Policy Updates

5/11/22 — The CDC is issuing a Health Alert Network (HAN) Health Update to provide updated information and recommendations about an epidemiologic investigation of pediatric cases of hepatitis of unknown etiology in the United States. As of May 5, 2022, CDC and state partners are investigating 109 children with hepatitis of unknown origin across 25 states … Continued

5/10/22 — SML Distribution LLC is recalling the Skippack Medical Lab SARS-CoV-2 Antigen Rapid Tests (Colloidal Gold). The FDA has identified this issue as a Class I recall, the most serious type of recall, because this test is not authorized, cleared, or approved by the FDA for distribution or use in the United States. The FDA … Continued

Mesa Biotech is recalling the Accula SARS-CoV-2 PCR Test because certain lots have an increased risk of giving false positive results due to contamination at the manufacturing facility. The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries, serious health consequences, … Continued

5/6/22 — The FDA cleared the Spectrum Medical Quantum Heater-Cooler and the compatible Qura Quantum PureFlow Heat Exchangers used to warm or cool a patient during cardiopulmonary bypass procedures. Instead of using water, the Quantum Heater-Cooler device regulates the temperature of a glycol-based heat transfer fluid (HTF), which then enters the compatible PureFlow heat exchangers to … Continued

5/5/22 — The FDA Administration has limited the authorized use of the Johnson & Johnson/Janssen COVID-19 Vaccine to individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, or who would otherwise not receive a COVID-19 vaccine. Updated evaluations led the FDA to determine that, … Continued

5/6/22 — The FDA issued a Letter to Healthcare Providers to share information about the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using the following hemodialysis machines manufactured by Fresenius Medical Care: the 2008T, 2008K2, and 2008K models. The 2008K2 and 2008K models are no … Continued

4/28/22 — APIC Public Policy Committee Chair Lisa Sturm, MPH, CIC, FAPIC represented APIC at an informal hearing on occupational exposure to COVID-19. OSHA has reopened the comment period following its withdrawal of the June 2021 COVID-19 Healthcare Emergency Temporary Standard. The agency is now working on developing a permanent COVID-19 standard. Read the APIC statement … Continued

4/28/22 — Celltrion USA is recalling certain Point of Care (POC) DiaTrust COVID-19 Ag Rapid Tests because they may have been distributed to unauthorized users. Emergency use of these tests is limited to authorized laboratories and use of these tests in unauthorized settings (for example, customers without CLIA-certification) may present an increased risk of false results … Continued

4/28/22 — The CDC Clinician Outreach and Communication Activity (COCA) will hold a webinar to discuss post-COVID conditions (PCC), an umbrella term for the wide range of health consequences that are present four or more weeks after infection with SARS-CoV-2, which includes long COVID. Cognitive symptoms, often described by patients as “brain fog”, are frequently reported … Continued