US FDA Issues Duodenoscope Reprocessing Guidance

FDA has provided a detailed list of duodenoscope reprocessing measures to be taken in addition to following manufacturer's reprocessing instructions.


This new guidance from FDA includes the following statements:

Among the variety of infection mitigation strategies discussed at the Advisory Committee meeting, several specific supplemental measures have been implemented in individual health care facilities. Combined with strict adherence to the duodenoscope manufacturer’s reprocessing instructions, the following supplemental measures may further help reduce the risk of infection transmission associated with the use of duodenoscopes:
  •  Microbiological Culturing
  •  Ethylene Oxide Sterilization
  •  Use of a Liquid Chemical Sterilant Processing System
  •  Repeat High-Level Disinfection

The FDA recommends health care facilities performing ERCP evaluate whether they have the expertise, training and resources to implement one or more of these options.

Ethylene oxide (EtO) sterilization following cleaning and high-level disinfection:

At a minimum, as per the manufacturer’s instructions, duodenoscopes should be subjected to high-level disinfection following manual cleaning after each use. When possible and practical, duodenoscopes should be sterilized due to the greater margin of safety provided by sterilization. Sterilization is a validated process used to render a product free from all viable micro-organisms. Since it does not rely on heat, EtO gas sterilization may be an effective method for heat-sensitive instruments that can be damaged by high temperatures. Following cleaning and high-level disinfection, EtO is an additional measure that may eliminate the presence of micro-organisms on a device through the introduction of EtO gas. A growing number of professionals in the medical sector are turning to EtO for endoscope sterilization.


The full FDA guidance may be found here.