sELf-sTudy sERiE
January 2013
The self-study lesson on this central service topic was
developed by STERIS. The lessons are administered by
KSR Publishing, Inc.
earn ceUs
The series can assist readers in maintaining their CS
certification. After careful study of the lesson, complete the examination at the end of this section. Mail
the complete examination and scoring fee to Healthcare Purchasing News for grading. We will notify you
if you have a passing score of 70 percent or higher,
and you will receive a certificate of completion within
30 days. Previous lessons are available on the Internet
at www.hpnonline.com.
certification
The CBSPD (Certification Board for Sterile Processing
and Distribution) has pre-approved this in-service for
one (1) contact hour for a period of five (5) years from
the date of original publication. Successful completion
of the lesson and post test must be documented by
facility management and those records maintained
by the individual until re-certification is required. DO
NOT SEND LESSON OR TEST TO CBSPD.
For additional information regarding certification contact CBSPD - 148 Main Street, Suite C-1, Lebanon, NJ
08833 • www.sterileprocessing.org. For more information direct any questions to Healthcare Purchasing
News (941) 927-9345, ext 202.
Learning Objectives
1. Explain why water treatment is
necessary in a sterile processing
department
2. Describe how to establish a baseline
of water quality and how to plan
a water treatment system for a
specific department
3. Discuss the importance of water
treatment monitoring
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Water quality systems
in sterile processing
by James Baker and George Godfrey
i
t doesn’t take long to realize that a sterile
processing department (SPD) needs a
lot of water to function. Almost every
step in the process, including presoaking,
decontamination, sonic cleaning, washing, detergent selection, and sterilization,
are dependent upon water. Furthermore,
the quality of that water is important to
the operation of your processing equipment. Water can actually be detrimental
to washing, disinfection and sterilization
equipment, and to the condition and life
of surgical instruments, if it does not meet
manufacturers’ specifications. For this
reason, SPD managers need to better
understand the water they have in their
departments, and what they need to do to
ensure best processes.
Water is the universal solvent
The only place pure water exists in nature
is when a water drop forms in clouds and
starts to fall as rain. As it falls it picks up
gases and particles in the air. As it continues
to the tap, it picks even more contaminants
from the earth.
There are generally five types of contaminants found in water that may interfere
with its use.
• Particulate – sand, silt, rust, sediment,
grit, colloids
• Organic – chemicals, chlorine, chloramines, solvents and others
• Inorganic – salts or minerals, calcium,
magnesium, chlorides, iron and more
• Microbiological – Bacteria, pyrogens,
endotoxins, viruses, spores
• Gases – carbon dioxide, hydrogen sulfide,
methane
Each of these contaminants requires a different water treatment technology or group
of technologies to remove or control it. The
table below provides examples of treatment
technologies and what they do.
How does this relate to your
equipment?
Most of the machines used in sterile processing departments require water to function. Some of the systems that require high
purity water include:
• Automated endoscope reprocessors
(AERs) – potable (tap) water is usually
used for the initial flushing and cleaning
cycles, but the high level disinfection cycle
and final rinse will work more effectively
and not leave scaling and staining on the
endoscope if high purity water that meets
the AAMI water quality standards for
medical device reprocessing is used.
• Stills and steam disinfection boilers – feed
water that is high purity ASTM Type II
will improve the product and prevent
scale and maintenance problems.
• Medical washer/disinfectors – for both
semi-critical and critical devices, the
post-flush rinse should be performed with
high purity water that meets AAMI water quality standards for medical device
reprocessing (see table above right).
Each manufacturer has specific requirements for their washer/disinfectors. You
must check the technical literature provided
by the manufacturer to determine the water
quality needs for that equipment.
Water quality requirements are different
based on the type and level of contaminant
that will interfere with the process for
which the water is being used. Many of
the contaminants are fine to drink, so the
municipal water treatment plant does not
remove them.
A high purity water treatment system is
designed to remove the residual contami-
Technology
function
Technology
function
Sediment filter
Captures particulate
Ultraviolet light
Kills bacteria/viruses
Carbon filter
Adsorbs chlorine/organics
Submicron filter
Removes bacteria
Anti-scalant feed
Contain water hardness
Pyrogen filter
Removes endotoxin
Water softener
Remover water hardness
Storage tank
Pure water storage
Reverse osmosis
Remove inorganics
Distribution pump
Distribution/recirculation
Deionization
Remove inorganics
Source: AmeriWater, Inc. (SUEZ Environnement)
32 January 2013 • HEALTHCARE PuRCHAsing nEWs • www.hpnonline.com
sELf-sTudy sERiEs
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cal properties. Some manufacturers
can also perform an analysis of surgical wraps and instruments. This will
contaminant
Level
determine the cause of deposits or
scales on the instruments (the wraps
Bacteria
≤ 10 CFU/mL
and instruments are typically not
Endotoxin
<10 EU/mL
returned when you submit them for
analysis).
Total Organic Carbon (TOC) <0.05 mg/L (ppm)
There are other reasons to do a waPH
n/a
ter analysis in your department. For
example, you may want to consider
Water hardness
<1 ppm as CaCO3
requesting a water analysis if you
Resistivity
>1,000,000 ohm/cm
are a new manager and a baseline
Conductivity
<1 uS
analysis has not been done. This
is especially important if you are
Ionic contaminants
having issues with instrument spotChloride
<0.2 mg/L (ppm)
ting, staining, and corrosion. Or, if
you are undergoing construction or
Iron
<0.2 mg/L (ppm)
renovation, a water analysis might
Copper
<0.1 mg/L (ppm)
also provide valuable information.
You should also consider performing
Manganese
<0.1 mg/L (ppm)
an analysis if they are doing a major
Source: AAMI TIR34-2007
construction project elsewhere in the
nants from tap water in order to provide hospital that involves the plumbing and
the specified water for each system in your steam lines. Also, when you are making
decisions about detergents and the dosing
sterile processing department.
There are many different specifications of those detergents, a water analysis could
for the processes used in healthcare facili- help you save on the amount of detergent
ties. This means there will be many different and water you use.
components that make up a “high purity
water” system. The actual contaminants Building the optimal water
in your feed (tap) water will be a factor in treatment system
determining the components and the ap- When making a determination of what
type of treatment system to use, the desired
plication specifications.
quality and quantity of output needs to be
considered. The design of the system for
Where do you start?
To learn more about the water in your your department should plan for:
department, you should
start with a baseline
analysis of the water you
currently have. Most
equipment and detergent manufacturers will
conduct a water analysis
of your department if
you request it. This will
assist in helping you
choose the appropriate
cleaning products, troubleshooting problems
with current processes,
and establishing a baseline in an effort to avoid
future problems.
In order to assure a
thorough report, you
need to obtain samples
from make-up water, final rinse, steam condensate return, and boiler
Example of water treatment systems for the SPD
water, so they can be
Photo courtesy AmeriWater, Inc. (SUEZ Environnement)
analyzed for their chemiWater quality for medical device reprocessing
AAMI TIR34:2007
• Routine equipment maintenance
• Routine monitoring of water quality
• Requirements for the system for incoming
water quality
• Maximum and minimum pressure
allowances
• Inlet flow rate
• Drain size
• Electrical needs
In addition, the water treatment system
should be located, if possible, in a secure
area immediately adjacent to where it will
be used, in order to minimize the length and
complexity of the distribution piping. Schematic diagrams identifying components,
valves, sample ports, gauges and meters
should be available, and flow direction
should be indicated on the drawing. This
is especially important in new construction
and renovation, because the architect and
engineers will want to account for the treatment system in their drawing.
In addition to the removal of organic and
inorganic contaminants, the design of the
water treatment system may require microbial considerations. The system components
will usually have storage and distribution
loop functions that need to be addressed in
the design as well.
Monitoring to maintain quality
Bacterial contamination is a persistent
problem with high purity waters systems.
Bacteria grow well in the nutrient-poor
environment of a high purity water system.
They establish and build biofilm structures
that provide a self-sustaining community
that can be very difficult to remove. Maintenance and monitoring of these systems is
critical for long-term quality performance.
Procedures must be established for maintenance and replacement of components
that will ensure that the product water
continues to meet specifications.
Water treatment equipment monitoring
is part of a quality assurance program and
should be performed by water maintenance
personnel daily. In addition, the monitoring
and measuring equipment itself needs to be
inspected and calibrated on a regular schedule. You should keep logs on monitoring,
maintenance, replacement and disinfection
of your high purity water system.
The table on the next page is a general
layout of what should be monitored on
each component, how often and what
parameters should be met. Typically, the
equipment manufacturer works with the
customer to set up a specific log for their
system.
See self-study on page 34
Self-Study Test Answers: 1. A, 2. d, 3. A, 4. e, 5. f, 6. e, 7. B, 8. c, 9. d, 10. d
www.hpnonline.com • HEALTHCARE PuRCHAsing nEWs • January 2013 33
sELf-sTudy sERiEs
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device
What to monitor
frequency
Parameters
Sediment and cartridge filters
Pressure drop across the filter (∆P)
Daily
<10 psig. (∆P)
Water softener
Outlet water hardness
Daily
<1GPG
Anti-scalant feed
Usage and container level
Daily
Liquid level
Carbon adsorption
Outlet chlorine level (free chlorine or total chlorine)
Daily
<0.1 ppm
Reverse osmosis
Product conductivity
Product flow rate
Reject flow rate
Pump pressure
Daily
Daily
Daily
Daily
* uS
* GPM
* GPM
* PSIG
Deionizer
Product Resistivity
Daily
* ohms or megaohms
Submicron and Ultrafilters
Pressure drop across the filter (∆P)
Daily
* (∆P)
Ultraviolet disinfector
Energy output
Monthly
* mJ
Distribution piping or loop
Bacteria (and endotoxin)
Monthly
* CFU/EU
* Levels are set by the application and/or manufacturer’s recommendation.
Source: AmeriWater, Inc. (SUEZ Environnement)
Knowledge assures water and
process quality
Before investing in a water treatment system,
select a vendor who will educate you about
the water you have in your department. With
a thorough understanding of your water
composition and how your water quality can
impact equipment, instruments and processes,
you can customize a water treatment system
that will help optimize the condition, operation and useful life of your washing and sterilization equipment and produce high quality
reprocessing results. HPn
James Baker is the Vice President of AmeriWater, Inc. (SUEZ Environnement). He is a leading
industry authority on water quality with over 30
years of experience in the water treatment industry.
He is a member of AAMI Sterilization Standards
Committees, ST/WG84 and ST/WG 95; and on the
AAMI Renal Disease and Detoxification Commit-
tee. He is also past president of the International
Water Quality Association, serving on the Board
of Directors and on various committees, and was
inducted into the International Water Quality
Hall of Fame.
endoscopes inadequately reprocessed and automated endoscope
reprocessing system. Rockville (MD): FDA, September 10, 1999.
George Godfrey is the Director of National
Accounts for STERIS Corporation. A registered
nurse by training, he has worked in the healthcare
field for over 30 years, and has two decades of experience in operating rooms and sterile processing
departments. He is a member of AMSUS (society
of federal health professionals) and the Health
Facility Institute.
7. Centers for Disease Control and Prevention and the Healthcare
Infection Control Practices Advisory Committee (HICPAC). Guidelines
for environmental infection control in health-care facilities. Atlanta
(GA) CDC, 2003.
References
1. STERIS Corp TSSR (Technical Service Sales Request) Program – Water
Analysis.
2. Water Quality for Health Care, AmeriWater White Paper, Jim Baker,
January 2012.
3. U.S. Food and Drug Administration and Centers for Disease Control
and Prevention. FDA and CDC Public Health Advisory: Infections from
4. U.S. Pharmacopeial Convention. The United States Pharmacopeia.
Current ed Rockville (MD): USP.
5. Water Quality Association. Glossary of terms. Lisle (II.), 1997.
6. British Standards Institute. Washer-disinfectors for medical purposes. BS2745. BSI: London, 1993.
8. Clinical and Laboratory Standards Institute. Preparation and testing
of reagent water in the clinical laboratory. Approved Guideline – Fourth
Edition, 2006.
9. CSA International. Decontamination of Reusable medical devices.
CSA Z314.8-00(R2005). Toronto (ON): CSA International, March 2000.
10. International Organization for Standardization. Washer-disinfectors. Part 5: Test soils and methods for demonstrating cleaning
efficacy of washer disinfectors. ISO/TS 15883-5 2005: Geneva
(Switzerland) ISO. 2005.
11. Muscarella LF. Application of environmental sampling to flexible
endoscope reprocessing. The importance of monitoring the rinse
water, Infect control Hosp Epidemol. 23(5) 285-289. 2002.
12. Phillips G. McEwan H. and Butler J. Quality of water in washerdisinfectors. J Hosp Infect. 31: 152-154, 1995.
13. ASTM International. Standard guide for biomedical grade water.
ASTM d5196-91 (1999). Philadelphia (PA). ASTM International, 1999.
14. Association for the Advancement of Medical Instrumentation.
Comprehensive guide to steam sterilization and sterility assurance
in health care facilities. ANSI/AAMI ST79: 2006 Arlington (VA):
AAMI, 2006.
ETO Sterilant Phaseout Notice: Action Required
All Oxyfume® ethylene oxide (ETO)
sterilant blend production will cease
at Honeywell at the end of 2013 in
response to U.S. EPA Clean Air Act
regulations. Even if you no longer use
this product, check your facility for
old cylinders today. Then, contact
Honeywell for free information on how
to return the cylinders you find. Doing
so could help you avoid the high
costs of hazardous waste disposal.
To contact Honeywell and learn more about what you should do,
visit www.sterilantphaseout.com.
34 January 2013 • HEALTHCARE PuRCHAsing nEWs • www.hpnonline.com
15. Association for the Advancement of Medical Instrumentation.
Baterial endotoxin – Test methodology, routine monitoring and
alternatives to batch testing. ANSI/AAMI ST72:2002. Arlington
(VA). AAMI, 2002.
16. Association for the Advancement of Medical Instrumentation.
Water for the reprocessing of medical devices. AAMI TIR34-2007.
17. Association for the Advancement of Medical Instrumentation.
Water treatment equipment for hemodialysis applications and related
therapies. ANSI/AAMI/ISO 26722:2009. Arlington (VA). AAMI, 2011.
18. Association for the Advancement of Medical Instrumentation.
Water for hemodialysis and related therapies. ANSI/AAMI/ISO 13959:
2009. Arlington (VA). AAMI, 2011.
19. Association for the Advancement of Medical Instrumentation.
Concentrates for hemodialysis and related therapies. ANSI/AAMI/
ISO 13958: 2009. Arlington (VA). AAMI, 2011.
20. Association for the Advancement of Medical Instrumentation.
Water treatment equipment for hemodialysis applications. ANSI/
AAMI RD62:2006. Arlington (VA). AAMI, 2007.
21. Association for the Advancement of Medical Instrumentation.
Dialysate for hemodialysis. ANSI/AAMI RD52:2004. Arlington (VA)
I. AAMI, 2004.
22. Association for Professionals in Infection Control and Epidemiology, APIC Text of infection control and epidemiology. Washington
(DC). APIC, 2005.
sELf-sTudy sERiEs
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Continuing eduCation test • January 2013
Water quality systems in sterile processing
circle the one correct answer:
1. Water is considered the universal solvent.
a. True
b. False
2. Analysis of which of the below can assist in determining water quality?
a. Condensate return
b. Water make-up
c. Instruments
d. All of the above
3. Some contaminants in water are ok to drink.
a. True
b. False
4. Which of the following is/are true?
a. Bacterial contamination is a persistent problem with high purity waters systems.
b. Bacteria grow well in a high purity water system.
c. Bacteria build biofilm structures that can be very difficult to remove.
d. Bacteria cannot grow in water treatment systems.
e. a, b and c
f. None of the above
5. Which statements are true about monitoring?
a. Water treatment equipment monitoring is part of a quality assurance program.
b. Monitoring should be performed daily.
c. The monitoring equipment itself should be regularly inspected and calibrated.
d. Departments should maintain logs on monitoring, maintenance and disinfection
of their high purity water system.
e. b and d
f. All of the above
6. Some of the contaminants in water include:
a. Particulate, organic and inorganic materials
b. Sand, silt, rust, sediment, grit and colloids
c. Chemicals, chlorine, chloramines and solvents
d. Salts or minerals, calcium, magnesium, chlorides and iron
e. All of the above
7. High purity water is not needed for rinsing instrumentation.
a. True
b. False
8. each manufacturer has specific _________ for each of their washer/disinfectors.
a. technical literature
b. water quality specifications
c. a and b
d. None of the above
9. factors to consider when planning a water treatment system include:
a. Routine equipment maintenance and monitoring of water quality
b. Requirements for incoming water quality and the inlet flow rate
c. Maximum and minimum piping
d. a and b
e. None of the above
10. Some of the reasons to do a water analysis in your department are:
a. When construction involving water lines is occurring in your department, or
between your department and the boiler.
b. To provide a baseline analysis.
c. When there is a change of instrument cleaning chemistries in washers.
d. All of the above
Continuing eduCation test • January 2013
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