Policy Updates

The FDA is recommending that consumers, healthcare providers, and facilities not use certain surgical N95 respirators manufactured by O&M Halyard, and to use caution with certain surgical masks and pediatric face masks manufactured by O&M Halyard. Test results show certain models of these products do not meet quality and performance expectations and may not provide … Continued

The FDA issued a safety notice to remind consumers that hand sanitizers are regulated as over-the-counter (OTC, or nonprescription) drugs by the FDA. The notice included safety tips for the storage and use of alcohol-based hand sanitizers. Read more.

The FDA amended the emergency use authorizations (EUAs) of the Moderna and Pfizer-BioNTech COVID-19 bivalent mRNA vaccines to simplify the vaccination schedule for most individuals. This action includes authorizing the current bivalent vaccines (original and omicron BA.4/BA.5 strains) to be used for all doses administered to individuals 6 months of age and older, including for … Continued

April 6: CDC has issued a Health Alert Network (HAN) Health Advisory to inform clinicians and public health departments in the United States about two confirmed outbreaks of Marburg virus disease (MVD)—one in Equatorial Guinea and one in Tanzania. Currently, there is no evidence to suggest that these two outbreaks are related; most experts agree … Continued

March 30: CMS has issued enhanced enforcement policy for infection control deficiencies (QSO-20-31-ALL) with revisions focusing on severe and actual harm levels. This refocused enforcement will increase civil monetary penalties, shorten notice for discretionary denial of payment for new admissions, and require the directed plans of correction to include hiring an external infection control consultant … Continued

The FDA issued two guidance documents to help prepare medical device manufacturers, distributors, healthcare facilities and providers, and other stakeholders through the expiration of the COVID-19 Public Health Emergency (PHE). The two guidance documents are: “Transition Plan for Medical Devices that Fall Within Enforcement Policies Issued During the COVID-19 Public Health Emergency” and “Transition Plan … Continued

The U.S. Government Accountability Office (GAO) released a report identifying actions to improve infection prevention and control practices in nursing homes. The report is based on recommendations of a panel of infectious disease specialists, nursing home staff and other experts convened by GAO to examine infection control practices in nursing homes. Many of the actions … Continued

APIC has developed a survey to help us quantify IP challenges with medical device instructions for use (IFUs). Your response will help us better serve the needs of our members and inform U.S. regulatory agencies of these challenges. Please respond to the survey by April 11. Respondents should be currently practicing IPs in a healthcare … Continued

The CDC published updated and expanded recommendations for screening and testing for chronic hepatitis B virus infection. New recommendations include hepatitis B screening using three laboratory tests at least once during a lifetime for adults aged 18 and older. The report also expands risk-based testing recommendations for certain populations. Read the new recommendations.