improving the performance of your medical automatic washer improving performance automatic washer...

ObjectivesAfter completion of this self-study activity, the learner

will be able to:1. Discuss the variables that influence the automatic

washing process.2. Design a quality improvement program for a medical

automatic washer.3. Describe the various guidelines and recommendations

concerning monitoring the automatic washing process.4. List the differences between various types of medical

automatic washers.

Test QuestionsTrue or False

1. Blood cells colored with hemoglobin are fairly easy towash off instruments; clear fibrin material is much moredifficult to remove.

2. Moist alkaline detergents dissolve dry proteins and causefibrin to break, mimicking enzyme action.

78 February 2007MANAGING INFECTION CONTROL

Education & Training

Many thanks to the team at 3M Health Care forworking with Managing Infection Control to providethe following accredited course. IAHCSMM hasawarded one and one-half (1.5) contact points forcompletion of this continuing education lessontoward IAHCSMM recertification. The CBSPD haspreapproved this inservice for one and one-half (1.5)contact hours for a period of five (5) years from thedate of publication, and to be used only once in arecertification period. This inservice is 3M HealthCare Provider approved by the California Board ofR e g i s t e red Nurses, CEP 5770 for one (1) contacthour. This form is valid up to five (5) years from thedate of publication. Instructions for submittingresults are on page 103.

Managing Infection Control and 3M HealthC a re will be working collaboratively to pro v i d econtinuing education courses in monthly editions ofManaging Infection Control.

3. In general, the harder the water, the more cleaning solution will be needed in the cleaning process.

4. American Society of Testing and Manufacturing (ASTM)has recently established a new standard D7225—Guidefor Blood Cleaning Efficiency of Detergents and WasherDisinfectors.

5. Association for the Advancement of Medical Instrumentation(AAMI) and Joint Commission for Accreditation ofHealthcare Facilities (JCAHO) support implementation ofQuality Improvement Processes in the Sterile Processingdepartment.

6. Cleaning is the removal of all visible dust, soil, otherforeign material and some microorganisms.

7. A solution with a pH of 9 is an acidic solution.8. Following the manufacturer’s instructions is not important

in the cleaning process.9. The prewash cycle temperature should be colder than 113

degrees Celcius.10. Staff should have at least yearly training on the operation

of the automatic washing equipment.

Introduction“The reliability of sterilization is affected negatively by

the number, type, and inherent resistance of microorganisms,including biofilms, on the items to be sterilized. Soils, oils, and other materials may shield items from contact with thesterilant or combine with and inactivate the sterilant.”1

Providing a properly assembled sterile instrument to theoperating room is paramount to the success of any surgicalprocedure. Doing so is not an easy task, however. Hospitalsthat implement a Quality Improvement Program for theirmedical automatic washer help ensure that patients enjoy thebest possible outcome of surgery.

One only has to think of the “circle of life” from themovie The Lion King to begin to understand the complexprocess of providing a properly assembled sterile instrument tothe OR (see Figure 1 on page 79). Providing instrumentssterile and ready for use requires many steps. Each stepdepends on successful completion of the previous step. Forexample, a hospital can clean and sterilize items properly; butif instruments are transported improperly, the effort made tosterilize them is wasted (see Figure 2 on page 79).

Improving the Performance ofYour Medical Automatic Washerby Stephen M. Kovach, BS, CSPDT

79February 2007 MANAGING INFECTION CONTROL


Figure 1. Automatic cleaning is part of the circle of life insterile processing.

Figure 2. Improper transportation of item under the arm.

Cleaning is one of the first steps to providing a workable and sterile instrument to the operating room. Cleaning has threemajor objectives: Remove visible soil. Remove invisible soil. Remove as many harmful microorganisms as possible.

Manual or mechanical processes or a combination of the twocan be used to achieve these objectives.

Cleaning involves many steps, each of which influences theoutcome. This article will focus on the medical automatic washerand the variables that influence its effectiveness.

A properly functioning medical automatic washer isvital to the process of providing a clean item for staff toassemble and prepare for sterilization, and eventually useon a patient. Staff must understand the variables that affectthe medical automatic washer’s performance and mustmonitor and correct any deviations from the washer’starget parameters in order to assure that the process works.

Note: The author realizes that much is being donewithin the global community with regard to verifying theeffectiveness of medical automatic washers. This articledeals with practices within the United States only. It doesnot address flexible automatic scope washers (automaticendoscope reprocessors), only washers intended forcleaning surgical instruments.

What is a medical washer/disinfector? What does it do?

“A medical washer or washer-disinfector is a medicaldevice intended to process medical devices. The FDAregulates the introduction of medical devices in interstatecommerce. A medical washer-disinfector intended to cleanand provide high level disinfection of medical devicesmust have a FDA cleared pre-market notification [510(k)]submission before it can be sold. A medical washerintended to clean medical devices or a medical washer-disinfector intended to clean and provide either low orintermediate level disinfection of medical devices isexempt from 510(k) requirements.”2

The majority of medical automatic washers used in U.S. hospitals today deliver low- to intermediate-level disinfection and are exempt from the 510(k) submission requirements.

Medical automatic washers (also known as washer-decontaminators, washer/disinfectors or automaticinstrument washers) initially developed from commercialdishwasher technology and have adapted to today’sscience-based requirements. Maybe this is the reason that, even today, many institutions regard the medicalautomatic washer as nothing more than a dishwasher,when in fact it is one of the most vital pieces of equipmentin the fight to reduce healthcare-acquired infections.

The simple definition of a medical automatic washeris a piece of equipment that cleans and decontaminatesdirty surgical instruments so they can be handled safely,repackaged and sterilized for a future procedure. Somemedical automatic washers can process only bedpans,while others can process a variety of items, includings u rgical instruments with and without lumens. Somewasher manufacturers offer racks specially designed forlumen-type and minimally invasive surgery instruments(see Figure 3 on page 80 ).

Figure 4. Batch washer—basic design (coupler system can be located on the side wall insome models).

Regardless of the model or the theory behind amedical automatic washer, if it is maintained (preventa-tive maintenance by a qualified person), properlycalibrated, variables monitored, and used accordingly, itis capable of effective cleaning.


Figure 3. Special rack for lumen items.

Medical automatic washers fall into two distinct categories ofoperation. In North America, machines rely on “high impingement”and softer chemistry; in Europe, machines rely on “low impinge-ment,” high water volume, and more aggressive chemistry. Thereare two basic types of medical automatic washers:1. Batch-type:

This washer has a closed cabinet that is linked to the watersupply and drainage system. The machine is loaded with thesoiled instruments/utensils, and the doors are locked before thecycle commences. All stages are performed in one chamber(see Figure 4 right).

2. Indexed/rack conveyor washers (tunnel washers): This type operates as a continuous-feed system in which soiledinstruments are loaded on one end and reprocessed instru-ments are ejected on the other. Soiled instruments/utensils aretransported from chamber to chamber in which different stagesof the process are performed (i.e., rinse-wash-disinfect-dry)(see Figure 5 Tunnel washer below).


Figure 5. Basic tunnel washer.



Variables that impact cleaningA w a s h e r’s effectiveness depends on several variables that are equally

important in achieving the desired result—clean instruments that are safe tohandle and then sterilize. These variables include: Target soil—type of soil to be cleaned; Instrument design—item to be cleaned; Water quality (e.g., hardness, pH); Temperature and time; Chemical activity—the ability of the cleaning solution to hydrolyze

target soils; Mechanical action—the energy needed to clean (agitation); Human variables and intangibles (e.g., staff training, loading methods).

The final variable is active monitoring of these input parameters and of the final outcome: instrument cleanliness. This can only be done via a qualityimprovement program in which a Sterile Processing department maintains andimproves the medical automatic washing process (following the equipmentmanufacturer’s instructions) and its staff understands the variables and howthey interact. A good quality improvement program should be based on thesevariables. Let us examine them individually.

Target soil“Many types of soil could be present on reusable medical devices, but

dried blood is especially difficult to clean. As a liquid, blood tends to flow overand into joints, hinges, grooves, and other difficult-to-clean locations. It thencoagulates and dries to create a significant challenge to cleaning.”4

Blood is the soil most often found on surgical instruments. Thus it is bloodthat is the residual soil one most often looks for when making sure items are clean.

Dried blood on instruments is hazardous to the employees of the hospitaland to the next surgical patient upon which the instruments are used. T h edanger of handling instruments contaminated with blood is obvious in this ageof hepatitis and HIV. The procedures for sterilizing instruments are based onyears of scientific testing of clean instruments. If surgical instruments are notclean, the procedures are ineffective.

Cleaning dried blood is much more difficult than cleaning other soils.Blood coagulates, which means it goes from a free-flowing liquid to a solid thatcontains tough, microscopic fibers called fibrin. Fibrin is formed as the bloodcoagulates. The fibers jam themselves into microscopic irregularities in thesurface of the stainless-steel instrument. This is a physical attachment to thesurface through mechanical means, not just chemical means as with traditionaladhesives. The action is similar to the roots of plants growing into cracks inrocks, anchoring themselves to the surface.

Hemoglobin (the red-colored cells of blood), when wet, is fairly easy towash off instruments. However, should hemoglobin dry it becomes highlyinsoluble and very difficult to clean.

Removing blood from a surgical instrument can be difficult. Ensuring thatno residual blood remains after cleaning is critical to the sterilization process.

Instrument designThe complexity of an instrument’s design is directly proportional to

the complexity of cleaning it and the difficulty of verifying cleanliness.

binding with the target soil. Dissolved solids in waterpresent obstacles to good cleaning. Hardness mineralscan also cause spotting and filming on instruments. Theymust be effectively tied up or sequestered if the cleaningresults are to be satisfactory. The harder the water, themore concentrated the cleaning solution will need to be.Water hardness thus can diminish product efficacy andefficiency. Routine monitoring of water hardness helps toensure the optimum performance of equipment andcleaning solutions (see Figure 7 below).

Figure 7. Water hardness chart.

pHThe pH level indicates the acidity or alkalinity of

water on a scale from 0 to 14. A solution is consideredneutral if it has a pH-level of 7. One to 6 on the scale isconsidered acidic; 8 to 14 on the scale is called alkalineor a base. Improper pH can compromise the effectivenessof cleaning solutions. Knowing the water’s pH helpsensure optimum performance of the cleaning solution.

Temperature and timeThese two parameters are interdependent at almost

every stage of the automatic washer process. A low temperature at the start (to prevent denaturing) and highertemperature later (to maximize enzymatic solution or d e t e rgent) are crucial for thorough instrument cleaning.Monitoring the temperature at all stages of the process isimportant because improper temperature can cause adversereaction and poor performance.

Water temperature is the key to thermal disinfectionin a medical automatic washer. The level of disinfectiond i ffers between brands of medical washers, as does the time and temperature required to achieve the specified disinfection level. One must remember that the target ofthermal disinfection is the surface of the instrument. Thus, itis key to monitor the surface temperature of instruments toknow whether disinfection has occurred. Water temperature


Twenty years ago surgical instruments were simpler in design.Today we have: Long narrow lumens; Tiny serrations; Multiple parts; Higher quality stainless steel; Various metals and plastics.

But even traditional instruments pose a challenge. One ofthe most challenging areas to clean is an instrument box lock(see Figure 6 below). This tiny narrow area is often foundwith dried blood inside. The dried blood not only damages theinstrument itself but also is a place where microorg a n i s m s“hide” and are protected during the sterilization process. The cannulated areas of instruments also can harbor hard-to-clean blood. After surgery box locks should be opened andinstruments with removable parts should be disassembled.This will limit drying of blood on instruments, which maycause corrosion.5

Figure 6. Box locks.

Water qualityWater as a variable in the cleaning process is sometimes

underappreciated. Failure to recognize poor quality water,failure to treat water as needed, or failure to monitor and take action on poor water quality places patients at risk. Therelevant measurable characteristics of water in the cleaningprocess are hardness, pH-level, temperature and purity (micro-bial contamination). Hardness

Hardness is usually defined as the concentration ofcalcium and magnesium ions expressed in terms ofcalcium carbonate. These and other minerals bind with thecleaning agents in detergents, preventing them from



needs to be monitored and documented independently of themachine for two reasons:1. Washers only monitor the temperature of water in the sump, not

at the instrument surface level.2. Thermal couplers and heaters can fail.

With enough time, simple water will remove all types of bloodand other soils (the Grand Canyon is evidence of this). Of course,surgical services do not operate on geologic time scales—more likesupersonic. As a result chemical solvents (e.g., enzymes, soaps) arerequired to speed the hydrolysis of target soils. The contact time forthe various cleaning solutions needs to be optimized so they canwork as intended. Cleaning solutions should be applied for at leastthe minimum time specified on the product label. More contact timebetween the cleaning solution and the target soil might be needed tocompletely clean some instruments. Decontamination holding time (DHT)

DHT is the duration of time between an instrument’s lastsurgical use and the moment the cleaning process begins. DHTcan vary in length from just a few minutes to hours or evendays. The longer the time before the cleaning process begins,the greater chance instruments will arrive for assembly dirty onthe clean side. Thus, it is important to keep soiled instrumentsmoist after use. This can be done by placing a wet towel over the instruments or by using one of the many sprays nowavailable to keep instruments moist. Sterile Processing staffshould remind their colleagues in the Operating Room of theimportance of wiping down instruments during surgery andsending them back to the decontamination area in the bestcondition possible (see Figure 8 below).

Figure 8. Decontamination area with supplies coming backfrom the Operating Room.

Chemical activity—cleaning solutionsThe two types of cleaning solutions normally used in

medical automatic washers are enzymes and detergents. Studies


have demonstrated clear differences between cleaning agents.6

Enzymes are biological agents that break downt a rget soils, making them more soluble through aprocess called hydrolysis. Time is needed for this actionto take place. The time needed to act depends on factorssuch as concentration, temperature, pH, and the typeand amount of soil to be removed. Four basic types ofenzymes are used to clean surgical instruments: Lipase—breaks down fats and greases; Protease—breaks down protein; Cellulase—breaks down cellulosic materials such

as wood, cotton and paper; Amylase—breaks down carbohydrates and starches.

D e t e rgents are chemicals that reduce surfacetension during cleaning so that water can spread andwet surfaces. These chemicals are also called surface-active agents, or surfactants. Surfactants perform other important functions in cleaning, such as loosening, emulsifying (dispersing in water), andholding soil in suspension until it can be rinsed away.Similar to protease enzymes, high alkaline surfactantshydrolyze proteinaceous soils.7 Foaming is also afactor; low-foaming detergents are preferable formedical automatic washers.

Note: Remember no two enzymes or detergents areexactly alike. Knowing the difference between them andwhat they can do gives the Central Sterile Processingp rofessional a better understanding of the cleaningprocess and his/her particular needs.

The effectiveness of any cleaning solution dependson certain factors, including dosing, concentration,storage conditions, age, decontamination room environ-ment and adherence to label instructions.

According to Martin We i d e r, a major washerconcern is the dosage and control mechanisms fordispensing cleaning solutions.1 8 These variables should be validated and monitored because they are asignificant cause of poorly cleaned instruments.Blocked or kinked feed tubing may limit the amount ofchemicals being pumped into the washer. Brokenpumps, incorrect temperature, misaligned couplingmechanisms and compromised spinner arms, all play arole in delivering the proper dosage of chemical agents.The length of the tubing from the source (cleaning solution) to the pump is also important. Inherently,pumps are capable of delivering solution at a maximumdistance. Sterile Processing staff should know themaximum length of tube their machine’s pump isdesigned to work with (see Figure 9 on page 86).

Users should be aware that, although most washers are designed to alarm when the volume of cleaning solution inthe storage barrel is low, most washers will not warn whendetergent is not being delivered. For instance, a washer willcontinue to run even if it is pumping only air. It is important to ensure that the dosage pump is properly functioning and calibrated. A simple way to monitor the pump is to mark thebarrel of solution daily (see Figure 10 left).

Each cleaning solution has a minimum concentration forpotency. The ratio between the target soil (contaminant) and the applied cleaning solution is important. Follow label requirements for concentration levels; they vary according tothe water quality and amount of target soil present.

Cleaning solutions should always be stored according to the manufacturer’s directions. Some cleaning solutions (particularly enzymes) can be deactivated by heat, so it isimportant to store and transport them at the proper temperature(see Figure 11). Likewise, relative humidity of the decontami-nation room can affect the solution’s penetration, so the room’srelative humidity should be monitored and documented. Thiscan be done with simple wall monitors or electronic devices thatcan store the data for later retrieval. Temperature and humiditylevels should be documented at least every shift.

Figure 11. Temperature on the barrel.

Cleaning solutions that have passed the manufacturer’susage date will not clean as validated by the manufacturer. Staffshould know their solutions’ expiration dates and be sure torotate product.

Always follow the manufacturer’s guidelines and labelinstructions. No two products or pieces of equipment are thesame, and instructions can vary: “Do not use on anodized aluminum…automatically feed at

1/4 to 2 fluid ounces per gallon of water depending on soilload and water conditions...”8


Figure 9. Examples of poor administration of cleaning solution.

Air in line.


Figure 10. Barrel marked.

optimum exposure to the cleaning solution and sprayaction. Stringing instruments is an excellent way toexpose all the areas of an instrument to the cleaning actionof a medical automatic washer (a five-inch stringer willkeep instruments open and exposed) (see Figure 12). Ablocked spray nozzle decreases cleaning power. If twoholes are blocked on a 10-hole spray arm, the spray isonly 80 percent efficient. Such a blockage affects not onlythe cleaning power but also the effective rinsing of thecleaning solutions. Verifying that spray arms achieve fullrotation and that the nozzles are clean will help ensureeffective cleaning action (see Figure 13 below).

Figure 13. Spray arm concerns.

Yuck! Two holes blocked.

Side holes blocked.

LoadingIf instruments are not loaded properly they will not

come clean, even in a properly performing washer. Thus,staff must know proper loading techniques (see Figure 14on page 89).


“May be used in manual or ultrasonic/automated cleaningsystems... Do Not use for cleaning spinal syringes orneedles...”9

“...works in all water temperatures”10

Central service staff should understand how each piece ofequipment works, which cleaning solutions are best for theirequipment, and the limitations of those solutions. Choosing thewrong cleaning solution can cause problems down the line.S t a ff should read all labels and product safety information(e.g., Material Safety Data Sheets [MSDS]), as well as anywhite papers the company provides for its product. A file oneach product should be located in the department for easyreference. The more information available, the better preparedthe staff.

Mechanical actionThe mechanical efficiency of a washer is vitally important

to performance. Each washer has its own cycle setting(prewash, rinse, enzymatic/detergent, sonic, disinfection,drying), which must be matched with the cleaning solution andthe instruments to be cleaned (general instrument, micro,orthopedic). Other important variables include the length of thecycle, agitation, instrument loading, tray and rack selection,rinsing and staff training regarding proper use of the machine. Agitation

Physical agitation from water spray brings freshcleaning solution to the soiled area and washes away useddetergent. Spray impulses loosen blood through physicalimpact. Spray from different angles helps preventblocking from instruments piled on top of one another.Instruments must not be stacked or overloaded in any tray.Evenly spreading instruments within the tray provides


Figure 12. Stringing instruments.


One washer manufacturer’s guide to operation includesthe following instructions for loading instruments: “Open allinstruments, especially clamps; keep spray arms free fromobstructions; keep instruments in a basket; avoid overloading

a basket; do not allow items to protrude outside of the rack. Wire mesh baskets are better than perforated trays.Avoid solid side trays or trays with limited perforations on the bottom.”11


Figure 14. Improperly loaded instruments—How clean do you think these instruments will be when they come outof the medical automated washer regardless of how well the washer is performing?

February 2007MANAGING INFECTION CONTROL

When loading the washer, staff must separate multilayertrays so that cleaning solutions can have direct contact with theinstruments. The Sterile Processing staff should also followthese rules for loading an automatic washer: Open hinged instruments and place on stringer if possible

(at least 5 inches). Disassemble sets and instruments according to manufac-

turer’s instructions. Place concave instruments on their side or upside down. Use specialty baskets/trays when available (e.g., basins). Separate stainless-steel instruments from other metals. To

avoid electrolysis, place different metals in their owntray/basket if possible.

Put the heaviest instruments at bottom of the basket. Donot place them on top of delicate instruments (see Figure15 below).

Figure 15. Properly loaded trays (5-inch stringer).Notice how wide the instruments are open to getmaximum exposure to the cleaning process.


Tray and rack selectionTrays for washing can be different than trays for

sterilization. It is important to pick and use the correcttype of tray in order to optimize cleaning results. In hispaper “…And then there was Decontam,” a paperauthored by Richard Schule, Director, Clinical SterileProcesses at Clarian Health, he notes that loading racks have variations and should be numbered. If aproblem arises, staff can track back to a specific rack forfollow up.1 9

Metal racks are subjected to strenuous conditionsthat can cause them to warp and break down. Couplingsmay show fatigue; spray arm bushings may break andfail. Such failures indicate that the correct water pressure(cleaning power force) is not being delivered.

RinsingThorough rinsing is needed at various stages of the

washing cycle. The quality of the rinse may differ fromstage to stage. Rinsing between stages prevents residualsfrom being transmitted from one stage to the next. Thefinal rinse after cleaning is extremely important becauseany residuals after this stage will likely remain on theinstrument and could detrimentally affect disinfectionand sterilization, and/or cause adverse reactions in the patient. Some medical automatic washers areprogrammed with only 15 seconds of rinse time. SterileProcessing staff should verify that the rinse time is longenough to remove all residue. Quality of the rinse watershould be monitored as well.

BiofilmBiofilms are a concern with medical automatic

washers. Biofilms are produced by microorganisms and consist of a sticky rigid structure of organic contaminates. A slime layer anchors firmly to a surfaceand provides a protective environment for microorgan-isms to grow. The chamber walls inside medicalautomatic washers are an area that staff should checkroutinely for any biofilm build up. Some companiesrecommend using a de-scaler to clean the chamber wallson a routine basis. Poor water quality, poor rinsing andtoo much cleaning solution are possible reasons for abuild up of biofilm inside the medical automatic washer(see Figure 16 on page 91).

Washer featuresWhen purchasing a washer, staff should know

which optional features are most important. Forexample, a washer with a window allows the user to view what is going on inside the chamber. Staff should



Figure 16. Biofilm example.

Yellow film on wall. White and red film on wall.


be able to print out the cycle parameters for each machine.If more than one machine is in use, each should have itsown alarm system for detecting low levels of eachcleaning solution. Features such as a window and an alarmhelp staff identify and solve problems in the automaticwasher cleaning process.

Always follow the manufacturer’s guidelines for replacement of parts and service. Factory-trained techniciansshould perform replacement and servicing of the equipment.For example, temperature variations in a washer can be causedby a faulty thermostat or heating element. The dosage pumpmust be calibrated regularly to ensure delivery of the correctamount of cleaning solution. Review the preventative mainte-nance manual with the repair technician. Involving thehospital’s biomedical department in this review can help ensurethat the proper work is being done.

Staff trainingThe most critical component in any cleaning process is

the human one. The staff working in the decontamination area must understand the importance of their work and howthey affect not only patient health and safety, but also that ofthemselves and their fellow staff. Regular, professional stafftraining will help ensure that instruments are clean. Trainingshould include, but not be limited to, cleaning solutions, equipment and personal protective apparel. Training should bemandatory for new employees, and conducted annually for alls t a ff. A certified Sterile Process staff only enhances theoutcome of the facility’s cleaning process. Certification ensures a level of understanding of the cleaning process that iscontinually updated and enhanced through recertification.

It takes time and dedication to keep the medical automaticwasher functioning properly. Running instruments through awasher does not guarantee that they will be fully cleaned; all of the variables mentioned in this article must be working attheir optimum for the process to be complete and for staff tohave confidence in their equipment. A quality improvementprogram takes time to implement but will prevent futureheadaches, such as additional manual cleaning and reduceds t a ff productivity. It allows staff to better understand thecleaning process and to solve problems more easily when theydo occur.

The importance of monitoringTesting a medical automatic washer to ensure it is properly

calibrated is vital to any hospital’s infection control program.Washers fail to clean for many reasons. Independent testingprovides a means of monitoring the variables that influence the effectiveness of an automatic washer. Professional o rganizations and government agencies including JCAHO,

FDA, AORN, IAHCSMM, ASHCSP, ASTM, CDC and AAMI,as well as equipment manufacturers, recommend that SterileProcessing departments have a quality improvement programin place to reduce the incidence of dirty instruments resultingfrom a poorly functioning washer.

The following statements from professional organizationssupport implementation of quality improvement programs: J C A H O Standard E.C.6.20: “Medical equipment is

maintained, tested and inspected.”(2005)

A A M I ST79:2006, 7.5.5 Verification of the cleaningprocess: “…. processing personnel are increasingly awareof the need to control and standardize the steps taken toensure the sterility of devices for patient use. Becausedisinfection and sterilization cannot be assured unless thecleaning process is successful, professionals in the fieldought to seek out whatever means are available and practical to verify this function. A quality system wouldcall for monitoring and documenting decontaminationprocessing parameters, whether the process is accom-plished by hand or mechanically.”

AAMI ST79:2006, Annex D User verification of cleaningprocesses: “Ideally, cleaning verification by users shouldinclude visual inspection combined with other verificationmethods that allow the assessment of both externalsurfaces and inner housing and channels of medicaldevices. Manufacturers should strive to provide users withsuch tests so that medical devices can be tested directlyafter cleaning in a way that will not damage the device orrequire recleaning…”

I A H C S M M ’s Central Service Technician Manual 6th(2003) edition contains a section on ways to verify thecleaning process.

AAMI TIR12:2004 defines verification and validation forthe user and the manufacturer:1. “2.38 user verification: Documented procedures,

performed in the user environment, for obtaining,recording and interpreting the results required toestablish that predetermined specifications have been met.”

2. “2.39 validation: Documented procedures forobtaining, recording and interpreting the resultsrequired to establish that a process will consistentlyyield product complying with predetermined specifi-cations.”

The Getinge Company offers a performance monitoringprogram that allows users to independently verify the key



variables of the medical automatic washing process. This isexactly what AAMI TIR12:2004 calls for: that companiesprovide a way to verify their equipment is working properly.Ideally, when the washer is serviced a test object is used toverify the machine is operating at the same level as when it wasoriginally installed. The user has proof the equipment isworking properly and has been independently verified. At thiswriting Getinge is the only company of which the author isaware that is providing this service as part of its documentedservice program.

Setting up a quality improvement programProper cleaning then is very critical to the sterilization

process. A quality improvement program with an independent,objective test for the variables that affect the automaticcleaning process allows the Sterile Processing professional tomonitor and ensure that proper cleaning is being done.

Because no two Sterile Processing departments have thesame cleaning process, the quality improvement programoutlined below is necessarily generic, but does include many of

the variables mentioned earlier in this article. The programassumes the following: Appropriate facilities are provided; Appropriate equipment is used; Equipment is fit for its purpose, properly maintained and

calibrated, and properly monitored and validated; Staff are properly trained and supervised; Single use medical devices are not reused; Records of decontamination are kept.12

A quality improvement program should be based on staffobservations and on data obtained by monitoring the key variables. The process should be ongoing; tests can beconducted each shift, weekly, monthly, quarterly or yearlydepending on the variable monitored. Water quality testing

Water quality in a hospital can change from when it enters the building to when it is used. Water can be easilymonitored by using a dipstick test. Staff should monitorand document at least the basic parameters (pH, hardness,



alkalinity) at least weekly. Documenting the results over time allows staff to discern trends. When troublearises staff can use this data to help solve the problem.Many cleaning solution manufacturers will provide a freewater-quality analysis. Sterile Processing staff can also askthe hospital maintenance department for the records theykeep on the quality of water entering the hospital.

Temperature monitoringProper temperature at the various stages of cleaning isvital to the successful function of an automatic washer.Water temperatures must not exceed certain levels atcertain cleaning stages. Temperatures at the various stagesshould be monitored and documented at least weekly. A simple irreversible thermometer can be used to verifyand document the highest temperature reached during a cycle or stage of a process. Alternatively, a temperaturedata logger can be used to record and store the full temperature profile of an automatic washer cleaning cycle.The data can then be downloaded and stored for futurereference. Either way, recording and documenting the data is key to ensuring the washer runs at the correcttemperature for each cycle or stage of the process.

Instrument and target soil testingAs stated previously, blood is the primary target soil forthe medical automatic washer. Logically, therefore, a soiltest should contain a sample of this target soil. Two typesof test kits containing blood or a blood substitute are avail-able today—a paint-on type such as an Edinburgh soil13,and the TOSI™14, a prepared test object.The Edinburgh soil is made up in the department by s t a ff. The paint-on soil is spread over the instrumentsbeing tested. The soil must be applied consistently eachtime the test is performed. The soil is allowed to dry(follow manufacturer’s instructions regarding length of

drying time), and the instruments are loaded into themedical automatic washer using a normal loading pattern.A visual inspection of the instruments is required after thewashing process is complete. Results are recorded andinterpreted according to the soil manufacturer’s guide-l i n e s .The TOSI (Test Object Surgical Instruments) (see Figure17 below) has three components: the blood soil, a stainlesssteel plate and a clear plastic holder. The soil is comprisedof blood components that have been mixed and applied ina precise manufacturing process. The stainless steel plateis “scratched” or grooved, replicating the uneven surface of surgical instruments. The plate is mounted in the plasticholder at an angle, providing a gradually more difficultcleaning test from one end to the other. This mimics a boxlock of a surgical instrument (see Figure 6). The TOSI ismade in a quality-controlled environment (InternationalStandards Organization [ISO] certified facility), ensuringconsistency among individual tests. During the test, one TOSI is placed inside an empty tray/basket for one complete cycle. In some washers, oneTOSI test goes on each level. Users should follow manu-f a c t u r e r’s instructions and refer to the troubleshootingguide in case of unsatisfactory results. Results of the testare recorded, and problems are addressed. The result of aTOSI test help staff to diagnose problems and address theroot cause(s).The American Society of Testing and Manufacturingrecently established a new standard D7225—Guide forBlood Cleaning Efficiency of Detergents and Wa s h e rDisinfectors. The design of the TOSI complies withD7225, providing the user with the means to implementthis method. Following D7225, the user performs a quali-tative evaluation of the cleaning efficiency of theirmedical automatic washer. Hospitals and equipmentmanufacturers can use available test methods to help


Figure 17. Blood soil tests—TOSI™ and LumCheck.™


ensure that medical automatic washers are performingp r o p e r l y, thereby reducing healthcare - a c q u i red infectionsthat result from using dirty instruments.

Testing for hollow/lumen instrumentsMany of today’s advanced medical automatic washershave the ability to irrigate hollow instruments, allowingthe Sterile Processing department to better clean lumenitems. Refer to the article “Manual versus automatedmethods for cleaning reusable accessory devices used forminimally invasive surgical procedures.”1 5 A new test, the LumCheck™15 (see Figure 17) can be used to evaluatethe cleaning performance of washers that irrigate lumenitems. The test consists of a capsule with lumens on either end, into which a TOSI test strip is inserted. Thedimensions of the test capsule are similar to those of longhollow instruments. Users should read the manufacturer’sinstructions for hooking up lumen/hollow instruments tothe equipment, and use the same procedure to hook up the

test device. Run a complete cycle and record the results. Incase of unsatisfactory results, refer to the troubleshootingguide for the LumCheck. Report any concerns to theappropriate management staff for follow-up.

Sonic testingSome medical automatic washers have a sonic cycle. Thiscycle can be monitored using any of three methods: a foil test, a sonic probe test or a SonoCheck™. The sonicprobe test and the foil test are somewhat difficult toperform in a washer’s sonic chamber. The SonoCheck iseasy to use and read. Proper use of the SonoCheck wasdiscussed in the article “Improving the Quality of theSonic Cleaning Process,” which appeared in the July 2006issue of Managing Infection Control.

Picking the right testThe Sterile Processing staff must determine the best testmethod for their particular facility. Some tests are subjec-



tive in nature, and consistency (repeatability) is a concern.Criteria for test selection should include:• Ease of use and interpretation of results;• Consistency of application of the test;• Availability and cost;• Correlation of test soil with the actual target soil(s);• Reliability and reproducibility of the test results;• Ability of test results to indicate the source of

problem(s); • Scientific data supporting use of the test.

TrainingProper staff training is vital to the process. Document all in-services, and have competencies for the variousactivities performed.

Equipment maintenanceAfter any maintenance is done on the washer, all testsshould be conducted to ensure that the equipment is

functioning properly. The type of maintenance done andthe results of all tests should be documented and recorded.The person who performs the maintenance should notleave until the tests have been completed so that anynecessary adjustments can be made immediately.

SummarySimply running a test through the automatic water is not

enough to ensure that the process is working properly. T h eSterile Processing department should implement a qualityimprovement program for the washer that includes: Measuring pH and water hardness; Monitoring the temperature of the water at various stages; Performing a target soil cleaning test; Performing an appropriate lumen test on cannulated/lumen

type cleaning equipment; Daily/weekly visual inspection of equipment (observations

of machine operation/conditions); Constant daily visual inspection of all instruments;


Figure 18. Working with your Automated Washer—Work Flow (Duties)™

continued on page 102



Figure 19. Sample quality improvement program form.

AAMI ST79:2006 states, “Sterile processing personnel areincreasingly aware of the need to control and standardize thesteps taken to ensure the sterility of devices for patient use.Because disinfection and sterilization cannot be assured unlessthe cleaning process is successful, professionals in the fieldought to seek out whatever means are available and practical toverify this function. A quality system would call for monitoringand documenting decontamination processing parameters,whether the process is accomplished by hand or mechanically.”

JCAHO’s (2005) standard E.C.6.20 says, “Medical equipmentis maintained, tested and inspected.”

An ineffective automatic washer compromises sterilization and places both employee and patient at risk. “Improperly cleaneditems can result in patient infections, delayed cases (need to re-set up room) and even death!”14 A hospital that does not have aquality improvement program (see Figure 20) in place for thewasher risks not meeting the fundamental goal of to “do no harm.”Regular testing of the key variables just makes “Common Sense”for Sterile Processing.

Figure 20. Quality improvement program cycle.

References 1. AORN Journal. Recommended Practices for Sterilization in the

Perioperative Practice Settings. March:2006.2. http://www.fda.gov/cdrh/ode/guidance/1252.html.3. Rudin, D. Efficacy Against Infection Prions in Instrument Reprocessing.

Infection Control Technology. March:2006.4. The Association for the Advancement of Medical Instrumentation. Safe

handling and biological decontamination of medical devices in health carefacilities and in nonclinical setting. ANSI/AAMI ST35:2003.


Training of staff on a continuous basis; Degassing procedure if the washer has a sonic

cycle; Proper loading of instruments; Appropriate tray selection; Other key factors/inputs relevant to each hospital’s

process; Recording all test results and observations in a

log/book; Referring to the equipment manufacturer’s trou-

bleshooting guide in case of unsatisfactory results.16

Figure 18 illustrates a sample flow diagram for a quality improvement program in a hospital SterileProcessing department. Figure 19 (page 97) is anexample of a quality improvement program checklistprovided by Healthmark Industries.

The Sterile Processing management team is ultimately responsible for providing clean, properly functioning sterile instruments. Part of that process in the majority of hospitals is making sure the medicalautomatic washer is working properly. Issues concerningthe operation of a medical automatic washer and thecleaning process in general, and results of monitoringshould be reported routinely to the infection controlcommittee and to risk management. Incorporating thesereports as part of a monthly quality management meetingis an effective way to achieve and document this type ofc o m m u n i c a t i o n . Audits of practice (e.g., observations,random conversations with staff at work) will helpensure that all staff are following policy and procedureand can identify situations where changes might need tobe made. A quality improvement program will assurecompliance with regulations and will help to prevent theincidence of unclean, unsterile instruments.

Closing CommentsR e m e m b e r, the first goal and focus of any health-

care facility is to ”do no harm.” Delivering the highestquality of care possible is a key element in achievingthat goal.

Residual of any type (detergent, blood, protein, etc.)on any instrument can cause harm. The author realizesthat there is much research and debate concerning the level of detection necessary. However, failure tomonitor the cleaning process or to implement a qualityimprovement program to provide better patient outcomesis counter to the concept of to “do no harm.”

The following quotes from two of the best sourceson the subject sum up why a hospital/clinic shouldmonitor the medical automatic washer cleaning process:


continued from page 96


5. h t t p : / / w w w. b e e r e m e d i c a l . c o m / P r i n t s / p d f /Guide-Instr.520care.pdf.

6. Australian Infection Control. Relative efficacyand activity of medical instrument cleaningagents. Volume 7, issue 3, 9:2002.

7.h t t p : / / w w w.cleaning101.com/cleaning/chemistry

8. Criti-Klenz®:1479-08:label instructions.9. MetriWash®:10-3300:label claim.

10. Endozyme. AW-triple Plus with a A.P.A.(R);345A.P.A., label claim.

11. AV E N ATECDH, INC washer/Decontaminators-In-Service Training Guide-Operation of theBelimed. SM-100:1998.

12. Basile, Browne, Kovach. Measuring Clean inCentral Service. Managing Infection Control.8:2004.

13. h t t p : / / w w w. m e d i s a f e u k . c o . u k / s g j l i b / d e f a u l t .a s p ? s r c = i t e m & i d = { 0 f 7 1 E 4 B E - 4 B E 7 - 4 A 3 0 -A B 6 C - 3 0 1 A 2 8 D 1 A C E E } & t i t l e = Wa s h e r % 2 FDsinfection+Test+Soil.

14. h t t p : / / w w w. h e a l t h m a r k . i n f o / p r o f o r m a n c e . h t m l .15. Alfa, Nemes. Y J H I W 1720-1/6/2004-09: 05-

DMESSENGER-106432-MOEDLG-pp.1-6.16. Basile, Kovach. The Cleaning Process.

Managing Infection Control. 7:2003.17. Chobin, Nancy. Role of Central Service in

Infection Control. Nebraskaland CentralService Meeting. 10/19/2005.

18. ZenSentrile Forum 2004, Martin We i d e r,Dosage and Control Mechanisms in Validation ofAutomated Cleaning and Disinfection Processes.

19. “and then there was Decontam.” Richard W.Schule; Paper submitted for the Ruth A n n eBrooks,RN Past Presidents award IAHCSMM.

Stephen M. Kovach is the director ofeducation for Healthmark Industries in St. Clair Shores, Mich. He has been in the hospital field for more than 30 years.Stephen has been active with his state andnational Central Service org a n i z a t i o n s ,having held many leadership positions. He also belongs to the Michigan LakeshoreChapter #2307 of AORN. He has receivedrecognition in both his personal and business profession.

Stephen is very proud to say he has“WORKED IN CENTRAL SERVICE.”


Nursing CE Application Form3M Health Care provider approved by the California Board of Registered Nurses, CEP

5770 for 1 contact hour. This form is valid up to five years from the date of publication.1. Make a photocopy of this form.2. Print your name, address and daytime phone number and position/title.3. Add your social security number or your nursing license number.4. Date the application and sign. 5. Answer the CE questions. 6. Submit this form and the answer sheet to:

Workhorse PublishingManaging Infection ControlPO Box 25310, Scottsdale, AZ 85255-9998

7. Participants who score at least 70% will receive a certificate of completion within30 days of Managing Infection Control’s receipt of the application.

ApplicationPlease print or type.

Name______________ _ _ _ _ _ _ _ _ _ _ _____ _ _ _ _ _ _ _ __ _ _ _ _ _ _ _______________ ___

Mailing Address__________________________________ _ _ _ _ _ _ _ _ _ _ _ _ _ ____ _ __

City, State, Country, Zip __________________________ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _____

Daytime phone ( )_____________________ _ _ _ _ _ _ _ _ _ _ _ _ _ ____ _ _ __

P o s i t i o n / Ti t l e _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ ________ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ ____ _ __

Social Security or Nursing License Number _________ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _____

Date application submitted ___________________________ _ _ _ _ _ _ _ _ _ _ ________

Signature _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ ___________________ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ ____ _ _ _

Offer expires February 2012

On a scale of 1-5, 5 being Excellent and 1 being Poor, please rate this programfor the following:

1) Overall content ___________________

2) Met written objectives ______________

3) Usability of content ________________

Sterile Process and Distribution CEU InformationCEU Applicant Name _________________________________________________

Address_________________ _ _ _ _ _ _____ _ _ _ _ _ _ _ _ _ _ ______ _ _ _ _ __ _ _ ________

City____________________________ State________ Zip Code _______ _ _ _ _ ___

The CBSPD (Certification Board for Sterile Processing and Distribution) haspre-approved this inservice for 1.5 contact hours for a period of five years from thedate of publication and to be used once in a re-certification period. Successfulcompletion of the lesson and post test must be documented by facility managementand those records maintained by the individuals until re-certification is required. DONOT SEND LESSON OR TEST TO CBSPD.

For additional information regarding Certification contact: CBSPD, 2 IndustrialPark Road, Suite 3, Alpha, NJ 08865 or call 908.454.9555 or visit Web site atwww.sterileprocessing.org.

IAHCSMM has awarded 1.5 contact points for completion of this continuing e d u c a t i o n lesson toward IAHCSMM recertification.

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6. T7. F8. F9. T10. T

ANSWERS

70-2009-7526-9 Copyright©2007/Workhorse Publishing L.L.C./All Rights Reseved.Reprint with permission from Workhorse Publishing L.L.C.

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