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High-level disinfection, sterilization, and antisepsis: Current issues in reprocessing medical and surgical instruments

      Technology is rapidly changing many aspects of health care. The intricate design of instruments, the configuration of instrument trays, and evidence-based practice have resulted in the need for complicated and specific reprocessing recommendations from instrument manufacturers. Patient safety depends on instruments that are appropriately cared for and adequately reprocessed. This article covers current issues that sterile processing and operating room professionals must deal with regarding reprocessing of medical and surgical instruments.

      Key Words

      Technology is rapidly changing many aspects of health care. The intricate design of instruments, the configuration of instrument trays, and evidence-based practice have resulted in the need for complicated and specific reprocessing recommendations from instrument manufacturers.
      Patient safety depends on instruments that are appropriately cared for and adequately reprocessed (ie, cleaned and disinfected and sterilized). This article covers some current issues that sterile processing and operating room professionals must deal with regarding reprocessing of medical and surgical instruments.

      Manufacturers’ instructions for use

      Manufacturers of reusable medical devices and surgical instruments must receive clearance from the Food and Drug Administration before the product can be made available for purchase and use in the United States. Part of the labeling claim process requires that manufacturers produce validated instructions for use (IFU) for reprocessing of the reusable device. The medical device manufacturer’s (MDM) validated IFU for each device must be provided in writing to the health care facility purchasing or borrowing these devices. The instructions should describe, in detail, the validated steps for disassembly, lubrication, cleaning, disinfecting, packaging, and sterilization.

      Sterilization of medical devices—information to be provided by the manufacturer for the processing of resterilzable medical devices. ANSI/AAMI ST81:2004/(R)2010. Available from: http://marketplace.aami.org/eseries/scriptcontent/docs/Preview%20Files/ST811003_preview.pdf. Accessed February 12, 2013.

      Written recommendations from MDMs for reprocessing surgical instruments and medical devices should be on file and consistently followed by health care facilities.

      Comprehensive guide to steam sterilization and sterility assurance in health care facilities. ANSI/AAMI ST79:2006 and ANSI/AAMI ST79/A1:2008 (consolidated text). Available from: http://marketplace.aami.org/eseries/scriptcontent/docs/Preview%20Files/ST791110_preview.pdf. Accessed January 16, 2013.

      Recommended practices for cleaning and care of surgical instruments and powered equipment. Association of periOperative Registered Nurses Web site. Available from: http://aornstandards.org/search?fulltext=Recommended+Practices+for+Cleaning+and+Care+of+Surgical+Instruments+and+Powered+Equipment&submit=yes&x=8&y=9. Accessed January 16, 2013.

      Recommended practices for selection and use of packaging systems. Association of periOperative Registered Nurses Web site. Available from: http://aornstandards.org/search?fulltext=Recommended+Practices+for+Selection+and+Use+of+Packaging+Systems&submit=yes&x=0&y=0. Accessed January 16, 2013.

      Recommended practices for sterilization. Association of periOperative Registered Nurses Web site. Available from: http://aornstandards.org/search?fulltext=Recommended+Practices+for+Sterilization&submit=yes&x=0&y=0. Accessed January 16, 2013.

      Extended cycle times

      The MDM IFU may recommend sterilization cycle times beyond the standard procedures practiced in health care facilities. These are commonly referred to as extended sterilization cycle times. The need for additional processing times may be the result of the complex design of a device (eg, very long or narrow lumens) the dense configuration of a tray, multiple layers in the tray, the weight of the set, or the design of the containment device itself. To help ensure sterility the MDM-validated recommendations for cycle times must be followed.
      Manufacturers of steam sterilizers validate their autoclaves according to specific cycles spelled out in American National Standards Institute (ANSI) and Association for the Advancement of Medical Instrumentation (AAMI)

      Comprehensive guide to steam sterilization and sterility assurance in health care facilities. ANSI/AAMI ST79:2006 and ANSI/AAMI ST79/A1:2008 (consolidated text). Available from: http://marketplace.aami.org/eseries/scriptcontent/docs/Preview%20Files/ST791110_preview.pdf. Accessed January 16, 2013.

      standard (ST) 8, Hospital Steam Sterilizers

      Hospital steam sterilizers. ANSI/AAMI ST78:2008. Available from: http://marketplace.aami.org/eseries/scriptcontent/docs/Preview%20Files/ST80812_preview.pdf. Accessed February 12, 2013.

      (see Table 1, Table 2). This validation process does not include extended cycles; therefore, when facilities run longer exposure times to comply with MDM IFUs they are essentially performing an off-label use of the sterilizer.
      • Klacik S.
      It’s about “Time”: extended cycles.
      Table 1Minimum cycle times for gravity-displacement steam sterilization cycles
      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.
      ItemExposure time at 121°C (250°F)Exposure time at 132°C (270°F)Exposure time at 135°C (275°F)Drying times
      Min
      Wrapped instruments301515-30
      1030
      Textile packs302515
      1030
      Wrapped utensils301515-30
      1030
      Unwrapped nonporous items (eg, instruments)330-1
      Unwrapped nonporous and porous items in mixed load10100-1
      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.
      Table 2Minimum cycle times for dynamic air removal steam sterilization cycles
      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.
      ItemExposure time at 132°C (270°F)Exposure time at 135°C (275°F)Drying times
      Min
      Wrapped instruments420-30
      316
      Textile packs45-20
      33
      Wrapped utensils420
      316
      Unwrapped nonporous items (eg, instruments)33NA
      Unwrapped nonporous and porous items in mixed load43NA
      NA, Not applicable.
      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. Dynamic air removal steam sterilization includes prevacuum sterilizers.
      Some MDMs recommend 5, 8, 10, 18, or 20 minutes or longer exposures (see Table 3).
      New guidance examines process challenge devices.
      In addition, some IFU recommendations require devices to be run in an otherwise empty chamber. If an extended cycle time is used and devices that have not been validated at the longer exposure time are placed in that load, the functionality or the lifespan of those devices may be damaged. To avoid this, facilities often run additional loads, which is inefficient.
      • Klacik S.
      It’s about “Time”: extended cycles.
      Table 3Examples of devices that require extended cycle times for sterilization
      NOTE. Reprinted from AAMI TIR31:2008 with permission of Association for the Advancement of Medical Instrumentation, Inc. © 2008 AAMI (www.aami.org). All rights reserved. Further reproduction or distribution prohibited.
      DevicePhase I conditionsTemperatureSterilization time (min)Dry time (min)CommentsDevice type
      Tract trial with uniball clampsPrevacuum preceded by 15-min conditioning and purge132°C [270°F]10None listedNoneSolid
      Endoscope132°C-134°C [270°F-274°F]5None listedNoneSolid
      Pediatric Bivona tracheostomy tube121°C [250°F]40None listedDo not use deep vacuum flash cycles or pulse vacuum cycles. Gravity onlyHollow
      Autoclavable fiber-illuminated laparoscoope132°C [270°F]520It is recommended that all telescopes be gas sterilized to achieve maximum life expectancy, unless otherwise requiredSolid
      Spine surgical instruments4 pulses132°C-135°C [270°F-275°F]

      or

      134°C-137°C [273°F-277°F]
      6

      or

      4
      None listedPrevacuum multiple (3-4) insert sets at 275°F for 40 min or single and dual insert sets at 275°F for 14 minSolid/hollow
      Prosthetic ring models 4500 and 4400121°C [250°F]

      or

      132°C [270°F]
      30-40

      or

      15-20
      None listedFlash sterilizationHollow
      Spine instrument sets132°C [270°F]1590Maximum chamber contents: 9 cases

      Empty chamber: preheat 15 min
      Solid or hollow
      Silicone resuscitation132°C-135°C [270°F-275°F]15None listedNoneHollow
      Large bone4 prevacuum pulses132°C-134°C [270°F-274°F]

      or

      134°C-137°C [273°F-277°F]
      8

      or

      5
      20 (metal)

      or 45

      (poly)
      NoneSolid or hollow
      28-lb instrument set132°C [270°F]15None listedWeighs 28 lbSolid or hollow
      Congruent bone plate system132°C [270°F]15None listedAlso states to follow ST79Solid or hollow
      The AAMI technical information report (TIR) on process challenge devices and test packs for health care facilities known as TIR31:2008 focuses on extended sterilization cycles. The TIR includes some recommendations for MDMs to target just a few cycles, such as 10- or 20-minute extended cycle times at 270°F in prevacuum cycles and 40- or 60-minute extended cycles at 250°F for gravity cycles.

      Process challenge devices/test packs for health care facilities. The Association for the Advancement of Medical Instrumentation Web site. Available from: http://marketplace.aami.org/eseries/scriptcontent/docs/Preview%20Files%5CTIR310811_preview.pdf. Accessed January 16, 2013.

      These new recommendations should make dealing with extended cycles a little less challenging in the future.

      Weight limits for instrument trays

      AAMI and the Association of periOperative Registered Nurses (AORN) recommend a maximum weight limit of 25 lb for instrument sets.

      Comprehensive guide to steam sterilization and sterility assurance in health care facilities. ANSI/AAMI ST79:2006 and ANSI/AAMI ST79/A1:2008 (consolidated text). Available from: http://marketplace.aami.org/eseries/scriptcontent/docs/Preview%20Files/ST791110_preview.pdf. Accessed January 16, 2013.

      Recommended practices for selection and use of packaging systems. Association of periOperative Registered Nurses Web site. Available from: http://aornstandards.org/search?fulltext=Recommended+Practices+for+Selection+and+Use+of+Packaging+Systems&submit=yes&x=0&y=0. Accessed January 16, 2013.

      Overweight sets can create concerns with sufficient steam contact and a problem with drying that may results in wet packs.
      • Seavey R.
      Just say no! Don’t get weighed down by instrument sets that are too heavy.
      Each surgical instruments set may be lifted an average of 12 to 15 times every time the set is used. This repetitive lifting can be a real ergonomic issue when multiple sets weigh >25 lb. The health and safety of health care workers should be protected through limited tray weight limits.
      • Seavey R.
      Just say no! Don’t get weighed down by instrument sets that are too heavy.
      Every facility should have a scale specifically assigned to weighing instrument sets. Sample scales are shown in Fig 1, Fig 2.
      Figure thumbnail gr1
      Fig 1Example of a scale that could be used to weigh instruments.
      Figure thumbnail gr2
      Fig 2Example of a scale that could be used to weigh instruments.

      Wet packs

      A package is considered a wet pack if moisture in the form of dampness, droplets, or puddles of water is found on or within a textile pack, instrument, basin set, or rigid container or containment devices after the sterilization and cool-down process.

      Comprehensive guide to steam sterilization and sterility assurance in health care facilities. ANSI/AAMI ST79:2006 and ANSI/AAMI ST79/A1:2008 (consolidated text). Available from: http://marketplace.aami.org/eseries/scriptcontent/docs/Preview%20Files/ST791110_preview.pdf. Accessed January 16, 2013.

      If packs are found to be wet after sterilization, they should not be released for use. ANSI and AAMI ST79

      Comprehensive guide to steam sterilization and sterility assurance in health care facilities. ANSI/AAMI ST79:2006 and ANSI/AAMI ST79/A1:2008 (consolidated text). Available from: http://marketplace.aami.org/eseries/scriptcontent/docs/Preview%20Files/ST791110_preview.pdf. Accessed January 16, 2013.

      recommends any set containing moisture inside the container system should be considered contaminated because there are no scientific studies to prove otherwise.
      Wet pack issues should be explored to resolve the problems. Internal or external moisture has the potential to provide pathways for microorganisms to go into the package, contaminating the contents. Moisture found on the outside of a package is usually caused by condensation dripping from above. This is sometimes the result of improper loading of the cart. Moisture found on the inside of a package can also be the result of a too-large metal mass that can trap water, an overloaded tray, or lack of absorbent material such as towels or textiles.
      Precondition of the load is 1 method frequently used to minimize wet pack issues. To precondition a load, place the instruments inside the steam sterilizer with the door closed for 10-15 minutes before starting the cycle. This will heat the instruments, helping to resolve some wet pack problems not related to steam quality or inadequate packaging or loading configurations.

      Recommended practices for selection and use of packaging systems. Association of periOperative Registered Nurses Web site. Available from: http://aornstandards.org/search?fulltext=Recommended+Practices+for+Selection+and+Use+of+Packaging+Systems&submit=yes&x=0&y=0. Accessed January 16, 2013.

      Sterilized packages should not be touched until after the cool-down period. Cooling packages is an important step in preventing wet packs. According to sterilizer unloading procedures in ANSI and AAMI ST79 section 8.8.1:All items removed from the sterilizer after sterilization processing, including items packaged in rigid sterilization container systems, should remain on the sterilizer cart until adequately cooled. They should not be touched during the cooling process. Rigid sterilization container systems should remain on the sterilizer cart until container surfaces are cool to the touch and can be handled safely by the operator with bare hands. The cool-down period begins within the sterilizer chamber. The door may be opened slightly at the end of the cycle and the items left inside for a period of time in order to reduce the potential for condensation formation.

      Comprehensive guide to steam sterilization and sterility assurance in health care facilities. ANSI/AAMI ST79:2006 and ANSI/AAMI ST79/A1:2008 (consolidated text). Available from: http://marketplace.aami.org/eseries/scriptcontent/docs/Preview%20Files/ST791110_preview.pdf. Accessed January 16, 2013.

      The time allowed for cooling should take into account the type of sterilizer being used, the design of the device being sterilized, the temperature and humidity of the ambient environment, and the type of packaging used. A minimum cooling time of 30 minutes is recommended. During cooling, the sterilizer cart should be placed in a low-traffic area where there are no air-conditioning or other cold-air vents in close proximity. Warm items should never be transferred from the cart to cold metal racks or shelves for cooling or placed within dust covers before completion of the cooling process.

      Comprehensive guide to steam sterilization and sterility assurance in health care facilities. ANSI/AAMI ST79:2006 and ANSI/AAMI ST79/A1:2008 (consolidated text). Available from: http://marketplace.aami.org/eseries/scriptcontent/docs/Preview%20Files/ST791110_preview.pdf. Accessed January 16, 2013.

      Updates in packaging

      The purpose of any sterilization packaging system is to allow sterilization of the package contents, maintain sterility of contents until the package is opened, and permit delivery of contents without contamination. Sterilization packaging is classified by the Food and Drug Administration as a class II medical device intended to be used to surround another medical device that is to be sterilized in a health care facility.
      • Seavey R.
      Packaging for sterilization: it’s not just a box, a bag or gift wrapping!.

      Sterilization packaging options

      A variety of packaging systems are in use, including woven fabrics, nonwoven materials, peel pouches, and rigid container systems (see Fig 3). To help protect sharp or small items and keep some items together, containment devices are frequently used when instrument trays are assembled. AORN recommendations state,Paper-plastic pouches should not be used within wrapped sets or containment devices because the pouches cannot be positioned to ensure adequate air removal, sterilant contact, and drying. The practice of confining instruments in paper-plastic pouches and then including them in wrapped or containerized sets has not been validated as appropriate and efficacious by packing and container manufacturers.

      Recommended practices for selection and use of packaging systems. Association of periOperative Registered Nurses Web site. Available from: http://aornstandards.org/search?fulltext=Recommended+Practices+for+Selection+and+Use+of+Packaging+Systems&submit=yes&x=0&y=0. Accessed January 16, 2013.

      There are several other options for containing devices within a wrapped tray, such as all-paper peel packs, foam, woven material, or basket-type accessory containers that are designed and tested for this purpose (see Fig 4, Fig 5, Fig 6).
      Figure thumbnail gr4
      Fig 4Example of all-paper peel packs container for containing devices within a wrapped tray.
      Figure thumbnail gr5
      Fig 5Example of all-paper accessory container for containing devices within a wrapped tray.
      Figure thumbnail gr6
      Fig 6Examples of basket-type accessory containers for containing devices within a wrapped tray.
      At least 1 chemical indicator/integrator (CI), should be used within each package. The internal CI should be placed in the area of the package considered to be the least accessible to sterilant penetration and air removal. AORN-recommended practices for selection and use of packaging systems

      Recommended practices for selection and use of packaging systems. Association of periOperative Registered Nurses Web site. Available from: http://aornstandards.org/search?fulltext=Recommended+Practices+for+Selection+and+Use+of+Packaging+Systems&submit=yes&x=0&y=0. Accessed January 16, 2013.

      identifies specific placement of internal CIs within wrapped and containerized sets in the geometric center (ie, not on top). For wrapped packages the updated recommendation states to place the CI in the geometric center (ie, not on top) of the devices. In addition, a CI should be placed in the geometric center of each level of all multilevel sets.
      For ridged containers, AORN recommends 2 CIs, 1 in each of 2 opposite corners of the inner basket. If ridged containers have multilevels there should be 2 CIs placed in 2 opposite corners (ie, 1 in each of 2 corners) of every level.

      Recommended practices for selection and use of packaging systems. Association of periOperative Registered Nurses Web site. Available from: http://aornstandards.org/search?fulltext=Recommended+Practices+for+Selection+and+Use+of+Packaging+Systems&submit=yes&x=0&y=0. Accessed January 16, 2013.

      Before opening a sterile package, personnel should ensure the external CIs have changed appropriately ensuring the package has been exposed to the sterilization process.
      Protection of the sterility of a device to the point of use is vital. The majority of packaging does not provide an absolute microbial barrier; therefore, it is important that environmental contamination be minimized to avoid compromising the sterility of devices 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/or the effectiveness of the seal.

      Recommended practices for selection and use of packaging systems. Association of periOperative Registered Nurses Web site. Available from: http://aornstandards.org/search?fulltext=Recommended+Practices+for+Selection+and+Use+of+Packaging+Systems&submit=yes&x=0&y=0. Accessed January 16, 2013.

      There has been much discussion and debate over where and how instrument inventory count sheets should be placed. According to the latest AORN recommendations,

      Recommended practices for selection and use of packaging systems. Association of periOperative Registered Nurses Web site. Available from: http://aornstandards.org/search?fulltext=Recommended+Practices+for+Selection+and+Use+of+Packaging+Systems&submit=yes&x=0&y=0. Accessed January 16, 2013.

      these papers should not be placed inside wrapped or containerized instruments sets. Chemicals used in the manufacture of paper and toner ink may pose a risk of reaction in some patients. Further, ink used to print inventory lists have been known to bleed onto instruments and containers (see Fig 7, Fig 8, Fig 9).
      Figure thumbnail gr7
      Fig 7Ink transfer from papers placed inside instrument container.
      Figure thumbnail gr8
      Fig 8Ink transfer from papers placed inside instrument container.
      Figure thumbnail gr9
      Fig 9Ink transfer from papers placed inside instrument container.
      Because paperwork materials have not been shown to be safe for patient use, the best practice is to leave the instrument inventory count sheets outside instrument trays. Some facilities attach the lists to the outside of containers or wrapped packages (see Fig 10).
      Figure thumbnail gr10
      Fig 10Examples of ways to attach inventory count sheets outside instrument trays.

      Loaned or borrowed instruments

      Facilities frequently borrow surgical instruments or implants for specialty operative procedures. The management of loaner instrumentation and implants is recognized as a concern by many health care professionals.
      • Seavey R.
      Loaner instrumentation: SPD and OR working together to manage loaner instrumentation.
      AORN recommended practices documents

      Recommended practices for selection and use of packaging systems. Association of periOperative Registered Nurses Web site. Available from: http://aornstandards.org/search?fulltext=Recommended+Practices+for+Selection+and+Use+of+Packaging+Systems&submit=yes&x=0&y=0. Accessed January 16, 2013.

      state: “A formalized program between healthcare organizations and healthcare industry representatives should be established for the receipt and use of loaner instrumentation.”
      A collaborative, well-written policy with specific controls must be in place to ensure successful management of these instruments and implants.
      • Seavey R.
      Loaner instrumentation: SPD and OR working together to manage loaner instrumentation.
      The International Association of Healthcare Central Service Materiel Management (IAHCSMM) agrees

      IAHCSMM position paper on the management of loaner instrumentation. Available from: http://www.iahcsmm.org/CurrentIssues/Loaner_Instrumentation_Position_Paper_Sample_Policy.html. Accessed January 17, 2013.

      that health care facilities that borrow surgical instruments should have a well-developed loaner program and written policy that establishes standardized receipt and use of all loaner instrumentation. Because of the need for consistent controls this policy should be established with input from sterile processing units, surgeons and operating room staff, and various departments such as infection prevention and control, administration, materials management, and risk management. The IAHCSMM sample policy

      IAHCSMM position paper on the management of loaner instrumentation. Available from: http://www.iahcsmm.org/CurrentIssues/Loaner_Instrumentation_Position_Paper_Sample_Policy.html. Accessed January 17, 2013.

      states that health care facilities should have loaner trays at least 2 business days before the scheduled use and, if it is a first-time vendor, the loaned sets should be obtained 3 business days before the scheduled use for in-servicing, inspection, testing, and processing. The IAHCSMM position paper and the policy template can be downloaded from the association’s Web site (www.iahcsmm.org).
      Loaning and borrowing of surgical instruments and implants should be consistently managed according to the written policy of each facility. Tracking loaners, either manually or automatically, is necessary for quality controls as well as asset management of loaners.
      • Seavey R.
      Loaner instrumentation: SPD and OR working together to manage loaner instrumentation.

      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, documentation should be made on an exception form stating the reasons for early release.

      Comprehensive guide to steam sterilization and sterility assurance in health care facilities. ANSI/AAMI ST79:2006 and ANSI/AAMI ST79/A1:2008 (consolidated text). Available from: http://marketplace.aami.org/eseries/scriptcontent/docs/Preview%20Files/ST791110_preview.pdf. Accessed January 16, 2013.

      Recommended practices for selection and use of packaging systems. Association of periOperative Registered Nurses Web site. Available from: http://aornstandards.org/search?fulltext=Recommended+Practices+for+Selection+and+Use+of+Packaging+Systems&submit=yes&x=0&y=0. Accessed January 16, 2013.

      Annex L in ANSI and AAMI ST79

      Comprehensive guide to steam sterilization and sterility assurance in health care facilities. ANSI/AAMI ST79:2006 and ANSI/AAMI ST79/A1:2008 (consolidated text). Available from: http://marketplace.aami.org/eseries/scriptcontent/docs/Preview%20Files/ST791110_preview.pdf. Accessed January 16, 2013.

      gives examples of necessary documentation of premature release of implants.

      Water quality

      Water quality is a vital concern in all steps of reprocessing surgical and medical instruments. The quality of water used is very important to prolong the life of the medical devices as well as minimizing the risk to patients.

      Water for the reprocessing of medical devices. Available from: http://marketplace.aami.org/eseries/scriptcontent/docs/Preview%20Files%5CTIR340710_preview.pdf. Accessed January 16, 2013. P. 37-46.

      There are 2 general methods used to deal with water impurities related to reprocessing of surgical and medical instruments. The first is the use of a water treatment system that reduces or removes impurities before use. The second method involves adding chemicals to address water impurities during the decontamination process.
      • Lyon S.
      Water quality and its impact on the decontamination process.
      Steam quality is affected by the quality of the water being used to generate the steam. Pretreatment of water may be required to eliminate the possibility of residuals or deposits when the steam is used for sterilization, especially in flash sterilization.

      Water for the reprocessing of medical devices. Available from: http://marketplace.aami.org/eseries/scriptcontent/docs/Preview%20Files%5CTIR340710_preview.pdf. Accessed January 16, 2013. P. 37-46.

      Water purification systems

      There are many different types of water purification systems. The most common water treatment is a water softener. A water softener purifies with a process of ion exchange. Other treatments commonly used to purify water are deionization system and reverse osmosis. Deionization removes ions to purify the water and requires tank exchanges. Reverse osmosis purifies by using a semipermable membrane to remove or reduce impurities. Reverse osmosis generally requires more space and has a higher start-up price; however, reverse osmosis systems do not require tank exchanges.

      Water for the reprocessing of medical devices. Available from: http://marketplace.aami.org/eseries/scriptcontent/docs/Preview%20Files%5CTIR340710_preview.pdf. Accessed January 16, 2013. P. 37-46.

      • Lyon S.
      Water quality and its impact on the decontamination process.
      For devices that will come in contact with the bloodstream or sterile areas of the body, high purity water is recommended for the final rinse of the item. Health care facilities should evaluate the water used in the various steps of reprocessing.
      • Lyon S.
      Water quality and its impact on the decontamination process.
      Water impurities can also affect the functionality, effectiveness, and life span of automated reprocessing equipment. There are several tools and test strips available to monitor the quality of water used in sterile processing.
      • Lyon S.
      Water quality and its impact on the decontamination process.
      Sterile processing staff members should work closely with water service maintenance personnel to establish and monitor the water treatment systems used for cleaning, disinfecting, and sterilizing all reusable devices.

      Verification of cleaning

      In the past, health care personnel relied only on visual inspection of the cleaning process. We now have many tools, such as adenosine triphosphate, or protein, that can be used to verify that cleaning processes are adequate. These tests can help us determine if we have done a good job of manually cleaning items and if our automatic washers are working properly.

      Reprocessing intraocular surgical instruments

      Toxic anterior segment syndrome (TASS) is an acute inflammatory response caused when foreign material is introduced into the anterior chamber of the eye. TASS may lead to severe visual impairment or blindness. Special processing considerations are necessary for eye instrumentation because of the nature of the instruments themselves and the sensitive nature of the eye.

      Comprehensive guide to steam sterilization and sterility assurance in health care facilities. ANSI/AAMI ST79:2006 and ANSI/AAMI ST79/A1:2008 (consolidated text). Available from: http://marketplace.aami.org/eseries/scriptcontent/docs/Preview%20Files/ST791110_preview.pdf. Accessed January 16, 2013.

      Annex N of the ANSI and AAMI ST79

      Comprehensive guide to steam sterilization and sterility assurance in health care facilities. ANSI/AAMI ST79:2006 and ANSI/AAMI ST79/A1:2008 (consolidated text). Available from: http://marketplace.aami.org/eseries/scriptcontent/docs/Preview%20Files/ST791110_preview.pdf. Accessed January 16, 2013.

      addresses TASS and the processing of intraocular surgical instruments. According to AAMI, the introduction of TASS may be associated with specific products, such as contaminated balanced salt solution, detergent residues, endotoxins, preservatives, foreign matter, and residues from sterilization processing. Therefore, particular care must be taken in the processing of intraocular surgical instruments. Many eye instruments are complex and delicate and must be cleaned manually. Manual cleaning methods may be less controlled, so additional care must be taken during processing to ensure effective cleaning and rinsing.
      Specific eye instrument cleaning and sterilization recommendations are published by the American Society of Cataract and Refractive Surgery and the American Society of Ophthalmic Registered Nurses. Annex N of AAMI ST79

      Comprehensive guide to steam sterilization and sterility assurance in health care facilities. ANSI/AAMI ST79:2006 and ANSI/AAMI ST79/A1:2008 (consolidated text). Available from: http://marketplace.aami.org/eseries/scriptcontent/docs/Preview%20Files/ST791110_preview.pdf. Accessed January 16, 2013.

      highlights those existing recommendations for reducing the risk of TASS. Important elements of a processing program for intraocular surgical instruments include, but are not limited to, maintaining an adequate inventory of eye instruments, allowing adequate time for processing instruments according to MDM instructions, processing intraocular surgical instruments separately from general surgical instruments in a designated cleaning area with dedicated equipment, and following manufacturers’ current written instructions for the cleaning and sterilization of eye instruments. Auditing the cleaning process will ensure procedures comply with manufacturer instructions and that personnel performing cleaning procedures have received documented training and have demonstrated competency in the cleaning process.

      Comprehensive guide to steam sterilization and sterility assurance in health care facilities. ANSI/AAMI ST79:2006 and ANSI/AAMI ST79/A1:2008 (consolidated text). Available from: http://marketplace.aami.org/eseries/scriptcontent/docs/Preview%20Files/ST791110_preview.pdf. Accessed January 16, 2013.

      Only cleaning agents that have been recommended by the specific eye instrument’s manufacturer should be used on intraocular instruments. Particular attention should be directed toward ensuring that the specified concentration of the recommended cleaning agent and water quality are used. Final rinsing of instruments should be performed with the volume of sterile, distilled, or deionized water recommended by the manufacturer. Single-use brushes of the correct size should be used and then disposed of.

      Comprehensive guide to steam sterilization and sterility assurance in health care facilities. ANSI/AAMI ST79:2006 and ANSI/AAMI ST79/A1:2008 (consolidated text). Available from: http://marketplace.aami.org/eseries/scriptcontent/docs/Preview%20Files/ST791110_preview.pdf. Accessed January 16, 2013.

      Eye instruments should be sterilized using the methods and conditions recommended in the MDM IFU. The sterilization process should be effective, monitored, and documented. AAMI ST79

      Comprehensive guide to steam sterilization and sterility assurance in health care facilities. ANSI/AAMI ST79:2006 and ANSI/AAMI ST79/A1:2008 (consolidated text). Available from: http://marketplace.aami.org/eseries/scriptcontent/docs/Preview%20Files/ST791110_preview.pdf. Accessed January 16, 2013.

      provides detailed recommendations for sterilization processing, including quality control and restrictions regarding the use of flash sterilization.

      Maintenance of processing equipment

      Cleaning and sterilization equipment, boilers, and water filtration systems should be properly maintained. Otherwise, foreign materials such as endotoxins, heavy metals, or chemical contaminants or impurities may be deposited onto the instruments during processing and induce TASS. Because many different materials can elicit a TASS response if they are inadvertently introduced into the anterior chamber of the eye, the importance of following the proper intraocular surgical instrument processing procedures cannot be overemphasized.

      Comprehensive guide to steam sterilization and sterility assurance in health care facilities. ANSI/AAMI ST79:2006 and ANSI/AAMI ST79/A1:2008 (consolidated text). Available from: http://marketplace.aami.org/eseries/scriptcontent/docs/Preview%20Files/ST791110_preview.pdf. Accessed January 16, 2013.

      Conclusions

      Reprocessing plays a very important role in helping to prevent infections. Technology is changing how procedures are performed and requiring more complicated devices to be reprocessed. Published recommended practices are constantly being updated to reflect evidence-based practices and validated practices. Patient safety depends on instruments that are appropriately cared for and effectively reprocessed; therefore, the most current best practices should be identified and followed. Some of the most current issues relating to reprocessing surgical and medical devices are the importance of following the manufacturer’s written IFUs, including cycle parameters; a pan weight not exceeding 25 lb; investigating the reason(s) for wet packs; being aware of updates in packaging; managing loaner instrumentation efficiently; monitoring water quality needs; and handling of intraocular instruments appropriately.

      References

      1. Sterilization of medical devices—information to be provided by the manufacturer for the processing of resterilzable medical devices. ANSI/AAMI ST81:2004/(R)2010. Available from: http://marketplace.aami.org/eseries/scriptcontent/docs/Preview%20Files/ST811003_preview.pdf. Accessed February 12, 2013.

      2. Comprehensive guide to steam sterilization and sterility assurance in health care facilities. ANSI/AAMI ST79:2006 and ANSI/AAMI ST79/A1:2008 (consolidated text). Available from: http://marketplace.aami.org/eseries/scriptcontent/docs/Preview%20Files/ST791110_preview.pdf. Accessed January 16, 2013.

      3. Recommended practices for cleaning and care of surgical instruments and powered equipment. Association of periOperative Registered Nurses Web site. Available from: http://aornstandards.org/search?fulltext=Recommended+Practices+for+Cleaning+and+Care+of+Surgical+Instruments+and+Powered+Equipment&submit=yes&x=8&y=9. Accessed January 16, 2013.

      4. Recommended practices for selection and use of packaging systems. Association of periOperative Registered Nurses Web site. Available from: http://aornstandards.org/search?fulltext=Recommended+Practices+for+Selection+and+Use+of+Packaging+Systems&submit=yes&x=0&y=0. Accessed January 16, 2013.

      5. Recommended practices for sterilization. Association of periOperative Registered Nurses Web site. Available from: http://aornstandards.org/search?fulltext=Recommended+Practices+for+Sterilization&submit=yes&x=0&y=0. Accessed January 16, 2013.

      6. Hospital steam sterilizers. ANSI/AAMI ST78:2008. Available from: http://marketplace.aami.org/eseries/scriptcontent/docs/Preview%20Files/ST80812_preview.pdf. Accessed February 12, 2013.

        • Klacik S.
        It’s about “Time”: extended cycles.
        Healthcare Sterilization Horizons. 2008; 27
      7. New guidance examines process challenge devices.
        AAMI News. Feb 2009; 44: 8
      8. Process challenge devices/test packs for health care facilities. The Association for the Advancement of Medical Instrumentation Web site. Available from: http://marketplace.aami.org/eseries/scriptcontent/docs/Preview%20Files%5CTIR310811_preview.pdf. Accessed January 16, 2013.

        • Seavey R.
        Just say no! Don’t get weighed down by instrument sets that are too heavy.
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        Packaging for sterilization: it’s not just a box, a bag or gift wrapping!.
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        • Seavey R.
        Loaner instrumentation: SPD and OR working together to manage loaner instrumentation.
        Healthcare Purchas News. 2008; 32: 78-92
      9. IAHCSMM position paper on the management of loaner instrumentation. Available from: http://www.iahcsmm.org/CurrentIssues/Loaner_Instrumentation_Position_Paper_Sample_Policy.html. Accessed January 17, 2013.

      10. Water for the reprocessing of medical devices. Available from: http://marketplace.aami.org/eseries/scriptcontent/docs/Preview%20Files%5CTIR340710_preview.pdf. Accessed January 16, 2013. P. 37-46.

        • Lyon S.
        Water quality and its impact on the decontamination process.
        Manag Infect Control. 2008; 8: 82-97