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Endoscope Reprocessing (4.1.11)

Endoscope Reprocessing (4.1.11) - Policies, Clinical, UW Health Clinical, Infection Control

4.1.11


UW HEALTH CLINICAL POLICY 1
Policy Title: Endoscope Reprocessing
Policy Number: 4.1.11
Category: UW Health
Type: Ambulatory and Inpatient
Effective Date: November 13, 2017

I. PURPOSE

To prevent transmission of pathogens associated with use of endoscopes by ensuring that proper cleaning
and disinfection or sterilization of these devices consistently occurs between patient uses.

II. DEFINITIONS

A. Endoscope: An instrument designed to visually examine the interior of a bodily canal or hollow organ such
as the colon, bladder, or stomach.
B. Cleaning: Physical removal of gross soilage and patient materials by use of a combination of physical
scrubbing or agitation, enzymatic agents or detergents. Diligent cleaning substantially reduces the numbers
of contaminating microorganisms and removes soilage which could inhibit the action of
disinfectants/sterilants.
C. High-level disinfection: A disinfection process which reliably kills or inactivates most microbial forms,
including mycobacteria.
D. Sterilization: A process which ensures that all microbial forms, including bacterial endospores, are killed or
inactivated.

III. POLICY ELEMENTS

A. It is imperative that endoscopes be thoroughly cleaned before attempting any disinfection or sterilization
procedure. Inadequate cleaning may result in failure to achieve disinfection or sterilization, and could lead to
transmission of infection.
B. A plan to ensure prompt reprocessing will be in place when endoscopes are removed from typical
endoscopy areas to accommodate urgent patient needs (e.g., taking endoscope to Emergency Department
or Inpatient unit) in order to avoid delays in precleaning and lumen flushing intended to minimize drying of
patient materials on endoscope surfaces or within channels.
C. Endoscope manufacturers’ recommendations for proper cleaning and disinfection or sterilization will guide
reprocessing practice.
D. Properly trained Reprocessing personnel or properly trained unit staff are responsible for ensuring that the
endoscope is adequately leak tested, cleaned, and disinfected or sterilized, as appropriate, after each
patient use.
E. Competency of staff members reprocessing endoscopes will be assessed at the time such duties begin,
when a new endoscope brand or type, or new reprocessing equipment or methods are introduced, and at
regular intervals as needed, but at least annually.
F. Automated systems for endoscope washing and disinfection will be the preferred method of reprocessing
endoscopes, and will be used when feasible.
G. Unused endoscopes subjected to high level disinfection will be reprocessed if there is any suspicion that
contamination has occurred during storage, or if the endoscopes have been in storage for more than 21
days since the last reprocessing date.
H. Endoscopes which have undergone sterilization will not have a time-related need for reprocessing, other
than that imposed by limitations on the method of packaging the sterile item, as described in UW Health
Clinical Policy #4.1.20, Assessing Sterility of Packaged Items at Point of Use.

IV. PROCEDURE

A. Endoscopes for Which Sterilization is Necessary
i. Endoscopes which will enter sterile body sites must be subjected to a sterilization process in order
to ensure the complete absence of microbial forms. These include the following:
a. Laparoscopes
b. Arthroscopes
c. All other scopes that enter sterile body cavities
ii. These endoscopes which require sterilization must be sent to reprocessing for appropriate
cleaning, packaging and sterilization.



UW HEALTH CLINICAL POLICY 2
Policy Title: Endoscope Reprocessing
Policy Number: 4.1.11

B. Endoscopes Which Require High Level Disinfection
i. Endoscopes which have contact with patients' mucous membranes but which do not penetrate
them require, at a minimum, high-level disinfection. Sterilization is not essential for these
endoscopes, but is an acceptable alternative. Endoscopes which require at least high-level
disinfection include:
a. Cystoscopes
b. Rigid and flexible upper and lower gastrointestinal endoscopes
c. Flexible bronchoscopes
d. Sinuscopes
ii. High level disinfection with an FDA registered high level disinfectant following thorough cleaning is
adequate for endoscopes which do not penetrate sterile tissues. Disinfectant manufacturer's
recommended exposure times will be followed, except as in IV.B.iii., below.
iii. If an FDA registered high-level disinfectant containing over 2% glutaraldehyde is utilized for
disinfection after the endoscope is thoroughly cleaned, a minimum 20 minute exposure time will be
used.
a. Disinfectant concentration will be monitored prior to each disinfection cycle to ensure that
adequate activity remains. Results will be documented and retained in a log.
1. If monitoring reveals that the disinfectant concentration has fallen below the
manufacturer's recommended level to achieve high level disinfection, the solution
must be immediately discarded.
2. Prior to initial use of a new bottle of test strips, staff will follow manufacturer's
guidance in performing quality control testing to ensure proper function of the test
strips. Results will be recorded in the log book.
b. The post-activation shelf life of alkaline glutaraldehyde disinfectants recommended by the
manufacturer will be adhered to.
1. If the post-activation shelf life of the disinfectant has been exceeded the solution
must be immediately discarded, regardless of concentration monitoring results.
2. In the event that fresh disinfectant is added to the reservoir of in-use disinfectant
in order to maintain adequate volume, the post-activation shelf life of the original
preparation will be used to determine the discard date.
c. Glutaraldehyde is an OSHA regulated chemical. Unit managers who wish to utilize this
disinfecting agent must contact the hospital Safety and Hazard Control Manager for
worksite assessment and employee protection information prior to its use.
iv. Automated washer/disinfecting systems will be used whenever possible to achieve consistent
disinfection.
a. Protocols of the manufacturer of the automated disinfecting system addressing machine
maintenance, component testing, ensuring proper solution flow through channels, etc., will
be followed.
v. If an automated system is equipped with a process parameter readout slip, the personnel
responsible for reprocessing the instrument will examine the readout and initial it if all parameters
have been met. For automated systems with electronic display of run parameters, the individual will
review and acknowledge that run parameters have been met.
a. If the printed or electronically displayed parametric readout indicates that all parameters
have not been met, and that disinfection failure is possible, the Central Reprocessing
Supervisor will be notified immediately. The instruments will NOT be considered
disinfected and will NOT be used until subjected to a disinfection/sterilization procedure in
which proper parameters have been successfully met.
b. In the event that disinfection failure has occurred but endoscopes have been inadvertently
released for patient use, Infection Control must be notified as described in UW Health
Clinical Policy #4.1.14, Response to Failed High Level Disinfection or Sterilization Cycle.
1. If it is found that an inadequately disinfected endoscope was used on a
subsequent patient, Infection Control will investigate and notify Risk Management
of the potential exposure event.
vi. Filtered water (not untreated tap water) must be used for the final rinse of endoscopes reprocessed
in to achieve high-level disinfection. Isopropyl alcohol (70%) will then be used to ensure that the
internal channels of endoscopes are subjected to high-level disinfection and to aid in drying.
vii. After high level disinfection, flexible endoscopes will be hung in a manner which allows any residual
alcohol to drain from internal channels and which protects these instruments from dust and



UW HEALTH CLINICAL POLICY 3
Policy Title: Endoscope Reprocessing
Policy Number: 4.1.11

inadvertent contamination.
viii. For endoscopes which have undergone proper high-level disinfection and then properly stored, it is
not necessary to again reprocess the unused device unless one of the following criteria are met:
a. There is evidence that proper storage has not been maintained (e.g., evidence of
splashes, sprays or dust accumulation within the storage cabinet) or if unclean items have
direct contact clean scopes within the storage cabinet.
b. The endoscope has been in storage for more than 21 days since its last reprocessing
date.
C. Endoscope Accessories
i. Reusable biopsy forceps and snares, or any other accessory which enters tissues or other sterile
body sites, must be thoroughly cleaned and sterilized after each use.
ii. Single-use biopsy forceps, snares or any other accessories will NOT be reprocessed at UWHC.
iii. All other accessories must be cleaned and receive high-level disinfection after each endoscopic
procedure. Water bottles and non-disposable cleaning brushes can be disinfected at the end of the
day.

V. COORDINATION

Author: Infection Control Practitioner
Senior Management Sponsor: SVP/Chief Nurse Executive
Reviewers: Reprocessing Manager
Approval committees: Infection Control Committee; UW Health Clinical Policy Committee
UW Health Clinical Policy Committee Approval: March 20, 2017

UW Health is a cohesive, united and integrated academic medical enterprise comprised of several entities.
This policy applies to facilities and programs operated by the University of Wisconsin Hospitals and Clinics
and the University of Wisconsin Medical Foundation, Inc., and to clinical facilities and programs
administered by the University of Wisconsin School of Medicine and Public Health. Each entity is
responsible for enforcement of this policy in relation to the facilities and programs that it operates.

VI. APPROVAL

Peter Newcomer, MD
Chief Clinical Officer

J.Scott McMurray, MD
Chair, UW Health Clinical Policy Committee

VII. REFERENCES

Petersen, B.T., et. al., 2017. Multisociety Guideline on Reprocessing Flexible GI Endoscopes:2016 Update .
ASGE (American Society of Gastrointestinal Endoscopy Guideline. Gastrointestinal Endoscopy Vol 84, no.
2, 2017.
Centers for Disease Control and Prevention/Hospital Infection Control Practices Advisory Committee.
Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008.
UW Health Clinical Policy #4.1.7, Cleaning, Disinfection and Sterilization of Patient Care Devices and
Equipment.
UW Health Clinical Policy #4.1.14, Response to Failed High Level Disinfection or Sterilization Cycle.
UW Health Clinical Policy #4.1.15, Precautions for Transmissible Spongiform Encephalopathy (CJD and
Other Prion Diseases).
UW Health Clinical Policy #4.1.20, Assessing Sterility of Packaged Items at Point of Use.

VIII. REVIEW DETAILS
Version: Revision
Last Reviewed: April 2017
Next Revision Due: April 2020
Formerly Known as: Hospital Administrative policy #13.05