Public Policy Updates

The FDA issued final guidance to clarify the distinction between “servicing” and “remanufacturing” reuseable medical devices. The guidance also includes recommendations for information that should be included in labeling to help assure the continued quality, safety, and effectiveness of devices that are intended to be serviced over their useful life. Read the FDA final guidance … Continued

NIOSH has honored a request by Honeywell International to voluntarily rescind 22 NIOSH approvals. As of May 24, 2024, any respirator marked with these approval numbers is no longer NIOSH approved and may not be used, manufactured, assembled, sold, or distributed. Read the NIOSH notice for a list of rescinded devices.

NIOSH has honored a request by 3M Scott Fire & Safety to voluntarily rescind 19 respirator approvals. As of May 15, 2024, these respirators are no longer NIOSH approved and may no longer be used, manufactured, assembled, sold, or distributed. See the NIOSH notice 1 and NIOSH notice 2 for more information. Approval Number Part … Continued

As part of AHRQ’s ongoing efforts to advance patient safety, the agency has published a new evidence review to help healthcare leaders prioritize and implement safety strategies. Read the AHRQ Making Healthcare Safer IV report: Active Infection Surveillance of Clostridioides difficile and Multi-Drug Resistant Organisms: Methicillin-Resistant Staphylococcus aureus (MRSA), Carbapenem-Resistant Enterobacterales (CRE), Candida auris.

The CDC issued a Health Alert Network (HAN) Health Advisory to alert healthcare providers to cases of meningococcal disease linked to travel to Saudi Arabia. Since April 2024, 12 cases of meningococcal disease have been reported to national public health agencies in the United States (5 cases), France (4 cases), and the United Kingdom (3 … Continued

On Thursday, May 23, the FDA will host a virtual Town Hall panel discussion on what to consider when choosing or changing methods for medical device sterilization. The meeting will be at 1:00 – 2:15 pm ET. Registration is not required. Learn more.

The CDC is hosting “LTC Townhall: Understanding Enhanced Barrier Precautions” on Wednesday, May 22 at 1 pm ET. This webinar, led by CDC experts Dr. Bola Ogundimu, Dr. Kara Jacobs Slifka, and Dr. Heather Jones, is designed for anyone involved with or working in long-term care facilities who seeks to deepen their understanding of Enhanced … Continued

The FDA sent warning letters to users and manufacturers of plastic syringes made in China. The letters to Cardinal Health, Jiangsu Shenli Medical Production Co., Medline Industries, and Sol-Millennium Medical express concern over violations related to the sale and distribution of unauthorized plastic syringes that have not been cleared or approved by the FDA for … Continued

The Agency for Healthcare Research and Quality (AHRQ) published a Technical Brief summarizing definitions of long COVID and describing what is known about long COVID models of care. The brief includes models currently in use, promising approaches, advantages and disadvantages of models in different populations and settings, barriers and facilitators to implementation, access and equity … Continued