On Jan. 16, the FDA released a new draft guidance document on cross contamination in flexible GI endoscopes. Here are four things to know about the guidance.
1. The FDA guidance focuses on cross contamination risk associated with irrigation valves and accessories commonly used with GI endoscopes during colonoscopy and esophagogastroduodenoscopy.
2. The guidance raises concerns about the use of a water bottle used for irrigation during GI procedures. Frequently, a single water bottle is used and is not preprocessed between patients, according to the report.
3. The guidance, still in draft form, will offer recommendations for mitigating cross contamination risk once finalized.
4. The recommendations will focus on device design, labeling and proper handling.