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Response to Failed High Level Disinfection or Sterilization Cycle (4.1.14)

Response to Failed High Level Disinfection or Sterilization Cycle (4.1.14) - Policies, Clinical, UW Health Clinical, Infection Control

4.1.14


UW HEALTH CLINICAL POLICY 1
Policy Title: Response to Failed High Level Disinfection or Sterilization Cycle
Policy Number: 4.1.14
Category: UW Health
Type: Ambulatory and Inpatient
Effective Date: May 26, 2017

I. PURPOSE

To ensure that failures of high level disinfection or sterilization cycles occurring in any UW Health location
are immediately identified in order to prevent inadequately reprocessed instruments from being used on
patients, and to ensure prompt investigation if instruments from failed cycles may have resulted in exposure
to patients.

II. POLICY ELEMENTS

Parameters of every high level disinfection and sterilization cycle will be reviewed to ensure that the
prescribed run parameters have been met before items are released for use. Chemical and Biological
indicators will be used at appropriate intervals to monitor conditions of the sterilization cycle and to verify
sterilization, respectively, as described in Central Services departmental policy #3052, “Routine Monitoring
of Sterilizers.” Items will be recalled that do not meet established criteria for high level disinfection or
sterilization, as appropriate to the item.

III. PROCEDURE

A. Disinfection/Sterilization Process
i. Only after thorough cleaning and function testing as needed (e.g., leak testing of flexible
endoscopes), will items be subjected to disinfection or sterilization.
ii. Device manufacturer’s recommendations will be used to guide the appropriate reprocessing
method for the individual type of device.
a. The OneSource online reference website is available for reviewing reprocessing
recommendations for specific devices.
b. A binder is available in the D6/152 Reprocessing Office which contains hard copies of
device–specific reprocessing information for items which may not be present on the
OneSource online resource.
c. If no manufacturer’s recommendation is available to guide reprocessing, the Reprocessing
Manager will consult with the Infection Control Department to ensure that adequate
disinfection or sterilization can be achieved.
iii. Manufacturer’s recommendations for the operation of systems for achieving high level disinfection
(e.g., automated endoscope reprocessors, pasteurization unit) or sterilization (e.g., steam
autoclaves, Sterrad, ethylene oxide gas) will be followed.
B. Recognition of Failure of High level Disinfection or Sterilization
i. Parametric Failure
a. The parameters of each cycle of high level disinfection or sterilization will be reviewed at
the completion of the cycle and before items are released for use.
1. Manufacturer’s parameters may include temperature, pressure, disinfectant
concentration, exposure time, etc, depending on the modality used.
2. Manual verification of high level disinfectant concentration (e.g., glutaraldehyde,
ortho-pthalaldehyde, peracetic acid) is required on some reprocessing systems
and this must be performed, and the test result recorded, at the beginning of
each cycle in which the disinfectant is used.
3. The manufacturer recommended use life of high level disinfectants will not be
exceeded regardless of the disinfectant concentration value obtained with
manual testing.
b. If all parameters defined by the manufacturer for high level disinfection or sterilization are
met, reprocessing staff will initial the hard copy printout to acknowledge that they have
reviewed the parameters and that they are acceptable.
1. For systems with electronic parameter recording, such as the automated
endoscope reprocessor with a computer screen display of parameters,
reprocessing staff must still review and acknowledge the parameter results.
c. Failure of any of the parametric values defined by the manufacture as crucial indicators of



UW HEALTH CLINICAL POLICY 2
Policy Title: Response to Failed High Level Disinfection or Sterilization Cycle
Policy Number: 4.1.14

cycle success indicates failure of the high level disinfection or sterilization cycle.
ii. Chemical Indicator Failure
a. Chemical indicators, or integrators, respond with a color change when time, temperature
and steam exposure of the cycle has been adequate to achieve sterilization.
b. Chemical indicators are read immediately at the conclusion of the steam sterilization
cycle.
c. Failure of the chemical indicator to undergo the prescribed color change will indicate
sterilization failure.
iii. Biological Indicator Failure
a. Biological tests use viable bacterial endospores, the most difficult microbial form to kill, to
monitor sterilization efficacy. After being subjected to the sterilization process, test
organisms are cultured for a defined period of time to monitor for the presence of surviving
organisms. Some biological indicators also have a rapid readout capability to detect the
presence of enzymatic activity which may indicate ongoing metabolism in surviving test
organisms.
b. Biological tests with a rapid readout function will be examined at the manufacturer’s
recommended interval as this presents the first opportunity to identify a failed biological
test.
c. Culture of biological tests will be performed regardless of a negative rapid readout result.
d. A positive result of either the rapid test or the culture indicates sterilization failure.
iv. Prompt review of monitors to assess cycle adequacy
a. The goal is always to identify a high level disinfection or sterilization process failure as
quickly as possible in order to prevent the release of any items from potentially inadequate
cycles.
b. Cycle monitoring results should be reviewed sequentially in order of the most immediately
available to the least timely. Temporal availability of monitors is as follows:
1. Cycle parameter records are available at the conclusion of each cycle and some
systems allow intra-cycle monitoring of run parameters, or will alarm if intra-cycle
failure has occurred, providing the most immediate indication of process failure.
2. Chemical indicators are available at the conclusion of each cycle.
3. Biological indicators verify sterility, but typically have delays of several hours
before definitive culture results are available.
c. Depending on the high level disinfection or sterilization process used, one or all of the
noted cycle monitors may be appropriate for use. Failure of any one of these monitors will
be an indication to withhold release of items for patient use.
d. Note: Process indicators (e.g., autoclave tape, indicators on peel packs or indicators
placed in pans during some low temperature sterilant methods such as ethylene oxide or
H202 gas plasma) undergo a color change when subjected to a sterilization cycle but do
not verify cycle adequacy. All end users are expected to monitor process indicators as one
element of ensuring that a packaged item is appropriate for patient use as described in
UWHC policy #13.18, Assessing Sterility of Packaged Items at Point of Use.
C. Response to failure of high level disinfection or sterilization
i. Identify and label the affected system and instruments.
a. If cycle failure has been indicated by any one of the monitors described in section III.B.,
immediately label both the processing system (i.e., autoclave, automated endoscope
reprocessor, Sterrad) and also the contents of the cycle (i.e., autoclaved trays or
instrument pans) as “FAILED CYCLE, DO NOT USE” to ensure that the instruments are
not released for use on patients.
b. If a tag had been placed on an instrument (e.g., flexible endoscope) at the beginning of
the high level disinfection cycle as a means of indicating that it has been subjected to the
disinfection process, the tag must be removed immediately upon cycle failure so that it is
not inadvertently presumed to be patient-ready.
ii. Notify the Reprocessing Manager immediately.
a. The Reprocessing Manager or his/her designee will take the affected system off line until
a service representative can arrive to trouble shoot the system and verify proper function.
b. Load logs will be reviewed and all items or trays will be immediately retrieved and
accounted for.
1. Instruments from failed loads must be removed from trays and returned for



UW HEALTH CLINICAL POLICY 3
Policy Title: Response to Failed High Level Disinfection or Sterilization Cycle
Policy Number: 4.1.14

repackaging and resterilization.
2. Endoscopes from failed cycles must be returned to the soiled side of the
reprocessing area to again undergo high level disinfection.
iii. The Reprocessing Manager will immediately notify the on-call Infection Control Practitioner and the
manager of the affected area (e.g., OR Director, Endoscopy Manager) in the following instances:
a. Implants, instruments, or trays subjected to a failed high level disinfection or sterilization
cycle have been used on a patient, or may have been used on a patient.
b. Implants, instruments or trays subjected to a failed high level disinfection or sterilization
cycle cannot be immediately accounted for.
D. Response to exposure of patients to instruments from a failed high level disinfection or sterilization cycle.
i. The Reprocessing Manager, in consultation with the manager of the affected area (e.g., OR
Director, Endoscopy Manager) will identify all patients on whom instruments or implants were used,
or may have been used.
a. The Reprocessing Manager will provide this list of potentially exposed patients to the
Infection Control and Risk Management departments.
ii. The Infection Control Practitioner, in consultation with the Hospital Epidemiologist, will investigate
the exposure event. Elements which affect assessment of infection risk may include:
a. Patient population affected.
b. Complexity of device.
c. Type of high level disinfection or sterilization system.
d. Magnitude of parametric failure.
e. Possibility of false positive monitoring result.
f. Definitive biological test culture results obtained after initial positive rapid readout.
g. If the failed cycle may indicate that potentially inadequate high level disinfection or
sterilization cycles have occurred prior to the recognized failure event.
iii. The Hospital Epidemiologist will have authority to define the level of risk which items from the failed
cycle pose and to make recommendations for notification and follow-up of exposed patients, which
may include testing for specific pathogens or prophylactic treatment.
iv. The decision to notify patients or to recommend or provide follow-up care or testing will be made in
coordination with Risk Management and Hospital Administration.
a. Hospital Administration, in conjunction with Infection Control staff, will determine which
method or methods of disclosure (e.g., phone call, face to face meeting, letter) and
individuals (e.g., Infection Control staff, Hospital Epidemiologist, Attending physician,
Infectious Disease staff physician, Surgeon) are best suited to convey information to the
exposed individuals.
b. In order to ensure that consistent and accurate information is conveyed to each exposed
patient, an information sheet will be generated by Infection Control to be provided to the
patient and used in explaining the event, the potential risks and recommended follow-up.
E. Ongoing oversight
i. All failure events reported to Infection Control as described in III.C.iii will be reviewed by the
Infection Control Committee. Monitoring of biological test results from sterilizers maintained by
Central Reprocessing and at The American Center is a standing item on the monthly Infection
Control Committee agenda. Process reviews of locations outside of UH and TAC performed by
Infection Control and the Reprocessing Coordinator will be periodically reported to the Infection
Control Committee. Representation from the Reprocessing Department and from The American
Center will be maintained on this Medical Board Committee to convey these results.

IV. COORDINATION

Author: Infection Control Practitioner
Senior Management Sponsor: SVP/Chief Nurse Executive
Reviewers: none
Approval committees: Infection Control Committee; UW Health Clinical Policy Committee
UW Health Clinical Policy Committee Approval: May 15, 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



UW HEALTH CLINICAL POLICY 4
Policy Title: Response to Failed High Level Disinfection or Sterilization Cycle
Policy Number: 4.1.14

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.

V. APPROVAL

Peter Newcomer, MD
Chief Clinical Officer

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

VI. REFERENCES

Central Services departmental policy #3052, Routine Monitoring of Sterilizers
Surgical Services departmental policy #2.31, Immediate Use Steam (Flash) Sterilization in the UW
Operating Room
UW Health clinical policy #4.1.7, Cleaning, Disinfection and Sterilization of Patient Care Devices and
Equipment
UW Health clinical policy #4.1.11, Endoscope Reprocessing
UW Health clinical policy #4.1.15, Precautions for Transmissible Spongiform Encephalopathy (CJD & Other
Prion Diseases)
UWHC policy #13.18, Assessing Sterility of Packaged items at Point of Use

VII. REVIEW DETAILS

Version: Revision
Last Full Review: May 26, 2017
Next Revision Due: May 2020
Formerly Known as: Hospital Administrative policy #13.30