The U.S. Food and Drug Administration has been working with suppliers and thought leaders in infection control to cap the outbreaks linked to poor scope reprocessing, specially flexible endoscopes and duodenoscopes. It released a new evaluation of one key component of the disinfection process – automated endoscope reprocessors (AERs).
The February evaluation targeted the automoatic reprocessing of duodenoscopes, the culprits associated with CRE infections in 2015. The agency announced it plans to:
- Collaborate with suppliers as they modify and validate reprocessing instructions to enhance the safety margin of the methods used to clean and disinfect endoscopes
- Review AER manufacturer validation study protocols and test data as additional testing with duodenoscopes is conducted to demonstrate AER reprocessing effectiveness
- Evaluate information from multiple sources to analyze the possible association between AERs and the transmission of infectious agents to patients
- Analyze data from validation studies for cleaning and high level disinfection or liquid chemical sterilization
- Collaborate with hospitals experiencing outbreaks to understand how AERs are related
- Communicate recommendations to healthcare providers and end users to help mitigate the possible risk associated with duodenoscopes reprocessed in AERs
This announcement is the latest in a series of steps the FDA has taken to reduce scope-related infections, specifically duodenoscopes. In 2015, it requested AER suppliers conduct thorough validation testing and share the data with the FDA. It required a 99.9999 percent reduction in microbes, including at common sites, such as in the scope channels and the elevator mechanism of the scope. This is in addition to the recommended manual cleaning of scopes, which the FDA states should always precede the process.
So far, Medicators and Steris Corporation are the only two AER suppliers the FDA has received complete and adequate testing data from.
This is in addition to working with the three leading scope manufacturers, including Olympus, Fuji Medical Systems and Hoya Corporation, to study reprocessing procedure compliance.