Endoscope Reprocessing – Studies Prove There Are Many Concerns

endoscope Each year more than 11 million endoscope procedures are performed in the United States.1 Reprocessing challenges and lapses have recently brought increasing awareness to endoscope processing.  Thorough and efficient endoscope reprocessing, which includes point-of-use cleaning, manual cleaning and high-level disinfection (HLD), is necessary between patients to minimize the risk of cross contamination. Contaminated endoscopes have been linked to more outbreaks of health-associated infections than any other medical device.3

While many of the documented incidents of exposures to contaminated scopes involved mistakes or shortcuts taken in reprocessing steps, studies have confirmed that scopes can remain contaminated even after proper cleaning and adherence to published guidelines.4  According to studies conducted by epidemiologist Cori Ofstead, MSPH, President and CEO of Ofstead & Associates Inc., and other well-published scientific data, even when following written guidelines for endoscope reprocessing, the devices may still contain bioburden which can be transmitted from one patient to the next.4

According to microbiologist Michelle Alfa, Ph.D., prior to the 2011 FDA draft guidelines, manufacturers of endoscopes were not required to validate cleaning as part of their 510K FDA process.5  Flexible endoscopes have the lowest margin of safety of any reprocessed devices.  Flexible scopes used for ERCP (Endoscopic Retrograde Cholangiopancreatography) procedures are very complex and the most complicated flexible scopes to adequately clean.5  In research conducted by Alfa, 14% of scopes reprocessed on a Friday by competent personnel and stored according to written guidelines had viable bacteria/fungi growing the following Monday morning.4,5

Ofstead and Alfa recommend facilities review current guidelines, and manufacturer’s instructions for use and develop scope-specific house-wide policies and procedures.  Competencies should be conducted with direct observation of each endoscope processing step.  Ensure that the correct HLD concentration, recommended temperature and exposure time are followed every time for every make and model of scope.  Keep records of leak testing and be sure to not handle scopes with bare hands after HLD process.

In addition, audits using specific step-by-step checklists should be conducted routinely by someone other than the staff doing the processing. These audits should be announced and unannounced and any non-compliance addressed immediately.  Verifying the effectiveness of manual cleaning with products such as ATP, protein and hemoglobin/blood should be routinely used.  In addition, cultures of the internal channels and hard to reach areas should be taken monthly or quarterly to check for contamination on patient-ready scopes.

References:

  1. Centers for Disease Control and Prevention. National Hospital Discharge Survey: 2009 table, procedures by selected patient characteristics.  Available from http://www.cdc.gov/nchs/fastats/inpatient-surgery.htm.  Accessed July 8, 2014.
  2. Dirlam Langlay, A. et al. Reported gastrointestinal endoscope reprocessing lapses: The tip of the iceberg. American Journal of Infection Control 41 (2013) 1188-94.
  3. Rutala, W. A., Weber, D. J., & Healthcare Infection Control Practices Advisory Committee. (2008). Guidelines for disinfection and sterilization in Healthcare facilities. Atlanta. GA: Centers for Disease Control and Prevention.
  4. Ofstead, C. The Real Dirt on Flexible Endoscopes. Presentation given at IAHCSMM Annual Conference, Columbus, Ohio, May 5, 2014.
  5. Alfa, M. Medical Device Reprocessing: A Paradigm Shift. Presentation given at 3M Sterilization Leadership Advisory Council Meeting, June 19, 2014.

Other Resources:

  • Ofstead, C. et all. Re-evaluating endoscopy-associated infection risk estimates and their implications. American Journal of Infection Control 41 (2013) 734-6.
  • Ofstead, C. et al. Endoscope Reprocessing Methods – A Prospective Study on Impct of Human Factors and Automation. Society of Gastroenterology Nurses and Associates. Vol 33 No 4 July/August 2010.
  • Rutala, W. A., Weber, D. J., (2004) Reprocessing endoscopes: United States perspective. Journal of Hospital Infection, 56(Suppl. 2), S27-S39.
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