Updated rules in response to contaminated duodenoscopes
THURSDAY, March 12, 2015 (HealthDay News) — The U.S. Food and Drug Administration has issued final recommendations for the cleaning and sterilization of medical devices used in invasive procedures. The updated rules, first proposed in 2011, were released in response to last month’s reports of seven serious infections and two deaths at the Ronald Reagan UCLA Medical Center in Los Angeles, which were caused by contaminated duodenoscopes.
Stephen Ostroff, M.D., the FDA’s chief scientist, said during a Thursday afternoon news conference that the agency has been studying the problem and working with the three makers of these devices to come up with better ways to ensure their safety. These efforts include going over the manufacturers’ instructions for cleaning the devices, enhancing the disinfectant procedures, and looking into design changes to the scopes to make them easier to clean, he said.
To further ensure the safety of these devices, the U.S. Centers for Disease Control and Prevention has provided information on how hospitals can test scopes for lingering bacteria after they have been cleaned and disinfected. Going forward, the FDA recommends that all manufacturers of reusable medical devices, not just duodenoscopes, show that they have taken steps to improve the way their devices are cleaned so as not to pass along infections.
In addition, manufacturers will have to provide data on the effectiveness of their cleaning instructions, William Maisel, M.D., M.P.H., deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health, said during the news conference. “Manufacturers will be expected to conduct validation testing to show with a high degree of assurance that their cleaning and disinfection or sterilization instructions will consistently reduce contamination,” he said. Furthermore, manufacturers who want to market certain reusable devices, such as duodenoscopes, bronchoscopes, and endoscopes, should submit data to the FDA that validates the effectiveness of their cleaning and sterilizing methods and instructions.
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