Policy Updates

Adam’s Polishes, LLC is voluntarily recalling lot 133475 of Adam’s Polishes Hand Sanitizer to the consumer level. FDA testing has found this lot to contain undeclared methanol. Adam’s Polishes is recalling 19 other lots in an abundance of caution. Read the FDA recall notice.

CMS has revised guidance for healthcare facility staff COVID-19 vaccination requirements to address the frequency of review of the facility staff vaccination requirement compliance policies. CMS emphasizes that, per the Omnibus COVID-19 Health Care Staff Vaccination interim final rule, implemented November 5, 2021, facility staff vaccination rates under 100 percent constitute noncompliance (although facilities must … Continued

The FDA is alerting patients, caregivers, and healthcare providers that there is a shortage of tracheostomy tubes, including Bivona tracheostomy tubes manufactured by ICU Medical. A shortage of Bivona tracheostomy tubes is more likely to impact pediatric patients because the supply of alternative tubes with similar functionality may be limited. While FDA and the HHS Administration … Continued

The CDC Health Alert Network (HAN) issued a Health Advisory to notify providers of multiple outbreaks of nontuberculous Mycobacteria (NTM) infections in children who received pulpotomies in pediatric dental clinics where the dental treatment water contained high levels of bacteria. The CDC emphasizes the importance of following existing recommendations for maintaining and monitoring dental waterlines. Read the CDC … Continued

The FDA issued an Emergency Use Authorization (EUA) to Abbott Molecular, Inc., for the Alinity m MPXV, a real-time polymerase chain reaction (PCR) test intended to detect monkeypox DNA using lesion swab specimens from individuals suspected of monkeypox virus infection. The Alinity m MPXV test is the first commercial test kit to be authorized for detection of … Continued

QSO-20-38-NH, revised on September 23, 2022, updates the CMS requirement originally released in August 2020 requiring COVID-19 testing for all staff and residents in Long-Term Care (LTC) facilities. The revised rule no longer recommends routine testing of asymptomatic staff, but such testing may be performed at the discretion of the facility. The guidance also includes … Continued

10/6/22 — The CDC issued a Health Alert Network (HAN) Health Advisory to alert clinicians and health departments about an outbreak of Ebola virus disease (EVD) in Central Uganda. As of October 6, no suspected, probable, or confirmed cases related to this outbreak have been reporting in the U.S. or other countries outside of Uganda. … Continued

9/28/22 — The FDA issued a warning letter jointly with the Federal Trade Commission to Bespoke Apothecary LLC for selling unapproved and misbranded COVID kit and Post Virus Recovery Herbal Tea products as drugs for use in treating or preventing COVID-19. 

6/3/22 — CMS issued updated surveyor guidance for ambulatory surgical centers that included a clarification related to reporting of infection control breaches that could potentially expose patients to the blood or bodily fluids of another. Read QSO-22-16-ASC (see Infection Control Sec. 416.51).