American Gastroenterological Association - Advancing the Science and Practice of Gastroenterology

AAMI-FDA Endoscope Reprocessing Summit

The AGA is pleased to have been a supporting organization of the Association for the Advancement of Medical Instrumentation (AAMI) and FDA endoscope reprocessing summit held in White Oak, MD, on Oct. 11 and 12. The summit was attended by 276 people across the health-care industry. By the end of the event, the attendees agreed on priority items for follow-up, which fell into six major themes:  

1. Gain consensus on “how clean is clean.”
2. Create standardized, clear instructions and repeatable steps for reprocessing.
3. Take human factors into account when developing reprocessing requirements.
4. Make effective reprocessing a priority from the very beginning of device design planning.
5. Improve information collection and sharing to broaden the use of best practices in reprocessing.
6. Improve reprocessing competencies by strengthening training, education and certification.

The presentations, which informed the discussions and subsequent follow-up items, provided an excellent foundation for understanding the reprocessing landscape. They addressed not only the regulatory and economic environments, but also the current science of reprocessing. The importance of considering human factors when translating manufacturer instructions into standardized, simple and repeatable instructions for those in the frontlines was discussed throughout the summit. The meeting materials and presentations can be accessed at www.aami.org/reprocessing/materials.html.

A post-summit publication is scheduled to be completed by January 2012. The publication will be free of charge and posted on the AAMI and AGA websites.

The AGA will continue to work with AAMI and communicate to our members as follow-up work from the summit moves forward.