May 2010 - Viewpoint

INSIDE THE CURRENT ISSUE

May 2010

IAHCSMM Viewpoint

Agencies partner to release new flexible scope guidelines

by Julie E. Williamsom

Well-educated, experienced Central Sterile Supply Department professionals understand that safe, effective handling and processing of flexible endoscopes takes diligence and a department-wide adherence to industry guidelines and manufacturer instructions.

But dangerous scope-related mistakes are all too common – a point that was underscored last year after widely publicized flexible endoscope reprocessing errors at several Veterans Affairs facilities potentially exposed thousands of patients to HIV and hepatitis. While such reports are indeed startling, it’s important to recognize that most errors never make headlines, and quite often, CSSD staff and other healthcare workers, as well as patients, are unaware that mistakes have occurred. Still, the risks are no less great.

The report by ECRI made that point clear when it placed "cross-contamination of flexible endoscopes" in the Number One spot on its 2010 Top Ten Health Technology Hazards list.

The good news is that the number of reported infection transmissions falls to zero when cleaning and high-level disinfection of endoscopes are performed in accordance to reprocessing guidelines. IAHCSMM believes that any professional responsible for endoscope reprocessing must not only have ready access to the most current endoscope reprocessing guidelines, but also have stringent policies in place to ensure that those guidelines are fully understood and consistently followed. CSSD professionals must also work closely with their vendor partners to ensure that endoscopes are being properly handled and that the products and equipment used to reprocess these complex devices are also being used consistently, and according to manufacturer recommendations.

Guidelines get an update

To help ensure that flexible endoscopes are processed properly every time, and to help eliminate confusion regarding proper scope handling and processing, the U.S. Food and Drug Administration, the Centers for Disease Control and Prevention, and the Department for Veterans Affairs issued a new set of guidelines for all healthcare facilities that perform endoscopic procedures, including hospitals, ambulatory surgery centers and private practices. [Note: The guidelines, "Preventing Cross-Contamination in Endoscope Processing: Safety Communication from FDA, CDC, and the VA," are available online at: www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm190273.htm.

The Joint Commission reviewed the guidelines and developed the following recommendations, which are based on the new FDA/CDC guidelines:

Establish an institutional program for endoscope processing, along with written procedures for monitoring adherence to the program, and a chain of accountability. Ensure that those responsible for endoscope processing understand the importance of this job and that they maintain proficiency in performing it for each type of endoscope they handle.

Train employees to set-up, clean, disinfect or sterilize, and store endoscopy equipment properly. Periodically retrain and assess competence. Endoscopy is a constantly evolving technology, so it is essential to stay up-to-date with the specifics of each device your institution uses.

Instruct staff to read and follow the endoscope manufacturer’s instructions for use. People responsible for reprocessing endoscopes must have the manufacturer’s instructions available for each endoscope and its accessories because various endoscopes and their accessories often must be processed differently (e.g., most flexible endoscopic equipment cannot tolerate steam sterilization).

Ensure that staff members understand that the cleaning and disinfecting of endoscopes are two separate processes. Thorough cleaning of the endoscope must be done first to remove gross contamination and debris. Without this step, the endoscope cannot be effectively disinfected or sterilized. Cleaning should begin immediately after use by thoroughly flushing the channels and rinsing/wiping the outside of the endoscope. This must be followed by a very thorough cleaning with brushes, concentrating especially on the channels. Only then is the endoscope ready for high-level disinfection, which can be done manually or in an automatic endoscope reprocessor. During disinfection, the high-level disinfectant must contact every contaminated surface/channel for the time recommended by the disinfectant manufacturer.

Ensure that the AER or sterilizer is compatible with the endoscope. Before using an AER, confirm that it properly fits the endoscope. Adhere to the AER or sterilizer instructions that specify which endoscope makes and models it can process, and be sure that the instructions for endoscopes, AERs and germicides do not contradict one another. If you become aware that instructions are contradictory, inform the endoscope and AER manufacturers, as well as the FDA.

Ensure that endoscopes or accessories that contact sterile tissue are sterilized before each use, and that endoscopes that contact intact mucous membranes (e.g., the respiratory and gastrointestinal tracts) undergo at least high-level disinfection before each use.