Meeting the standards of ASGE, SGNA and AAMI, Conmed has a portfolio of products designed to help ensure your patients’ safety and reduce the risk of endoscopy related infections.
Improper scope reprocessing is dangerous and has caused patient infections. 1-6
The improper cleaning of scopes used in GI procedures can expose patients to carbapenem resistant enterobacteriaceae (CRE) infections. Resistant to most available antibiotics, the CDC states that these infections are very difficult to treat, and can be deadly – with one report citing they can contribute to death in up to 50% of patients who become infected.1
38 patients at a hospital contracted the deadly superbug CRE after being treated with duodenoscopes.3,4
39 patients at a hospital were infected with antibiotic-resistant infections after undergoing ERCP. At least 18 of those patients later died.2,3
In another outbreak at a hospital, 5 patients were sickened, and 3 died.6
2 patients died and 6 more were sickened in a new outbreak suspected of being caused by contaminated medical scopes.5
FDA & Professional Societies Respond with New Standards
Following these outbreaks, many of the world’s leading authorities for healthcare professionals issued new standards and best practices for safer, more effective reprocessing.
- In 2015, The FDA issued a Safety Communication recommending strict adherence to general endoscope reprocessing guidelines and practices established by the infection control community and endoscopy professionals.12
- The Society of Gastroenterology Nurses and Associates (SGNA) released a revised version of their Standards of Infection Control in Reprocessing of Flexible Gastrointestinal Endoscopes.8
- The American Society for Gastrointestinal Endoscopy (ASGE) released new guidelines recommending endoscope pre-cleaning should be performed at the point of use.13
- In 2015, The Association for the Advancement of Medical Instrumentation (AAMI) and American National Standards Institute (ANSI) released ANSI/ AAMI Standard ST91:2015.7
- In 2015, The ECRI Institute issued a High Priority
Hazard Report with recommendations to help
reduce the risk of ERCP endoscope-related patient
CleanCageTM Endoscope Valve-Tracking System
CleanCage™ helps ensure safe handling and
tracking of endoscope valves during cleaning,
disinfection & storage.
Clean TrayTM Endoscope Pre-Cleaning System
Simply add water to this all-in-one tray, channel cleanser and scope sponge to simplify and
standardize your immediate post-procedure bedside endoscope pre-cleaning.
Related Biliary solutions:
1 Centers for Disease Control & Prevention. http://www.cdc.gov/HAI/organisms/cre/ 2 “Preventable Tragedies: Superbugs and How Ineffective Monitoring of Medical Device Safety Fails Patients” United States Senate Health, Education, Labor & Pensions Committee. Minority Staff Report. 1/13/2016. 3 McCaughey, Betsy. “The Feds Dawdle While Patients Die Needlessly.” The New York Post. 4/6/2016. 4 McCoppin, Robert and Cynthia Dizikes. “Superbug found at suburban hospital.” The Chicago Tribune. 1/10/2014. 5 Peterson, Melody. “Two more deaths may be linked to contaminated medical scopes.” The Los Angeles Times. 4/25/2016. 6 Terhune, Chad. “Tainted Scope Infections Far Exceed Earlier Estimates.” Kaiser Health News. 4/15/2016. 7 “Flexible and semi-rigid endoscope processing in health care facilities.” ANSI/AAMI ST91:2015. Association for the Advancement of Medical Instrumentation (AAMI). 4/8/15. 8 “SGNA Releases Revised Standards of Infection Control in Reprocessing of Flexible GI Endoscopes.” Infection Control Today. Press Release. 9/10/2012. 9 “High Priority Hazard Report: ECRI Institute Recommends Culturing Duodenoscopes as a Key Step to Reducing CRE Infections.” ECRI Institute. 5/13/2015. 10 “Superbug Outbreak Triggers Need for Better Tracking of Scopes.” ECRI Institute. Press Release. 9/9/2015 11 “Tracking Scopes: Best Practices for Identifying Endoscopes During Cleaning and Patient Use.” ECRI Institute. Press Release. 9/30/2015. 12 “Design of Endoscopic Retrograde Cholangiopancreatography (ERCP) Duodenoscopes May Impede Effective Cleaning.” FDA Safety Communication. 2/23/2015. 13 Multi-society guideline on reprocessing flexible GI endoscopes: 2011 1078 GASTROINTESTINAL ENDOSCOPY Volume 73, No. 6 : 2011. 14 BSG Guidelines for Decontamination of Equipment for Gastrointestinal Endoscopy. The Report of a Working Party of the British Society of Gastroenterology Endoscopy Committee. February 2008.