FDA Reissues EUA for Certain Disposable FFRs
The FDA reissued the Emergency Use Authorization (EUA) for imported, non-NIOSH-approved, disposable filtering facepiece respirators (FFRs) manufactured in countries other than China. The FDA revised and reissued this EUA to authorize for emergency use only those respirators listed in the EUA’s Exhibit 1. Effective immediately, the FDA will no longer be reviewing requests and adding new … Continue reading “FDA Reissues EUA for Certain Disposable FFRs”
FDA Approves Molecular COVID Test for Use Beyond Pandemic
The FDA granted BioFire Diagnostics LLC marketing authorization for its BioFire Respiratory Panel 2.1 diagnostic test. This is the first SARS-CoV-2 diagnostic test that will be permitted to be marketed beyond the public health emergency. The BioFire Respiratory Panel 2.1 is a multi-analyte molecular test that simultaneously detects 22 different viruses and bacteria associated with … Continue reading “FDA Approves Molecular COVID Test for Use Beyond Pandemic”
OSHA Launches Programs to Protect High-Risk Workers from COVID-19
In response to President Biden’s executive order on protecting worker health and safety, the Occupational Safety and Health Administration (OSHA) has launched a national emphasis program focusing enforcement efforts on companies that put the largest number of workers at serious risk of contracting the coronavirus. The program also prioritizes employers that retaliate against workers for complaints about … Continue reading “OSHA Launches Programs to Protect High-Risk Workers from COVID-19”
FDA Alerts Providers About Inaccurate Roche COVID Test Results
The FDA alerted healthcare providers and clinical laboratory staff that false positive results can occur with the Roche Molecular Systems, Inc. (Roche) cobas SARS-CoV-2 & Influenza A/B Nucleic Acid Test for use on the cobas Liat System. Read more.
Joint Commission to Resume Surveys
As COVID-19 incidence and caseloads across the country are decreasing, beginning March 15, 2021, The Joint Commission will return to its usual pre-pandemic procedures, including unannounced onsite surveys. Read more.
CDC Updated COVID-19 Recommendations for Infection Prevention and Control
CDC has updated select healthcare infection prevention and control recommendations in response to COVID-19 vaccination. These recommendations may be adapted by state and local health departments to respond to rapidly changing local circumstances. Updated recommendations include those related to nursing home visitation, work restrictions for asymptomatic HCP, SARS-CoV-2 testing, and PPE use. Read the updated … Continue reading “CDC Updated COVID-19 Recommendations for Infection Prevention and Control”
CMS Updates Visitation Recommendations for Nursing Homes
The Centers for Medicare & Medicaid Services (CMS), in collaboration with the Centers for Disease Control and Prevention (CDC), issued updated guidance for nursing homes to safely expand visitation options during the COVID-19 pandemic public health emergency (PHE). Revisions reflect administration of millions of doses of COVID-19 vaccines, but emphasize the importance of maintaining infection prevention … Continue reading “CMS Updates Visitation Recommendations for Nursing Homes”
FDA Grants EUA for T-Detect COVID Test
The FDA issued an emergency use authorization (EUA) for the T-Detect COVID Test developed by Adaptive Biotechnologies. The T-Detect COVID Test is a next generation sequencing based (NGS) test to aid in identifying individuals with an adaptive T-cell immune response to SARS-CoV-2, indicating recent or prior infection with SARS-CoV-2. Read the FDA announcement.
CDC Issues Guidance on Post-Vaccination Activities
The CDC has issued new guidance on how to protect yourself and others from COVID-19 transmission after you have been vaccinated. A person is considered fully vaccinated two weeks after receiving the second dose of a 2-dose series (such as the Pfizer or Moderna vaccines) or two weeks receiving a single-dose vaccine (such as the … Continue reading “CDC Issues Guidance on Post-Vaccination Activities”
ACIP Votes on Interim Recommendations for COVID-19 Vaccine
The CDC’s Advisory Committee on Immunization Practices (ACIP) made its recommendation regarding the early distribution of a COVID-19 vaccine when it is authorized by FDA. By a vote of 13-1, ACIP recommended initial vaccinations should be offered to healthcare personnel and residents of long-term care facilities. Further considerations regarding distribution were discussed during the meeting … Continue reading “ACIP Votes on Interim Recommendations for COVID-19 Vaccine”