Automated Endoscopy Reprocessor Evaluation and Validating

Automated Endoscope Reprocessor

Automated Endoscope Reprocessor (AER) are crucial equipment used in the health care sector to reprocess endoscopes and endoscope attachments, such as duodenoscopes. By exposing the exterior surfaces and inner channels of reusable endoscopes to high-level disinfectant or liquid chemical sterilant solutions, AERs are designed to destroy bacteria in or on them. AERs are Class II devices that have received approval.

Evaluation of Automated Endoscope Reprocessors

• Investigate all essential aspects that contribute to patient infections caused by duodenoscope exposure and how to effectively minimize them, including how Automated Endoscope Reprocessor are utilized in clinical settings.
• To assist decrease the risk of patient infection, the examination of AER safety and effectiveness includes the following actions:
• Collaborating with industry to improve the safety margin of the procedures used to clean and disinfect endoscopes by modifying and validating their reprocessing instructions, particularly makers of AERs that reprocess duodenoscopes as specified on their labeling.
• As they do additional testing with duodenoscopes to demonstrate AER reprocessing effectiveness, they are reviewing AER manufacturer validation study protocols and test data.
• To investigate the probable link between Automated Endoscope Reprocessor and the transfer of infectious pathogens to patients, researchers looked at data from a variety of sources, including medical device adverse event reports reported, medical literature, the health care community, and federal partners.
• Analyzing data from cleaning and high-level disinfection or liquid chemical sterilisation validation trials.
• Collaborating with hospitals that have had infection outbreaks to learn more about how AERs may play a role in infectious disease epidemics.
• To help limit the potential risk connected with duodenoscopes reprocessed in AERs, health care practitioners and end-users will be given guidance.

Validating Automated Endoscope Reprocessors Effectiveness

The validation testing data from all companies that have AERs labeled to reprocess duodenoscopes because of the potential link between reprocessed duodenoscopes and patient infection. In response to this request, Automated Endoscope Reprocessors manufacturers did further rigorous validation testing using duodenoscopes to assess the effectiveness of AER reprocessing of the recess around the elevator area of the duodenoscope. Testing should show a 99.9999 percent reduction of the most resistant microorganisms at many spots on the duodenoscope to support acceptable high-level disinfection or liquid chemical sterilization and avoid infection transfer.