cleaning of medical instruments before reuse is critical in order to reduce the
incidence of surgical site infections (SSI’s) and healthcare-associated
infections (HAI’s). Four critical factors (enzymatic detergent concentration/activity, wash cycle time, wash cycle
temperature, and mechanical action) influence effectiveness of all cleaning
processes and are essential for proper cleaning of medical instruments. A deficiency with any of these key factors may
cause inadequate cleaning of medical instruments. Verification tests for washer disinfector validation
and ultrasonic cleaners must respond to all 4 of these critical factors to
adequately verify the entire cleaning process.
Why is testing important?
device cleaning validation is an integral component of quality assurance
programs for hospitals and surgery centers. Regular testing verifies that the
equipment is functioning properly, identifies any potential deficiencies, and
decreases the risk of surgical site infections.
for the Advancement of Medical Instrumentation (AAMI ST79:2017) currently
recommends testing mechanical cleaning equipment daily
and after any
major repairs. AAMI also states that “Effective
cleaning is a multistep process that relies on several interdependent factors:
the quality of the water; the quality, concentration, and type of detergent or
enzymatic cleaner; the washing method… the time and temperature parameters and
load capacity of the equipment; and operator and equipment performance.1
” These guidelines are supported by AORN and
Why use the PINNACLE AEC Test for Washer Disinfectors and ultrasonic Cleaners?:
The PINNACLE™ Monitor for Automated Enzymatic Cleaning Process (AEC) monitors the cleaning efficacy of automated instrument cleaning units when using enzymatic detergents. This test was specifically
designed to respond to the overall enzymatic activity which is influenced by
all critical factors of cleaning. The PINNACLE AEC test can be used to confirm
proper enzymatic cleaning processes for both washer disinfectors and
ultrasonic cleaners and provides the following benefits:
- Used for both washer-disinfector validation AND as an ultrasonic cleaner test
- Responds to all 4 cleaning parameters
(enzymatic detergent concentration and activity, wash cycle time, temperature
and mechanical action
- Easy to interpret pass/fail results
- Can be saved as a record of your medical device cleaning validation program.
- Cost-effective to
support current DAILY testing guidelines
See recent publication by Dr. Michele Alfa comparing results of washer disinfector validation products tested under a variety of conditions.
Why use The PINNACLE MEC Test for manual cleaning solutions?:
The Serim PINNACLE™ Manual Enzymatic Cleaning Process (MEC) is the only test available for cleaning
verification of manual cleaning solutions using enzymatic detergents. This test
ensures that manual bath solutions are properly mixed and contain active enzymes.
The MEC test:
- Is the only test available for this purpose
- Offers quick results (90 seconds)
- Ensures proper dilution and temperature of manual cleaning solutions using
- Provides a visual indication that the enzymatic detergent needs changed
- May be used as a diagnostic tool for expired or degraded enzymatic detergent
Water Quality Matters
quality is also an important consideration for medical device reprocessing. Poor quality water can affect the sterility and functionality of surgical instruments as well as the performance and efficiency of mechanical washer-disinfectors. AAMI’s Technical Information Report, TIR34:2007 Water for the Reprocessing of Medical Devices states that, “Where applicable, monitoring procedures should be established to ensure the treated water is of adequate quality for medical device reprocessing.2” The report recommends that healthcare facilities monitor their water’s pH, hardness, and other factors.
For over two decades Serim has been developing and manufacturing test strips that accurately measure water quality and disinfectants levels. Our strips are used in thousands of medical facilities worldwide.
Our line of Water Quality products includes tests for:
- Low-range water hardness
- High-range water hardness
- pH (from 0-14)
for the Advancement of Medical Instrumentation. Comprehensive guide to steam sterilization and sterility
assurance in health care facilities. ANSI/AAMI ST79:2017
for the Advancement of Medical Instrumentation.
Water for the reprocessing of
medical devices. ANSI/AAMI Technical Information Report TIR34:2014
To place an order or to get more information: