Safe Reprocessing Practices an AGA Priority

December 09, 2011

In October, the Association for the Advancement of Medical Instrumentation (AMMI) and the FDA sponsored a summit of stakeholders to address concerns regarding endoscope reprocessing. The AGA was pleased to be a supporting organization and participant in the program. What started as an attempt for attendees to define "clean" resulted in much learning across disciplines and organizations.

The first essential step of reprocessing is cleaning, yet there are several definitions of cleaning by the major standards organizations that are recognized by the FDA. To ensure that an instrument can be cleaned to standard, manufactures are required to soil test their product under a worst-case scenario. Once the cleaning process has been validated, instructions must be written in scientifically technical (epidemiological) terms.

Basic principles of quality improvement include understanding the specific role of each individual in a process and how each step in the process provides the foundation for the next. Thinking about all the individuals, the steps and the importance of each in reprocessing endoscopes, the opportunities for something to go wrong can be overwhelming.

The average hospital central supply department deals with thousands of different instruments, manufactured by numerous different device manufactures, each type of which has lengthy technical instructions to meet FDA requirements. These instructions are carried out by staff positions that require minimal education, training and generally no certification (except in New Jersey where it is mandated).

Please see the full AAMI-FDA Reprocessing Summit article below for a more detailed summary of summit results and presentations.

The AGA is committed to working closely with GI practices to support safe reprocessing practices. To that end, I am requesting that readers share with AGA staff their best practices related to endoscope reprocessing and staff training so that that information might be shared across practices.

— John Inadomi, MD, AGAF