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Quality Assurance and

tracing of Endoscope
Reprocessing
BY
Iman M. Abdullah Afifi
IC Consultant ASUH
 A quality control program
Should target
1- Man power to achieve the best practice by
continuous training , evaluation , monitoring their
competency
2- Materials to ensure their efficacy and efficiency
3- Method follow national and international
guidelines
4- Money to be cost effective
5- Machines to ensure their efficacy and efficiency
As part of a quality control program, documentation
may include, but is not limited to the following
(American Society for Gastrointestinal Endoscopy,
2011 & APIC guidelines for infection prevention and
control in flexible endoscope)
1. The procedure date and time,
2. The patient’s name and medical record number,
3. The endoscopist,
4. The endoscope’s model and serial number or other
identifier,
5. The AER (if used) model and serial number or other
identifier, and
6. The staff member(s) reprocessing the endoscope.
Quality Assurance of Reprocessing
Manual Automated
1- Endoscope 1- Endoscope
- residual proteins ( e.g. Hem check E
- residual proteins ( e.g. Hem
Test)
check E Test) - Bacteriological
- Bacteriological 2- Biocide
2- Biocide - MEC (Strips)
- MEC (Strips) 3- Water
- Water supply, bottle and
3- Water connecting tubes
- Water supply - Final rinse water
- Final rinse water 4- Machine Bacteriological
 MONITORING THE BIOCIDE
Minimum effective
concentration (MEC)
The MEC of the biocide must
be checked. The frequency of
testing should be based on
how frequently the solutions
are used (e.g. used daily, test
daily; used weekly, test before
use; used 25 times per day,
test each tenth use).
A log of the results of
the MEC testing and the
signature of the person
performing the test
should be maintained
. The bottle of the test
strip should be dated
when opened and used
for the period of time
indicated on the bottle.
The manufacturers of Cidex OPA
recommend using their test strips
prior to each cycle. Like other high-
level disinfectant manufacturers, they
recommend discarding the
disinfectant even if the disinfectant
has met the MEC test, but has gone
beyond the reuse date.

It is important to store the chemical

test strips according to their
instructions to prevent them from
drying out and be sure to check that
the bottles are properly sealed and
closed.
 Mic robiol ogi cal Testing

Is an indirect marker of adequacy and

completeness of the cleaning and disinfection
process.
Contaminated machines should not be used
until cleaned and proven to be
microbiologically safe.
Contamination of endoscopes may occur if:
reprocessing has been inadequate or otherwise
deficient;
the endoscope is damaged.
 FREQUENCY OF TESTING
Every 1 month Every 4 months
AFER's All other gastrointestinal
Duodenoscopes, endoscopes
bronchoscopes and water used for manual
endoscopic ultrasound rinsing if 0.2u filter is
used
The water used for
Endoscopes that have
manual rinsing if there
been reprocessed through
is no filter a sterilization cycle and
stored in a wrapped state
Although recommendations exist for the final
rinse water used during endoscope
reprocessing to be microbiologically cultured
at least monthly , a microbiologic standard
has not been set, and the value of routine
endoscope cultures has not been shown .
In addition, neither the routine culture of
reprocessed endoscopes nor the final rinse
water has been validated by correlating viable
counts on an endoscope to infection after an
endoscopic procedure. (CDC)
Further microbiological screening if:

1 - There is clinical suspicion of cross infection related

to endoscopy
 2 - Positive surveillance cultures occur
 3 - Alterations are made to the plumbing of the
endoscopy reprocessing area
 4 - New reprocessing protocols are introduced in the
unit
 5 - New models of equipment (endoscope or AFER)
are used
 6 - As a means of quality check for new staff
responsible for endoscope reprocessing
 Interpretation of results and corrective
measures in case of contamination
1- Total microbiological count
a. Liquid samples from endoscope channels. The maximal total
count should be <20cfu/channel. It should be calculated taking into account
the amount of saline used to rinse the channel. - - - Indicator organisms
should not be found at any time.
b. Swabs. Cultures taken from swabs should be focused on the
growth of indicator organisms .
Quantification of microorganisms is not recommended.
c. Water samples. Indicator organisms should not be found at any
time.
2. Detection of special microorganisms
A criterion for acceptability is the absence of growth of indicator
organisms
 Bio burden assays
The ChannelCheck test offers the
advantages of
- ease of test sample collection,
- simple test methodology using a test
strip similar to a urine dipstick,
- detection of a wider range of biological
soils.
The assay uses testst rips with 3 pads
that allow detection of residual
carbohydrate, protein, and hemoglobin.
The endoscope’s biopsy channel is flushed with 10
mL of sterile deionized water, followed by 10 mL of
air to promote expulsion of the water from the
distal end of the endoscope.
This water is collected into a sample collection
container, and the test strip is immersed within it for
10 seconds.
The 3 test pads on the test strip indicate the
presence of residual carbohydrate, protein, and
hemoglobin by a color change within 90 seconds.
The colors on the test strip are compared with those
on a color indicator chart provided on the test strip
bottle.
 Novel approaches (e.g., detection of
adenosine triphosphate [ATP]) to evaluate the
effectiveness of endoscope cleaning or
reprocessing also have been evaluated, but
no method has been established as a
standard for assessing the outcome of
endoscope reprocessing.
 Adenosine triphosphate bioluminescence
Adenosine triphosphate (ATP) bioluminescence is
present in microorganisms and human cells and
therefore offers a means of testing for microbial and
biological residue.
ATP bioluminescence testing provides results within
a few minutes.
The test has been performed after manual cleansing
steps only (ie, before HLD) as an audit tool to
determine the adequacy of cleaning and/or after
complete reprocessing (ie, after manual cleaning
and HLD).
 Outbreak
January 6, 2014
The Chicago Sun-Times reported the largest
outbreak of a superbug “CRE” in U.S. history, has
been confirmed at a hospital outside of Chicago.

The hospital linked these Critical patient infections

of CRE (Carbapenem-Resistant Enterobacteriaceae)
to an ERCP (endoscopic retrograde
cholangiopancreatography) procedure
 Largest outbreak of dangerous
bacteria
between January and September of 2013, 243 patients
who had undergone ERCP were notified by the hospital of
their increased risk of CRE infection. Of the 114 patients
who were tested, 38 were either infected or colonized
with CRE, with 28 not displaying symptoms of infection.
Unfortunately, 10 patients infected, some of them
critically, has infections of the blood, urine or in wounds.
this outbreak involving 38 patients (16% of the total
that underwent ECRP) is especially concerning because CRE
mortality rate is nearly 50 %
 The CDC reported that a likely contributing factor to
this “superbug” outbreak was the improper
automated cleaning and/or disinfection of the
implicated ERCP endoscopes.

The CDC reported that previous studies have shown

an association between ERCP endoscopes and
transmission of multidrug resistant bacteria; the
design of the ERCP endoscopes might pose a
particular challenge for cleaning and disinfection