How to Load a Medical Automatic Washer

Tag : overloading protector

With the increase of complicated medical devices, central servicedepartments (CSDs) face challenges like this one posted on a CSDchat room: “Is it acceptable to wash instrument sets throughthe washer in the rigid containers with the lids on? Or should thelids at least be taken off? And how much handwashing should be donebefore processing? I am told that our operating room (OR) cleansand washes its own instruments and then sends them down to us in CSto sterilize, run the sets through the washers in the containerswith the lids on. To me, this just doesn’t sound as if theinstruments would be getting cleaned.” 1
An example of instrument trays entering the automatic washer, allinner trays enclosed in the container with lids securely fastenedand stacked on top of each other.
An example of instrument trays entering the automatic washer, allinner trays enclosed in the container with lids securely fastenedand stacked on top of each other.
Every CSD has issues with dirty instruments. The difficulty hasincreased, however, as surgical instruments and surgical instrumentcases have gotten more complex, creating a greater challenge to thecleaning process. Research shows that dirty medical devices are areal problem:
16 percent of loaner instruments tested positive for blood 2
When placing the tissue protector on the drill, old dried blood andtissue came out 3
Particles of tissue were found in cannulated instruments 4
There are eight factors that affect the cleaning process:
1. Soil type
2. Medical device design
3. Water quality
4. Water temperature
5. Chemical activity of the cleaning solution
6. Mechanical action
7. Human factor (loading and training)
8. Verification
One of the main reasons for the aforementioned problems is that theinstruments are not being exposed and rinsed properly during thecleaning process. The focus of this article is to look at the humanfactor – and the impact of how surgical instruments areloaded into a medical automatic washer (MAW).
Sources of Guidance
Many times, instruments are just processed without separating orexposing the instruments completely to the cleaning process.
Instruments placed in a washer as is.
To reduce the problem of poor loading we need to look at thevarious sources that reference loading as a factor in the cleaningprocess:
Instrument manufacturers
MAW manufacturers
Standards and guidelines
Current literature
Instrument Manufacturers
Almost every surgical instrument catalog contains information intheir annex similar to this:
“Yellow-brown discoloration – cause: this may beprotein residuals, improperly cleaned surfaces, proteins left onthe surface for a long period of time and then not thoroughlycleaned.” 5
“With manual orthopedic surgical instruments, automatedcleaning may not be effective. A thorough, manual cleaning processis recommended. Where applicable, disassemble instruments prior tocleaning.” 6
“After surgery, open all box locks and disassembleinstruments with removable parts. This will limit blood drying oninstruments that may cause them to corrode. ” 7
One of the most comprehensive instructions can be found at theSmith and Nephew Web site at http://ortho.smith-nephew.com/us/node.asp?NodeId=3248 ). The following are excerpts from their site: 8
Cleaning is dependent upon thorough coverage of the device and theforce of the water spray. Therefore, all sections of the devicemust be accessible for ease of cleaning and penetration of cleaningagents.
When cleaning instrument sets, the case and instruments are treatedas separate items. For automatic washing, devices that havechallenging design features (see “Cleaning Categories ininstructions”) must be cleaned separately from the instrumentcase.
Automatic washing: Dried-on soil is difficult and sometimesimpossible to remove with automatic washing, especially atchallenging design features on devices like cannulas, interfaces,crevices, joint, hinged/mating surfaces, etc. The removal of grosssoil from these areas prior to washing in the automatic washer iscritical for achieving adequate cleaning.
Load the instruments in the washer such that all design features ofthe device are accessible to cleaning and such that design featuresthat might retain liquid can drain (for example, hinges should beopen and cannulations and holes positioned to drain).
Run the automatic wash cycle — minimum cycle parameters:
5-minute cold prewash
5-minute enzyme wash at 43 degrees Celsius minimum temperature
5-minute detergent wash at 55 degrees Celsius minimum temperature
1-minute rinse at 45 degrees Celsius minimum temperature
Check instruments for visible soil (see “Verifying Cleaningin instructions”). Repeat cleaning if soil is visible.
Some companies even tell the user that their instruments in certaincases should not be exposed to a medical automatic washer:“Standard spray type washer/disinfectors are not recommendedfor devices in graphic cases as the spray generally cannotpenetrate the graphic case with the requisite pressure to beeffective.” 9 This company also states that “the user is responsible forvalidating their specific cleaning using their specificequipment.” 10 This raises the question, how many hospitals are really verifyingtheir cleaning process and know their sonic, medical automaticwasher and their manual process is really doing the job?
Regarding tray design, here are some pointers: 11
Rounded corners and modern, space-age looks also are permeatingdesigns.
Manufacturers say their original equipment manufacturers (OEMs)want delivery systems that will catch a surgeon’s eye when asales representative walks into the doctor’s office.
Even if an OEM has spent millions developing implants, the firstthing the surgeon is going to see is the delivery system.
Aside from aesthetics, the most important factor is how well thesystem performs in terms of facilitating effective sterilization.
Sterilization is probably the most important consideration indesigning a system. You want to make sure the cases and instrumentsinside are sterile.
This list of considerations suggests that the designers of thesecomplicated trays may not be adequately concerned about thechallenge to proper cleaning, but rather are focused primarily onthe sterilization cycle. For example, holes that will allow steampenetration may still prevent the cleaning solution and rinse waterfrom reaching the inner compartments of the tray.
Manufacturers of MAWs
Manufacturers of the MAW are instructing CSD professionals onproper preparation and the loading of instruments into theirequipment. That information can be found in their user manuals andwhite papers:
“Over recent years, there have been growing concerns aboutthe effectiveness of decontamination techniques for reusablemedical instrumentation in healthcare facilities... another concernis for the safety of the healthcare workers handling productspotentially contaminated with bloodborne pathogens.” 12
“A low-level disinfection process is required to ensure theprotection of hospital staff handling the items during there-assembly, preparation, and packing for sterilization.” 13
Ensuring the MAW is working properly and staff understands how toload instruments into the MAW is crucial to achieving the goal ofsurgical instruments that are safe to handle and assemble.
Tips for loading surgical instruments: 14
Open all instruments, especially clamps
Keep spray arms free from obstructions
Keep instruments in a basket; avoid overloading a basket
Do not allow items to protrude outside confines of the rack
Incorrect basket loading/overloading could lead to serious personalinjury and/or costly damage. 15
Improper loading can be both a safety factor for staff and patientsas well as causing damage to surgical instruments if not doneproperly according to the manufacturer’s recommendations.
Standards and Guidelines
Standards and guidelines from the various standards bodies,including the Association for the Advancement of MedicalInstrumentation (AAMI), the Association of periOperative RegisteredNurses (AORN), and the American Society for Testing and Materials(ASTM), are clear on the importance of cleaning and cleaningcorrectly:
“Most sterilizer failures result from inadequate cleaning ofthe instruments before sterilization.” 16
“Instruments should be kept free of gross soil duringsurgical procedures. (PNDS; 170,198)” 17
Statements like these testify to AORN’s strong commitment tothe proper cleaning of instruments. AAMI ST 79 states that medicaldevices should be disassembled in order for all surfaces to beexposed to the cleaning process. 18 AAMI TIR 12 states that manufactures should instruct medicalfacilities on the proper method for preparing instruments forreprocessing. These same groups also support the use of qualityimprovement programs to help ensure that the cleaning process iseffective.
Current Literature
Exposure of the instruments to the mechanical action of the washeris important in having clean and safe instruments to handle, andthe literature on this subject supports this general statement. Arecent CSD article explains that tray selection has a directcorrelation on the ability of instruments to get clean by means ofa MAW. 19
We also know from published articles ( http://www.healthmark.info/proformance.html ) that water quality, 20 detergent, mechanical failure of the dosage system, 21 and basic equipment maintenance are major factors to optimalperformance of washer disinfector equipment. All must be workingproperly for any item to be cleaned properly. 22-23 Also, if the MAW process is not independently verified in some waythere is no way to know if other factors have impacted the cleaningprocess.
In 1969 Perkins wrote the following on loading: “... whenassembling instruments in a tray for processing, care should beexercised to guard against overloading. Jointed instruments withbox locks should be opened wide to expose the maximum surface area.Sharp instruments should be carefully spaced in the tray in orderto prevent contact with the easily damaged surfaces. Theinstruments are stacked less than three inches high, which isconsidered maximum for optimum cleaning, rinsing, and drying. Usecare to ensure that stainless steel instruments are not mixed withaluminum, or with brass or copper. Also be certain that detergentsused in the cleaning process are not harmful to theinstruments.” 24
In the eighth edition (2004) of Proper Maintenance of Instruments , published by the Instrumentation Preparation Working Group inGermany, it is suggested that when using machine-based processes,the following should be observed:
To ensure effective cleaning, all trays, inserts, holders, etc.,must be loaded correctly.
For the same reason, all articulated instruments must be processedin the open position
Avoid overloading trays to ensure that all instrument surfaces canbe readily accessed by the cleaning/disinfecting solutions.
When placing large instruments on trays, make sure that they do notobscure other instruments thus preventing proper cleaning.
Instruments with cavities or hollow spaces (such as shafts, tubing,hoses, and respiration systems) need careful cleaning and rinsingon the inside as well. For this purpose, special(instrument-specific) inserts with appropriate rinsing facilitiesshould be used.
The instruments must be arranged in such a way to preventmechanical damage through contact.
The role of the MAW is to make sure items are safe to handle at thenext stage in the process. If instruments are not exposed to theprocess there can be concerns. The International Association forHealth Care Service Materiels Management (IAHCSMM) technical manualpoints this out: “Washer-decontaminators help reduce thehandling of contaminated articles by central service employeeswhich, in turn, limits their exposure to biohazards.” 25
This statement supports exposing the instruments to the cleaningprocess and following manufacturers' guidelines: “Theinstruments should be placed on instrument carriers (trays)suitable for machine-based cleaning, thereby helping to ensure thatthey will be properly washed and rinsed. Effective cleaningrequires that articulated instruments (such as scissors, clamps,and forceps) be processed in the open position to minimize surfaceoverlapping. Complex instruments must be taken apart for cleaningin accordance with the manufacturer’s instructions.” 26
Steve Johnson, a CSD manager, wrote, “... in order to ensureadequate mechanical cleaning, you must avoid excess density in eachbasket, as well as over stacking many baskets...prepare instrumentwasher loads by opening instruments box locks, organizing washerbaskets to keep sets from being mixed and arranging the baskets toensure all items come in contact with detergent and sprayaction...” 27
Solutions to Poor Loading
To decrease the frequency of poor loading practices and its impact,medical facilities need to employ solutions based upon sources ofhelp:
Stringing of instruments
Verification of the process
Education and training
From the OR
Checklist
From the OR
“The first steps in proper reprocessing cycle are taken inthe operating theatre.” 28 The condition in which instruments are sent back is important. Arethe instruments in the “open position,” are they“‘soaking in a solution,” have they been“wetted or sprayed with something?” The condition ofinstruments returned to decontamination plays a major role in thesuccessful cleaning of the instruments. The length of time aninstrument waits to begin the cleaning process can be a problem;this could be called decontamination holding time (DHT).Cooperation from the user of the instruments is important; how theysend the instruments to be cleaned can add time to the process.
Actual instruments being returned to be processed after surgery(notice the blood on the drill handle,not even wiped off afteruse).

In recent years we have seen an increase in the use of sprays andgels to help break down the various bioburden found on surgicalinstruments. One reason is the DHT factors; it could be minutes tohours and even days in some cases when instruments actually getprocessed. These types of products help in keeping the instrumentsmoist and usually include hydrolyzing enzymes which begin theprocess of breaking down blood and other soils. In fact sprays andgels have replaced the more traditional method of placing a wetcloth over instruments after surgery.
In its recommended practice, AORN clearly supports the wiping downand the proper preparation of instruments after use. Here are justa few points: “All instruments opened on the sterile fieldrequire decontamination... instruments should be prepared fordecontamination after use. Instruments should be taken apart andarranged in an orderly fashion in mesh bottom trays... openinstruments' box locks... cover instruments with a damp towel, at aminimum, to prevent drying during transportation to thedecontamination area...” 29
If surgical instruments are not returned in the proper way it willtake the decontamination staff longer to prepare them for thecleaning process. If you do not take the time on the front end ofthe process that time has to be made up some place and that someplace is usually the department that does the cleaning, assemblyand sterilization of those instruments.
Stringing
Stringing instruments for decontamination is an important step.This exposes instruments to the complete cleaning process. Evidenceof the benefit of stringing comes from these comments by a CSDmanager, “We did implement the re-stringing of instrumentsprior to placing in the washer. This reduced the number of lostinstruments, assembly of sets was easier and best of all, we hadclean instruments!” 30
Other medical facilities are also seeing the benefits of stringinginstruments and exposing them to the cleaning process. At a recentGreater Detroit central service meeting, Randy Sprouse, manager ofcentral processing at Beaumont Hospital in Royal Oak, Mich.,informed the audience that his medical facility not only restringsinstruments (opens instruments to at least six inches, whenpossible) in the decontamination area but they also count them. Hisfindings have shown an improvement in not only the cleanliness ofthe instruments but a reduction in instrument loss and quickerassembly and turn-around time. 31 Stringing can reduce the stacking of instruments, and can alsomake the assembly process smoother.


Instrument stringing (top photo), positioning instruments in thetray (middle photo), proper exposure of instruments in the medicalautomatic washer (bottom photo).

Verification
CSD professionals challenge their sterilizer with a biologicalindicator (BI); on multi-layer trays many place an indicator oneach level to insure sterilization has taken place throughout thetray. It is with that same philosophy we should approach testingthe proper loading of the MAW. John MacDougall, RN, MS, pastpresident of the Michigan Society of Central Service Professional,uses the TOSI™ as a tool to help his staff understand how toload instruments properly and verify that his equipment is meetinga standard. MacDougall states, “The TOSI™ representswhat I am trying to clean, blood on a stainless steel instrument,and with a physical challenge to the cleaning process. It is a truemodel of what I am actually processing.”
MacDougall has used the TOSI™ to help show his staff howtrays with multi-levels must be separated. The TOSI™ is firstused to verify that the equipment is working by testing in an emptyload. After that a multi-layer tray is processed using the samecycle parameters with the lid on and a TOSI™ on each level.Upon completion of the cycle the TOSI™ on each level isexamined. Notice that the TOSI™ did not come clean on thesecond level. This simple exercise shows how trays withmulti-layers need to be disassembled so they can be properlyexposed to the cleaning process. Staff now has a visualunderstanding of the importance of separating multi-layer trays.
T.O.S.I. Cleaning verification test

Verification of the automatic cleaning process is now supported bymany organizations. AAMI ST 79 states, ”The efficacy of anysterilization process, including saturated steam, depends on aconsistent system for lowering and limiting bioburden beforesterilization. Appropriate documentation and reporting practicesthat enable traceability of each facility-sterilized medical deviceto the patient on whom it is used.” 32 This is just one of the many statements throughout this documentthat supports verification of the cleaning process.
AORN’s Recommended Practice for Cleaning and Care of SurgicalInstruments and Powered Equipment Recommendation XXII –Quality section is now supporting the testing of mechanicalinstrument washers before initial use, weekly during service, andafter major maintenance. The Joint Commission standard E.C.6.20states that medical equipment is maintained tested and inspected.
Verifying this process is so important that medical facilities arefollowing the recommendations of the various regulatory bodies thatany simulated-use testing be done with a surrogate device thatclosely approximates the actual types of soils the instrument is tobe exposed to in clinical use. Further, the surrogate device shouldbe made of the same type of material as the instrument itrepresents. They are now making testing part of their everydayquality process improvement program.
Education and Training
Education of staff is vital to achieve the proper processing ofinstruments. This can only be accomplished by training, teamworkand understanding the various standards and the role they play inthe cleaning process. Without training, people will not understandthe need for change. Education is two-fold:
CSD: how the technician loads the instrument into the MAW
User: how the user (usually the OR) returns the instruments to bereprocessed
Checklist
Make a simple checklist with the following steps:
Work with your medical automatic washer manufacturer to make sureyour items can be processed in their equipment.
Understand the optimal way to use the MAW on your surgicalinstruments.
Involve your instrument manufacturers' and follow theirinstructions for cleaning.
Understand how your various cleaning solutions work.
Flow chart your process so you have a complete understanding ofwhat is going on; different instruments might require differentprocesses, (i.e., orthopedic might be processed differently thangeneral or eye instruments)
Expose as much of the instrument as you can to the MAW cleaningprocess (open those box locks), take apart instruments as directed
Disassemble all instruments and expose them to the cleaning process(manual or automatic)
Monitor your process with quality improvement tools that will helpsolve and reduce current or future problems
Do not stack instruments on top of each other. Stringing of theinstruments in an open position in the decontamination area is abetter method
Look at new products to help expose instruments to the cleaningprocess; notice the exposure of the instruments when using asix-inch stringer over a two-inch stringer
Use the proper type of rack to load instruments into the MAW
Use the equipment for processing instruments
Conduct yearly in-service for all employees
Use cleaning verification products as an independent challenge toyour process to ensure your equipment and your staff are workingproperly
Involve all of your customers in the process by explaining theimportant role they have in proper preparation of instruments forreprocessing
Combine all of the information from the various sources and adaptthem to your process (instrument, cleaning solutions, equipment...)to load the trays correctly


Easy Stringer and six-inch wide stringer (notice the difference inthe exposure of the instruments from 2 to 6 inches)


This system shows how the positions of the magnets will decide thetype of cycle the instruments will be processed at.

This is an example of a bar code type system for programming.

An example of poor use and loading of equipment in a MAW.

Proper way to expose instrument to the cleaning process of amedical automatic washer; all instruments in the open position,entering the automatic washer.

Conclusion
“Washers can only be effective when they are properly used,loaded, and serviced in compliance with the manufacturers’recommendation.” 35 These are words to live by for every CSD. As this article hasdemonstrated, implementation of current standards; close adherenceto instructions from device manufacturers; comprehensive routineeducation and training of staff; and a program of quality checksincluding independent verification of the cleaning process are thekeys to achieving proper loading of the MAW. The result will be adramatically reduced incidence of dirty instruments. This in turnwill provide better patient care and a better and more efficientCSD.
Stephen M. Kovach is director of education for HealthmarkIndustries in St. Clair Shores, Mich. Kovach is educationalchairperson for the AORN Specialty Assembly for SP/MM. He is amember of AORN Lakeshore Chapter 2307, a member of IAHCSMM, and hisState Central Service professional group MSHCSP, and is on manyAAMI standards committees.
References:
1. IAHCSMM Forum; post 7; April 18, 2007, washing instruments in acontainer.
2. AORN J. March 2007. Vol. 85, No. 3; page 566.
3. Pennsylvania Patient Safety Authority 2006. Page 1.
4. Pennsylvania Patient Safety Authority 2006. Page 1.
5. Pilling Weck Surgical-Lit.99-1007. 1/99; 17M; page 364.
6.http://www.zimmer.com/web/enUS/pdf/Surgical_Cleaning_Instructions_Final.pdf
7. http://www.beeremedical.com/Prints/pdf/Guide-Instr.%20care.pdf
8. http://ortho.smith-nephew.com/us/node.asp?NodeId=3248
9. Coatesworth letter from SYNTHES®; Request for CleaningParameters. Nov. 23, 2004.
10. Ibid.
11. www.odtmag.com/articles/2007/01/case-closed-delivery-system.php
12. Technical Data Monograph: Decontamination of Reusable MedicalDevices using FAST Cycles on Reliance®Synergy™Washer/Disinfectors. STERIS®. Aug. 1, 2004.
13.Ibid.
14. AVENATECH, Inc. Washer/Decontaminators – In-ServiceTraining Guide-Operation of The Belimed SM-100. Pages 18-19. 1998.
15. RELIANCE®777, Equipment Manual; 9/1/91-Rev2.
16. AORN Perioperative Standards and Recommended Practices, 2008.Page 423.
17. AORN Perioperative Standards and Recommended Practices, 2008.Page 434.
18. ANSI/AAMI ST 79:2006
19. Recommendations by the Quality Task Group (33) Mesh Trays andtheir Implication for successful Cleaning in thewasher-Disinfector; Zentr Steril.
20. Basile R and Kovach S. A Thorough Cleaning part 2. ManagingInfection Control. February 2003.
21. Zentr Steril Forum 2004. M.Wieder. Dosage and Control Mechanismin Validation of Automatic Cleaning and Disinfection Processes.
22. Basile R and Kovach S. A Thorough Cleaning part 3. ManagingInfection Control. March 2003.
23. Basile R and Kovach S. The Cleaning Process. Managing InfectionControl. July 2003.
24. Principles and Methods of Sterilization in Health Sciences,second edition. Perkins. Page 250.
25. IAHCSMM. Fundamentals of Cleaning for Decontamination. SelfStudy Series Lesson 42.
26. Proper Maintenance of Instruments, eighth edition. 2004. Page20. www.a-k-i.org
27. Johnson S. Infection prevention: are those instruments setsready yet? Outpatient Surgery.
28. Proper Maintenance of Instruments, eighth edition. 2004. Page19. www.a-k-i.org
29. AORN 2006 Standards, Recommended Practices, and Guidelines.Pages 555-556.
30. Personal correspondence between D. Coatsworth and S. Kovach,Nov. 12, 2007.
31. Dec. 7, 2007 Greater Detroit Central Service meeting.
32. ANSI/AAMI ST79:2006. Page 1.
33. www.trucleaninnovations.com
34. www.hmark.com
35. IAHCSMM. Seventh edition Central Service Technical Manual. Page145.