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