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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: rose@seaveyhealthcareconsulting.com.
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
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.
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]
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
S113
S114 R. Seavey / American Journal of Infection Control 41 (2013) S111-S117
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 10. Examples of ways to attach inventory count sheets outside instrument trays.
IMPLANTS
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
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.