Policy Updates

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

4/26/22 — The FDA expanded the approval of the COVID-19 treatment Veklury (remdesivir) to include pediatric patients ages 28 days and older with positive results of direct SARS-CoV-2 viral testing, who are hospitalized, or have mild-to-moderate COVID-19 and are at high risk for progression to severe COVID-19. This makes Veklury the first approved COVID-19 treatment for children … Continued

4/21/22 — The CDC issued a Health Alert Network (HAN) Health Advisory to notify clinicians and public health authorities of a cluster of children identified with hepatitis and adenovirus infection at a large children’s hospital in Alabama. Nine children have been admitted to that hospital with hepatitis and adenovirus infection between October 2021 and February 2022. … Continued