The FDA wants to raise awareness among healthcare professionals, including those working in reprocessing units in healthcare facilities, that the complex design of endoscopic retrograde cholangiopancreatography (ERCP) endoscopes (also called duodenoscopes) may impede effective reprocessing. Reprocessing is a detailed, multistep process to clean and disinfect or sterilize reusable devices. Recent medical publications and adverse event reports link multidrug-resistant bacterial infections in patients who have undergone ERCP with reprocessed duodenoscopes, even when manufacturer reprocessing instructions are followed correctly. Meticulously cleaning duodenoscopes prior to high-level disinfection should reduce the risk of transmitting infection, but may not entirely eliminate it.
The tip of a duodenoscope. Photo courtesy of the FDA.
The FDA wants to raise awareness among healthcare professionals, including those working in reprocessing units in healthcare facilities, that the complex design of endoscopic retrograde cholangiopancreatography (ERCP) endoscopes (also called duodenoscopes) may impede effective reprocessing. Reprocessing is a detailed, multistep process to clean and disinfect or sterilize reusable devices. Recent medical publications and adverse event reports link multidrug-resistant bacterial infections in patients who have undergone ERCP with reprocessed duodenoscopes, even when manufacturer reprocessing instructions are followed correctly. Meticulously cleaning duodenoscopes prior to high-level disinfection should reduce the risk of transmitting infection, but may not entirely eliminate it.
For more information and recommendations, visit: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm434871.htm.
For a slide show from ICT on Duodenoscopes and the Dangers of Improper Reprocessing, 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.