Policy Updates

3/11/22 — The FDA authorized an extension for the shelf life of the refrigerated Janssen COVID-19 Vaccine, from six to nine months, allowing the product to be stored at 2-8 degrees Celsius. This extension applies to all refrigerated vials of the Janssen COVID-19 vaccine that have been held in accordance with the manufacturer’s storage conditions. Read … Continued

3/7/22 — The FDA and the Federal Trade Commission (FTC) issued a joint warning letter to Viraldine, LLC for selling unapproved products with fraudulent COVID-19 claims. Read the FDA/FTC warning letter.

3/14//22 — LuSys Laboratories, Inc. is recalling COVID-19 antigen (nasal/saliva) and COVID-19 IgG/IgM antibody tests because they do not have an Emergency Use Authorization (EUA), 510(k) premarket notification, or premarket approval (PMA) and therefore cannot be marketed and distributed in the U.S. The risks include potential false negative, false positive, and misinterpretation of results from these … Continued

3/10/22 — Trust for America’s Health (TFAH) released its annual evaluation of states’ performance on ten key emergency preparedness indicators in Ready or Not 2022: Protecting the Public’s Health from Diseases, Disasters, and Bioterrorism. The report identifies gaps in states’ readiness to respond to emergencies and includes policy recommendations for strengthening the nation’s health security. This year’s … Continued

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