The U.S. Food and Drug Administration (FDA) has released a summary of recent news and updates. First, the FDA issued a letter to health care providers recommending conservation strategies for non-sterile, single-use pneumatic tourniquet cuffs. The agency provided a list of best practices for cleaning and sterilization/disinfection of these devices and recommended the use of alternative devices during supply constraints. These cuffs are commonly used in elective limb surgeries and emergency and trauma settings.
Next, the FDA approved Advanced Medical Solutions Limited’s LIQUIFIX Hernia Mesh Fixation (HMF) Devices. These devices, including the FIX8 Laparoscopic HMF Device and Precision Open HMF Device, consist of an adhesive preloaded into a single-use handheld applicator. They are intended for the fixation of prosthetic polypropylene or polyester mesh in laparoscopic and open surgical repair of femoral and inguinal hernias. The HMF Devices use an acrylic glue for the first time to secure the mesh.
In addition, the FDA authorized the marketing of Tristel Solutions Limited’s Duo UL, a high-level disinfectant foam for reprocessing ultrasound probes. The foam contains chlorine dioxide and is manually spread on the probes for a required two-minute contact time. It is intended for use by qualified healthcare personnel.
Furthermore, on June 9th, the Peripheral and Central Nervous System Drugs Advisory Committee will hold a virtual meeting to discuss the confirmatory study for the supplemental biologics license application for Leqembi (lecanemab) solution. Leqembi was approved under the accelerated approval pathway for the treatment of Alzheimer’s disease in January 2023. Confirmatory studies are conducted to verify and describe the clinical benefit of a product after it receives accelerated approval.
The FDA, an agency within the U.S. Department of Health and Human Services, is responsible for ensuring the safety, effectiveness, and security of human and veterinary drugs, vaccines, and other biological products. The agency also oversees the safety and security of the nation’s food supply, cosmetics, dietary supplements, electronic radiation-emitting products, and tobacco products.
