AOK Tooling Issues Stop Use Order for N95s
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.
CDC Recommends COVID Vaccine for Children Under 5, CDC Webinar June 22
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 … Continue reading “CDC Recommends COVID Vaccine for Children Under 5, CDC Webinar June 22”
APIC Provides Input on CMS Payment Rules
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 … Continue reading “APIC Provides Input on CMS Payment Rules”
CDC COCA Webinar June 16: What Clinicians Need to Know About Available Therapeutic Options for COVID-19
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 … Continue reading “CDC COCA Webinar June 16: What Clinicians Need to Know About Available Therapeutic Options for COVID-19”
CDC HAN Updates Monkeypox Definition
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, … Continue reading “CDC HAN Updates Monkeypox Definition”
FDA Authorized Labcorp COVID Test to identify PANGO Lineages
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 … Continue reading “FDA Authorized Labcorp COVID Test to identify PANGO Lineages”
Buzzagogo Recalls Kids Nasal Swabs Due to Microbial Contamination
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.
FDA Considering Pilot Program for Devices Using Radiation Sterilization
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 … Continue reading “FDA Considering Pilot Program for Devices Using Radiation Sterilization”
FDA Provides Guidance on Drug Interactions with Paxlovid
6/7/22 — The FDA provided additional guidance to help prescribers evaluate potential drug interactions when using Paxlovid therapy for COVID-19. Prescribers should review each patient’s full list of medications and use other resources to evaluate for potential drug interactions in patients who take medications that are not included on the Fact Sheet or checklist at this … Continue reading “FDA Provides Guidance on Drug Interactions with Paxlovid”
CDC Clarifies When Healthcare Facilities Should Make Changes to IPC Interventions Based on Community Transmission Levels
6/8/22 — In response to the question, “When should healthcare facilities make changes to interventions based on changes in community transmission levels?,” CDC provided this answer: “Some CDC infection prevention and control recommendations for healthcare settings are based on Community Transmission levels. In general, healthcare facilities should consider checking their local Community Transmission level weekly. When a … Continue reading “CDC Clarifies When Healthcare Facilities Should Make Changes to IPC Interventions Based on Community Transmission Levels”