Public Policy Updates

3/10/22 — The CDC released new evidence-based recommendations for the prevention of central line-associated blood stream infections (CLABSI) in Neonatal Intensive Care Unit (NICU) patients. Where evidence was insufficient for CDC to make a recommendation, companion guidance is available from the Society for Healthcare Epidemiology of America (SHEA).

3/8/22 — Tennessee Technical Coatings Corp. is voluntarily recalling all lots of hand sanitizer Isopropyl Alcohol Antiseptic 75% to the consumer/user level. FDA analysis has found the product to contain methanol. Read the FDA safety announcement.

3/8/22 — OSHA released an enforcement memorandum for a short-term increase in highly focused inspections directed at hospitals and skilled nursing care facilities that treat or handle COVID-19 patients. The intent of this initiative is to magnify OSHA’s presence in high-hazard healthcare facilities over a three-month period (March 9, 2022 to June 9, 2022), to … Continued

3/4/22 — B. Braun Medical Inc. is voluntarily recalling five lots of 0.9% Sodium Chloride for Injection USP 250ML in Excel within the United States. The voluntary recall has been initiated due to fluid leakage or low fill volume of the respective containers. The biggest risk with a slow leak in any intravenous solution preparation is … Continued

3/1/22 — During the State of the Union Address on March 1, President Biden will announce nursing home reforms to ensure that: every nursing home provides a sufficient number of staff who are adequately trained to provide high-quality care; poorly performing nursing homes are held accountable for improper and unsafe care and immediately improve their … Continued

3/1/22 — The FDA is warning people not to use certain COVID-19 rapid antigen tests that have not been authorized, cleared, or approved by the FDA for distribution or use in the United States. These tests include, Celltrion USA Inc. DiaTrust COVID-19 Ag Rapid Tests the SD Biosensor STANDARD Q COVID-19 Ag Home Test, and the ACON Flowflex SARS-CoV-2 … Continued

2/28/22 — According to a February 2022 Conformity Assessment Letter to Manufacturers, NIOSH will give approval priority to applications for filtering air-purifying respirators that are produced in the United States. This includes filtering facepiece respirators (e.g. N95s) and powered air-purifying respirators (PAPRs). Read the NIOSH letter.

The FDA issued an emergency use authorization (EUA) for a new monoclonal antibody for the treatment of COVID-19 that retains activity against the omicron variant. The EUA for bebtelovimab is for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age and older) with a positive COVID-19 test, and who are … Continued

SD Biosensor, Inc. is voluntarily recalling its STANDARD Q COVID-19 Ag Home Test in the United States, due to confirmed reports that the test kits were illegally imported into the United States. The STANDARD Q COVID-19 Ag Home Test is not authorized, cleared or approved by the U.S. Food and Drug Administration (FDA) for distribution … Continued