https://safetynetalliance.org/wp-content/uploads/2020/04/cdc.png 193 262 Joseph Steinbock https://safetynetalliance.org/wp-content/uploads/2018/09/nasnh-logo.png Joseph Steinbock2020-06-08 09:48:152020-06-08 09:49:53Coronavirus Update for Friday, June 5
Coronavirus update for Friday, June 5 as of 2:30 p.m.
Centers for Medicare & Medicaid Services
- In the past week CMS issued six section 1135 waivers to give states greater flexibility to serve their Medicaid beneficiaries during the COVID-19 public health emergency. It issued waivers to Alaska (two waivers), Arizona, Mississippi, Ohio, and Wisconsin.
Centers for Disease Control and Prevention
- The CDC has updated its guidance on recommendations for people who believe they have been exposed to people with confirmed or suspected COVID-19 when the people to whom they have been exposed are neither health care workers nor critical infrastructure workers – that is, possible community transmission of COVID-19.
- The CDC has updated its FAQ on laboratory biosafety and COVID-19.
- The CDC has updated its guidance for the collection and submission of postmortem specimens from deceased persons under investigation for COVID-19, including recommendations for biosafety and infection control practices during specimen collection and handling, including during autopsy procedures.
Food and Drug Administration
- The FDA approved an abbreviated new drug application for dexmedetomidine hydrochloride in 0.9% sodium chloride injection (ANDA 209307), indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive-care setting.
- The FDA issued a letter to clinical laboratory staff and health care providers about a safety risk with using transport media and SARS-CoV-2 testing platforms that are not compatible. There is a risk of exposure to harmful cyanide gas when certain transport media are used with an incompatible testing platform or laboratory process that uses bleach.
- The FDA has issued an emergency use authorization (EUA) for a new test to assist in identifying severe inflammatory response in patients with confirmed COVID-19 illness to aid in determining the risk of intubation with mechanical ventilation. Find that EUA here and go here for an FDA fact sheet on the known and potential risks and benefits of this test.
- On Tuesday, June 9 at 12:00 p.m. (eastern), the FDA will launch a webinar series on the topic of Respirators for Health Care Personnel Use during COVID-19 Pandemic. The webinar will provide FDA information and answer questions about emergency use authorizations (EUAs) for respirators, importing respirators, and overall FDA actions to help ensure that health care personnel on the front lines have the necessary supplies of respirators to meet the demand. Go here for further information.
- The FDA has updated its enforcement policy for non-invasive remote monitoring devices used to support patient monitoring during the COVID-19 emergency.
- The FDA has posted test performance data from four more serology test kits from its independent performance validation study.
- The FDA has issued an EUA for a new commercial serology test for COVID-19. Find it here.
- The FDA has issued an EUA for a new commercial test to diagnose COVID-19. Find it here.