Flexible Endoscope Reprocessing: The Journey of a Dirty Endoscope

Endoscopy is a procedure to visually examine the inside of the body using an endoscope. Duodenoscope is an example of a flexible endoscope used in endoscopic retrograde cholangiopancreatography (ERCP) procedures and have received attention due to the infections associated with the improper reprocessing in recently years.1

Duodenoscope are complex instruments that contain intricate working parts, and if not thoroughly cleaned and disinfected, tissue or fluid from one patient can remain when it is used on a subsequent patient.1

Seven Critical Steps for Flexible Endoscope Reprocessing

The Center for Disease Control (CDC) recommends seven critical reprocessing steps to ensure endoscopes are safe for patient use. The chart below is a summary of the CDC’s guidance:2

STEPS What is it? Why Is It Important?
1 Pre-Cleaning Cleaning often performed in the examination room immediately following the procedure2 Helps prevent the formation of biofilm on the instrument2
2 Leak-Test Test to detect damage to the external and internal channels of the scope2 A leak can lead to inadequate disinfection and further damage of the endoscope2
3 Manual Cleaning Manual cleaning including brushing and flushing channels and ports consistent with the manufacturer’s instructions for use (IFU)2 The most critical step in the disinfection process since remaining organic material can reduce the effectiveness of high-level disinfection (HLD) and sterilization2
4 Visual Inspection Visually inspect the endoscope and its accessories2 Visual inspection provides additional assurance that the endoscope and its accessories have been throughly cleaned and are free of any visible defects2
5 Disinfection or Sterilization Perform high-level disinfection or sterilization in accordance with the manufacturer’s IFU2 Follow manufacturer’s instructions and IFU to help ensure effective disinfection2
6 Storage Properly store endoscope and its accessories2 Store endoscopes and its accessories in a way that prevents recontamination, protects the instrument from damage and promotes drying2
7 Documentation Maintain documentation of these steps each time an endoscope is reprocessed2 Documentation is necessary for quality assurance purposes and for patient tracing if necessary2
STEPS What is it?/ Why Is It Important?
1 Pre-Cleaning
What is it?
Cleaning often performed in the examination room immediately following the procedure2
Why Is It Important?
Helps prevent the formation of biofilm on the instrument2
2 Leak-Test
What is it?
Test to detect damage to the external and internal channels of the scope2
Why Is It Important?
A leak can lead to inadequate disinfection and further damage of the endoscope2
3 Manual Cleaning
What is it?
Manual cleaning including brushing and flushing channels and ports consistent with the manufacturer’s instructions for use (IFU)2
Why Is It Important?
The most critical step in the disinfection process since remaining organic material can reduce the effectiveness of high-level disinfection (HLD) and sterilization2
4 Visual Inspection
What is it?
Visually inspect the endoscope and its accessories2
Why Is It Important?
Visual inspection provides additional assurance that the endoscope and its accessories have been throughly cleaned and are free of any visible defects2
5 Disinfection or Sterilization
What is it?
Perform high-level disinfection or sterilization in accordance with the manufacturer’s IFU2
Why Is It Important?
Follow manufacturer’s instructions and IFU to help ensure effective disinfection2
6 Storage
What is it?
Properly store endoscope and its accessories2
Why Is It Important?
Store endoscopes and its accessories in a way that prevents recontamination, protects the instrument from damage and promotes drying2
7 Documentation
What is it?
Maintain documentation of these steps each time an endoscope is reprocessed2
Why Is It Important?
Documentation is necessary for quality assurance purposes and for patient tracing if necessary2
Disinfection and Sterilization – What’s the Difference?

Disinfection and sterilization are essential for ensuring that medical and surgical instruments do not transmit infectious pathogens to patients.3

Sterilization is a process that destroys or eliminates all forms of microbial life.

Disinfection is a process that eliminates many or all pathogenic microorganisms, except bacterial spores.

There are three levels of disinfection:4

  • High-level disinfection - the destruction of all viruses, vegetative bacteria, fungi, mycobacterium, and some, but not all, bacterial spores
  • Intermediate-level disinfection - the destruction of all mycobacteria, vegetative bacteria, fungal spores, and some nonlipid viruses, but not bacterial spores
  • Low-level disinfection - a process that can kill most bacteria (except mycobacteria or bacterial spores), most viruses (except some nonlipid viruses), and some fungi
Illustration of microbial life post-reprocessing
Sterilization
High-level disinfection
Low-level disinfection
Illustration of microbial life post-reprocessing
Sterilization
High-level disinfection
Low-level disinfection
How to Determine Endoscope Reprocessing Modality

Determining the appropriate reprocessing modality will require an understanding of the Spaulding Classification of instrumentation. The Spaulding Classification defines the minimum levels of disinfection or sterilization that should be used according to the infection risk associated with a medical device.5

Critical

High Risk for Infection

Instrument enters the sterile tissue or the vascular system

Reprocessing Level Required:
Sterilization

Example
Surgical instruments and ultrasound probes used in sterile body cavity

Semi-Critical

Risk for Infection

Semi-Critical Risk for Infection Instrument contact mucous membranes or nonintact skin

Reprocessing Level Required:
High-level disinfection

Example
Laryngoscope blades and some endoscopes used in GI procedures

Noncritical

Lower Risk for Infection

Instrument comes in contact with skin, but not the mucous membranes

Reprocessing Level Required:
Intermediate/Low-level disinfection

Example
Bed pans or blood pressure cuffs

ASP Solutions
High-Level Disinfection

ASP Solutions High-Level Disinfection Institutions have several options for high-level disinfection of flexible endoscopes with biocide; manual soaking or automated reprocessing using an automated endoscope reprocessing (AER) system. All AER systems automate high-level disinfection, but some systems have additional features such as automated cleaning and automated leak testing. In addition, biocides monitoring is an important aspect with high-level disinfection reprocessing. ANSI AAMI ST91:2015 Flexible and semi-rigid endoscope reprocessing in health care facility recommends monitoring biocide Minimum Recommended Concentration (MRC) every cycle; MRC testing is typically performed with a manual test strip.6

ASP AEROFLEX™ Automatic Endoscope Reprocessor (AER) automates critical steps including the proper monitoring and documentation of MRC. ASP AEROFLEX™ AER is the only system with AUTOSURE™ MRC Monitor, an automatic, integrated system that eliminates the use of test strips. The exclusive AUTOSURE™ MRC monitor reduces the opportunity for human errors and reduces patient risk associated with manual test strip use.7 Learn more here.

Sterilization

According to researcher W.A. Rutala, PhD, MPH, CIC, " nearly all infections and patient exposures associated with reprocessing medical or surgical instruments involve high-level disinfection (HLD) of reusable semi-critical items", while "critical items are rarely, if ever, associated with disease transmission."8 STERRAD® System is a low-temperature hydrogen peroxide gas plasma sterilization system, a popular solution for institutions looking to sterilize flexible endoscopes.

The patented technology in the STERRAD NX® System and STERRAD® 100NX System deliveries a concentrated load of hydrogen peroxide sterilant through long and narrow lumens to terminal sterilize flexible endoscopes. There are hundreds of flexible endoscopes from the leading manufacturers such as Olympus, KARL STORZ and PENTAX that have been validated in STERRAD® Systems. Check out the STERRAD® Sterility Guide for an up to date list.

If you’d like a consultation with an ASP expert to help determine which semi-critical flexible endoscopes have been validated in STERRAD® Systems, please contact us today.

References
  1. U.S. Food & Drug Administration (FDA). Infections Associated with Reprocessed Duodenoscopes. Available: https://www.fda.gov/medical devices/reprocessing-reusable-medical-devices/infections-associated-reprocessed-duodenoscopes. Accessed August 4, 2020.
  2. Centers for Disease Control and Prevention (CDC). Essential Elements of a Reprocessing Program for Flexible Endoscopes – Recommendations of the Healthcare Infection Control Practices Advisory Committee. Last updated: June 28, 2017.
  3. Centers for Disease Control and Prevention (CDC). Introduction, Methods, Definition of Terms -Guideline for Disinfection and Sterilization in Healthcare Facilities (2008) https://www.cdc.gov/infectioncontrol/guidelines/disinfection/introduction.html. Accessed August 4, 2020.
  4. Lichtenstein D, Alfa MJ. Cleaning and Disinfecting Gastrointestinal Endoscopy Equipment. Clinical Gastrointestinal Endoscopy 2019: 32-50.e5.
  5. Centers for Disease Control and Prevention (CDC). A Rational Approach to Disinfection and Sterilization - Guideline for Disinfection and Sterilization in Healthcare Facilities (2008). https://www.cdc.gov/infectioncontrol/guidelines/disinfection/rational-approach.html. Accessed August 4, 2020.
  6. Association for the Advancement of Medical Instrumentation (2015). ANSI/AAMI ST91:2015. Flexible and semi-rigid endoscope processing in health care facilities. Arlington, VA.
  7. Ofstead CL, Hopkins KM, Buro BL, Eiland JE, Wetzler HP. Challenges in Achieving Effective High-Level Disinfection in Endoscope Reprocessing. Am J Infect Control 2019: 10.1016.
  8. Rutala WA, Weber DJ. Reprocessing semicritical ítems: Current issues of new technologies. Am J Infect Control 2016: 44 e53-62.

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