.

Pulse Oximeter Problems

Concerns about problem with pulse oximeters are not new. Studies from the mid-1990’s highlighted the inaccuracy of the readings on those of darker skin. The studies clearly indicate a flawed design. People with darker skin had healthy readings, despite blood tests indicating worsened health status.

Dr. Amal Jubran, pulmonary critical care doctor at Loyola Medicine in Chicago, testified Tuesday about the hazards the devices posed to patients during the pandemic. Jubran was one of the first doctors to identify the problem in 1990.

His testimony indicated the flawed readings contributed to a seven-fold increase in COVID-19 deaths among people of color, compared to white patients.

Blood oxygen levels are a deciding factor to determine who should receive certain medications, oxygen therapies and even receive hospital beds when hospitals resources were strained, and beds and medical treatments were in short supply.

Pulse oximeters used in hospitals were marketed based on studies of as few as 10 healthy people. Since then, a number of studies have raised red flags.

The FDA itself highlighted the pulse oximeter accuracy concerns in 2021, issuing a safety communication on the inaccuracies, and later called for the expert panel to be held this year.

Research from the University of Michigan indicate pulse oximeters that squeeze the finger tend to give elevated readings among Black people, but blood tests indicated “hidden” hypoxemia, or low blood oxygen. Black and Latino patients who had hidden hypoxemia during the pandemic had a 70% increased risk of death.

A study conducted by Johns Hopkins University School of Medicine concluded Black and Latino patients were 29% and 23% less likely to receive COVID treatments as a result of the flawed readings. Roughly one-quarter of patients never received treatment at all because of the problem.

While the panel did not formally take a vote on specific ways the FDA could regulate the problem, measures to add warnings to product labels and improving manufacturer standards were suggested.

The panelists agreed the current rules were too lax for medical devices, but only one community representative, the lone African American on the panel, called for manufacturers to be held accountable.

The FDA often convenes expert panels to advise the agency on important public health concerns. While the agency is not required to take the panel’s recommendations, it often complies with votes or calls for changes according to the panel’s recommendations.

0 Comments

Share Your Comments

I authorize the above comments be posted on this page*

Want your comments reviewed by a lawyer?

To have an attorney review your comments and contact you about a potential case, provide your contact information below. This will not be published.

NOTE: Providing information for review by an attorney does not form an attorney-client relationship.

This field is for validation purposes and should be left unchanged.

More Top Stories

BioZorb Lawsuit Alleges Breast Tissue Marker Failed, Requiring Surgical Removal
BioZorb Lawsuit Alleges Breast Tissue Marker Failed, Requiring Surgical Removal (Posted yesterday)

A BioZorb lawsuit has been filed by several breast cancer survivors after the BioZorb implants moved out of place and failed to dissolve int he body, requiring surgical removal.

Fairness Hearing For Philips CPAP Recall Medical Monitoring Settlement Set for October
Fairness Hearing For Philips CPAP Recall Medical Monitoring Settlement Set for October (Posted yesterday)

A U.S. District Court judge has scheduled a fairness hearing for October in order to determine whether final approval should be granted to a $25 million Philips CPAP recall settlement agreement, which would pay former users $25 million to pay for future medical monitoring needs.

Abbott Laboratories Faces Jury Trial Over Claims Similac Caused NEC For Premature Infant
Abbott Laboratories Faces Jury Trial Over Claims Similac Caused NEC For Premature Infant (Posted 2 days ago)

Following a $60 million verdict in a similar lawsuit earlier this year, trial is underway involving claims brought by an Illinois mother, whose premature daughter developed NEC from Similac, alleging that Abbott failed to warn parents and medical staff of the devastating risks associated with the cow's milk-based formula.