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Monitoring Washer-Disinfector Cleaning Efficiency with Enzymatic Tests
1. Purpose of the PINNACLE™ Enzymatic Detergent Test
Factors involved in automated cleaning
Verification of the cleaning process
How to use the PINNACLE™ Enzymatic Detergent Test
What does a FAIL result indicate?
References
Test your skills
2. ..follow all washer-disinfector
and detergent manufacturer
instructions and guidelines and all
hospital policies/procedures
regarding washer-disinfectors
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3. The test is to be used to monitor the effectiveness of the
washer-disinfector‟s instrument cleaning cycle when using
enzymatic detergent.
Recommended use: once daily in each washer-disinfector
The test will not react to other wash cycle additives such as
rinse aids or lubricants.
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4. The indicator pad detects enzymatic detergent
concentration and activity
The test is also sensitive to the medical washer-
disinfector‟s:
- mechanical action
- detergent contact time
- temperature of the wash cycle
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5. testing bedpan or cart washers that utilize lower
detergent concentrations and/or shorter cycle
times
plastic ware wash cycles using low temperature
settings and/or shorter wash cycles
wash cycles using neutral detergents NOT
containing enzymes
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6. A large portion of the
cleaning action is dependent
on the detergent chemistry
used.
When using neutral enzymatic
detergents exposure time as
well as the wash temperature
plays an important role in the
action of the active enzyme
on the contaminating soils.
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7. Wash Time: Mechanical Action:
Too short • Involves water
pressure, spray arm
• Detergent does not have rotation and spray nozzle
enough time to remove soil location
Temperature:
Too hot Detergent Chemistry :
• Blood coagulates and • Chosen for the soil type
becomes difficult to remove
• Use optimal detergent
• Enzymes may be inactivated concentration
Too cold • Enzymes in the detergent
• fats cannot be dissolved must be active
• enzyme activity is decreased
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8. The first critical step of Infection Control is cleaning
and decontamination of the instruments after use!
• ANY retained soil on the instrument
can protect microbes during
sterilization.
• Adherences to cleaning procedures
are imperative !!
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9. Definitions from Guidelines and Standards:
- AAMI TIR 301: Removal of contamination from an item to the
extent necessary for further processing or the intended use.
- ASTM E23142: Removal of foreign materials, including organic
soil (for example, protein) and microorganisms from medical
instruments.
- CDC Guideline 20083: Removal of visible soil (e.g., organic and
inorganic material) from objects and surfaces
See reference section for more info.
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10. ANSI/AAMI ST794 recommends:
- “Mechanical cleaning equipment should be tested
upon installation, weekly (preferably daily) during
routine use, and after major repairs”.
Verification of “visibly clean” may be difficult when inspecting
complicated instruments after a cleaning cycle.
The washer-disinfector’s functionality can be verified by using a
PINNACLE Enzymatic Detergent Test.
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11. Testing equipment upon installation is not enough.
Weekly - preferably daily - monitoring of your washer-
disinfectors efficiency is not just recommended, it is
necessary to ensure adequate cleaning results.
Disinfection and sterilization depend upon a successful
cleaning process.
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12. Test Device Components:
- Test Strip containing the Indicator Pad and the Internal Color
Standard.
- Comparison of Indicator Pad color with Internal Color Standard determines a
PASS or FAIL condition
- Test Strip Holder with hook to secure test device onto racks or
baskets in washer.
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13. Preparation of test
- Remove as many test strips from bottle as needed
- Write date/time, washer ID and location on strip
- Test devices should be used within 8 hours of preparation
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14. Placement in Washer-Disinfector
Test Device has to hang freely, without the pads being obstructed
In Baskets… • Use the hook to attach the PINNACLE
test device to the handles or wire
openings of baskets
• Place baskets on middle and bottom rack
• These locations represent potential problem
areas for decontamination and are
recommended for use in evaluating the
efficacy of the wash cycle.
• In rare occurrences, high impingement from
the upper spray arm may damage one or both
of the test pads on the strip.
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15. Placement in Washer-Disinfector
Test Device has to hang freely, without the pads being obstructed
On Racks … Hook the test around the perimeter of
the rack, do not obstruct the spray arm
movement
…away from spray arm
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16. Wrong or Incorrect Placement in Washer-Disinfector
Test pads are obstructed
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17. The Serim PINNACLE test incorporates a
dyed protein that is bound in the
indicator pad.
During the “Instrument” wash cycle the
color of the indicator pad will change in
response to detergent concentration and
exposure time, enzyme activity, wash
cycle temperature and mechanical action.
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18. Interpretation of Results:
PASS:
Indicator Pad is lighter than color standard
- Remove strip from
holder, ensure that you hold
strip with the PAD SIDE UP!
- Interpret the results by CAUTION:
comparing the color of Approaching F A I L conditions
the LARGER indicator pad
to the smaller internal
color standard.
FAIL:
Indicator Pad is similar to or
darker than color standard
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19. It is essential that either both pads are wet or both pads are dry when
interpreting results.
In this case, for easier interpretation, pads can be wetted with a small
amount of water.
PASS FAIL
dry
wet
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20. Record the appropriate results in a log sheet
- Download the log sheet from the Serim website at www.serim.com or
use your own
- Record date/time, washer ID and operator on the log sheet and attach
the test strips to the record.
- The color of reacted pads will not change if kept away from heat and
light
- A reacted Serim PINNACLE enzymatic detergent test strip can be kept
as a record for up to 2 years for auditing purposes
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21. To monitor each washers efficiency over time use PINNACLE tests :
- with the same wash cycle (e.g. “Instrument”; “MIS”)
- with the same enzymatic detergent
- at the same locations in the washer
Compare the results of the reacted test pads over time
A darkening of the indicator pad color can indicate a drift in the
washer‟s performance and should be investigated according to the
hospital‟s policies and procedures.
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22. Check your washer!
Since a washer‟s cleaning efficiency is dependent upon
mechanical action, detergent chemistry, time and
temperature, check for the following possible problems:
- Are spray arms moving freely, are nozzles clogged?
- Is the detergent dosage as recommended by manufacturer?
- Is the detergent expired or close to the expiration date?
- Is the wash cycle time and temperature adequate?
- Is an enzymatic detergent being used?
For more information, download the PINNACLE Reference
Guide from Serim‟s website at www.serim.com.
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24. • Hard water can clog and damage
pipes and ultimately cause leaks.
• Calcium build-up in the washer
could immobilize spray arms.
• Debris from surgical instruments
can accumulate in the washer and
eventually end up in spray
nozzles.
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25. Crack in
tubing
Leaky pump
tubing Plugged or kinked
delivery tubing or
expired detergents
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26. 1) AAMI TIR30:2011, A compendium of
process, materials, test methods, and acceptance criteria for
cleaning reusable medical devices. www.aami.org
2) ASTM E2314-03(2008) Standard Test Method for
Determination of Effectiveness of Cleaning Processes for
Reusable Medical Instruments Using a Microbiologic Method
(Simulated Use Test). www.astm.org
3) CDC Guideline for Disinfection and Sterilization in
Healthcare Facilities, 2008. www.cdc.gov
4) ANSI/AAMI ST79:2010/A2:2011 „Comprehensive guide to
Steam Sterilization and Sterility Assurance in Health Care‟ .
www.aami.org
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27. Download more information at www.serim.com
- Reference Guide
- Test Record Log Sheets
- Instructions for Use wall chart
PINNACLE™ Enzymatic Detergent Test
Patent pending.
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