The Association for the Advancement of Medical Instrumentation (AAMI) is reporting that the Food and Drug Administration (FDA) has published guidance for medical device manufacturers that is intended to mitigate the risk of cross-contamination from valves and accessories used with flexible gastrointestinal endoscopes. This is the latest in a series of recommendations the agency has released following an outbreak of infections linked to flexible endoscopes.
Between 2012 and the spring of 2015, endoscopes caused at least 250 life-threatening infections worldwide, including infections with the superbug carbapenem-resistant enterobacteriaceae, according to the results of an investigation conducted by a U.S. Senate committee. In its most recent guidance, which was first proposed in January 2015, the FDA aims to highlight the cross-contamination risk associated with specific irrigation valves and accessories used with flexible gastrointestinal endoscopes, clarify terminology related to these devices, and outline risk mitigation strategies.
To read further from AAMI, CLICK HERE.
An Infection Preventionist Considers Why Manufacturers Need to Update IFUs
July 11th 2024Katharine J. Hoffman, MPH, CIC, LSSGB: It’s time to take the devil out of the details in interpreting and successfully following manufacturers' instructions for use; why do manufacturers need to update IFUs?
New ANSI/AAMI Standard Transforms Ethylene Oxide Sterilization in Health Care
July 8th 2024The updated ANSI/AAMI ST24 standard outlines requirements for ethylene oxide sterilizers in health care, addressing advancements, regulatory changes, and new technology to enhance sterilization practices and safety.
The Value of Certification in Infection Prevention and Control: Why Is it important?
May 14th 2024Certification in infection prevention and control is essential for career growth, higher salaries, and improved patient outcomes. Learn why certification matters from Shazia Irum, MSC, MBA, RN, CIC, CPHQ, CBIC Ambassador in Saudi Arabia.