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

November 1, 2002

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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 the
sterile processing (SP) profession. Yet an honest appraisal of common industry
practice would conclude that the cleaning process lacks the rigorous testing,
validation, verification and documentation employed in the sterilization

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

The Food and Drug Administration (FDA) has nearly completed its new Class II
Special Controls Guidance Document for Automated Washers (,
reclassifying all automated washers as Class II medical devices and mandating
510(k) submission for all washers claiming high-level disinfection capability.
Similarly, the Centers for Disease Control and Prevention (CDC) is working on
draft guidelines on disinfection and sterilization in healthcare facilities (
These guidelines address issues related to the proper cleaning of surgical
instruments. Other organizations have followed suit. The Association for the
Advancement of Medical Instrumentation (AAMI) (
is in the process of promulgating its own updated guidelines for the cleaning of
surgical instruments. These guidelines are likely to advocate the verification
of the cleaning process. The European Committee for Standardization (
is working on a draft guideline for washer-disinfectors. This will be the
European equivalent to the FDA guidelines.

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

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

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

Cleaning is a process that produces an end result, one with an objective
measure of success. Several things affect the cleaning process -- water,
chemical agent(s) (e.g., enzyme, detergent), mechanical operation and human
performance, to name a few. Water hardness is the most important chemical
property with a direct effect on cleaning. Detergent effectiveness is
particularly influenced by water hardness. Additionally, water hardness can
contribute to the staining or the pitting of instruments, shortening instrument
life. Alkalinity influences the stability of water -- a sufficient level of
alkalinity means that the pH level of water will not change dramatically in a
short period of time. Water temperature is also key to performance. In general,
the warmer the water, the more effective the cleaning action. However, at each
stage 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 is
suggested that temperatures remain significantly below this level. At 45 degrees
C, blood denatures; it cooks on to instruments and becomes highly insolvent,
making removal very difficult. In the enzyme soak, each enzyme cleaner has an
optimal temperature range for best performance. Outside of this range, enzymes
become less effective and ultimately inactive. Water temperature is also the
primary source of thermal disinfection in the washer-disinfector. High-level
disinfection is considered to have occurred when a surface reaches a temperature
of 90 degrees C for at least 1 minute.

The water used for cleaning needs to be relatively pure. The level of purity
varies 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 and
disinfecting the water used. Enzymes and detergents are used to speed the
breakdown of bioburden found on instruments.

In addition to water quality, it is important that the right cleaners are
used for the targeted soil to be removed. Using the right amount of cleaner is
instrumental to the process as well. Insufficient amounts will not clean
effectively -- and excessive amounts may shorten the life of instruments and
leave harmful residue. Proper mechanical operation requires preventive
maintenance and accurate monitoring of machine-generated parameter reports. In
addition, periodic machine independent monitoring of parameters is recommended

The human element is critical and yet is likely to be the most difficult to
monitor and document. Staff must be well trained and there must be a systemic
test 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 cleaning
process, and provides a result that can be easily interpreted, which is
correlated 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 these
modifications are obvious, the transformation is under way. The change will take
us from an individual, adhoc practice of monitoring cleaning, to an
industry-wide, standardized practice of monitoring cleaning. In our view, nearly
every institution will see the wisdom of employing tools for judging the
effectiveness of the cleaning process very soon. The technology has arrived and
it is time to use it.

Ralph J. Basile is vice president and director of marketing for Healthmark
Industries in St. Clair Shores, Mich. Stephen M. Kovach is presently an
instructor at Macomb Community College in the Allied Health Department, focusing
on central service.