The FDA has released supplemental guidance on reprocessing duodenoscopes, the scopes used during ERCP.
Here are four things to know about the supplemental recommendations.
1. The FDA recommends strict adherence to the scope manufacturer's reprocessing instructions, but also suggests taking additional measures.
2. The additional measures in the FDA recommendations include microbiological culturing, ethylene oxide sterilization, use of a liquid chemical sterilant processing system and repeat high-level disinfection.
3. The FDA recommends healthcare facilities performing ERCP evaluate whether they have the resources to implement one more of its supplemental suggestions.
4. These recommendations are intended to supplement the FDA's recent safety communication on duodenoscope reprocessing. The recommendations in this communication included:
• Meticulously cleaning the elevator mechanism and surrounding recesses by hand
• Implementing a comprehensive quality control program
• Referring to the Multisociety Guideline on Reprocessing Flexible Gastrointestinal Endoscopes: 2011 for evidence-based recommendations on endoscope reprocessing