SUGGESTED POLICY FOR

THE MONITORING OF THE CLEANING EFFICIENCY OF

AN AUTOMATED INSTRUMENT WASHER DISINFECTOR USING THE

 ProFormance™Washer Test

 

SUBJECT:  Automated Instrument Washer/Disinfector Cleaning Monitoring

 

DEPARTMENT:  Central Service

 

APPROVED BY: 

 

EFFECTIVE: 

 

REVISED: 

 

 

PURPOSE: 

 

To test the automated instrument washer/disinfector to ensure proper cleaning.(19)

 

POLICY: 

 

Instrument washer tests are designed to monitor the cleaning function of an automated instrument washer.  To ensure that the automated instrument washer is cleaning properly, a test indicator should be used to monitor the occurrence of cleaning instruments.  The ProFormance™ Washer Test is designed to monitor the cleaning process of an automated washer.  The use of the ProFormance™ Washer Test is to be used according to the manufacture's guidelines to ensure that the cleaning process is occurring and the automated instrument washer is functioning properly. (15,16,17,18,19)

 

RATIONALE :

 

"Cleaning, not sterilization (or disinfection), is the first and most important step in any instrument processing protocol.  Without first subjecting the instrument to a thorough, validated and standardized (and ideally automated) cleaning process, the likelihood that any disinfection or sterilization process will be effective is significantly reduced".  (20)

 

An automated washer/disinfector cleans and decontaminates dirty surgical instruments so they can be handled safely, repackaged, and sterilized for a future surgery.  The danger of handling instruments contaminated with blood is obvious in this age of hepatitis, CJD and HIV.  The procedures for sterilizing instruments are based on years of scientific testing of cleaning instruments.  If surgical instruments are not clean, the procedures are ineffective.  Dried blood on instruments is hazardous to the employees of the hospital and to the next surgical patient upon which the instruments are used.  (5,6,7,17)

 

The cleaning of dried blood is much more difficult than cleaning dirt.  Blood coagulates, which means it goes from a free flowing liquid to a solid that contains tough, microscopic fibers called fibrin.  These fibers are formed as the blood coagulates and jam themselves into microscopic irregularities in the surface of the stainless steel instrument.  This is a physical attachment to the surface through mechanical means, not just chemical means as with traditional adhesives.  The action is similar to the roots of plants growing into cracks in rocks, anchoring themselves to the surface. 

 

The blood cells colored with hemoglobin are fairly easy to wash off instruments but the clear fibrin material is much more difficult.  Thick droplets of dried blood have so much fibrin, even the colored hemoglobin can be trapped and held in place.  (5,6)

 

Another thing that makes blood difficult to clean is its ability to become insoluble when heated.  Heating causes blood to “denature".  Denaturing is similar to eggs cooking in a frying pan.  Transparent uncooked egg whites are fairly easy to wash away, but opaque, cooked egg whites are much more difficult.  Dried, uncooked egg is even more difficult to wash away, just like blood.  The proteins in blood are similar to albumin proteins in eggs. 

 

Washers fail for many reasons.  A test should provide a means of monitoring the variables that influence the effectiveness of a washer.  Some of these variables are water, time, detergent, enzyme, temperature, high pH, agitation, speed, initial heat, drying, obstructions, and insufficient amount of chemicals.  (16)

 

Proper cleaning is critical.  The ProFormance™ Washer Test provides an independent objective test of clean and allows the Sterile Processing professional to monitor and ensure proper cleaning in the automated instrument washer/disinfector. 

 

JCAHO and AAMI both recommend that Sterile Processing department have process performance in place. (1,2,3,8,9,10,11)  Using the ProFormance™ Washer Test according to the manufacture's guidelines helps ensure adherence to both JCAHO and AAMI standards and having a properly functioning cleaning process. 

 

PROCEDURE:

 

Initial Validation (15,19):

 

·        Secure three ProFormance™'s in one large tray (use non-mesh style mini baskets). 

·        Position a ProFormance™ Washer Test in each of the two corners farthest away from the spray arms and one in the middle (picture1). 

·        Place the tray on one of the shelves if multiple shelves are present. 

·        Run test in an empty washer. 

·        Process using your normal procedure. 

·        Examine the ProFormance™ Washer Test for visual cleanliness.  Compare the test to the chart scale ( 0-5 ).

·        Record results, 

·        Repeat for each shelf. 

·        Adjust the washer disinfector cleaning function by comparing the test outcome to the ProFormance™ Washer Test chart. 

·        Record all changes and adjustments to the washer disinfector according to the results found from the test object and comparing them to the chart.

 

Weekly Testing (15, 19)

 

·        Secure one(1) ProFormance™ per level of the instrument rack in the center of an empty tray (position “A” in the diagram to below).

 

 

·        Be sure to run tests in an otherwise empty washer.

·        Process using the “instrument” wash cycle.

·        If using with TempaChekTM-170, you may remove test prior to the Drying Cycle.

·        Compare the test to the Interpretation Guide. Record results. 

·        If less than optimal results were obtained (1-5) make adjustments to the equipment utilizing the Interpretation Guide.

 

Daily Testing to Challenge Staff Practice(15,19):

 

·        Follow this protocol to challenge the loading practices of Sterile Processing Personnel.

·        At the beginning of each day in each washer/disinfector, secure one ProFormance™ Washer Test, in the center of a tray of dirty instruments. 

·        The larger the set, the greater the cleaning challenge for the Washer (use a non-mesh style mini basket). 

·        Place the tray on only one of the shelves if multiple shelves are present. 

·        Load the washer/disinfector with a normal load of dirty instruments. 

·        Process using your normal procedure. 

·        Examine the ProFormance™ Washer Test for visual cleanliness.  Compare the test to the 0-5 ProFormance™ Washer Test chart scale. 

·        Record results. 

·        Make any adjustments to the washer/disinfector, loading practices, etc., as needed according to the results found from the test object and comparing them to the ProFormance™ Washer Test chart. 

·        The next day, place the tray on a different shelf. 

·        Over time, continue to vary the shelf and position the tray to test all possible configurations. 

·        Record all results. 

·        Make any adjustments to the washer/disinfector as needed according to the results found from the test object and comparing them to the ProFormance™ Washer Test chart. 

 

Maintenance on Equipment(15,19):

 

·        After any maintenance on the equipment, perform a test using the ProFormance™ Washer Test to ensure that the equipment is cleaning properly. 

·        Follow the weekly test process. 

·        Have the maintenance person wait until the test results are complete.

 

RESPONSIBILITY:

 

Central Service personnel are responsible for the proper use, result interpretation, and documentation of the ProFormance™ Washer Test indicator when used on an automated instrument washer.(12)

 

REFERENCES:

 

1.      ANSI/AAMIST35 - 1996 - 9.2e- Documentation of decontamination processing parameters

2.      ANSI/AAMIST35 - 1996 - 9.1 -  General Rationale

3.      ANSI/AAMIST35- 1996 - 9.2  - Quality process

4.      ANSI/AAMIST35 -  1996 - 7.4.3.3

5.      Blood as a Soil on Surgical Instruments ; Cleaning Profile, Cleaning , Detection; M.Pfeifer, Zentr  Steril 1998;6 (6);381-385

6.      Standardized Test Soil Blood 1 : Composition, Preparation, Application ; M.Pfeifer, Zentr  Steril 1998;6 (6);304-310

7.      OSAKA REPORT; Importance of the cleaning test; University of Osaka, Department of Medicine, Ryo Fushimi, 2000

8.      JCAHO - 2000 Hospital Standards -IC.1- The organization uses a coordinated process to reduce the risks of endemic and epidemic nosocomial infections in patients and health care workers.

9.      JCAHO - 2000 Hospital Standards - IC.6.2 - The infection control process includes at least one activity aimed at preventing the transmission of epidemiologically significant infections between patients and staff

10.  JCAHO - 2000 Hospital Standards- PE.1.15 - Quality control checks, as defined by the hospitals, are conducted on each procedure.

11.  JCAHO - 2000 Hospital Standards - Pl.5-Improved performance is achieved and sustained

12.  JCAHO - 2000 Hospital Standards -  EC.2.1- Staff members have been oriented to and educated about the environment of care, and process the knowledge and skills to perform their responsibilities under the environment of  care management plans

13.  JCAHO - 2000 Hospital Standards

14.  ANSI/AAMI

15.  http://www.proformance-test.com/WallChart/WallChart.html

16.  http://www.proformance-test.com/SupportMaterial/TechnicalBulletin1.html

17.  http://www.proformance-test.com/SupportMaterial/BloodAsASoilonSurgicalInstruments.htm

18.  http://www.proformance-test.com/SupportMaterial/StandardisedTestSoilBlood1.htm

19.  http://www.proformance-test.com/index.html

20.  510(k) Summary and Overview ; Safety, Efficacy and Microbiological Considerations,. The System 83 plus Washer -Disinfector; Custom Ultrasonics, Inc,1998,page 7.

 

 

ProFormance™ Washer Test