ASGE and SHEA issue updated multisociety guideline on reprocessing flexible gastrointestinal endoscopes

JUNE 1, 2011 – The American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Healthcare Epidemiology of America (SHEA) have updated their 2003 joint guideline for reprocessing gastrointestinal endoscopes to reaffirm reprocessing methods and take into account evolved technology and disinfection systems.

The initial guideline, published in 2003, was drafted in collaboration with multiple physician and nursing organizations, infection prevention and control organizations, federal and state agencies, and industry leaders to develop evidence-based guidelines for reprocessing gastrointestinal (GI) endoscopes. ASGE, SHEA and nine other collaborating organizations have updated the previous guideline with additional discussion of new or evolving reprocessing issues and updated literature citations. The updated guideline, "Multisociety guideline on reprocessing flexible gastrointestinal endoscopes: 2011," is published in the June issues of GIE: Gastrointestinal Endoscopy, the monthly peer-reviewed scientific journal of the ASGE, and of Infection Control and Hospital Epidemiology, the scientific journal of SHEA.

To date, all published occurrences of pathogen transmission related to GI endoscopy have been associated with failure to follow established cleaning and disinfection/sterilization guidelines or use of defective equipment. Despite strong data regarding the safety of endoscope reprocessing, clinicians' concerns about the potential for pathogen transmission during endoscopy have raised questions about the best methods for disinfection or sterilization of these devices between patient uses. Since the 2003 guideline, high-level disinfectants, automated reprocessing machines, endoscopes and endoscopic accessories have all evolved; however, the efficacy of decontamination and high-level disinfection is unchanged and the principles guiding both remain valid.

"Endoscopy is a safe and effective procedure. Despite the large number and variety of GI endoscopic procedures performed, documented instances of infectious complications remain rare, with an estimated frequency of 1 in 1.8 million procedures," said Bret T. Petersen, MD, FASGE, chairman, ASGE Quality Assurance in Endoscopy Committee. "Since the 2003 guideline was published, additional outbreaks of infection related to suboptimal infection prevention practices during endoscopy or lapses in endoscope reprocessing have been well publicized. Given the ongoing, but rare, occurrences of endoscopy-associated infections attributed to lapses in infection prevention, an update of the multisociety guideline was warranted."

Flexible GI endoscopes should first be completely cleaned and then subjected to at least high-level disinfection. This standard has been recommended by federal agencies such as the FDA and CDC; professional organizations such as ASGE, SHEA, the American College of Gastroenterology, the American Gastroenterology Association, the Society of Gastroenterology Nurses and Associates (SGNA), the Association of periOperative Registered Nurses (AORN), and the Association for Professionals in Infection Control and Epidemiology. These organizations have developed guidance documents that detail the sequence and specifics of each element of appropriate endoscope reprocessing. There are no published studies of confirmed transmission of infection when these guidelines have been followed.

"These guidelines ensure that all clinicians are following the most up to date evidence-based methods to help keep patients safe," said Keith Woeltje, MD, PhD, FSHEA, chair of SHEA's Guidelines Committee. "The rare occurrence of transmission via endoscope speaks to the efficacy of reprocessing methods and shows the impact this guidance has in practice."

• Review of expanded details related to critical reprocessing steps (including cleaning and drying)
• Review of reprocessing issues for various endoscope attachments such as flushing catheters
• Distinction between risks related to endoscope reprocessing and those related to periprocedural practices, including medication administration
• Discussion of related issues for which data are absent or insufficient to guide practice, including:
  • Endoscope shelf life or "hang time" (the interval of storage after which endoscopes should be reprocessed before use)
  • The role of microbiological surveillance testing of endoscopes after reprocessing
  • Questions regarding endoscope durability and longevity from the standpoint of infection prevention

To read all of the recommendations in the guideline, see the June issues of GIE: Gastrointestinal Endoscopy and Infection Control and Hospital Epidemiology.

The 2011 update was initially drafted by the Quality Assurance in Endoscopy Committee of ASGE and the Guideline Committee of the Society for Healthcare Epidemiology of America. Thereafter, significant input from the endorsing organizations was incorporated and distributed for consensus. The updated guideline has received the endorsement of the following organizations, which are committed to assisting the FDA, equivalent international agencies and manufacturers in addressing critical infection control issues in GI device reprocessing:

• American Society for Gastrointestinal Endoscopy
• Society for Healthcare Epidemiology
• American College of Gastroenterology
• American Gastroenterological Association
• American Society of Colon and Rectal Surgeons
• Accreditation Association for Ambulatory Health Care
• Association of periOperative Registered Nurses
• Association of Professionals in Infection Control and Epidemiology
• The Joint Commission
• Society of American Gastrointestinal and Endoscopic Surgeons
• Society of Gastroenterology Nurses and Associates

Endoscopy is performed by specially-trained physicians called endoscopists using the most current technology to diagnose and treat diseases of the gastrointestinal tract. Using flexible, thin tubes called endoscopes, endoscopists are able to access the human digestive tract without incisions via natural orifices. Endoscopes are designed with high-intensity lighting and fitted with precision devices that allow viewing and treatment of the gastrointestinal system. Millions of endoscopic procedures are performed in the U.S. each year. It is a safe, effective and well-tolerated procedure. Sedation is commonly used to make the patient comfortable throughout the exam.

Since its founding in 1941, the American Society for Gastrointestinal Endoscopy (ASGE) has been dedicated to advancing patient care and digestive health by promoting excellence in gastrointestinal endoscopy. ASGE, with nearly 12,000 members worldwide, promotes the highest standards for endoscopic training and practice, fosters endoscopic research, recognizes distinguished contributions to endoscopy, and is the foremost resource for endoscopic education. Visit www.asge.org and www.screen4coloncancer.org for more information and to find a qualified doctor in your area.

The Society for Healthcare Epidemiology of America (SHEA) represents more than 1,800 physicians, infection preventionists and other healthcare professionals dedicated to maintaining the utmost quality of patient care and healthcare worker safety in all healthcare settings. The society, continually strives toward better patient outcomes by applying epidemiologic principles and prevention strategies to healthcare-associated infections and a wide range of quality-of-care issues. SHEA achieves its mission through education, research, evidence-based guideline development, and public policy.