It Can't Be Sterile If It's Not Clean"

November 1, 2002

It Can't Be Sterile If It's Not Clean"

It Can't Be Sterile If It's Not Clean"

By Ralph J. Basile and Stephen M. Kovach

Sterile is not sterile if clean is not clean." This is axiomatic in thesterile processing (SP) profession. Yet an honest appraisal of common industrypractice would conclude that the cleaning process lacks the rigorous testing,validation, verification and documentation employed in the sterilizationprocess.

What is the cleaning equivalent to the chemical indicator, the biologicalindicator, the Bowie-Dick Test, etc.? Things are changing, however. In 1999, atthe World Symposium for Central Service in Orlando, Fla., the ProFormance (TOSI)was introduced -- the first-ever standardized soil test for judging theeffectiveness of the automated instrument washer process. Since that time, anumber of organizations responsible for setting industry standards have movedcloser to establishing new guidelines for testing, validating, verifying anddocumenting the cleaning process.

The Food and Drug Administration (FDA) has nearly completed its new Class IISpecial Controls Guidance Document for Automated Washers (www.fda.gov/cdrh/ode/guidance/1252.html),reclassifying all automated washers as Class II medical devices and mandating510(k) submission for all washers claiming high-level disinfection capability.Similarly, the Centers for Disease Control and Prevention (CDC) is working ondraft guidelines on disinfection and sterilization in healthcare facilities (www.cdc.gov/ncidod/hip/dsguide.htm).These guidelines address issues related to the proper cleaning of surgicalinstruments. Other organizations have followed suit. The Association for theAdvancement of Medical Instrumentation (AAMI) (www.aami.org/)is in the process of promulgating its own updated guidelines for the cleaning ofsurgical instruments. These guidelines are likely to advocate the verificationof the cleaning process. The European Committee for Standardization (http://www.cenorm.be/)is working on a draft guideline for washer-disinfectors. This will be theEuropean equivalent to the FDA guidelines.

Of course, these new initiatives have an underpinning; the Health TechnicalMemoranda 2030 (HTM 2030) is the United Kingdom's 1999 published standard forthe cleaning and disinfecting of surgical instruments with washer-disinfectors.The control protocols described in HTM 2030 describe the means for ensuring thata washer-disinfector is fit for its intended purpose and is subject to a plannedprogram of tests ensuring that standards of performance and safety are met.

The Australian Standard AS 4187-1998 addresses the use of blood soil tests asa way to monitor the cleaning process. Australia looks at monitoring,calibration and performance testing of the cleaning process as part of the wholesterilization process, and all the associated equipment as part of the processthat needs to be monitored.

So the landscape of regulatory standards is changing and this change isworldwide. What does this mean for healthcare institutions and professionalsresponsible for getting instruments clean? What should be tested to ensure thatthe cleaning process is effective?

Cleaning is a process that produces an end result, one with an objectivemeasure of success. Several things affect the cleaning process -- water,chemical agent(s) (e.g., enzyme, detergent), mechanical operation and humanperformance, to name a few. Water hardness is the most important chemicalproperty with a direct effect on cleaning. Detergent effectiveness isparticularly influenced by water hardness. Additionally, water hardness cancontribute to the staining or the pitting of instruments, shortening instrumentlife. Alkalinity influences the stability of water -- a sufficient level ofalkalinity means that the pH level of water will not change dramatically in ashort period of time. Water temperature is also key to performance. In general,the warmer the water, the more effective the cleaning action. However, at eachstage of cleaning, it is important that water not exceed a certain temperature.In the initial rinse, the water should not exceed 45 degrees Celsius, and it issuggested that temperatures remain significantly below this level. At 45 degreesC, blood denatures; it cooks on to instruments and becomes highly insolvent,making removal very difficult. In the enzyme soak, each enzyme cleaner has anoptimal temperature range for best performance. Outside of this range, enzymesbecome less effective and ultimately inactive. Water temperature is also theprimary source of thermal disinfection in the washer-disinfector. High-leveldisinfection is considered to have occurred when a surface reaches a temperatureof 90 degrees C for at least 1 minute.

The water used for cleaning needs to be relatively pure. The level of purityvaries with the stage of cleaning. In all stages, the water needs to be potable.In the rinse stage, standards in Europe are very specific for storing anddisinfecting the water used. Enzymes and detergents are used to speed thebreakdown of bioburden found on instruments.

In addition to water quality, it is important that the right cleaners areused for the targeted soil to be removed. Using the right amount of cleaner isinstrumental to the process as well. Insufficient amounts will not cleaneffectively -- and excessive amounts may shorten the life of instruments andleave harmful residue. Proper mechanical operation requires preventivemaintenance and accurate monitoring of machine-generated parameter reports. Inaddition, periodic machine independent monitoring of parameters is recommended

The human element is critical and yet is likely to be the most difficult tomonitor and document. Staff must be well trained and there must be a systemictest that validates the final outcome.

Cleaning is a result ... a measurable result (more than just visibly clean).The secret is to have a standardized test, which challenges the overall cleaningprocess, and provides a result that can be easily interpreted, which iscorrelated to a recognized industry standard

How the SP profession views the cleaning process is undergoing major change.While it may be six months to a year before the full impact of thesemodifications are obvious, the transformation is under way. The change will takeus from an individual, adhoc practice of monitoring cleaning, to anindustry-wide, standardized practice of monitoring cleaning. In our view, nearlyevery institution will see the wisdom of employing tools for judging theeffectiveness of the cleaning process very soon. The technology has arrived andit is time to use it.

Ralph J. Basile is vice president and director of marketing for HealthmarkIndustries in St. Clair Shores, Mich. Stephen M. Kovach is presently aninstructor at Macomb Community College in the Allied Health Department, focusingon central service.