Unreliable Pulse Oximeter Readings Due To Skin Color Reviewed By FDA Panel
The FDA's Medical Devices Advisory Committee examined clinical data Tuesday and discussed interim steps — like box labels to warn of potentially inaccurate readings for patients with darker skin tones — to provide more time for the agency to investigate. The devices have been widely used by consumers during the covid pandemic.
CNN:
FDA Panel Examines Evidence That Pulse Oximeters May Not Work As Well On Dark Skin
A panel of the US Food and Drug Administration’s Medical Devices Advisory Committee met Tuesday to review clinical data about the accuracy of pulse oximetry in patients with darker skin and to discuss recommendations on using these devices on people with dark skin tones and whether they should have labels – such as a black box warning – noting that inaccurate readings may be associated with skin color. (Howard, 11/1)
More on the spread of covid —
AP:
Education Secretary Tests Positive For COVID-19
President Joe Biden’s education secretary has tested positive for COVID-19. Miguel Cardona, who has been vaccinated and boosted against the virus, tested positive Tuesday and has mild symptoms, the Education Department said in a statement. (11/1)
CIDRAP:
Study: US Political Divide May Help Explain Shrinking Racial COVID Death Gap
New evidence suggests that the shrinking gap in US COVID-19 racial death disparities is being driven by political division and increasing total deaths—mostly among White people—rather than by decreasing deaths among Black Americans, according to a new study published in PLOS One. (Van Beusekom, 11/1)
Los Angeles Times:
How L.A.'s Sprawl Fueled COVID Deaths
Having so many people in such tight quarters has had deadly consequences for the people who live there. The neighborhood’s COVID-19 mortality rate — 825 per 100,000 residents — is the second highest in the county. (The top spot belongs to Little Armenia, where there have been 1,172 deaths per 100,000 residents.) (Kaplan, 11/1)
Des Moines Register:
Iowa School Mask Mandate Ban Must Yield To ADA, Federal Judge Rules
Iowa school districts must consider medically sensitive students' requests to require mask wearing of those around them, notwithstanding a state law that banned school mask mandates, a federal judge ruled Tuesday. (Morris, 11/1)
In news about other outbreaks and health threats —
CIDRAP:
WHO Keeps Monkeypox Public Health Emergency In Place
The World Health Organization (WHO) monkeypox emergency committee met for the third time on Oct 20 to discuss the latest developments, concluding that the situation still warrants a public health emergency of international concern (PHEIC).In a statement today on their deliberations, the group said progress has been made, such as behavioral interventions and increasing vaccine uptake. However, they raised concerns about ongoing transmission in some regions, health inequities in a number of countries, and impacts on vulnerable populations, especially in those with HIV and in countries with weak health systems. (11/1)
NBC News:
CDC Warns Of Bacteria In Dental Waterlines After Disease Outbreaks In Children
The Centers for Disease Control and Prevention on Monday issued a health advisory about waterborne bacteria in dental plumbing systems after children who visited pediatric dental clinics were infected with nontuberculous Mycobacteria. (Alsharif, 11/1)
The Boston Globe:
Active Case Of Tuberculosis Confirmed At Dartmouth College, Officials Say
New Hampshire health officials have identified an active case of tuberculosis at Dartmouth College, according to a community advisory issued Monday by the Ivy League school. The statement did not say if the person diagnosed is a student or staff member. (Fonseca, 11/1)
On malaria treatments and dengue fever vaccines —
CIDRAP:
Monoclonal Antibody Infusion 88% Effective Against Malaria
Yesterday the New England Journal of Medicine published the results of a phase 2 trial showing 88% efficacy for a monoclonal antibody against malaria. The antibody infusion, CIS43LS, was protective against Plasmodium falciparum infection over a 6-month malaria season in Mali without evident safety concerns, with participants performing blood-smear tests every 2 weeks during the phase 2 trial. (Soucheray, 11/1)
Bloomberg:
Takeda Dengue Fever Vaccine Had Bumpy Path To Market
After decades of delays, the first vaccine for dengue fever was introduced seven years ago. But that formula, from Sanofi, was soon found to be suitable only for people who had previously been infected with the disease, spurring researchers at Japan’s Takeda Pharmaceutical Co. to redouble efforts on an alternative. That work is finally paying off, with their version expected to hit the market early next year. (Matsuyama, 11/2)
