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ASSESSING THE RISK OF DISEASE TRANSMISSION
WHEN THERE IS A POSSIBLE FAILURE OF
DISINFECTION OR STERILIZATION
David Jay Weber, M.D., M.P.H.
Professor of Medicine, Pediatrics & Epidemiology
Associate Chief Medical Officer, UNC Health Care
Medical Director, Hospital Epidemiology & Occupational Health
University of North Carolina, Chapel Hill
LECTURE OBJECTIVES
Understand why endoscopes are the medical devices that most
commonly are involved in outbreaks and pseudo-outbreaks
Understand the most common reasons for failure to properly
disinfect or sterilize an endoscope
Understand how to manage the situation when there is a failure to
properly disinfect or sterilize an endoscope (or another medical
device)
---------------------------------------------------------------------------------------------
Disclosures: Speakers bureau = Merck, Pfizer; Consultation = Merck, Pfizer,
Germitec, PAI, Johnson and Johnson
GI ENDOSCOPES AND BRONCHOSCOPES
Widely used for diagnostic and therapeutic procedures
Endoscope contamination during use (GI 109 in/105 out)
Semicritical items require high-level disinfection minimally
Most flexible scopes require low temperature disinfection
Inappropriate cleaning and disinfection has lead to multiple
outbreaks of cross-transmission (and multiple pseudo-outbreaks)
Medical device most commonly linked to cross-transmission
FREQUENCY OF
ENDOSCOPIC PROCEDURES, US
Procedure Total Procedures Inpatient Procedures,
2009
Outpatient Procedures,
2006
All procedures 101,262,000 47,962,000 53,300,000
Endoscopy, small
intestines
4,562,000 1,095,000 3,467,000
Endoscopy, large
intestines
6,266,000 525,000 5,741,000
Bronchoscopy 442,000 269,000 173,000
Cystoscopy 881,000 130,000 751,000
Hysteroscopy --- Not available 313,000
Arthroscopy, knee --- Not available 956,000
VA-ASSOCIATED LOOK-BACK INVESTIGATIONS AS A
RESULT OF IMPROPER REPROCESSING
January 2008 to February 2009: ENT endoscopes were cleaned using sanitizing
cloths and did not undergo high-level disinfection in accordance with
manufacturer’s and CDC recommendations (1,104 patients notified)
February 2004 to January 2009: ENT endoscopes wiped off, placed on a clean towel
saturated with 1:6 Waxide dilution for 10 min instead of manufacturer’s
recommended 1:128 dilution for general disinfection; wiped with a clean cloth
saturated with Hibiclens, rinsed under warm running tap water, dried, and wiped
twice with 70% isopropyl alcohol (297 patients notified)
1 December 2008: Patient underwent colonoscopy and blood noted in auxiliary
water tubing (AWT), used for irrigation. A required one way valve was absent and
two components of the AWT system were not disinfected or discarded according to
manufacturer’s instructions (6,805 patients notified)
Colonoscope AWT was not reprocessed after each patient, but rather only rinsed
with sterile water and never sent to Sterile Processing Department for reprocessing
(patients notified 2,531)
Holodniy M, et al. ICHE 2012;33:649-656
VA-ASSOCIATED LOOK-BACK INVESTIGATIONS AS A
RESULT OF IMPROPER REPROCESSING
Holodniy M, et al. ICHE 2012;33:649-656
Rutala WA, Weber DJ. ICHE 2007;28:146-155
OUTBREAKS AND PSEUDO-OUTBREAKS DUE TO
IMPROPERLY DISINFECTED BRONCHOSCOPES
0
2
4
6
8
10
12
14
1975-79 1980-84 1985-89 1990-94 1995-99 2000-04 2005-09 2010-14
Weber DJ, Rutala WA. 2001;ICHE 22:403 – Weber DJ, Rutala WA. ICHE 2012;33:230
PATIENTS EXPOSED TO ENDOSCOPY-
RELATED CONTAMINATION, 1974-2005
Seoane-Vazquez E, et al. Endoscopy 2007;39:742-745
RATIO OF NUMBER OF PATIENTS CONTAMINATED
TO NUMBER OF PATIENTS EXPOSED, 1974-2004
Seoane-Vazquez E, et al. Endoscopy 2007;39:742-745
INFECTIONS ASSOCIATED
WITH UPPER GI ENDOSCOPY
Kovaleva J, et al. Clin Microbiol Rev 2013;26:231
FEATURES OF ENDOSCOPES THAT
PREDISPOSE TO DISINFECTION FAILURES
Require low temperature disinfection
Long narrow lumens, right angle turns, blind lumens
May be heavily contaminated with pathogens
Use of AERs has led to a new set of problems Kovaleva J. Clin Microbiol Rev 2013;26:231
ENDOSCOPE REPROCESSING Multi-Society Guideline on Endoscope Reprocessing, 2011
PRECLEAN-point-of-use remove debris by wiping exterior and aspiration of
detergent through air/water and biopsy channels
CLEAN-mechanically cleaned with water and enzymatic cleaner
HLD/STERILIZE-immerse scope and perfuse HLD/sterilant through all channels
for exposure time (>2% glut at 20m at 20oC). If AER used, review model-specific
reprocessing protocols from both the endoscope and AER manufacturer
RINSE-scope and channels rinsed with sterile water, filtered water, or tap water.
Flush channels with alcohol and dry
DRY-use forced air to dry insertion tube and channels
STORE-hang in vertical position to facilitate drying; stored in a manner to protect
from contamination
STEPS IN THE DISINFECTION PROCESS
AND MECHANISMS OF FAILURE
Murphy Was an ICP!
Murphy’s Law
“Whatever can go wrong will go wrong”
Corollary
“…in the worst possible way at the worst possible time”
PROTOCOL FOR EXPOSURE INVESTIGATION AFTER
A FAILURE OF DISINFECTION OR STERILIZATION
PROTOCOL FOR EXPOSURE INVESTIGATION AFTER
A FAILURE OF DISINFECTION OR STERILIZATION
Step 1 - Confirm failure of sterilization or disinfection reprocessing
Confirm that the suspected failure did, in fact, occur.
IP must review the circumstances of the reported failure including: the time and date of
the possible failure; type of D/S method; and evidence of process parameters
(printout) and results of physical, chemical and/or biological indicators
If the initial evaluation reveals that no medical items that were potentially inadequately
processed were used in patient care, there is no patient safety issue involved
Then one can limit the evaluation to determining if the disinfection/sterilization process
failed and correcting the processing error
All potentially inadequately processed items must, of course, be reprocessed
If a disinfection/sterilization failure is not confirmed, the investigation may be concluded
PROTOCOL FOR EXPOSURE INVESTIGATION AFTER
A FAILURE OF DISINFECTION OR STERILIZATION
Step 2 - Embargo improperly D/S items
If a D/S failure has occurred, one should immediately embargo any medical
items that may not have been appropriately D/S
All items since the last successful processing (as demonstrated by process
measures and/or physical, chemical, or biological indicators) should be
embargoed.
Retrieving all items may require visiting all areas where the medical/surgical
items may be stored or used including CP, ORs, community-based practices,
storerooms, etc
Step 3 - Do not use questionable D/S unit (e.g., sterilizer, AET)
The incriminated D/S unit should be immediately placed off line and not used for
D/S of medical or surgical devices until its proper function can be assured
This may involve several runs with assessment of process parameters and
physical, chemical and/or biological indicators
Medical engineering or the manufacturer’s representative usually performs
repairs and evaluation of the unit
PROTOCOL FOR EXPOSURE INVESTIGATION AFTER
A FAILURE OF DISINFECTION OR STERILIZATION
PROTOCOL FOR EXPOSURE INVESTIGATION AFTER
A FAILURE OF DISINFECTION OR STERILIZATION
Step 4 - Inform key stakeholders
All key stakeholders should be informed of the problem
Risk management
Medical/nursing director of the involved units (e.g., OB, GI)
Personnel involved in disinfection/sterilization
If is often easier to arrange a face-to-face conference to assure complete
transmission of the facts with feedback than to use email or telephone
consultation
PROTOCOL FOR EXPOSURE INVESTIGATION AFTER
A FAILURE OF DISINFECTION OR STERILIZATION
Step 5 – Conduct a complete and thorough evaluation of the cause of
the disinfection/sterilization failure
An IP should review the exact circumstances of the possible D/S failure including
the dates and results of all process measures and physical, chemical and
biologic indicators far enough back in time to assess date of first possible
malfunction
Common problems with AERs have included failure to properly clean the item,
set the correct duration of exposure to the high level disinfectant, attach the
channel connectors properly, and use of the correct channel connectors
Failure to Follow Disinfection and
Sterilization Principles
Step 6 – Prepare a line listing of potentially exposed patients
Once a failure of D/S has been documented, it is important to initiate the
evaluation of potential patient exposures
First step is to create a line listing of all possible patients who may have been
exposed to possibly contaminated medical/surgical devices
Patient name, identification number, date(s) of exposure, contaminated
device used, underlying risk factors for infection, development of HAIs
(pathogen, body site), and other potentially adverse events
PROTOCOL FOR EXPOSURE INVESTIGATION AFTER
A FAILURE OF DISINFECTION OR STERILIZATION
Step 7 – Assess whether D/S failure increases patient risk for infection
Once a failure of D/S process has been documented with possible exposure to a
contaminated item, it is crucial to determine whether in fact the failure could
result in an adverse patient event.
For example, 3 min for flash sterilization rather than 4 min. Would not consider 3
min flash sterilization cycle as representing a patient hazard.
Assessing risk should always include a review of the scientific literature and
national guidelines
PROTOCOL FOR EXPOSURE INVESTIGATION AFTER
A FAILURE OF DISINFECTION OR STERILIZATION
Step 8 - Inform expanded list of stakeholders
All stakeholders should be informed of the progress of the investigation,
especially if an increased risk to patients is possible or documented
Risk management
Medical/nursing director of the involved units (e.g., OB, GI)
Personnel involved in disinfection/sterilization
Public relations, healthcare administration, and legal
A press release should be prepared in case of need and a spokesperson
appointed
PROTOCOL FOR EXPOSURE INVESTIGATION AFTER
A FAILURE OF DISINFECTION OR STERILIZATION
Step 9 - Develop hypothesis for D/S failure and initiate corrective
action Corrective actions (e.g., reset timer, monitor concentration of HLD) should be
initiated to correct the deficiencies in reprocessing
Reprocessing of any item that may not have been appropriately
disinfected/sterilized must be done
PROTOCOL FOR EXPOSURE INVESTIGATION AFTER
A FAILURE OF DISINFECTION OR STERILIZATION
Step 10 – Develop a method to assess potential adverse patient events
Initiate a more detailed study, if necessary, of possible adverse outcomes in
patients
This may entail designing a prospective cohort study
This may require reviewing medical records and/or examining patients for
infections, chemical reactions, or other adverse events
Specific laboratory tests may be necessary such as testing source patients and
exposed persons for bloodborne pathogens such as HIV, HBV, and HCV
PROTOCOL FOR EXPOSURE INVESTIGATION AFTER
A FAILURE OF DISINFECTION OR STERILIZATION
Step 11 – Consider notification of appropriate state and federal
authorities
In conjunction with the legal department, notify state and federal authorities if
required by regulation or law
PROTOCOL FOR EXPOSURE INVESTIGATION AFTER
A FAILURE OF DISINFECTION OR STERILIZATION
Step 12 - Consider patient notification
Consider whether patients should be notified of the disinfection failure
If it is determined the failure could result in adverse patient events, then patients
should be notified
Determine who will notify the patients: Patient’s local medical provider, risk
management, attending physician at the time of failure, ICP
One should develop a script to be used in notification to ensure all patients
receive the same information
Notification may be accomplished by a face-to-face meeting, phone or mail
More than one method may be used to ensure complete notification
PROTOCOL FOR EXPOSURE INVESTIGATION AFTER
A FAILURE OF DISINFECTION OR STERILIZATION
Step 12 (continued) Notification should include: an assessment of risk, possible adverse events that
may occur, symptoms and signs of the adverse event, time period for the adverse event, risk to other contacts, possible prophylactic therapy (risks and benefits) and recommended medical follow-up
The healthcare facility must decide who will provide these services and whether the facility will cover the cost of care.
In general, we believe that if the facility was responsible for the failure then it should provide these services at no patient charge
However, it the exposure resulted from failures outside the institution (receipt by the facility of inadequately sterilized devices), then the facility may want to offer the services but at patient expense or causative party’s expense (e.g., manufacturer)
ESTIMATING RISK OF
DISEASE TRANSMISSION I
Scenario: Endoscopes were processed in an AER using OPA for 2m rather than the recommended 12m. The HLD exposure time in the AER was incorrectly reset by the biomedical engineer to 2min 10 months ago. During that period of time there were 2,134 patients that received GI endoscopy procedures. All the endoscopes were reprocessed in the same AER.
Can estimate the per patient risk for HIV as follows:
HIV prevalence in the US population: 0.37%, ~4:1000, ~4x10-3
Risk of transmission (via mm): 0.09%, 1:1000, 1x10-3
Efficacy of AER without HLD: 99.999%, 1:100,000, 1x10-3
Efficacy or OPA against HIV in 2m: 99.999%, 1:100,000, 1x10-5
Effect of HIV drying: 99%, 1:100, 1x10-2
Individual risk = ~4 x 10-16 (4 in 10 quadrillion)
Risk analysis of surgical instruments inside a Sterisen container that had been
autoclaved on a gravity cycle rather than on the recommended pre-vacuum cycle,
potentially exposing 72 patients who underwent surgery with the instruments
Donskey CJ, et al. Antimicrob Resistance & Infect Control 2014;3:4
LIFETIME ODDS OF DEATH FOR SELECTED
CAUSES, US, 2009
Type of injury or event Lifetime odds of deaths
Cancer 1 in 7
Intentional self harm 1 in 106
Motor vehicle incidence 1 in 108
Falls 1 in 158
Pedestrian 1 in 749
Accidental drowning and submersion 1 in 1,112
Contact with hornets, wasps, and bees 1 in 71,107
Bitten or struck b dog 1 in 122,216
Cataclysmic storm 1 in 126,158
Lightning 1 in 126,158
http://www.nsc.org/news_resources/injury_and_death_statistics/Pages/TheOddsofDyingFrom.aspx
DECISIONS WHETHER TO NOTIFY PATIENTS OF
EXPOSURE TO CJD CONTAMINATED INSTRUMENTS
Belay ED, et al. ICHE 2013;34:1272-1280
PROTOCOL FOR EXPOSURE INVESTIGATION AFTER
A FAILURE OF DISINFECTION OR STERILIZATION
Step 13 – If patients are notified, consider whether such patients
require medical evaluation for possible post-exposure prophylaxis
(PEP) with appropriate anti-infectives
Consider whether follow-up to infection (e.g., HIV, HBV, HCV) should be
offered
Consider duration of follow-up
Decide on who will cover the costs of PEP (facility, insurance, patient)
SAMPLES PATIENT NOTIFICATION LETTER
AND PRESS RELEASE
Rutala WA, Weber DJ. ICHE 2007;28:146-155
PROTOCOL FOR EXPOSURE INVESTIGATION AFTER
A FAILURE OF DISINFECTION OR STERILIZATION
Step 14 - Develop a detailed plan to prevent similar failures in the
future
Once the problem leading to the D/S failure has been identified and corrective
action initiated, it is essential to assess whether these interventions have
eliminated the problem over the long-term
This may require long-term surveillance, changes in current policies or
procedures, development of new policies or procedures, evaluation of current
equipment, etc
PROTOCOL FOR EXPOSURE INVESTIGATION AFTER
A FAILURE OF DISINFECTION OR STERILIZATION
Step 15 - -Perform after-action report
A report of the event should be prepared for presentation to the appropriate
healthcare system committees
Consideration should be given to publishing the evaluation it it provides a
contribution to the scientific literature
CONCLUSIONS
Endoscopy is a common medical procedure
Endoscopes represent the greatest challenge for proper cleaning
and disinfection
Multiple outbreaks and pseudo-outbreaks have resulted from the
failure to properly disinfect or sterilize endoscopes
A published step-by-step method for managing the failure
disinfection can be used to aid in outbreak management
If the risk of infection is sufficiently low, the healthcare facility may
choose not to notify the patient
THANK YOU!!