Policy Updates

3/25/22 — The FDA has rescinded EUA for sotrovimab to treat COVID-19 in HHS Regions 1 and 2 because the authorized dose is unlikely to be effective against the Omicron BA.2 sub-variant. CDC Nowcast data estimates that, as of March 19, 2022, the BA.2 sub-variant accounts for more than 50 percent of COVID-19 cases in these regions. HHS Regions … Continued

3/25/22 — Plastikon Healthcare, LLC is voluntarily recalling three (3) lots of Milk of Magnesia 2400 mg/30 mL Oral Suspension, one (1) lot of Acetaminophen 650mg/ 20.3mL, and six (6) lots of Magnesium Hydroxide 1200mg/Aluminum Hydroxide 1200mg/Simethicone 120mg per 30 mL to the hospital, clinic and patient level.  The products are being recalled due to microbial … Continued

3/28/22 — The National Institutes of Health (NIH) COVID-19 Treatment Guidelines Panel updated the following treatment recommendations: Testing for SARS-CoV-2 Infection Pre-exposure prophylaxis (PrEP) Prioritization of anti-SARS-CoV-2 therapies for treatment and prevention of COVID-19 when there are logistical or supply constraints Granulocyte-macrophage colony-stimulating factor inhibitors (GM-CSF)

3/23/22 — The Agency for Healthcare Research and Quality (AHRQ) developed a toolkit to help hospital infection prevention programs implement a decolonization protocol that was found to reduce bloodstream infections by more than 30 percent in adult inpatients who were not in intensive care units (ICUs) and who had specific medical devices. It includes implementation instructions, … Continued

3/21/22 — The FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet on April 6 to discuss considerations for future COVID-19 vaccine booster doses and the process for selecting specific strains of the SARS-CoV-2 virus for COVID-19 vaccines to address current and emerging variants. Read the FDA announcement.

3/21/22 — In recognition of interruptions in the supply of prefilled 0.9% sodium chloride (saline) intravenous (IV) lock/ flush syringes, the FDA sent a letter to healthcare personnel that included recommendations, including conservation strategies, to maintain the quality and safety of patient care. Read the FDA letter.

3/17/22 — Celltrion USA is recalling specific lots of the DiaTrust COVID-19 Ag Rapid Test due to a high number of false positive reports. Additionally, the tests’ labeling for the affected products includes a shelf life of 18 months. However, the FDA’s emergency use authorization specifies these tests may only be used for 12 months. Read the FDA … Continued

3/18/22 — The FDA issued a safety communication reminding people that at-home COVID-19 diagnostic tests should only be used according to manufactures’ instructions, and that tests kits should be kept out of reach of children and pets. The agency has received reports of injuries cause by incorrect use or storage of at-home COVID-19 diagnostic tests. Read … Continued

3/14/22 — In response to public comments and feedback, The Leapfrog Group Hospital Survey as announced that it will be offering an alternative path to meeting the organization’s Hand Hygiene Standard.  In its March 14 “Summary of Changes to the 2022 Leapfrog Hospital Survey & Responses to Public Comments,” Leapfrog said that the alternative path “requires … Continued