American Journal of Infection Control 41 (2013) S111-S117

Contents lists available at ScienceDirect

American Journal of Infection Control American Journal of

Infection Control

journal homepage: www.ajicjournal.org

Original research article

High-level disinfection, sterilization, and antisepsis: Current issues

in reprocessing medical and surgical instruments
Rose Seavey MBA, BS, RN, CNOR, CRCST, CSPDT *
Seavey Healthcare Consulting, LLC, Arvada, CO

Key Words: Technology is rapidly changing many aspects of health care. The intricate design of instruments, the
Decontamination configuration of instrument trays, and evidence-based practice have resulted in the need for complicated
Cleaning and specific reprocessing recommendations from instrument manufacturers. Patient safety depends on
Devices
instruments that are appropriately cared for and adequately reprocessed. This article covers current
Processing
issues that sterile processing and operating room professionals must deal with regarding reprocessing of
medical and surgical instruments.
Copyright Ó 2013 by the Association for Professionals in Infection Control and Epidemiology, Inc.
Published by Elsevier Inc. All rights reserved.

Technology is rapidly changing many aspects of health care. The Extended cycle times
intricate design of instruments, the configuration of instrument
trays, and evidence-based practice have resulted in the need for The MDM IFU may recommend sterilization cycle times beyond
complicated and specific reprocessing recommendations from the standard procedures practiced in health care facilities. These
instrument manufacturers. are commonly referred to as extended sterilization cycle times.
Patient safety depends on instruments that are appropriately The need for additional processing times may be the result of the
cared for and adequately reprocessed (ie, cleaned and disinfected complex design of a device (eg, very long or narrow lumens) the
and sterilized). This article covers some current issues that sterile dense configuration of a tray, multiple layers in the tray, the weight
processing and operating room professionals must deal with of the set, or the design of the containment device itself. To help
regarding reprocessing of medical and surgical instruments. ensure sterility the MDM-validated recommendations for cycle
times must be followed.
MANUFACTURERS’ INSTRUCTIONS FOR USE Manufacturers of steam sterilizers validate their autoclaves
according to specific cycles spelled out in American National
Manufacturers of reusable medical devices and surgical instru- Standards Institute (ANSI) and Association for the Advancement of
ments must receive clearance from the Food and Drug Adminis- Medical Instrumentation (AAMI)2 standard (ST) 8, Hospital Steam
tration before the product can be made available for purchase and Sterilizers6 (see Tables 1 and 2). This validation process does not
use in the United States. Part of the labeling claim process requires include extended cycles; therefore, when facilities run longer
that manufacturers produce validated instructions for use (IFU) for exposure times to comply with MDM IFUs they are essentially
reprocessing of the reusable device. The medical device manufac- performing an off-label use of the sterilizer.7
turer’s (MDM) validated IFU for each device must be provided in Some MDMs recommend 5, 8, 10, 18, or 20 minutes or longer
writing to the health care facility purchasing or borrowing these exposures (see Table 3).8 In addition, some IFU recommendations
devices. The instructions should describe, in detail, the validated require devices to be run in an otherwise empty chamber. If
steps for disassembly, lubrication, cleaning, disinfecting, packaging, an extended cycle time is used and devices that have not been
and sterilization.1 Written recommendations from MDMs for validated at the longer exposure time are placed in that load,
reprocessing surgical instruments and medical devices should be the functionality or the lifespan of those devices may be damaged.
on file and consistently followed by health care facilities.2-5 To avoid this, facilities often run additional loads, which is
inefficient.7
* Address correspondence to Rose Seavey, MBA, BS, RN, CNOR, CRCST, CSPDT, The AAMI technical information report (TIR) on process chal-
Seavey Healthcare Consulting, LLC, Arvada, CO 80002. lenge devices and test packs for health care facilities known as
E-mail address: [email protected].
TIR31:2008 focuses on extended sterilization cycles. The TIR
Publication of this article was supported by Advanced Sterilization Products
(ASP). includes some recommendations for MDMs to target just a few
Conflicts of interest: None to report. cycles, such as 10- or 20-minute extended cycle times at 270
F

0196-6553/$36.00 - Copyright Ó 2013 by the Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved.
http://dx.doi.org/10.1016/j.ajic.2012.09.030
S112 R. Seavey / American Journal of Infection Control 41 (2013) S111-S117

Table 1
Minimum cycle times for gravity-displacement steam sterilization cycles

Exposure time at Exposure time at Exposure time at

121
C (250
F) 132
C (270
F) 135
C (275
F) Drying times

Item Min
Wrapped instruments 30 15 15-30
10 30
Textile packs 30 25 15
10 30
Wrapped utensils 30 15 15-30
10 30
Unwrapped nonporous items (eg, instruments) 3 3 0-1
Unwrapped nonporous and porous items in mixed load 10 10 0-1

NOTE. This table represents the variation in sterilizer manufacturers’ recommendations for exposure at different temperatures. For a specific sterilizer, consult only that
manufacturer’s recommendations. Reprinted from ANSI/AAMI ST79:2010, A1:2010, A2:2011, & A3:2012 (Consolidated Text) with permission of the Association for the
Advancement of Medical Instrumentation, Inc. (C) 2012 AAMI (www.aami.org). All rights reserved. Further reproduction or distribution prohibited.

containing moisture inside the container system should be

Table 2
Minimum cycle times for dynamic air removal steam sterilization cycles considered contaminated because there are no scientific studies to
prove otherwise.
Exposure time at Exposure time at Drying
Wet pack issues should be explored to resolve the problems.
132
C (270
F) 135
C (275
F) times
Internal or external moisture has the potential to provide pathways
Item Min
for microorganisms to go into the package, contaminating the
Wrapped instruments 4 20-30 contents. Moisture found on the outside of a package is usually
3 16
caused by condensation dripping from above. This is sometimes the
Textile packs 4 5-20
3 3 result of improper loading of the cart. Moisture found on the inside
Wrapped utensils 4 20 of a package can also be the result of a too-large metal mass that can
3 16 trap water, an overloaded tray, or lack of absorbent material such as
Unwrapped nonporous items 3 3 NA
towels or textiles.
(eg, instruments)
Unwrapped nonporous and 4 3 NA
Precondition of the load is 1 method frequently used to mini-
porous items in mixed load mize wet pack issues. To precondition a load, place the instruments
inside the steam sterilizer with the door closed for 10-15 minutes
NA, Not applicable.
NOTE. This table represents the variation in sterilizer manufacturers’ recommen- before starting the cycle. This will heat the instruments, helping to
dations for exposure at different temperatures. For a specific sterilizer, consult only resolve some wet pack problems not related to steam quality or
that manufacturer’s recommendations. Dynamic air removal steam sterilization inadequate packaging or loading configurations.4
includes prevacuum sterilizers. Reprinted from ANSI/AAMI ST79:2010, A1:2010,
Sterilized packages should not be touched until after the cool-
A2:2011, & A3:2012 (Consolidated Text) with permission of the Association for the
Advancement of Medical Instrumentation, Inc. (C) 2012 AAMI (www.aami.org). All
down period. Cooling packages is an important step in preventing
rights reserved. Further reproduction or distribution prohibited. wet packs. According to sterilizer unloading procedures in ANSI and
AAMI ST79 section 8.8.1:
in prevacuum cycles and 40- or 60-minute extended cycles at
All items removed from the sterilizer after sterilization pro-
250
F for gravity cycles.9 These new recommendations should make
cessing, including items packaged in rigid sterilization container
dealing with extended cycles a little less challenging in the future.
systems, should remain on the sterilizer cart until adequately
cooled. They should not be touched during the cooling process.
WEIGHT LIMITS FOR INSTRUMENT TRAYS Rigid sterilization container systems should remain on the
sterilizer cart until container surfaces are cool to the touch and
AAMI and the Association of periOperative Registered Nurses can be handled safely by the operator with bare hands. The cool-
(AORN) recommend a maximum weight limit of 25 lb for instrument down period begins within the sterilizer chamber. The door may
sets.2,4 Overweight sets can create concerns with sufficient steam be opened slightly at the end of the cycle and the items left
contact and a problem with drying that may results in wet packs.10 inside for a period of time in order to reduce the potential for
Each surgical instruments set may be lifted an average of 12 to condensation formation.2
15 times every time the set is used. This repetitive lifting can be
The time allowed for cooling should take into account the type
a real ergonomic issue when multiple sets weigh >25 lb. The health
of sterilizer being used, the design of the device being sterilized,
and safety of health care workers should be protected through
the temperature and humidity of the ambient environment,
limited tray weight limits.10
and the type of packaging used. A minimum cooling time of
Every facility should have a scale specifically assigned to weigh-
30 minutes is recommended. During cooling, the sterilizer cart
ing instrument sets. Sample scales are shown in Figures 1 and 2.
should be placed in a low-traffic area where there are no air-
conditioning or other cold-air vents in close proximity. Warm
WET PACKS items should never be transferred from the cart to cold metal
racks or shelves for cooling or placed within dust covers before
A package is considered a wet pack if moisture in the form of completion of the cooling process.2
dampness, droplets, or puddles of water is found on or within
a textile pack, instrument, basin set, or rigid container or contain- UPDATES IN PACKAGING
ment devices after the sterilization and cool-down process.2 If
packs are found to be wet after sterilization, they should not be The purpose of any sterilization packaging system is to allow
released for use. ANSI and AAMI ST792 recommends any set sterilization of the package contents, maintain sterility of contents
 Table 3
Examples of devices that require extended cycle times for sterilization

Device Phase I conditions Temperature Sterilization time (min) Dry time (min) Comments Device type
Tract trial with uniball clamps Prevacuum preceded by 15-min 132
C [270
F] 10 None listed None Solid
conditioning and purge
Endoscope 132
C-134
C [270
F-274
F] 5 None listed None Solid
Pediatric Bivona tracheostomy tube 121
C [250
F] 40 None listed Do not use deep vacuum flash cycles or Hollow
pulse vacuum cycles. Gravity only
Autoclavable fiber-illuminated 132
C [270
F] 5 20 It is recommended that all telescopes be Solid
laparoscoope gas sterilized to achieve maximum
life expectancy, unless otherwise
required
Spine surgical instruments 4 pulses 132
C-135
C [270
F-275
F] 6 None listed Prevacuum multiple (3-4) insert sets at Solid/hollow
or or 275
F for 40 min or single and dual
134
C-137
C [273
F-277
F] 4 insert sets at 275
F for 14 min
Prosthetic ring models 4500 and 4400 121
C [250
F] 30-40 None listed Flash sterilization Hollow
or or
132
C [270
F] 15-20
132
C [270
F]

R. Seavey / American Journal of Infection Control 41 (2013) S111-S117

Spine instrument sets 15 90 Maximum chamber contents: 9 cases Solid or hollow
Empty chamber: preheat 15 min
Silicone resuscitation 132
C-135
C [270
F-275
F] 15 None listed None Hollow
Large bone 4 prevacuum pulses 132
C-134
C [270
F-274
F] 8 20 (metal) None Solid or hollow
or or or
134
C-137
C [273
F-277
F] 5 45
(poly)
28-lb instrument set 132
C [270
F] 15 None listed Weighs 28 lb Solid or hollow
Congruent bone plate system 132
C [270
F] 15 None listed Also states to follow ST79 Solid or hollow

NOTE. Reprinted from AAMI TIR31:2008 with permission of Association for the Advancement of Medical Instrumentation, Inc. Ó 2008 AAMI (www.aami.org). All rights reserved. Further reproduction or distribution prohibited.
a wrapped tray, such as all-paper peel packs, foam, woven

instrument trays are assembled. AORN recommendations state,

some items together, containment devices are frequently used when
systems (see Fig 3). To help protect sharp or small items and keep
fabrics, nonwoven materials, peel pouches, and rigid container

Sterilization packaging options

sterilized in a health care facility.11

ded to be used to surround another medical device that is to be
Food and Drug Administration as a class II medical device inten-
without contamination. Sterilization packaging is classified by the
until the package is opened, and permit delivery of contents
There are several other options for containing devices within
by packing and container manufacturers.4
ized sets has not been validated as appropriate and efficacious
pouches and then including them in wrapped or container-
drying. The practice of confining instruments in paper-plastic
tioned to ensure adequate air removal, sterilant contact, and
or containment devices because the pouches cannot be posi-
Paper-plastic pouches should not be used within wrapped sets

A variety of packaging systems are in use, including woven

Fig 2. Example of a scale that could be used to weigh instruments.

Fig 1. Example of a scale that could be used to weigh instruments.

S113
S114 R. Seavey / American Journal of Infection Control 41 (2013) S111-S117

Fig 3. Examples of packaging systems.

Fig 5. Example of all-paper accessory container for containing devices within

a wrapped tray.

Fig 6. Examples of basket-type accessory containers for containing devices within

a wrapped tray.

Fig 4. Example of all-paper peel packs container for containing devices within
a wrapped tray.
during storage. Immediately before opening any package the end
user should visually inspect the sterilized package or container’s
integrity looking for holes or worn spots in the fabric or paper and/
material, or basket-type accessory containers that are designed and or the effectiveness of the seal.4
tested for this purpose (see Figs 4-6). There has been much discussion and debate over where and
At least 1 chemical indicator/integrator (CI), should be used how instrument inventory count sheets should be placed. Accord-
within each package. The internal CI should be placed in the area ing to the latest AORN recommendations,4 these papers should not
of the package considered to be the least accessible to sterilant be placed inside wrapped or containerized instruments sets.
penetration and air removal. AORN-recommended practices for Chemicals used in the manufacture of paper and toner ink may
selection and use of packaging systems4 identifies specific place- pose a risk of reaction in some patients. Further, ink used to print
ment of internal CIs within wrapped and containerized sets in the inventory lists have been known to bleed onto instruments and
geometric center (ie, not on top). For wrapped packages the containers (see Figs 7-9).
updated recommendation states to place the CI in the geometric Because paperwork materials have not been shown to be safe for
center (ie, not on top) of the devices. In addition, a CI should be patient use, the best practice is to leave the instrument inventory
placed in the geometric center of each level of all multilevel sets. count sheets outside instrument trays. Some facilities attach the
For ridged containers, AORN recommends 2 CIs, 1 in each of 2 lists to the outside of containers or wrapped packages (see Fig 10).
opposite corners of the inner basket. If ridged containers have
multilevels there should be 2 CIs placed in 2 opposite corners (ie, 1 LOANED OR BORROWED INSTRUMENTS
in each of 2 corners) of every level.4 Before opening a sterile
package, personnel should ensure the external CIs have changed Facilities frequently borrow surgical instruments or implants for
appropriately ensuring the package has been exposed to the ster- specialty operative procedures. The management of loaner instru-
ilization process. mentation and implants is recognized as a concern by many health
Protection of the sterility of a device to the point of use is vital. care professionals.12 AORN recommended practices documents4
The majority of packaging does not provide an absolute microbial state: “A formalized program between healthcare organizations
barrier; therefore, it is important that environmental contamina- and healthcare industry representatives should be established for
tion be minimized to avoid compromising the sterility of devices the receipt and use of loaner instrumentation.”
 R. Seavey / American Journal of Infection Control 41 (2013) S111-S117 S115

Fig 9. Ink transfer from papers placed inside instrument container.

Fig 7. Ink transfer from papers placed inside instrument container.

Fig 10. Examples of ways to attach inventory count sheets outside instrument trays.

IMPLANTS

ANSI and AAMI’s and AORN’s current recommendations state

that a biologic indicator and a class 5 CI should be run with every
implant (eg, heart valve, prosthetic joint, and screw). Implants
should be quarantined and not used until the biologic indicator
reads negative. In the case of an emergency, when an implant must
be used before the biologic indicator results are known, docu-
mentation should be made on an exception form stating the
Fig 8. Ink transfer from papers placed inside instrument container. reasons for early release.2,4 Annex L in ANSI and AAMI ST792 gives
examples of necessary documentation of premature release of
A collaborative, well-written policy with specific controls must implants.
be in place to ensure successful management of these instruments
and implants.12 The International Association of Healthcare Central WATER QUALITY
Service Materiel Management (IAHCSMM) agrees13 that health care
facilities that borrow surgical instruments should have a well- Water quality is a vital concern in all steps of reprocessing
developed loaner program and written policy that establishes surgical and medical instruments. The quality of water used is very
standardized receipt and use of all loaner instrumentation. Because important to prolong the life of the medical devices as well as
of the need for consistent controls this policy should be established minimizing the risk to patients.14
with input from sterile processing units, surgeons and operating There are 2 general methods used to deal with water impurities
room staff, and various departments such as infection prevention related to reprocessing of surgical and medical instruments. The
and control, administration, materials management, and risk first is the use of a water treatment system that reduces or removes
management. The IAHCSMM sample policy13 states that health care impurities before use. The second method involves adding chem-
facilities should have loaner trays at least 2 business days before the icals to address water impurities during the decontamination
scheduled use and, if it is a first-time vendor, the loaned sets should process.15
be obtained 3 business days before the scheduled use for in- Steam quality is affected by the quality of the water being used
servicing, inspection, testing, and processing. The IAHCSMM posi- to generate the steam. Pretreatment of water may be required to
tion paper and the policy template can be downloaded from the eliminate the possibility of residuals or deposits when the steam is
association’s Web site (www.iahcsmm.org). used for sterilization, especially in flash sterilization.14
Loaning and borrowing of surgical instruments and implants
should be consistently managed according to the written policy of Water purification systems
each facility. Tracking loaners, either manually or automatically, is
necessary for quality controls as well as asset management of There are many different types of water purification systems.
loaners.12 The most common water treatment is a water softener. A water
S116 R. Seavey / American Journal of Infection Control 41 (2013) S111-S117

softener purifies with a process of ion exchange. Other treatments Only cleaning agents that have been recommended by the
commonly used to purify water are deionization system and specific eye instrument’s manufacturer should be used on intra-
reverse osmosis. Deionization removes ions to purify the water and ocular instruments. Particular attention should be directed toward
requires tank exchanges. Reverse osmosis purifies by using a sem- ensuring that the specified concentration of the recommended
ipermable membrane to remove or reduce impurities. Reverse cleaning agent and water quality are used. Final rinsing of in-
osmosis generally requires more space and has a higher start-up struments should be performed with the volume of sterile,
price; however, reverse osmosis systems do not require tank distilled, or deionized water recommended by the manufacturer.
exchanges.14,15 Single-use brushes of the correct size should be used and then
For devices that will come in contact with the bloodstream or disposed of.2
sterile areas of the body, high purity water is recommended for the Eye instruments should be sterilized using the methods and
final rinse of the item. Health care facilities should evaluate the conditions recommended in the MDM IFU. The sterilization process
water used in the various steps of reprocessing.15 should be effective, monitored, and documented. AAMI ST792
Water impurities can also affect the functionality, effectiveness, provides detailed recommendations for sterilization processing,
and life span of automated reprocessing equipment. There are including quality control and restrictions regarding the use of flash
several tools and test strips available to monitor the quality of water sterilization.
used in sterile processing.15 Sterile processing staff members
should work closely with water service maintenance personnel to
establish and monitor the water treatment systems used for Maintenance of processing equipment
cleaning, disinfecting, and sterilizing all reusable devices.
Cleaning and sterilization equipment, boilers, and water filtra-
VERIFICATION OF CLEANING tion systems should be properly maintained. Otherwise, foreign
materials such as endotoxins, heavy metals, or chemical contami-
In the past, health care personnel relied only on visual inspec- nants or impurities may be deposited onto the instruments during
tion of the cleaning process. We now have many tools, such as processing and induce TASS. Because many different materials can
adenosine triphosphate, or protein, that can be used to verify that elicit a TASS response if they are inadvertently introduced into the
cleaning processes are adequate. These tests can help us determine anterior chamber of the eye, the importance of following the proper
if we have done a good job of manually cleaning items and if our intraocular surgical instrument processing procedures cannot be
automatic washers are working properly. overemphasized.2

REPROCESSING INTRAOCULAR SURGICAL INSTRUMENTS CONCLUSIONS

Toxic anterior segment syndrome (TASS) is an acute inflam- Reprocessing plays a very important role in helping to prevent
matory response caused when foreign material is introduced into infections. Technology is changing how procedures are performed
the anterior chamber of the eye. TASS may lead to severe visual and requiring more complicated devices to be reprocessed. Published
impairment or blindness. Special processing considerations are recommended practices are constantly being updated to reflect
necessary for eye instrumentation because of the nature of the evidence-based practices and validated practices. Patient safety
instruments themselves and the sensitive nature of the eye.2 depends on instruments that are appropriately cared for and effec-
Annex N of the ANSI and AAMI ST792 addresses TASS and the tively reprocessed; therefore, the most current best practices should
processing of intraocular surgical instruments. According to AAMI, be identified and followed. Some of the most current issues relating to
the introduction of TASS may be associated with specific products, reprocessing surgical and medical devices are the importance of
such as contaminated balanced salt solution, detergent residues, following the manufacturer’s written IFUs, including cycle parame-
endotoxins, preservatives, foreign matter, and residues from ster- ters; a pan weight not exceeding 25 lb; investigating the reason(s) for
ilization processing. Therefore, particular care must be taken in the wet packs; being aware of updates in packaging; managing loaner
processing of intraocular surgical instruments. Many eye instru- instrumentation efficiently; monitoring water quality needs; and
ments are complex and delicate and must be cleaned manually. handling of intraocular instruments appropriately.
Manual cleaning methods may be less controlled, so additional care
must be taken during processing to ensure effective cleaning and
rinsing. References
Specific eye instrument cleaning and sterilization recommen-
dations are published by the American Society of Cataract and 1. Sterilization of medical devicesdinformation to be provided by the manufac-
turer for the processing of resterilzable medical devices. ANSI/AAMI ST81:2004/
Refractive Surgery and the American Society of Ophthalmic Regis- (R)2010. Available from: http://marketplace.aami.org/eseries/scriptcontent/
tered Nurses. Annex N of AAMI ST792 highlights those existing docs/Preview%20Files/ST811003_preview.pdf. Accessed February 12, 2013.
recommendations for reducing the risk of TASS. Important 2. Comprehensive guide to steam sterilization and sterility assurance in health
care facilities. ANSI/AAMI ST79:2006 and ANSI/AAMI ST79/A1:2008 (consoli-
elements of a processing program for intraocular surgical instru- dated text). Available from: http://marketplace.aami.org/eseries/scriptcontent/
ments include, but are not limited to, maintaining an adequate docs/Preview%20Files/ST791110_preview.pdf. Accessed January 16, 2013.
inventory of eye instruments, allowing adequate time for process- 3. Recommended practices for cleaning and care of surgical instruments
and powered equipment. Association of periOperative Registered Nurses Web site.
ing instruments according to MDM instructions, processing intra- Available from: http://aornstandards.org/search?fulltext¼Recommendedþ
ocular surgical instruments separately from general surgical PracticesþforþCleaningþandþCareþofþSurgicalþInstrumentsþandþPoweredþ
instruments in a designated cleaning area with dedicated equip- Equipment&submit¼yes&x¼8&y¼9. Accessed January 16, 2013.
4. Recommended practices for selection and use of packaging systems. Association of
ment, and following manufacturers’ current written instructions
periOperative Registered Nurses Web site. Available from: http://aornstandards.
for the cleaning and sterilization of eye instruments. Auditing the org/search?fulltext¼RecommendedþPracticesþforþSelectionþandþUseþofþ
cleaning process will ensure procedures comply with manufacturer PackagingþSystems&submit¼yes&x¼0&y¼0. Accessed January 16, 2013.
instructions and that personnel performing cleaning procedures 5. Recommended practices for sterilization. Association of periOperative Regis-
tered Nurses Web site. Available from: http://aornstandards.org/search?
have received documented training and have demonstrated fulltext¼RecommendedþPracticesþforþSterilization&submit¼yes&x¼0&y¼0.
competency in the cleaning process.2 Accessed January 16, 2013.
 R. Seavey / American Journal of Infection Control 41 (2013) S111-S117 S117

6. Hospital steam sterilizers. ANSI/AAMI ST78:2008. Available from: http:// 11. Seavey R. Packaging for sterilization: it’s not just a box, a bag or gift wrapping!
marketplace.aami.org/eseries/scriptcontent/docs/Preview%20Files/ST80812_ Manag Infect Control 2008;8:82-97.
preview.pdf. Accessed February 12, 2013. 12. Seavey R. Loaner instrumentation: SPD and OR working together to manage
7. Klacik S. It’s about “Time”: extended cycles. Healthcare Sterilization Horizons loaner instrumentation. Healthcare Purchas News 2008;32:78-92.
2008;27. 13. IAHCSMM position paper on the management of loaner instrumentation. Avail-
8. New guidance examines process challenge devices. AAMI News Feb 2009;44:8. able from: http://www.iahcsmm.org/CurrentIssues/Loaner_Instrumentation_
9. Process challenge devices/test packs for health care facilities. The Associ- Position_Paper_Sample_Policy.html. Accessed January 17, 2013.
ation for the Advancement of Medical Instrumentation Web site. Available 14. Water for the reprocessing of medical devices. Available from: http://marketplace
from: http://marketplace.aami.org/eseries/scriptcontent/docs/Preview%20Files% .aami.org/eseries/scriptcontent/docs/Preview%20Files%5CTIR340710_preview.pdf.
5CTIR310811_preview.pdf. Accessed January 16, 2013. Accessed January 16, 2013. P. 37-46.
10. Seavey R. Just say no! Don’t get weighed down by instrument sets that are too 15. Lyon S. Water quality and its impact on the decontamination process. Manag
heavy. Manag Infect Control 2006;6:86-97. Infect Control 2008;8:82-97.