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70 Executive Briefing: Endoscope Reprocessing Sponsored by: M ore than 20 million gastrointesti- nal endoscopic procedures are performed each year in the United States. According to the American Society for Gastrointestinal Endoscopy (ASGE), the risk of infection due to one of these proce- dures is approximately one in 1.8 million. While reports of endoscopy-associated patho- gen transmission are rare, any occurrence is a cause for serious concern, since a single transmission can result in a disease outbreak. However, strict adherence to validated endo- scope reprocessing protocols and the use of chemical agents in accordance with manufac- turer's instructions, have the potential to virtu- ally eliminate the risk. ASGE and the Society for Healthcare Epide- miology of America (SHEA) have published evidence-based guidelines ("Multisociety guideline on reprocessing flexible gastrointes- tinal endoscopes: 2011") for the cleaning and disinfection of endoscopes that have been endorsed by the major medical and nursing associations involved in endoscopy and infec- tion control. The guidelines state, "To date, all published occurrences of pathogen transmis- sion related to GI endoscopy have been asso- ciated with failure to follow established clean- ing and disinfection/sterilization guidelines or use of defective equipment." This year, ASGE issued "Guidelines for safety in the gastrointestinal endoscopy unit." These guidelines are designed to provide safety rec- ommendations and advise on the evaluation of endoscopy units. According to ASGE, the new guidelines, which were partly prompted by the Centers for Medicare and Medicaid Services (CMS) Ambulatory Surgical Center Condi- tions of Coverage, were issued in 2009. This requires non-sterile procedure environments, including endoscopy units, adhere to the same standards as those of sterile operating rooms. "Endoscope manufacturers can partner with ASCs in their quality care and patient safety mission. We work very closely with the GI community to ensure that our equipment is used safely and appropriately," said Len Far- ris, Vice President of Marketing, PENTAX Medical, a healthcare industry leader in en- doscopic imaging. "ASCs each have differ- ent needs, but face the same standards and requirements for cleaning and disinfection. Therefore, endoscopic imaging and training solutions must be customized to help ensure patient safety, while at the same time helping to deliver clinical and economic value." PENTAX Medical endoscopes have been safe- ly used in more than 1 million procedures over the past 10 years, helping clinicians to provide accurate diagnoses and make more informed treatment decisions with their patients. In order to help ASCs safeguard their patients and protect their equipment, PENTAX Medical routinely offers training that is supported by comprehensive instruction manuals and other resources that detail specific design features, handling, and storage of its endoscopes. While total prevention of infection is an achievable goal, it still presents its chal- lenges. Any lapses or missteps in cleaning and disinfection protocols and procedures, even if they appear to be minor, can lead to pathogen transmission. In addition, the need to remove even one endoscope from service can limit a center's capacity to provide qual- ity and efficient patient care. Here are some things to think about as you establish or seek to improve your cleaning and disinfection procedures. Managing the Process Step By Step Endoscope reprocessing must be managed and monitored from beginning to end, with clear accountability the rule, rather than the exception. Reprocessing technicians must be thoroughly trained on validated reprocessing methods and their sequence, periodically ob- served to ensure continual adherence to prop- er technique, and acknowledged for the vital role that they play in delivering an endoscope to the clinician that is safe and ready to use. Ongoing refresher training should reinforce the use of the correct cleaning materials and accessories for each model of endoscope, the use of materially compatible detergents and disinfectants, and proper handling and storage. It is advisable for ASCs to evaluate their endoscope reprocessing standard oper- ating procedures on a regular basis, as well as compliance to their comprehensive quality assurance and safety programs. Finally, facility management should conduct periodic assessments regarding the overall adequacy of their reprocessing and storage areas, ergonomic and worker safety consid- erations, equipment layout, and incoming in- strument flow, from dirty to clean areas. Not All Endoscopes are Alike There are a wide range of endoscope models, which means that reprocessing technicians must understand which disinfection and steril- ization methods are applicable to each of the different endoscope models in their inventory. "The design of an endoscope that is dedicated to a specific application generally varies by manufacturer. This situation also often extends to endoscopes made by the same manufac- turer," said Frank Canonica, PhD, Senior Mar- keting Manager at PENTAX Medical, who man- ages the cleaning, disinfection and sterilization services for the company's flexible endoscopes. "If a facility uses different models of endo- scopes from different manufacturers, it must ensure that its reprocessing technicians are thoroughly trained to effectively reprocess every instrument according to the specific manufacturer requirements. Even slight de- sign variations among endoscopes can pose unique challenges as it relates to cleaning and disinfection," Dr. Canonica added. Establish Realistic Turnover Times At the facility level, performance should not be measured solely upon quick procedural turn- around times. Turnaround times should be re- alistic and based upon strict adherence to es- tablished processes, protocols, and instrument manufacturer's recommendations for proper device maintenance. In addition, an insufficient inventory of the right endoscope models has the potential to reduce ASC efficiency. Manag- ing expectations up and down the chain of re- sponsibility is key to reducing errors and omis- sions and disruptions to patient care. No One Size Fits All Approach Clinical pathways and processes must be opti- mized to ensure patient safety, improve patient outcomes and satisfaction, and increase opera- tional efficiency. However, there is no "one size fits all" approach, particularly when it comes to endoscopic imaging and reprocessing. "PENTAX Medical works with the full range of healthcare systems and settings, including ASCs, not only to understand, analyze, and satisfy their endoscopy equipment needs, but to support their instrumentation with custom- ized service and software solutions based on volume, mix of procedures, and training re- quirements," said Farris. "It is our mission to partner with the healthcare community to en- able them to deliver on the promise of safe, effective, and affordable care." n Endoscope Reprocessing in ASCs By Len Farris, Vice President of Marketing, PENTAX Medical