Existing reprocessing techniques prove insufficient for flexible endoscopes


Arlington, VA, January 31, 2017

Current techniques used to clean endoscopes for reuse are not consistently effective, according to a study published in the February issue of the American Journal of Infection Control, the official journal of the Association for Professionals in Infection Control and Epidemiology (APIC). The findings of this study support the need for careful visual inspection and cleaning verification tests to ensure that all endoscopes are free of damage and debris before they are high-level disinfected or sterilized and used on another patient.

“APIC is concerned about the risk of infections related to endoscopic procedures,” said Linda Greene, RN, MPS, CIC, FAPIC, 2017 APIC president. “This study reinforces the importance of having strong infection prevention and control programs at all types of facilities, led by highly trained infection preventionists, to ensure that facilities are following the latest evidenced-based guidance.”

Currently, flexible endoscopes, including gastrointestinal, urological, and respiratory endoscopes, are reused following cleaning and high-level disinfection. However, results from the new study conducted by Ofstead & Associates, Inc., suggest that even more rigorous reprocessing techniques of endoscopes are not consistently effective, and organic residues often remain.

“Understanding issues with the effectiveness of reprocessing techniques is critically important as institutions seek to improve the quality of endoscope cleaning and disinfection,” said lead study author Cori L. Ofstead, MSPH, Ofstead & Associates, Inc. “Even though top-notch methods were used, the endoscopes in this study had visible signs of damage and debris, and tests showed a high proportion were still contaminated.”

Using a longitudinal study design, Ofstead, et al. performed three assessments of 20 endoscopes over a seven-month period. The assessments involved visual inspections with a tiny camera, microbial cultures, and biochemical tests to detect protein and adenosine triphosphate (ATP) – a marker that identifies organic matter. These assessments were used to identify endoscopes that required further cleaning and maintenance.

During the final assessment, the researchers found that all 20 endoscopes examined had visual irregularities, such as fluid, discoloration, and debris in channels. Furthermore, samples from 12 of 20 reprocessed endoscopes (60 percent) had microbial growth, indicating a failure of the disinfection process. Of note, endoscopes reprocessed using current recommended guidelines and those that were cleaned at least twice before high-level disinfection exhibited similar culture results.

Further results indicated that about 20 percent of endoscopes in each group exceeded post-cleaning benchmarks for ATP and protein residue. Moreover, ATP levels were higher for gastroscopes, which are used for upper GI procedures, than the endoscopes used for colonoscopy. “Since the same technicians used the same techniques to clean and disinfect these scopes, the findings and our visual observations suggest that something is happening to gastroscopes during procedures that changes the surfaces and causes reprocessing failures,” says Ofstead.

This study comes on the heels of a 2015 report of Carbapenem-resistant Enterobacteriaceae (CRE) infections related to Endoscopic Retrograde Cholangio-Pancreatography (ERCP) duodenoscopes—devices that are threaded through the mouth, throat, and stomach into the top of the small intestine (duodenum) for examinations and treatment. No breaches in reprocessing were identified and yet infections related to the duodenoscopes were uncovered, raising concerns that current reprocessing techniques were ineffective, and illuminating the challenges in reprocessing of such intricate medical devices.

“The finding of residual fluid in 95 percent of endoscopes tested was significant because moisture fosters microbial growth and the development of biofilm—which can be difficult or impossible to remove,” said Ofstead. “This confirms the importance of cleaning, disinfecting, and drying to ensure patient safety.”

Visit www.apic.org for resources on reprocessing reusable medical devices.

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Notes for editors
The article is “Longitudinal assessment of reprocessing effectiveness for colonoscopes and gastroscopes: Results of visual inspections, biochemical markers, and microbial cultures” by Cori L. Ofstead; Harry P. Wetzler; Otis L. Heymann; Ellen A. Johnson; John E. Eiland; and Michael J. Shaw (doi: 10.1016/j.ajic.2016.10.017). It is published in the American Journal of Infection Control, volume 45, issue 2 (February 2017) by Elsevier.

Authors:
Cori L. Ofstead, MSPH (Corresponding author)
Ofstead & Associates, Inc
Saint Paul, MN

Harry P. Wetzler, MD, MSPH
Ofstead & Associates, Inc
Saint Paul, MN

Otis L. Heymann, BA
Ofstead & Associates, IncSaint Paul, MN

Ellen A. Johnson, BAS
Ofstead & Associates, Inc
Saint Paul, MN

John E. Eiland, MS, RN
Ofstead & Associates, Inc
Saint Paul, MN

Michael J. Shaw, MD
Division of Gastroenterology, Department of Medicine, University of Minnesota Medical School
Minneapolis, MN

About AJIC: American Journal of Infection A
AJIC: American Journal of Infection Control
covers key topics and issues in infection control and epidemiology. Infection preventionists, including physicians, nurses, and epidemiologists, rely on AJIC for peer-reviewed articles covering clinical topics as well as original research. As the official publication of APIC, AJIC is the foremost resource on infection control, epidemiology, infectious diseases, quality management, occupational health, and disease prevention. AJIC also publishes infection control guidelines from APIC and the CDC. Published by Elsevier, AJIC is included in MEDLINE and CINAHL.

About APIC
APIC’s mission is to create a safer world through prevention of infection. The association’s more than 15,000 members direct infection prevention programs that save lives and improve the bottom line for hospitals and other healthcare facilities. APIC advances its mission through patient safety, implementation science, competencies and certification, advocacy, and data standardization. Visit APIC online at www.apic.org. Follow APIC on Twitter: www.twitter.com/apic and Facebook: www.facebook.com/APICInfectionPreventionandYou. For information on what patients and families can do, visit APIC’s Infection Prevention and You website at www.apic.org/infectionpreventionandyou.

About Elsevier
Elsevier is a global information analytics business that helps institutions and professionals progress science, advance healthcare and improve performance for the benefit of humanity. Elsevier provides digital solutions and tools in the areas of strategic research management, R&D performance, clinical decision support, and professional education; including ScienceDirect, Scopus, SciVal, ClinicalKey and Sherpath. Elsevier publishes over 2,500 digitized journals, including The Lancet and Cell, more than 35,000 e-book titles and many iconic reference works, including Gray's Anatomy. Elsevier is part of RELX Group, a global provider of information and analytics for professionals and business customers across industries. www.elsevier.com

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