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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23. Clogged spray
nozzles
Cracked and leaking spray arm
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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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