Siemens Healthineers (ETR:SHL) announced today that it is collaborating with the CDC and the JRC on a project to standardize COVID-19 assays. The collaboration with the CDC and Europe’s Joint Research Centre (JRC) is slated to develop a novel process for standardizing the SARS-CoV-2 antibody tests as they differ among manufacturers and currently can’t e analytically […]
How decontamination could solve the COVID-19 mask shortage problem
With cold and flu season rapidly approaching, public health officials worry about a resurgence of COVID-19 and personal protective equipment shortages. Protecting frontline workers will likely include decontaminating face masks. A spike in COVID-19 cases this fall and winter could leave healthcare facilities with renewed shortages of personal protective equipment — particularly masks. Hundreds of […]
FDA eases mask regulations, seeks to boost decontamination of used masks
The FDA yesterday further relaxed regulations on medical and surgical masks and face shields to ease shortages during the coronavirus pandemic, and invited companies that decontaminate masks to submit proposals for emergency authorizations. In a new guidance, the agency also gave its blessing to healthcare providers to use improvised masks during the public health emergency […]
Report: FDA promise of 1 million coronavirus tests this week unattainable
The FDA grossly overestimated the number of coronavirus diagnostic tests that would be available this week as well as U.S. laboratories’ capacity to process them, according to a report in the New York Times. FDA commissioner Stephen Hahn told reporters on Monday that the agency’s decision allowing private labs to make their own tests would […]
FDA authorizes industrial respirators for use during coronavirus
The FDA has authorized the use of certain industrial respirator masks for healthcare workers during the coronavirus outbreak. The N95 disposable filtering facepiece respirators have been approved by the National Institute for Occupational Safety and Health (NIOSH) as non-powered air-purifying particulate respirators. Healthcare workers will be allowed to use these, including those that have passed […]
Report: EtO blood levels higher in Illinois neighbors of Medline sterilization plant
This article has been updated with comments from Medline Industries. People who live about a mile away from a Medline device sterilization plant in Waukegan, Ill. have blood levels of the cancer-causing gas ethylene oxide that are about 50% higher than those who live farther away, according to a report by WebMD and Georgia Health News. Environmental health researchers from the […]
Another medtech sterilization plant will close in 2019
A second medical device sterilization plant is slated to close this year, prompting the FDA and medtech manufacturers to scramble for replacements. The FDA warned on March 1 about a potential medical device shortage due to the recent shutdown of a Sterigenics plant in Willowbrook, Ill. linked to emissions of the highly carcinogenic chemical compound ethylene oxide. […]
FDA warns of potential medical device shortage following Sterigenics plant shutdown
FDA is warning of a possible shortage of sterilized medical devices — and an accompanying threat to public health — due to the recent shutdown of a Sterigenics plant in Willowbrook, Ill. linked to emissions of the highly carcinogenic chemical compound ethylene oxide. Agency officials believe that more than 100 medtech manufacturers and hundreds of devices may be […]
‘Nightmare bacteria’ swarming the country, CDC reports
Last year, the Centers for Disease Control and Prevention identified more than 200 cases of bacteria that could resist nearly all antibiotics, the agency reported today. The CDC said that these “nightmare bacteria” are resistant to all or most antibiotics and are making their way through the country. In one assessment, a lab discovered that […]
The company behind Narcan looks toward a treatment for fentanyl overdoses
Despite growing attention from lawmakers and doctors, the opioid crisis is not slowing up in the U.S. A new report published last week by the Centers for Disease Control and Prevention showed that emergency room visits for opioid overdoses jumped 30% in 45 states from 2016 to 2017. The problem has morphed over the years […]
Needle-free flu vaccine will be back in clinics next flu season
MedImmune‘s FluMist, the only needle-free flu vaccine available in the U.S., has regained the support of an expert panel at the Centers for Disease Control & Prevention. The Advisory Committee on Immunization Practices has voted to recommend the nasal spray’s use, reversing a two-year-old decision to keep the product out of clinics due to efficacy […]
