Comment period ends soon for new USP 797
The U.S. Pharmacopeial Convention has made several revisions to USP 797 Pharmaceutical Compounding — Sterile Preparations, and will be accepting public comments until Jan. 31. USP 797 sets standard related to the safety of the pharmacy compounding environment and products produced in that environment.
The new chapter has four major revisions, including reorganizing existing sections and collapsing three compounded sterile preparation risk categories (low, medium and high risk) into two categories (Categories 1 and 2). The revised chapter also removed information on handling hazardous drugs and added cross-references to USP 800 Hazardous Drugs — Handling in Healthcare Settings.
Also this week:
CDC urging dialysis facilities to assess infection control practices amid increased hepatitis C infections
The Centers for Disease Control and Prevention (CDC) has received an increased number of reports of newly acquired hepatitis C virus (HCV) infection among patients undergoing hemodialysis, and is calling on health facilities to examine and improve their current infection control practices. The organization states infection control lapses may have contributed to HCV transmission between patients at nine clinics between 2014 and 2015. Safety lapses could involve improper injection safety, environmental disinfection and hand hygiene.
The CDC states that any case of new HCV infection in a patient undergoing hemodialysis should prompt immediate action and is urging dialysis providers and facilities to:
- Assess current infection control practices and environmental cleaning and disinfection practices within the facility to ensure adherence to infection control standards.
- Address any gaps identified by the assessments.
- Screen patients for HCV, following CDC guidelines, to detect infections,
determine treatment potential and halt secondary transmission.
- Promptly report all acute HCV infections to the state or local health department.
FDA issues draft guidance on medical device interoperability
The Food and Drug Administration (FDA) issued draft guidance to improve medical device interoperability, with the goal of setting standards related to the ability of electronic medical devices to safely and effectively exchange and use exchanged information. The draft touches on development and design of interoperable medical devices and recommendations for pre-market submissions and labeling.
Thornhill Research Inc. recalls MOVES Ventilator System because of battery problem
Excess glue on the battery connectors used in the MOVES Ventilator System battery connectors manufactured by Thornhill Research Inc. may prevent the battery from powering the device after the battery is stored. The issue may prevent the ventilator from providing patient breathing support and could cause injury or death. Thornhill has sent a recall notification to affected customers, instructing them to return the device for repair if it is not functioning.
Bedbugs in the U.S. have developed resistance to common insecticides, Study finds
A new study in the Journal of Medical Entomology found that the common bedbug has developed high levels of resistance to popular insecticides used to combat them. Researches studied three populations in New Jersey, Michigan and Ohio and found that bedbugs have developed resistance to neonicotinoids, acetamiprid, imidacloprid and thiomethoxam, which are all active ingredients used in various pyrethroid-neonicotinoid combination products registered for bedbug control in the United States.
Virus spreading 'explosively'; latest Zika news
The Zika virus is "spreading explosively" across the Americas, the World Health Organization (WHO) warned yesterday, estimating that there could be between 3 million and 4 million cases across the Americas over the next year. WHO also announced it will hold an emergency meeting Monday in Geneva to discuss the possibility of declaring a public health emergency.
Read the latest news about Zika virus from Hospitals & Health Networks.