USP delays enforcing chapter standards

USP delays enforcing chapter standards

The United States Pharmacopeia (USP) notified stakeholders that it is postponing the official effective dates of several new and revised standards pertaining to pharmaceutical handling until further notice while it reviews appeals to the standards. Those standards include general chapters <795> Pharmaceutical Compounding – Nonsterile Preparations, <797> Pharmaceutical Compounding – Sterile Preparations and <825> Radiopharmaceuticals – Preparation, Compounding, Dispensing, and Repackaging. In addition, due to the pending appeals, USP new general chapter <800> Hazardous Drugs ­– Handling in Healthcare Settings will remain official but only informational until the appeals process is complete.

HHS, CDC guide on managing Category A waste

The Department of Health and Human Services’ Office of the Secretary for Preparedness and Response and the Centers for Disease Control and Prevention have released updated guidance to help health care providers and other stakeholders to safely manage solid waste contaminated with infectious substances classified by the Department of Transportation as Category A waste, including waste contaminated with Ebola virus. The guidance was produced by a federal interagency group with input from stakeholders, including the Association for the Health Care Environment.

FDA alert on medical device cyber vulnerability

The Food and Drug Administration recommended medical device manufacturers, health care providers and patients take certain actions to reduce the risk that a remote attacker could exploit a set of cybersecurity vulnerabilities to control a medical device or prevent it from functioning. The agency to date has not received any adverse event reports associated with the vulnerabilities it announced in a July advisory from the Department of Homeland Security. The vulnerabilities exist in IPnet, a third-party software component that supports network communications between computers. The agency notified end users that the software is part of several operating systems and may be used in a wide range of medical
and industrial devices.

AAAHC report identifies areas for improvement

The Accreditation Association for Ambulatory Health Care (AAAHC) has issued the 2019 AAAHC Quality Roadmap, its report on accreditation survey results. The AAAHC Quality Roadmap provides an analysis of more than 1,250 surveys conducted using the current AAAHC standards. The report is designed to help ambulatory care facilities address common areas of deficiencies as they pursue ongoing quality improvement throughout the accreditation cycle. The report covers findings on high-compliance and high-deficiency standards, and presents actionable data that can be used to help ambulatory care facilities develop stronger policies, procedures and practices.