The Food and Drug Administration on March 12 issued final guidance for makers of reusable duodenoscopes and other reprocessed medical devices aimed at assuring that their cleaning and disinfection or sterilization instructions consistently reduce microbial contamination. In addition, the Centers for Disease Control and Prevention issued an interim protocol for health care facilities wishing to use routine culturing to assess the adequacy of duodenoscope reprocessing.
The FDA guidance lists six criteria manufacturers should address in their reprocessing instructions for users. In addition, the agency said manufacturers seeking to bring to market certain reusable devices (such as duodenoscopes, bronchoscopes and endoscopes) should submit for review their data validating the effectiveness of their reprocessing methods and instructions. FDA last month issued safety recommendations to prevent possible microbial infections from reprocessed reusable duodenoscopes – flexible, lighted tubes that are threaded through the mouth into the small intestine to drain fluids from blocked pancreatic and biliary ducts.
With input from health care facilities, professional partners and stakeholders, the CDC has developed an interim protocol for facilities that want to test their duodenoscopes for contamination with bacteria, including CRE, after the cleaning and disinfection process.
These interim protocols provide a step-by-step approach for facilities wanting to check whether scopes could be a source of infection for patients. Included are suggestions for how scopes should be sampled, options for the frequency and types of sampling, how to test those samples in a lab, and how to interpret results. Sampling is not a substitute for correct cleaning and disinfection (“reprocessing”) of these scopes. The interim protocols are intended to supplement and not replace manufacturer- recommended reprocessing procedures.
CDC is working with partners, including the U.S. Food and Drug Administration, medical specialty societies, subject matter experts, and state and local health departments to further understand and address the possibility of bacteria transmission related to duodenoscopes. Until more is known, this interim protocol can provide hospitals with an additional tool in their continued efforts to protect patients from infections. Learn more about the interim protocols from Michael Bell, MD, Deputy Director of CDC’s Division of Healthcare Quality Promotion at CDC’s Safe Healthcare Blog.
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