Public Policy Updates

6/23/22 — Between May and November 2020, NIOSH issued limited, temporary Public Health Emergency (PHE) approvals for N95 filtering facepiece respirators (FFRs) and powered air-purifying respirators (PAPRs) to address respirator supply shortages during that time. NIOSH is now phasing out these PHE approvals. Obsolete respirators are no longer permitted to be manufactured by the approval … Continued

6/21/22 — AOK Tooling, Hong Kong, issued a notice of stop sales, use and return of pattern mask model 20190029-S and 20190029-M N95 respirators (TC-84A-9286). The manufacturer alert followed notification from NIOSH that the models do not meet the specifications of its certification. Read more.

6/20/22 — Following FDA authorization, the CDC recommended COVID-19 vaccination for children ages 6 months and older with the Pfizer-BioNTech or Moderna vaccines. The Pfizer vaccine is administered in a three-dose series and the Moderna vaccine is administered in a two-dose series. Immunocompromised children may need additional doses for optimal protection. Learn more. The CDC Clinician … Continued

6/16/22 — APIC submitted comments to CMS on proposed rules updating Medicare payment programs for acute care hospitals, long-term acute care hospitals, cancer hospitals, inpatient rehabilitation facilities, and skilled nursing facilities. Among positions taken by APIC are support for continuing the measure suppression policy implemented during the COVID-19 pandemic, support for new NHSN digital HAI … Continued

6/13/22 — The CDC Clinician Outreach and Communications Activity (COCA) Network has scheduled a webinar to present an overview of COVID-19 therapeutic options, including indications, efficacy, and distribution. Presenters will include subject matter experts from NIH, FDA, ASPR, and CDC. It will include information about Paxlovid, including key points about COVID-19 rebound after use; Paxlovid … Continued

6/14/22 — The CDC issued a Health Alert Network (HAN) Health Update to alert clinicians to clinical presentations of monkeypox seen so far in the United States and to provide updated and expanded case definitions intended to encourage testing for monkeypox among persons presenting for care with relevant history, signs, and symptoms. Since May 2022, … Continued

6/14/22 — The FDA issued an emergency use authorization (EUA) for the Laboratory Corporation of America (Labcorp) VirSeq SARS-CoV-2 NGS Test on the PacBio Sequel II sequencing system. The SARS-CoV-2 virus has mutated over time resulting in genetic variation in circulating virus strains, also called lineages. The Labcorp VirSeq SARS-CoV-2 NGS Test is:  The first COVID-19 test … Continued

6/8/22 — Buzzagogo Inc. is voluntarily recalling one lot of Allergy Bee Gone for Kids Nasal Swab Remedy to the consumer level due to potential microbial contamination. FDA testing found some product to contain elevated levels of yeast and mold and may contain the bacteria Bacillus cereus. Read the FDA safety alert.

6/7/22 — The FDA is considering this pilot program due to global supply chain constraints and to support sterilization supply chain resiliency. If implemented, this program would help medical device manufacturers advance alternative ways to sterilize their approved medical devices, including changing radiation sources, in a least burdensome regulatory approach. The FDA is working actively … Continued