The controversy over the use of ethylene oxide (EtO) is back in play, thanks to a May 5 letter from the Office of Inspector General at the Environmental Protection Agency to the EPA. The letter recommends that the agency revisit its work on determining the status of EtO based on new data, data that may lead to more restricted use of EtO to sterilize medical devices.
HONG KONG – The Biden administration’s support for a TRIPS waiver of COVID-19 vaccine patents has already met a chorus of resistance from Western companies. In Asia, skepticism about how it would be achieved and what it will cover, is widespread.
A cautious optimism pervaded the March 11 Senate Health, Education, Labor and Pensions (HELP) Committee update on COVID-19, with witnesses and lawmakers alike welcoming the continuing decline of infections, hospitalizations and deaths in the U.S.
As expected, the FDA has expanded emergency use authorization (EUA) for Pfizer Inc. and Biontech SE’s COVID-19 vaccine, Comirnaty (tozinameran), to include adolescents 12 through 15 years of age, marking what Acting FDA Commissioner Janet Woodcock called "a significant step in the fight against the COVID-19 pandemic."
Almost 11 years to the day after first gaining FDA clearance, the Sonarmed airway monitoring system finally launched on a commercial scale in the U.S. The new rollout appears likely to revive the product’s prospects as it comes with significantly increased financial backing and deep connections to hospitals as a result of Sonarmed’s acquisition by Medtronic plc in December 2020. The system, which uses acoustic technology to identify endotracheal tube obstruction and verify proper tube positioning in neonates and infants who require invasive mechanical ventilation, has been implemented in a small number of hospitals to date.
The FDA’s presenters at this year’s joint FDA/Xavier med-tech conference presented on a range of issues, such as the breakthrough devices premarket program and the agency’s postmarket surveillance efforts. However, the two FDA presenters both remarked that these functional areas are hampered by lack of resources, suggesting the agency has a unified message about resources that permeates negotiations for the next device user fee agreement.
The COVID-19 pandemic’s impact on inspections of drug and device manufacturing sites is a matter of record, but the agency says it is on track to resume inspections for high-risk considerations. However, the FDA also said it will likely make more extensive use of virtual inspection tools going forward, a development that may ease some of the operational interruptions engendered by conventional on-site inspections.
The FDA’s operations have been badly hampered by the COVID-19 pandemic, but Jeff Shuren, director of the agency’s Center for Devices and Radiological Health (CDRH), said review times for most non-COVID product categories should resume their normal clip by the end of 2021. However, he acknowledged that the lag for in vitro diagnostics (IVDs) may not be fully resolved until 2022 because of the resources needed to review emergency use authorizations for tests for the SARS-CoV-2 virus.
My01 Inc. has received FDA clearance for its My01 Continuous Compartmental Pressure Monitor with full Bluetooth capabilities. The device is intended to help doctors diagnose and avert the risks of developing compartment syndrome, a potentially devastating complication of certain fractures and trauma injuries.