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FDA Offers Guidance on Duodenoscope Cleaning
The FDA has announced that it is providing a detailed list of supplemental duodenoscope reprocessing measures that emerged from an agency-led expert panel meeting earlier this year. Hospitals and health care facilities that use duodenoscopes can, in addition to meticulously following manufacturers’ reprocessing instructions, take one or more of these additional steps to further reduce the risk of infection and to increase the safety of these medical devices.
The complex design of duodenoscopes improves the efficiency and effectiveness of endoscopic retrograde cholangiopancreatography (ERCP), but it also presents challenges for effective reprocessing, according to the FDA. These challenges include the following:
- Duodenoscopes are complex instruments that contain many small working parts. Proper cleaning and disinfection of the elevator mechanism is of particular concern. The moving parts of the elevator mechanism contain microscopic, hard-to-reach crevices. If not thoroughly cleaned and disinfected, tissue or fluid and residual bacteria from one patient may remain in device crevices of a duodenoscope, exposing subsequent patients to the risk of infection.
- Meticulous adherence to the manufacturer’s reprocessing instructions is labor- intensive and prone to human error. It is critical that staff responsible for reprocessing duodenoscopes have the manufacturer’s instructions readily available to promote strict adherence to the reprocessing instructions in the device labeling, understand the importance of their role in reprocessing the device, and maintain proficiency in performing these reprocessing tasks.
The FDA is aware of instances of persistent bacterial contamination even following strict adherence to manufacturer reprocessing instructions. Because of this, the agency recommends that facilities and staff that reprocess ERCP duodenoscopes establish and implement a comprehensive quality-control program for reprocessing duodenoscopes.
At an expert panel meeting, representatives from several health care facilities and the panel discussed additional strategies that have been implemented to reduce the risk of infection transmission. In each case, staff applied these supplemental methods in addition to meticulous cleaning as part of strict adherence to the manufacturer’s reprocessing instructions, as recommended in previous FDA safety communications. Further, these measures may not be feasible in all health care facilities, and each of these options comes with its own benefits and limitations, the agency notes.
Among the variety of infection-mitigation strategies discussed at the advisory committee meeting, several specific supplemental measures have been implemented in health care facilities. Combined with strict adherence to the duodenoscope manufacturers’ reprocessing instructions, the following supplemental measures may further help reduce the risk of infection transmission associated with the use of duodenoscopes:
- Microbiological culturing. Microbiological culturing involves sampling duodenoscope channels and the distal end of the scope, and culturing the samples to identify any bacterial contamination that may be present on the scope after reprocessing.
Ethylene oxide sterilization following cleaning and high-level disinfection.
At a minimum, as per the manufacturers’ instructions, duodenoscopes should be subjected to high-level disinfection following manual cleaning after each use. When possible and practical, duodenoscopes should be sterilized because of the greater margin of safety provided by sterilization. Sterilization is a validated process used to render a product free from all viable microorganisms.
- Use of a liquid chemical sterilant processing system following cleaning and high-level disinfection. A liquid chemical sterilant processing system is a device that uses a chemical solution to destroy all viable forms of microbial life. The concentration, exposure time, and temperature of a liquid chemical sterilant are crucial because inappropriate dilution, insufficient exposure, or an inadequate temperature may result in ineffective reprocessing outcomes.
- Repeat high-level disinfection. Because a small number of duodenoscopes may have persistent microbial contamination despite reprocessing, some health care facilities have implemented repeat high-level disinfection (HLD) after the first HLD cycle in their duodenoscope reprocessing procedures, either manually or through the use of automated endoscope reprocessors (AERs). HLD involves immersing the device with a disinfectant and is expected to inactivate all microorganisms except for large numbers of bacterial endospores. AERs are devices that wash and high-level disinfect endoscopes and scope accessories to decontaminate them between uses.
Source: FDA; August 4, 2015.