How do You Know Your Automatic Washer is Safe to Use?

How do You Know Your Automatic Washer is Safe to Use?

By Stephen M. Kovach

Imagine this scenario: A surveyor forthe Joint Commission on the Accreditation of Healthcare Organizations (JCAHO)asks a central service (CS) manager, How do you know your automatic washer isworking properly? The CS manager replies, My instruments look clean.

It is no longer uncommon for such a question to be posed to CSstaff. Central service has become one of the hospitals most highly technicalareas. Professional organizations that set guidelines and standards for centralservice, such as JCAHO, the Food and Drug Administration (FDA), the Centers forDisease Control and Prevention (CDC), and the Association for the Advancement ofMedical Instrumentation (AAMI), have begun to focus on verifying and monitoringthe cleaning process, and on implementing quality improvement programs (QIPs.)Their guidelines pertain to ultrasonic cleaners and automatic washers.

The following paragraphs outline the various regulatoryorganizations guidelines concerning monitoring the cleaning process. CSprofessionals can use these guidelines to answer questions such as:

• How do I know my automatic washer and ultrasonic cleanerare working properly?

• What am I doing to ensure that these machines are workingthe way they are intended to?

• How do I ensure that these machines are rending itemsclean and safe for handling by staff and ready for use on a patient?

JCAHO

Darlene Christiansen, director of standards interpretationsand the Office of Quality Monitoring for JCAHO, states, Sterile processing isan integral part of the care process, so its important to assess thatequipment is being properly maintained, chemicals are being used properly,infection control and (safety) measures are being applied appropriately, andthat there is proper ventilation, for example.¹

Two new JCAHO standards support Christiansens assessment.Standards EC.6.10 and EC6.20 require organizations to manage the risks ofmedical equipment and that equipment be maintained, tested, and inspected on aprescribed basis. These standards require the organization to have a written plan in place.²

AAMI

AAMI is the primary resource for domestic and internationalstandards for the medical industry, medical professions, and the government. AAMIs revised TIR 12:2004, 2nd Edition Designing,testing, and labeling reusable medical devices for reprocessing in healthcarefacilities: A guide for device manufacturers is an excellent resource foridentifying the questions healthcare professionals should ask manufacturers whenconsidering a product for purchase or when devising a reprocessing protocol fora product already being used.

This new document is the most proscriptive thus far when itcomes to the monitoring of the cleaning process. It directs device manufacturersto provide not only specific instructions on how to clean their surgicalinstruments, but also how to verify that proper cleaning has occurred.Suggestions include monitoring water temperature for proper cleaning anddisinfection, employing a specific method to test the cleanliness of aninstrument, or using a suitable analogous device to verify the effectiveness ofthe cleaning process.

CS professionals should know that not only does the TIR 12document direct manufacturers, but also by inference, it empowers the hospitalCS department to insist on receiving proper and complete decontaminationdocumentation for each and every instrument.

The revised AAMI standard ST 35, 2003 (decontaminationdocument) recognizes the need for testing and the importance of having a qualityprocess in place when it comes to cleaning:

• 7.4.1: Effective cleaning is a multi-step process thatrelies on several interdependent factors: the quality of the water; the qualityand type of detergent; an acceptable washing method; proper rinsing and drying;correct preparation of items to be processed by cleaning equipment; the time andtemperature parameters and load capacity of the equipment; and operator performance

• 7.4.2 Cleaning agents: Many typesof soil could be present on reusable medical devices, but dried blood isespecially difficult to clean. As a liquid, blood tends to flow over and into joints, hinges,grooves, and other difficult-to-clean locations. It then coagulates and dries tocreate a significant challenge to cleaning

• 7.4.4 Verification of thecleaning process: There is an increasing awareness in sterile processing of theneed to control and standardize the steps taken to ensure a sterile device forpatient use. With the understanding that disinfection and sterilization cannotbe ensured unless the cleaning process is successful, it is incumbent uponprofessionals in the field to seek out whatever means are available andpractical to verify this function. A quality system would call for thedecontamination processing parameters to be monitored and documented, whetherthe process was accomplished by hand or mechanically

• 9.2 Quality process:Measurements of process performance allow the system to be monitored and theresults compared to a predetermined level of quality. Evaluation of the findingsprovides a method of identifying problems or shifts in activities, andfacilitates informed decision-making on policies and procedures. Ongoing auditing provides data to assess the effectiveness ofthe process and make ongoing improvements in performance.

FDA

The FDA document, Class II Special Controls GuidanceDocument: Medical Washers and Medical Washer-Disinfectors; Guidance for the Medical Device Industry and FDA Review Staffstates, The FDA believes that a safe and effective system for cleaning anddisinfecting medical devices is important in protecting the public health.(Feb. 7, 2002)

The Safe Medical Device Act of 1990 states that each institutionmust have processes in place for identifying and implementing the reporting ofincidents related to equipment failure.³ Equipment that fails or is taken out ofservice must be reported and documented. Failure of an automatic washer certainly warrantsdocumentation and follow-up.

CDC

Currently, the CDC is reviewing its Guideline forDisinfection and Sterilization in Healthcare Facilities. The final guidelinewill be published following revisions. The CDCs current recommendations canbe found at its Handwashing and Hospital Environmental Control page: Cleaningis the necessary first step of any sterilization or disinfection process... Ifthe surface is not cleaned before the terminal reprocessing procedures arestarted, the success of the sterilization or disinfection process is compromised.⁴

Industry

Companies serving the infection control market are beginningto supply users with information on how to test their automatic cleaningequipment. For example, in May 2005, Smith & Nephew updated its Cleaning andSterilization Guide for Orthopedic Instruments on its Web page. The new userguide includes the following recommendations:

• The quality of water should be carefully considered foruse in cleaning reusable devices. Water hardness is a concern because deposits left on medicaldevices may result in ineffective decontamination. The use of deionized waterwill reduce the mineral deposits on the devices.

• Ultrasonic cleaners should be monitored routinely toensure that they are working properly. Recommended monitoring methods are Sonocheck monitoring vialsfrom Healthmark Industries Co. which change color when the ultrasonic cleaner issupplying sufficient energy and conditions are correct. Getinge also hasdeveloped a performance-monitoring program that allows users to independentlyverify the key parameters of the automatic cleaning equation under theircontrol.

• On the subject of verifying the cleaning process, LindaClement and Heide Ames of STERIS Corporation state, Now you must investigatethe entire sterilization process, beginning with cleaning: a) verify that thewashing equipment is working properly (spray arms arent obstructed and waterheating element isnt malfunctioning, for example); b) verify that the washingequipment monitoring devices are functioning correctly; c) ensure that allcleaning chemistries used in the washer are appropriate for the equipment andthe devices being processed, and that they are being dispensed correctly.⁵

Why Test in the First Place?

Regulatory agencies and industry are promoting theimplementation of QIPs to monitor the cleaning process. Even with the advent ofsuch guidelines, some people question the need to monitor. The followingreallife examples illustrate why hospitals should implement QIPs for theirautomatic washers and sonic equipment.

• Switched at Birth: A CS manager implemented a cleaning QIPwhich included the use of a standardized blood soil test. The failed testresult, which included residual blood soil on the stainless steel coupon,indicated that water temperatures were not correct for the various cycles. Uponinvestigation staff discovered that the washer had been installed 10 years priorwith the cold and hot water delivery pipes reversed. This resulted in excessivepre-wash temperatures for the equipment cycle setting.  After the problem was corrected the washer was again testedand received a passing mark.

• How to Save Detergent: Shortly after switching brands ofdetergents for their automated washers, staff at one hospital reported a bloododor in the machine after the cycle was complete. The staff followed the recommended QIP, including use of astandardized blood soil test. They determined that the new detergent had produced excessivesudsing and that the detergent concentration had been set to nearly zero. Although this certainly would have saved the hospital a greatdeal on its detergent budget, the instruments were not getting clean.

• Im Melting: After implementing a new QIP program forthe automated washer, a CS department quickly discovered that a plastic supplyline for the detergent had, for a period of time, been in contact with anoninsulated portion of the hot water line. The tube had melted closed, completely eliminating detergentsupply to one of the washers. No one knew how long this condition had been in place.

• An Expensive Soaking Tank: A hospitals sonic cleanerlooked and sounded like it was functioning properly, but when staff used a newtest designed to detect cavitation energy, the sonic cleaner failed. A follow-upvisit by an independent service company confirmed that the transducers were notworking. No one in CS knew how long the cleaner had been malfunctioning; they had simply let the machine run longer (sometimes up to 15minutes) until they felt the instruments were clean.

• True Confessions from the Author: In my own experience asCS manager I have seen the need for monitoring the cleaning process. In one caseI was using a different detergent than what my washer company required. Aftervisual inspection we determined that the instruments were not clean. The washercompany blamed the failure on our use of the wrong detergent, but the detergentcompany defended its product. All I had was a visual assessment; I had noindependent test that could determine why my instruments were not as clean asthey had been before. Eventually we discovered it was a dilution problem, butonly after a lengthy, frustrating investigation that could have been avoided hadwe had a proper test.

I had a similar experience loading trays in my automaticwasher. The hospital where I was working had a problem processing trays; the CS department was very busy and the decontamination areakept backing up. A representative of the equipment company told me todouble-stack the baskets because the machine could handle it. He also told me Icould put the trays in without rinsing them, which would speed up the process.After running about five loads this way my staff informed me that theinstruments were not clean. We immediately stopped this process. Had I taken the time to learn more about how my equipmentworked and the impact of all the factors of the cleaning process, I could havesolved my problem more easily and with less frustration. At that time I not onlylacked education and training, I had no real method for monitoring my cleaningprocess.

These examples illustrate the frustration CS mangersexperience when cleaning instruments. This is not a new problem, nor has it gone unrecognized by thepublic. The following news headlines appearing over the past few years attest topublic concern about monitoring the cleaning process:

• The process of sterilization should not replace theprocess of cleaning. Soil is still soil, even though it may have been sterilized.⁶

• The quality of reusable equipment depends on thereliability of cleaning and sterilizing procedures.⁷

• Inadequate cleaning of medical or dental instrumentscan threaten the sterilization process.⁸

• Surgery halted over dirty instruments, in England.⁹

• North Carolina surgeons unwittingly used dirty tools.¹⁰

• In order to sterilize medical devices effectively, allorganic debris (e.g. blood, tissue, and other bodily fluids) have to be removedfrom the item prior to disinfection and/or sterilization. ¹¹

Concern is growing about the effectiveness of decontaminationtechniques for reusable instruments in healthcare facilities. These techniques have a direct impact on patient outcomes.Studies have shown the ability of sterilization technologies, which under normalconditions achieve acceptable sterility assurance levels, to be greatly impairedby the presence of residual soil containing serum and salt.¹² Residual organicdebris on processed surgical instruments is a concern, and visual inspection isnot 100 percent accurate.¹³

The best way a medical facility can determine whether itsequipment is working properly is to implement a quality improvement program. TheQIP should be used daily and after equipment is installed or relocated. Itshould also be used after a machine malfunctions, a process fails, or any majorrepair is made on the equipment. The QIP should include, but not belimited to, daily inspection of equipment (cleaning screens, spray arms,interior of the chamber, etc.), testing via a blood soil type test, andcontinuous staff training.

The Future

CS professionals need and are receiving support fromregulatory agency guidelines to implement quality improvement programs tomonitoring the cleaning process. Yet still we must answer to the public who readthe headlines and ask, How do you know your instruments are clean?Likewise, we may have to answer to a JCAHO surveyor who, as in the opening ofthis article, asks, How do you know your automatic washer is workingproperly?

It is my experience that if you ask 10 CS managers whatsterilization parameters they use, all 10 will respond, 273 degreesFahrenheit for four minutes. When you ask about the parameters used forcleaning, however, you are lucky if 50 percent know the answer for theirequipment. This lack of knowledge makes it very difficult to optimize thecleaning process.

Many CS professionals are already taking steps to monitor thecleaning process. These individuals responded as follows when asked the originalquestion, How do your know your washer is working properly?

• Penny Sabrosky, a senior manager at Spectrum Health: Wecurrently use the product TOSI to test the efficacy of our washer units on aweekly basis and when we discover problems with unusual soil, or rinsingproblems. We recently signed up for a preventative maintenance program from themanufacturer of the equipment and receive quarterly maintenance and service uponrequest for breakdowns. Typically we would run a TOSI test after the service isperformed for verification of the maintenance.

• Betty Strickland, director of materials management at Christus St. Joseph Hospital: I use the TOSI daily.

• Nyla Japp of Banner Health: I know my automatic washeris safe to use because I validate my cleaning process in every washer once aweek and following any needed repairs. I do this by a process called TOSIcleaning effectiveness indicators. I log the results as to whether or not theypass or fail this challenge. If they do not pass this challenge, the washermanufacturer is called in for repairs and the washer is taken out of serviceuntil it successfully passes the TOSI challenge.

• Denise Coatsworth, CS manager at Botsford GeneralHospital: (This question) can open up a can of worms. I dont believe avisual inspection of instruments defines cleanliness because cleanliness can besubjective. As a manager, I would look to CS organizations to establishstandard protocols for what conditions and testing determine a cleaninstrument. An instrument may appear clean once it comes out of the washer, butis there any way that the appearance and condition of that instrument can beimproved? We also want to ensure that the instrument is safe for handling. As weknow, an instrument cannot be determined sterile unless it is clean. Standardprotocols have been established and written for our institution and a routinequality test must be run weekly to maintain and document the quality of the washcycle. The TOSI test is an easy and reliable test for the wash cycle, but oncethat test is run and obtains less than optimum results, as the manager I mustthen be willing to take action to get the washer to the optimum level. In goodconscience, I could not run the test, obtain less than optimum results, and thentake no action.

The following quotations summarize why CS departments shouldmonitor their cleaning process.

• A problem analysis should be completed for any problemwith any aspect of decontamination that can pose a risk to personnel orpatients. The problem analysis should define and resolve the problem and thesystem should be monitored to ensure that the problem has been corrected.¹⁴

• Cleaning, not sterilization (or disinfection) is thefirst and most important step in any instrument processing protocol. Withoutfirst subjecting the instrument to a thorough, validated, and standardized (andideally automated) cleaning process, the likelihood that any disinfection orsterilization process will be effective is significantly reduced.¹⁵

Ensuring safety and quality is an active practice, not apassive one. Isnt it time for everyone to understand and monitor the cleaningprocess? When monitoring whether manual or automatic occurs, the winnersare both patients and staff.

Stephen M. Kovach,director of education for Healthmark Industries in St.Clair Shores, Mich., hasworked in the hospital field for more than 30 years. He has held many positions,including dialysis technician, cardiac catheterization technician, andperfusionist. For the last 18 years he has held various positions dealingwith central service. He also has been an instructor at the community collegelevel and published many articles varying in subject matter from perfusion tothe importance of cleaning surgical instruments.

References

1. Hospital Purchasing News. June 2004, page 32.
2. Joint Commission on the Accreditation of Healthcare Organizations. 2004 Standards for Accreditation, Environment of Care Standards EC.6.10,EC6.20. JCAHO, Oakbrook Terrace, Ill.
3. Food and Drug Administration. Center for Device and Radiological Health. Safe Medical Device Act of 1990.
4. http://www.cdc.gov/ncidod/hip/enviro/Enviro_guide_03.pdf, page 72.
5. Healthcare Purchasing News. September 2005. Page 41.
6. The Central Service Technicians Training and Supervision. IAHCSMM 1975.
7. Leon Hirsch, chairman, ES Surgical. Wall Street Journal, April 1993.
8. Janet Prust, technical services supervisor, 3M Health Care.
9. London Daily Telegraph. November 18, 2000.
10. http://www.usatoday.com/news/health/2005-06-13-surgery-nc_x.htm
11. http://www.smtl.co.uk/MDRC/VaginalSpecula/pelican-report.html Report No: 00/1192/1, Revision: 1.20, November 2000.
12. Alfa, M., et al. Comparison of ion plasma, vaporized hydrogen peroxide, and 100 percent ethylene oxide sterilization to the 12/88 ethylene oxide gas sterilizer. Infection Control and Hospital Epidemiology, 1996; 17:92-100.
13. AORN Journal. July 1995. Vol. 62, No. 1.
14. Section 9.2 ANSI/AAMIST35 - 2003. Page 23.
15. 510(k) Summary and Overview: Safety, Efficacy and Microbiological Considerations. The System 83 Plus Washer-Disinfector; Custom Ultrasonics, Inc. 1998, page 7.