Important New Information on Infection Prevention Improvement Opportunities
More than three million colonoscopies were performed in freestanding ambulatory facilities in 2006. Very specific national clinical practice guideline recommendations and manufacturers’ directions address instruction and competency testing for all staff who process endoscopes, as well sterilization of reusable forceps/cutting instruments that break the mucosal barrier, before each use, and high level disinfection (HLD) fluid testing and management. All accrediting bodies require ASCs to adhere to professional society guidelines and manufacturer recommendations for cleaning, disinfection, and sterilization of instruments and equipment.
The research literature indicates that, with the exception of unsafe injection practices, infectious outbreaks associated with colonoscopy procedures have been tied to lapses in instrument processing. Although the overall number of infectious outbreaks associated with colonoscopies is relatively low, these incidents are repeatedly reported in the research literature over the last couple of decades. In addition to the direct costs of infectious outbreaks, the expenses of patient follow up, testing, and treatment/management are very high.
"Due to several unfortunate and highly publicized lapses, public scrutiny is focused upon infection control practices in endoscopy," said Lawrence S. Kim, MD, AGAF, AGA representative to the Accreditation Association for Ambulatory Health Care (AAAHC). "AGA is committed to ensuring patient safety during endoscopic procedures; to this end, we have played an integral role in developing evidence-based guidelines and communicate regularly with FDA, manufacturers and accrediting bodies regarding reprocessing and disinfection issues. It is incumbent upon all gastroenterologists to follow recognized standards for cleaning and disinfection to protect the well-being of our patients as well as the integrity of our specialty."
From July to December 2012, the AAAHC Institute gathered information on organizational attributes and processes of 100 organizations that perform from 60 to 12,800 colonoscopies each year, representing a total of more than 353,307 annually.
The AAAHC Institute found that:
- 99 percent of responding organizations complied with all of the following clinical practice guideline-recommended processes prior to sterilization or HLD: leak testing; cleaning with an enzyme cleaner that is compatible with the scope; flushing and brushing all channels and ports; cleaning all external surfaces and accessories; and cleaning residue/debris until no more debris appears on cleaning brushes.
- However, only 88 percent of responding organizations indicated that they follow all of the recommended steps for testing fluids used for sterilization or HLD: test at least every day of use; test prior to each cycle/use; use the manufacturer’s recommended chemical indicator; document the results of testing; discard the solution if the chemical indicator shows the concentration is less than the manufacturer’s minimum effective concentration; and discard the solution if it is beyond the manufacturer’s recommended shelf or use life.
- And, only 59 percent of the 27 responding organizations reporting they use re-usable cutting instruments indicated that they follow both recommended processes (mechanically cleaning reusable biopsy forceps or other cutting instruments that break the mucosal barrier and sterilizing these) between each patient.
Although study results indicate a high percentage of compliance with pre-sterilization/high level disinfection processes, there are clear opportunities to increase compliance with national guidelines and manufacturers’ recommendations for sterilant fluid testing and management, as well as processing of reusable cutting instruments. This improvement will result in increasing patient safety by lowering the rates of health-care-acquired infections (HAIs) and the cost associated with testing for and treating or managing HAIs.
AGA was the first gastroenterology member organization of AAAHC and AGA's representatives have played important leadership roles in this accrediting body. In October, AGA was a supporting organization in the FDA-Association for the Advancement of Medical Instrumentation Reprocessing Summit, which addressed not only the regulatory and economic environments, but also the current science of reprocessing.
Please review to the AGA-endorsed 2011 revised multi-society guideline for reprocessing of flexible endoscopes.