The FDA has released a draft guidance on properly cleaning and labeling reprocessed endoscopes to reduce the number of infections.
The new guidance is needed because endoscopes now involve "more complex reusable medical device designs that are more difficult to clean and disinfect or sterilize," the FDA stated. The guidance provides recommendations on writing reuse instructions and validation of the recommended reprocessing instructions.
After reviewing records, the agency identified several other devices that are more likely to carry infections if not cleaned properly. These have features such as smooth inner surfaces of devices with long, narrow interior channels, clear identification of components that must be discarded after patient use and designs that take into account how fluid moves through reusable medical devices.
The agency said improperly cleaned endoscopes were responsible for more than 28 reports of infections from Jan. 2007-May 2010 and it received more than 80 reports of improperly reprocessed endoscopes during the past three years.
Comments on the draft guidance must be submitted within 90 days of publication in the Federal Register. When finalized, the guidance will replace "Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: FDA Reviewer Guidance."
Read the FDA draft guidance on endoscopes.
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The new guidance is needed because endoscopes now involve "more complex reusable medical device designs that are more difficult to clean and disinfect or sterilize," the FDA stated. The guidance provides recommendations on writing reuse instructions and validation of the recommended reprocessing instructions.
After reviewing records, the agency identified several other devices that are more likely to carry infections if not cleaned properly. These have features such as smooth inner surfaces of devices with long, narrow interior channels, clear identification of components that must be discarded after patient use and designs that take into account how fluid moves through reusable medical devices.
The agency said improperly cleaned endoscopes were responsible for more than 28 reports of infections from Jan. 2007-May 2010 and it received more than 80 reports of improperly reprocessed endoscopes during the past three years.
Comments on the draft guidance must be submitted within 90 days of publication in the Federal Register. When finalized, the guidance will replace "Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: FDA Reviewer Guidance."
Read the FDA draft guidance on endoscopes.
Related Articles on Improperly Disinfected Endoscopes:
Improperly Disinfected Endoscopes Used on Patients at Louisiana Hospital
STERIS Launches Device Designed to Aid Manual Reprocessing of Endoscopes
Selection of Disinfection or Sterilization