FDA grants EUA for COVID breath test
The U.S. Food and Drug Administration (FDA) has granted emergency use authorization (EUA) to the InspectIR COVID-19 Breathalyzer, the first COVID test that can detect compounds associated with SARS-CoV-2 infection in breath samples. It is intended for health care settings such as mobile testing sites, doctor’s offices, and hospitals, and results are returned in under three minutes.
The authorization comes after validation in a study of 2,409 people with and without COVID symptoms. The study found that the test had a sensitivity of 91.2%, a specificity of 99.3%, and yielded a negative predictive value of 99.6%, suggesting that people who receive a negative test result are likely truly negative in areas of low disease prevalence. Positive tests should be confirmed with a molecular test, while negative results should be considered in the context of recent exposures.
COVID-19 the third-leading cause of death in U.S. for second year
Two papers recently published in the Morbidity and Mortality Weekly Report used Centers for Disease Control and Prevention (CDC) National Vital Statistics System data to report on death rates in the U.S. in 2021 (MMR Morb Mortal Wkly Rep 2022;71:601-5; MMWR Morb Mortal Wkly Rep 2022;71:597-600). Researchers reviewed provisional mortality data for 2021 and found that COVID-19 was the third-leading cause of death, behind only heart disease and cancer. These top-three causes of death were unchanged from 2020, but COVID was found to be the underlying cause of death for 13.3% of all deaths in 2021, an increase from 10.4% in 2020.
FDA OKs U.S.-manufactured biodegradable medical gloves
Showa Group has announced FDA 510(k) clearance for its biodegradable, single-use medical gloves. The gloves were shown to break down by more than 80% over 386 days in laboratory tests, with full decomposition estimated within one to five years, compared to decades for regular surgical gloves. Though other biodegradable gloves are cleared for use, this is the first fully U.S.-manufactured glove to be granted FDA clearance. The health care field generates millions of tons of waste every year, which was compounded by increased use of personal protective equipment (PPE) and diagnostic testing during the COVID-19 pandemic; this new clearance could help reduce the environmental impact of PPE glove waste.
A study supported by the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health (NIH), found that law enforcement seizures of pills containing fentanyl increased nearly 50-fold between 2018 and 2021. The study, recently published in Drug and Alcohol Dependence (Drug Alcohol Depend 2022;234:109398), comes after a record high in the number of overdose deaths reported by the CDC.
The law enforcement seizure data were collected between January 2018 and December 2021 from the High Intensity Drug Trafficking Areas program, which is aimed at reducing drug trafficking and abuse. Researchers compared data from the first quarter of 2018 with the last quarter of 2021 and found that the number of seized pills containing fentanyl increased from 68 to 635, and the total number of pills seized increased from 42,202 to 2,089,186. Though drug seizure rates are not direct measures of drug availability, the increase in fentanyl-related drug seizures corresponds with increasing opioid-related overdose death rates.
FDA proposes rule to ban menthol cigarettes
The FDA has announced a plan to prohibit menthol flavoring in cigarettes and to ban all flavoring in cigars. The proposal is part of the Biden administration’s Cancer Moonshot to reduce the death rate from cancer by 50% over the next 25 years. Smoking is the leading cause of preventable death in the U.S., and approximately 30% of all cancer deaths in the U.S. are caused by smoking.
Menthol flavoring increases the appeal of cigarettes with a minty taste and reduction in irritation, thus attracting youth and making it more difficult for people to quit smoking. Menthol cigarettes are highly used among young smokers, African Americans, and other racial and ethnic groups. The planned proposal has the potential to reduce youth initiation and could help reduce tobacco-related health disparities. The rule does not include a prohibition on individual possession or use of menthol cigarettes or cigars, but addresses manufacturers, distributors, wholesalers, importers, and retailers.
CVS Health reaches opioid settlement with Florida
CVS Health has agreed to pay the state of Florida $484 million to settle claims related to opioid prescriptions filled at its pharmacy locations in the state. The settlement will resolve claims dating back over a decade and will be paid out over 18 years. The funds will be directed to combat opioid addiction and abuse in the state. Under this agreement, CVS will no longer be a defendant in the state’s lawsuit over the opioid addiction epidemic. CVS Health notes that the settlement includes no admission of wrongdoing and that it has established its own efforts to fight opioid abuse.
FDA grants premarket approval for software to automate anesthesia delivery
GE Healthcare has been granted premarket approval from the FDA for its End-tidal Control software for anesthesia delivery, approved to be used on GE’s Aisys CS2 Anesthesia Delivery System. The approval is based on findings from the MASTER-Anesthesia trial, which compared safety and effectiveness of the software with traditional methods of anesthesia delivery.
The software allows providers to set targets for end-tidal oxygen and anesthetic agents; once the target is set, the software achieves and maintains the target, enhancing the accuracy of anesthesia delivery, simplifying workflows, and reducing waste. Compared with manual processes, automated delivery could lead to a potential 44% decrease in greenhouse gas emissions due to more efficient use of anesthesia.
Study finds smartwatch app accurately detects atrial fibrillation
A study involving more than 2.8 million people suggests a smartwatch app could be a possible solution to help identify signs of atrial fibrillation (AF) for earlier diagnosis and treatment. The study, conducted in China, combined data from a downloadable app along with clinical data to examine the accuracy of AF screening using wearable devices. Researchers monitored people who had downloaded a screening app on a Huawei smart device. The app used photoplethysmography sensors found on most wearable devices to monitor pulse and detect abnormalities. If an abnormal heart rhythm was detected, the wearer would be contacted by a physician for a clinical assessment. Of those who received a notification of suspected AF and followed up with a doctor, AF was confirmed in 93% of patients. Only 52.3% of those who received a notification actually followed up with a physician, so researchers were unable to verify whether the remaining people had AF. However, the findings confirm similar data seen in previous investigations based on Fitbit and Apple Watch users.