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Recommended Practices for Selection and Use of Packaging Systems
DECEMBER 2000, VOL 72, NO 6
Recommended Practices for Selection and Use of Packaging Systems Editor‘s note: The AORN recommended practim (RPs) are witten by a standing cammihe of the Associuhan composed of AORN members and liaisons from the Centers far Disease Control and Prevention, the Association far Prah?ssianals in Infection Contra1 and Epidemiology, the American Socieiy of Heamcare Central Service Prafesionals, the lntemational Associtron of Healthcare Central Service Materiel Management the American College of Surgeons, and the American Socieiy of Anesthesialogisfs. Each recommended proctice is reviewed and revised as appfapriaie of regular periodic intervals. In 1998, AORN members asked the Recommended Proctim Committee fa develop a mare user-friendly and less reptitious formot far the RPs. ARer careful Consideration of several possible formats, the committee selected the format hey believed would best meet the member‘s criteria. The cammihe then asked AORN members fa campre this proposed famat to the present RP famat and to register a preference for Mure RPs. St@ members in he Center far Nursing Practice at AORN assisted the cammihe by soliciting feedback via the AORN w b site and individual mailings to a sample of the AORN membership. The avemhelming preference was far the new and improved farmat, and in 1999, the AORN Board of Directors approved Ihe new format far publication. Since the AORN Board of Directors‘ approval, nurses in the Center far Nursing Practice have been canverfing the existing RPs to this format. Watch far the new look in the 200 I edition of AORN’s Standards, Recommended Practices, and Guidelines. The following RP is the first in a series of RPs to be published in the new fomaf It is the cammi#ee’s hope that this famat will bener meet member needs and allow for easier implementation in the practice sefting.
T
he following recommended practices were developed by the AORN Recommended Practices Committee and have been approved by the AORN Board of Directors. They were presented as proposed recommended practices for comments by members and others. They are effective Jan 1 , 2001. These recommended practices are intended as achievable recommendations representing what is believed to be an optimal level of practice. Policies and procedures will reflect variations in practice
settings and/or clinical situations that determine the degree to which the recommended practices can be implemented. AORN recognizes the numerous types of settings in which perioperative nurses practice. These recommended practices are intended as guidelines adaptable to various practice settings. These practice settings include traditional ORs, ambulatory surgery units, physicians’ offices, cardiac catheterization suites, endoscopy suites, radiology departments, and all other areas where operative and other invasive procedures may be performed. Purpose: These recommended practices provide guidelines for evaluation, selection, and use of packaging systems for items to be sterilized. These packaging systems include woven fabrics, nonwoven materials, peel pouches of plastic and/or paper, and container systems. Packaging systems should ensure sterility of package contents until opened for use and should permit removal of contents without contamination. RECOMMENDED PRACTICE I
Packaging systems should be evaluated according to the AORN “Recommended practices for the evaluation and selection of products and medical devices used in perioperative practice settings.”’ 1 . Packaging systems should be appropriate to item(s) being sterilized (ie, permit identification of contents; permit complete and secured enclosure of item(s); protect package contents from physical damage; resist tears, punctures, and abrasions; be free of holes; be free of toxic ingredients; be low-linting; permit delivery of contents without contamination; maintain sterility of package contents until opened); be appropriate to the method of sterilization (ie, provide adequate seal integrity; be tamperproof and able to seal only once; provide an adequate
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package contents and packaging material, maintain sterility of package contents until opened, and permit delivery of contents without contamination? Woven, nonwoven, peel pouch package, and some rigid container materials are permeable to EO and do not impede rapid aeration of contents. Woven materials, however, absorb a large amount of the relative humidity needed for EO sterilization, which may prevent adequate penetration of EO to all surfaces of the package contents!
barrier to particulate matter and fluids; be compatible with and able to withstand physical conditions of the sterilization process; permit adequate air removal; allow penetration and removal of sterilant); have a favorable costbenefit ratio; and be used according to manufacturers' instructions?
2. Each facility should evaluate and test the performance of each packaging system before selection and implementation to ensure conditions for sterilization, storage, and handling can be met. RECOMMENDEDM
C
E II
Packaging systems should be compatible with the sterilization process. 1. Packaging systems for steam sterilization should provide adequate air removal, permit steam penetration and direct contact with item(s) surfaces, permit adequate drying, permit use of material compatible (ie, nondegradable) with the sterilization process, and maintain the integrity of the system.
4. Packaging systems for hydrogen peroxide plasma sterilization should be permeable to the process, maintain compatibility (ie, nondegradable, nonabsorptive) with the sterilization process, be made of a material recommended by manufacturers and used according to the manufacturers' instructions, and maintain the integrity of the system.
.
The purpose of packaging systems is to permit sterilization of the package contents, maintain sterility of the contents until the package is opened, and permit delivery of contents without contamination.' The low temperature plasma sterilization process is affected by altitude and peel pouch packaging material.
The purpose of packaging systems is to permit sterilization of the package contents, maintain sterility of the contents until the package is opened, and permit delivery of contents without contamination? Steam sterilization parameters can vary according to humidity, altitude, packaging material, package contents, load, position of item within each sterilizer, size of pack, weight of pack, density of pack, and efficacy of the sterilization cycle.
2. Manufacturers of packaging systems should provide materials data relevant to sterilization. Practice settings should follow manufacturers' instructions for each packaging system for steam Sterilization: 3. Packaging systems for ethylene oxide (EO) should be permeable to EO, moisture, and air; permit aeration; maintain material compatibility (ie, nondegradable) with the sterilization process; and maintain the integrity of the system. The purpose of packaging systems for EO sterilization is to permit sterilization and aeration of
5. Manufacturers of low-temperature plasma sterilizers should provide materials data relevant to peel pouch material. Because the absorption of the plasma sterilant (ie, hydrogen peroxide) could have an adverse affect on the effectiveness of the sterilization process and be absorbed by paper peel pouches, it is recommended that peel pouch material be made with polyester/nonwoven polyolefin laminate.8 RECOMMENDEDPRACTICE 111
Packaging materials should be processed to maintain the properties required for sterilization. 1. Packaging materials should be maintained at room temperature (ie, 18Q C to 22QC [64" F to 72" F]) and at a relative humidity of 35% to 70%. Maintaining room temperature and moisture content of packaging material facilitates steam penetration and prevents superheating during the sterilization process.' 2. Woven materials should be laundered between every
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use for rehydration. Resterilization without laundering may lead to superheating and could be a deterrent to achieving sterilization.’OOverdrying and/or pressing and storage in areas of low humidity may lead to overheating and sterilization failure. Woven packaging that is adequately hydrated should withstand multiple sterilization processes. For barrier quality wrappers, manufacturers’ instructions should be followed for the suggested number of processings.”
3. Reusable textiles should maintain a protective banier throughout the life of the product. Multiple processings eventually will diminish the protective barrier of the material. A method should be established to monitor, control, and determine useful life when reprocessing woven materials. This should include, but not be limited to, the number of sterilization processes and washing cycles that may occur while maintaining the acceptable barrier of the material.’? RECOMMENDED PRACTICE W
Package contents should be assembled, handled, and wrapped in a manner that provides for an aseptic presentation of package contents. 1. The appropriate size wrapping material should be selected to achieve adequate coverage of the item being packaged. It is essential to wrap the item securely to prevent gapping, billowing, and air pockets from forming, which could compromise sterility. Sequential wrapping using two barrier-type wrappers provides a tortuous pathway to impede microbial migration and permits ease of presentation to the sterile field without compromising sterility. A fused or bonded, double-layer, disposable, nonwoven wrapper used according to manufacturers’ recommendations may provide a bacterial barrier comparable to the sequential double wrap, allowing safe and easy presentation to the sterile field. Correct use of a single, disposable, nonwoven wrapper may eliminate the need to double wrap sequentially.” 2 . The technology of woven and nonwoven packaging material is rapidly evolving.“ Individuals involved in product selection should evaluate each specific product’s capability to meet the defined criteria for a packaging system. RECOMMENDED PRA-E
V
1. Peel packages should have as much air removed as possible before sealing. Air acts as a barrier to heat and moisture. Expansion of air may cause rupturing of packages during the sterilization process.” 2. Peel packages should provide a seal of proven integrity and not allow resealing. A break in the seal may allow microorganisms to enter and contaminate package contents.16
3. Peel pouches should be hermetically sealed. Heat is applied to the open end of the peel pouch. Pressure is applied to the mating surfaces of ‘selfsealing’ pouches. During the sterilization process, the seal adhesive ‘cures’ to become a permanent seal.” Packages should be inspected for intact seals before and after sterilization and before use. 4. Double-peel packaging is not routinely required for sterilization; however, double packaging may facilitate containment of multiple small items to be sterilized and facilitate aseptic presentation to the sterile field.lX
5. Double-peel packages should be used in such a manner as to avoid folding the inner package to fit into the outer package. Folding edges of inner peel packages may entrap air and inhibit the sterilization proce~s.‘~ 6. Peel packages made of plastic and paper combinations should be used according to manufacturers’ instructions. During sterilization of doublepeel packages, the paper portions should be placed together to ensure penetration and removal of the sterilant, air, and moisture. Sterilizing agents penetrate paper portions of peel packages, and plastic portions allow items to be viewed.*’ 7. Peel packages should open without tearing, linting. shredding, or delaminating. Contamination of sterile contents can occur due to functional failure of peel packages.”
8. The peel packaging should be compatible with the sterilization process, permit sterilization of the contents, and maintain package sterility until opened.” RECOMMENDED PRACTICE v1
Peel packages should be used according to manufacturers’ instructions.
Rigid container systems should be used according to manufacturers’instructions.
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1. The approved sterilization method and cycle exposure times for each rigid container system should be provided in the manufacturers’ data and instructions. Construction materials and container design may affect compatibility with the sterilization process (eg, penetration of sterilant [gas plasma], release of moisture or sterilant [EO]). Recommendationsrelated to the type of sterilization method vary by the manufacturer. Prevacuum sterilizers may be preferred, as air removal is difficult in gravity displacement sterilizers.’3 Rigid containers have filter and/or valve systems that should be secure and in proper working order before sterilization. The filter plate should be examined for integrity both before installation and after the sterilization process. If the filter is damp or dislodged or has holes, tears, or punctures, the contents should be considered contaminated. It is recommended that only components of the rigid container system specified by the manufacturer and compatible with the system be used in the practice setting.?‘
pressure-sensitive tape and not on the packing material. Peel packages may be labeled on the plastic portion or on the self-sealing tab. Markers used to label packaging systems should be indelible, nonbleeding, and nontoxic. Felt-tip ink pens or a very soft lead pencil may be used?’ RECOMMENDEDP R A M C E VIll
According to the AORN “Recommended practices for sterilization in perioperative practice settings,” shelf life of a packaged sterile item is event related.” 1. The length of time an item is considered sterile depends on the type and configuration of packaging materials used, number of times a package is handled before use, number of personnel who may have handled the package, storage on open or closed shelves, environmental conditions of the storage area (eg, cleanliness, temperature, humidity), and use of dust covers and method of sealing.2y RECOMMENDEDP R A M C E IX
3. The integrity of the rigid container system should be evaluated periodically.
Policies and procedures for the selection and use of packaging systems should be written, reviewed periodically, and readily available within the prac4. The purpose of packaging systems is to permit ster- tice setting. ilization of the package contents, maintain sterility 1. These recommended practices should be used as of contents until the package is opened, and permit guidelines for the development of policies and delivery of contents without contamination.” procedures for packaging. The AORN recommended practices that deal with sterilization and Loosened rivets, improperly maintained valves, protective bamer materials also should be consultworn gaskets, dents, or other compromises to the ed when developing policies and procedures. integrity of the container system will compromise Policies and procedures establish authority, the sterilization process and may not permit the conresponsibility, and accountability for the selection tents to remain sterile or be delivered aseptically.26 and use of packaging systems within the practice setting. Policies and procedures also establish RECOMMENDED PRACTICE VII guidelines for performance improvement activiPackages to be sterilized should be labeled ties to be used in monitoring packaging system according to the policies and procedures of the efficacy. An introduction to related policies and practice setting and according to manufacturers’ procedures should be included in the orientation instructions. and ongoing education of personnel to assist in the 1 . Packaging systems should be labeled before sterdevelopment of knowledge, skills, and behaviors ilization. The label information should include, that affect patient outcomes. but not be limited to, a description of package contents, GLOSSARY initials of the package assembler, and Hydrogen peroxide plasma sterilization: An a lot control number. ionizing hydrogen peroxide gas or cloud or low-temperature plasma produced by exciting a strong elec2. Label information should be documented on trical field over a contained precursor vapor that 1056 AORN JOURNAL
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serves as a sterilizing agent in this type of sterilization process. Nonwoven materials: A sheet, web, or batt of natural and/or synthetic fibers of filaments, excluding paper, that have not been converted into yams and that are not bonded to each other by several means. Packaging systems: A generic term meant to include all types of packaging, such as wrapping materials, pouches, and rigid container systems. Rigid steriliza&on container system: Specifically designed heat-resistant, metal, plastic, or anodized aluminum receptacles used to package items, usually surgical instruments, for sterilization. The lids and/or bottom surfaces contain steam- or gas-permeable, high-efficiency microbial filters. NOTES 1. “Recommended practices for the evaluation and selection of products and medical devices used in perioperative practice settings,” in Standards, Recommended Practices, and Guidelines (Denver: AORN, Inc, 2000) 3 17-320. 2. Association for the Advancement of Medical Instrumentation, “Good hospital practice: Steam sterilization and sterility assurance. ANSYAAMI ST46-1993,”in AAMI Standards and Recommended Practices vol 1.I:Sterilization,part 1 : Sterilization in Health Care Facilities (Arlington, Va: Association for the Advancement of Medical Instrumentation, 1998) 1920; A J Eagleton, “Packaging: Selection and use,” in Sterilization Technologyfor the Health Care Facility, second ed, M Reichert, J H Young, eds (Gaithersburg, M d Aspen Publishers, Inc, 1997) 85. 3. Ibid; L H Nicolette, “Sterilization and disinfection,”in Perioperative Nursing, hiid ed, L K Groah, ed (Stamford, COM: Appleton & Lange, 1996) 169. 4. Eagleton, “Packaging: Selection and use,” 87. 5. Ibid, 85; Association for the Advancement of Medical Instrumentation, “Good hospital practice: Steam sterilizationand
Sequential wrapping: A double-wrapping procedure that creates a package within a package. Superheating: A condition in which dehydrated textiles are subjected to steam sterilization. The package or product becomes too dry and causes destructive effects on the strength of the cloth fibers. Useful life: Length of time, as determined by the manufacturer, for which a product maintains acceptable safety and performance characteristics. The manufacturer should provide materials data to support useful life. Woven textile: A reusable fabric constructed from yams made of natural and/or synthetic fibers or filaments that are woven or knitted together to form a web in a repeated interlocking pattern. A
sterility assurance. ANSYAAMI ST46- 1993,” 19-20. 6. M L Young, “Ethylene oxide sterilization:Recommended practices,’’ in Sterilization Technology for the Health Care Facility, second ed, M Reichert, J H Young, eds (Gaithersburg,Md Aspen Publishers, Inc, 1997) 209-210; Association for the Advancement of Medical Instrumentation, Ethylene Oxide Sterilization in Health Care Facilities: Safety and Effectiveness ANSIIAAMI ST41-1999 (Arlington, Va: Association for the Advancement of Medical Instrumentation, 2000) 27. 7. Eagleton, “Packaging: Selection and use,’’ 85; Nicolette, “Sterilizationand disinfection,” 167. 8. D Alexander, “Packaging: Pouches,” in Sterilization Technologyfor the Health Care Facility, second ed, M Reichert, J H Young, eds (Gaithersburg, Md: Aspen Publishers, Inc, 1997) 69; Eagleton, “Packaging: Selection and use,” 90. 9. Nicolette, “Sterilizationand disinfection,” 169; Association for the Advancement of Medical Instrumentation, “Good hospital practice: Steam sterilizationand sterility assurance. ANSIJAAMI ST46-1993,” 19. 10. Association for the Advancement of Medical
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Instrumentation, “Good hospital practice: Steam sterilizationand sterility assurance. ANSIJAAMI ST46-1993,”20; N Fortunato, Berry & Kohn’s Operating Room Technique, ninth ed (St Louis: Mosby, Inc, 2000) 259; American Society for Healthcare Central Service Professionals,Training Manual for Central Service Technicians (Chicago: American Hospital Association, 1997) 141. 11. Association for the Advancement of Medical Instrumentation,Processing of Reusable Surgical Textilesfor Use in Health Care Facilities ANSIIAAMI ST65-2000 (Arlington,Va: Association for the Advancement of Medical Instrumentation,2000) 2226; Eagleton, “Packaging: Selection and use,” 87; B Stanewick, W Kogut, “Packaging: Textiles,” in Sterilization Technologyfor the Health Care Facility, second ed, M Reichert, J H Young, eds (Gaithersburg, M d Aspen Publishers, Inc, 1997) 82-83. 12. Eagleton, “Packaging: Selection and use,” 85, 87; Stanewick, Kogut, “Packaging: Textiles,” 82,83; “Recommended practices for use and selection of barrier materials for surgical gowns and drapes,” in Standards, Recommended Practices, and Guidelines (Denver: AORN, Inc,
DECEMBER 2000, VOL 72, NO 6
2000) 267-270; Association for the Advancement of Medical Instrumentation, Processing of Reusable Surgical Textiles for Use in Health Care Facilities ANSIIAAMI ST65-2000,25. 13. N Gorrnan-Annis, “Nonwovens,” in Sterilization Technology for the Health Care Facility, second ed, M Reichert, J H Young, eds (Gaithersburg, Md: Aspen Publishers, Inc, 1997) 60; Eagleton, “Packaging: Selection and use,” 8587. 14. Gorrnan-Annis, “Nonwovens,” 61. 15. Fortunato, Berry & Kohn’s Operating Room Technique, ninth ed, 259; Eagleton, “Packaging: Selection and use,” 90; Alexander, “Packaging: Pouches,” 65-66. 16. Alexander, “Packaging: Pouches,” 62, 65-66; Nicolette, “Sterilization and disinfection,” 169170; Fortunato, Berry & Kohn’s Operating Room Technique, ninth ed, 258-259. 17. Alexander, “Packaging: Pouches,” 65-66; American Society for Healthcare Central Service Professionals, Training Manual for Central Service Technicians, 149150. 18. Eagleton, “Packaging: Selection and use,” 90; Nicolette, “Sterilization and disinfection,” 169170. 19. Eagleton, “Packaging: Selection and use,” 90. 20. American Society for Healthcare Central Service Professionals, Training Manual for Central Sendce Technicians, 149150; Nicolette, “Sterilization and disinfection,” 169. 21. Nicolette, “Sterilization and disinfection,” 169; Alexander, “Packaging: Selection and use,” 67.
22. Alexander, “Packaging: Selection and use,” 62-67; American Society for Healthcare Central Service Professionals, Training Manual for Central Service Technicians, 131; Fortunato, Berry & Kohn’s Operating Room Technique,ninth ed, 258-259. 23. ECRI, “Sterilization containers,” in Healthcare Product Comparison System (Plymouth Meeting, Pa: ECRI, August 1997) 2; J Whitbourne, “Packaging: Rigid containers,” in Sterilization Technologyfor the Health Care Facility, second ed, M Reichert, J H Young, eds (Gaithersburg, Md: Aspen Publishers, Inc, 1997) 70-75; Association for the Advancement of Medical Instrumentation, “Guidelines for the selection and use of reusable rigid sterilization container systems for ethylene oxide sterilization and steam sterilization in health care facilities. ANSI/AAMI ST331996,” in M I Standards and Recommended Practices vol I . I : Sterilization,part I : Sterilization in Health Care Facilities (Arlington, Va: Association for the Advancement of Medical Instrumentation, 1998) 185-186; Nicolette, “Sterilization and disinfection,” 170; American Society for Healthcare Central Service Professionals, Training Manual for Central Service Technicians, 152. 24. Association for the Advancement of Medical Instrumentation, “Guidelines for the selection and use of reusable rigid sterilization container systems for ethylene oxide sterilization and steam sterilization in health care facilities. ANSI/AAMI ST33- 1996,” 181-183; Eagleton, “Packaging: Selection and use,” 88; American Society for Healthcare Central
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Service Professionals, Training Manual for Central Service Technicians, 151. 25. Eagleton, “Packaging: Selection and use,” 85. 26. ECRI, “Sterilization containers,’’ 2; American Society for Healthcare Central Service Professionals, Training Manual for Central Service Technicians, 151; Association for the Advancement of Medical Instrumentation, “Guidelines for the selection and use of reusable rigid sterilization container systems for ethylene oxide sterilization and steam sterilization in health care facilities. ANSI/AAMI ST33-1996,” 181. 27. Association for the Advancement of Medical Instrumentation, “Guidelines for the selection and use of reusable rigid sterilization container systems for ethylene oxide sterilization and steam sterilization in health care facilities. ANSI/AAMI ST33-1996,” 182; American Society for Healthcare Central Service Professionals, Training Manual for Central Service Technicians, 154. 28. “Recommended practices for sterilization in perioperative practice settings,” in Standards, Recommended Practices, and Guidelines (Denver: AORN, Inc, 2000) 347-358. 29. Ibid; Association for the Advancement of Medical Instrumentation, Ethylene Oxide Sterilization in Health Care Facilities: Safety and Effectiveness ANSIIAAMI ST41-I 999,33; N F Japp, “Packaging: Shelf life,” in Sterilization Technologyfor the Health Care Facility, second ed, M Reichert, J H Young, eds (Gaithersburg Md: Aspen Publishers, Inc, 1997) 99.
Recommended Practices for Selection and Use of Packaging Systems Editor‘s note: The AORN recommended practim (RPs) are witten by a standing cammihe of the Associuhan composed of AORN members and liaisons from the Centers far Disease Control and Prevention, the Association far Prah?ssianals in Infection Contra1 and Epidemiology, the American Socieiy of Heamcare Central Service Prafesionals, the lntemational Associtron of Healthcare Central Service Materiel Management the American College of Surgeons, and the American Socieiy of Anesthesialogisfs. Each recommended proctice is reviewed and revised as appfapriaie of regular periodic intervals. In 1998, AORN members asked the Recommended Proctim Committee fa develop a mare user-friendly and less reptitious formot far the RPs. ARer careful Consideration of several possible formats, the committee selected the format hey believed would best meet the member‘s criteria. The cammihe then asked AORN members fa campre this proposed famat to the present RP famat and to register a preference for Mure RPs. St@ members in he Center far Nursing Practice at AORN assisted the cammihe by soliciting feedback via the AORN w b site and individual mailings to a sample of the AORN membership. The avemhelming preference was far the new and improved farmat, and in 1999, the AORN Board of Directors approved Ihe new format far publication. Since the AORN Board of Directors‘ approval, nurses in the Center far Nursing Practice have been canverfing the existing RPs to this format. Watch far the new look in the 200 I edition of AORN’s Standards, Recommended Practices, and Guidelines. The following RP is the first in a series of RPs to be published in the new fomaf It is the cammi#ee’s hope that this famat will bener meet member needs and allow for easier implementation in the practice sefting.
T
he following recommended practices were developed by the AORN Recommended Practices Committee and have been approved by the AORN Board of Directors. They were presented as proposed recommended practices for comments by members and others. They are effective Jan 1 , 2001. These recommended practices are intended as achievable recommendations representing what is believed to be an optimal level of practice. Policies and procedures will reflect variations in practice
settings and/or clinical situations that determine the degree to which the recommended practices can be implemented. AORN recognizes the numerous types of settings in which perioperative nurses practice. These recommended practices are intended as guidelines adaptable to various practice settings. These practice settings include traditional ORs, ambulatory surgery units, physicians’ offices, cardiac catheterization suites, endoscopy suites, radiology departments, and all other areas where operative and other invasive procedures may be performed. Purpose: These recommended practices provide guidelines for evaluation, selection, and use of packaging systems for items to be sterilized. These packaging systems include woven fabrics, nonwoven materials, peel pouches of plastic and/or paper, and container systems. Packaging systems should ensure sterility of package contents until opened for use and should permit removal of contents without contamination. RECOMMENDED PRACTICE I
Packaging systems should be evaluated according to the AORN “Recommended practices for the evaluation and selection of products and medical devices used in perioperative practice settings.”’ 1 . Packaging systems should be appropriate to item(s) being sterilized (ie, permit identification of contents; permit complete and secured enclosure of item(s); protect package contents from physical damage; resist tears, punctures, and abrasions; be free of holes; be free of toxic ingredients; be low-linting; permit delivery of contents without contamination; maintain sterility of package contents until opened); be appropriate to the method of sterilization (ie, provide adequate seal integrity; be tamperproof and able to seal only once; provide an adequate
1052 AORN JOURNAL
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.
package contents and packaging material, maintain sterility of package contents until opened, and permit delivery of contents without contamination? Woven, nonwoven, peel pouch package, and some rigid container materials are permeable to EO and do not impede rapid aeration of contents. Woven materials, however, absorb a large amount of the relative humidity needed for EO sterilization, which may prevent adequate penetration of EO to all surfaces of the package contents!
barrier to particulate matter and fluids; be compatible with and able to withstand physical conditions of the sterilization process; permit adequate air removal; allow penetration and removal of sterilant); have a favorable costbenefit ratio; and be used according to manufacturers' instructions?
2. Each facility should evaluate and test the performance of each packaging system before selection and implementation to ensure conditions for sterilization, storage, and handling can be met. RECOMMENDEDM
C
E II
Packaging systems should be compatible with the sterilization process. 1. Packaging systems for steam sterilization should provide adequate air removal, permit steam penetration and direct contact with item(s) surfaces, permit adequate drying, permit use of material compatible (ie, nondegradable) with the sterilization process, and maintain the integrity of the system.
4. Packaging systems for hydrogen peroxide plasma sterilization should be permeable to the process, maintain compatibility (ie, nondegradable, nonabsorptive) with the sterilization process, be made of a material recommended by manufacturers and used according to the manufacturers' instructions, and maintain the integrity of the system.
.
The purpose of packaging systems is to permit sterilization of the package contents, maintain sterility of the contents until the package is opened, and permit delivery of contents without contamination.' The low temperature plasma sterilization process is affected by altitude and peel pouch packaging material.
The purpose of packaging systems is to permit sterilization of the package contents, maintain sterility of the contents until the package is opened, and permit delivery of contents without contamination? Steam sterilization parameters can vary according to humidity, altitude, packaging material, package contents, load, position of item within each sterilizer, size of pack, weight of pack, density of pack, and efficacy of the sterilization cycle.
2. Manufacturers of packaging systems should provide materials data relevant to sterilization. Practice settings should follow manufacturers' instructions for each packaging system for steam Sterilization: 3. Packaging systems for ethylene oxide (EO) should be permeable to EO, moisture, and air; permit aeration; maintain material compatibility (ie, nondegradable) with the sterilization process; and maintain the integrity of the system. The purpose of packaging systems for EO sterilization is to permit sterilization and aeration of
5. Manufacturers of low-temperature plasma sterilizers should provide materials data relevant to peel pouch material. Because the absorption of the plasma sterilant (ie, hydrogen peroxide) could have an adverse affect on the effectiveness of the sterilization process and be absorbed by paper peel pouches, it is recommended that peel pouch material be made with polyester/nonwoven polyolefin laminate.8 RECOMMENDEDPRACTICE 111
Packaging materials should be processed to maintain the properties required for sterilization. 1. Packaging materials should be maintained at room temperature (ie, 18Q C to 22QC [64" F to 72" F]) and at a relative humidity of 35% to 70%. Maintaining room temperature and moisture content of packaging material facilitates steam penetration and prevents superheating during the sterilization process.' 2. Woven materials should be laundered between every
1053 AORN JOURNAL
DECEMBER 2000, VOL 72, NO 6
use for rehydration. Resterilization without laundering may lead to superheating and could be a deterrent to achieving sterilization.’OOverdrying and/or pressing and storage in areas of low humidity may lead to overheating and sterilization failure. Woven packaging that is adequately hydrated should withstand multiple sterilization processes. For barrier quality wrappers, manufacturers’ instructions should be followed for the suggested number of processings.”
3. Reusable textiles should maintain a protective banier throughout the life of the product. Multiple processings eventually will diminish the protective barrier of the material. A method should be established to monitor, control, and determine useful life when reprocessing woven materials. This should include, but not be limited to, the number of sterilization processes and washing cycles that may occur while maintaining the acceptable barrier of the material.’? RECOMMENDED PRACTICE W
Package contents should be assembled, handled, and wrapped in a manner that provides for an aseptic presentation of package contents. 1. The appropriate size wrapping material should be selected to achieve adequate coverage of the item being packaged. It is essential to wrap the item securely to prevent gapping, billowing, and air pockets from forming, which could compromise sterility. Sequential wrapping using two barrier-type wrappers provides a tortuous pathway to impede microbial migration and permits ease of presentation to the sterile field without compromising sterility. A fused or bonded, double-layer, disposable, nonwoven wrapper used according to manufacturers’ recommendations may provide a bacterial barrier comparable to the sequential double wrap, allowing safe and easy presentation to the sterile field. Correct use of a single, disposable, nonwoven wrapper may eliminate the need to double wrap sequentially.” 2 . The technology of woven and nonwoven packaging material is rapidly evolving.“ Individuals involved in product selection should evaluate each specific product’s capability to meet the defined criteria for a packaging system. RECOMMENDED PRA-E
V
1. Peel packages should have as much air removed as possible before sealing. Air acts as a barrier to heat and moisture. Expansion of air may cause rupturing of packages during the sterilization process.” 2. Peel packages should provide a seal of proven integrity and not allow resealing. A break in the seal may allow microorganisms to enter and contaminate package contents.16
3. Peel pouches should be hermetically sealed. Heat is applied to the open end of the peel pouch. Pressure is applied to the mating surfaces of ‘selfsealing’ pouches. During the sterilization process, the seal adhesive ‘cures’ to become a permanent seal.” Packages should be inspected for intact seals before and after sterilization and before use. 4. Double-peel packaging is not routinely required for sterilization; however, double packaging may facilitate containment of multiple small items to be sterilized and facilitate aseptic presentation to the sterile field.lX
5. Double-peel packages should be used in such a manner as to avoid folding the inner package to fit into the outer package. Folding edges of inner peel packages may entrap air and inhibit the sterilization proce~s.‘~ 6. Peel packages made of plastic and paper combinations should be used according to manufacturers’ instructions. During sterilization of doublepeel packages, the paper portions should be placed together to ensure penetration and removal of the sterilant, air, and moisture. Sterilizing agents penetrate paper portions of peel packages, and plastic portions allow items to be viewed.*’ 7. Peel packages should open without tearing, linting. shredding, or delaminating. Contamination of sterile contents can occur due to functional failure of peel packages.”
8. The peel packaging should be compatible with the sterilization process, permit sterilization of the contents, and maintain package sterility until opened.” RECOMMENDED PRACTICE v1
Peel packages should be used according to manufacturers’ instructions.
Rigid container systems should be used according to manufacturers’instructions.
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1. The approved sterilization method and cycle exposure times for each rigid container system should be provided in the manufacturers’ data and instructions. Construction materials and container design may affect compatibility with the sterilization process (eg, penetration of sterilant [gas plasma], release of moisture or sterilant [EO]). Recommendationsrelated to the type of sterilization method vary by the manufacturer. Prevacuum sterilizers may be preferred, as air removal is difficult in gravity displacement sterilizers.’3 Rigid containers have filter and/or valve systems that should be secure and in proper working order before sterilization. The filter plate should be examined for integrity both before installation and after the sterilization process. If the filter is damp or dislodged or has holes, tears, or punctures, the contents should be considered contaminated. It is recommended that only components of the rigid container system specified by the manufacturer and compatible with the system be used in the practice setting.?‘
pressure-sensitive tape and not on the packing material. Peel packages may be labeled on the plastic portion or on the self-sealing tab. Markers used to label packaging systems should be indelible, nonbleeding, and nontoxic. Felt-tip ink pens or a very soft lead pencil may be used?’ RECOMMENDEDP R A M C E VIll
According to the AORN “Recommended practices for sterilization in perioperative practice settings,” shelf life of a packaged sterile item is event related.” 1. The length of time an item is considered sterile depends on the type and configuration of packaging materials used, number of times a package is handled before use, number of personnel who may have handled the package, storage on open or closed shelves, environmental conditions of the storage area (eg, cleanliness, temperature, humidity), and use of dust covers and method of sealing.2y RECOMMENDEDP R A M C E IX
3. The integrity of the rigid container system should be evaluated periodically.
Policies and procedures for the selection and use of packaging systems should be written, reviewed periodically, and readily available within the prac4. The purpose of packaging systems is to permit ster- tice setting. ilization of the package contents, maintain sterility 1. These recommended practices should be used as of contents until the package is opened, and permit guidelines for the development of policies and delivery of contents without contamination.” procedures for packaging. The AORN recommended practices that deal with sterilization and Loosened rivets, improperly maintained valves, protective bamer materials also should be consultworn gaskets, dents, or other compromises to the ed when developing policies and procedures. integrity of the container system will compromise Policies and procedures establish authority, the sterilization process and may not permit the conresponsibility, and accountability for the selection tents to remain sterile or be delivered aseptically.26 and use of packaging systems within the practice setting. Policies and procedures also establish RECOMMENDED PRACTICE VII guidelines for performance improvement activiPackages to be sterilized should be labeled ties to be used in monitoring packaging system according to the policies and procedures of the efficacy. An introduction to related policies and practice setting and according to manufacturers’ procedures should be included in the orientation instructions. and ongoing education of personnel to assist in the 1 . Packaging systems should be labeled before sterdevelopment of knowledge, skills, and behaviors ilization. The label information should include, that affect patient outcomes. but not be limited to, a description of package contents, GLOSSARY initials of the package assembler, and Hydrogen peroxide plasma sterilization: An a lot control number. ionizing hydrogen peroxide gas or cloud or low-temperature plasma produced by exciting a strong elec2. Label information should be documented on trical field over a contained precursor vapor that 1056 AORN JOURNAL
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serves as a sterilizing agent in this type of sterilization process. Nonwoven materials: A sheet, web, or batt of natural and/or synthetic fibers of filaments, excluding paper, that have not been converted into yams and that are not bonded to each other by several means. Packaging systems: A generic term meant to include all types of packaging, such as wrapping materials, pouches, and rigid container systems. Rigid steriliza&on container system: Specifically designed heat-resistant, metal, plastic, or anodized aluminum receptacles used to package items, usually surgical instruments, for sterilization. The lids and/or bottom surfaces contain steam- or gas-permeable, high-efficiency microbial filters. NOTES 1. “Recommended practices for the evaluation and selection of products and medical devices used in perioperative practice settings,” in Standards, Recommended Practices, and Guidelines (Denver: AORN, Inc, 2000) 3 17-320. 2. Association for the Advancement of Medical Instrumentation, “Good hospital practice: Steam sterilization and sterility assurance. ANSYAAMI ST46-1993,”in AAMI Standards and Recommended Practices vol 1.I:Sterilization,part 1 : Sterilization in Health Care Facilities (Arlington, Va: Association for the Advancement of Medical Instrumentation, 1998) 1920; A J Eagleton, “Packaging: Selection and use,” in Sterilization Technologyfor the Health Care Facility, second ed, M Reichert, J H Young, eds (Gaithersburg, M d Aspen Publishers, Inc, 1997) 85. 3. Ibid; L H Nicolette, “Sterilization and disinfection,”in Perioperative Nursing, hiid ed, L K Groah, ed (Stamford, COM: Appleton & Lange, 1996) 169. 4. Eagleton, “Packaging: Selection and use,” 87. 5. Ibid, 85; Association for the Advancement of Medical Instrumentation, “Good hospital practice: Steam sterilizationand
Sequential wrapping: A double-wrapping procedure that creates a package within a package. Superheating: A condition in which dehydrated textiles are subjected to steam sterilization. The package or product becomes too dry and causes destructive effects on the strength of the cloth fibers. Useful life: Length of time, as determined by the manufacturer, for which a product maintains acceptable safety and performance characteristics. The manufacturer should provide materials data to support useful life. Woven textile: A reusable fabric constructed from yams made of natural and/or synthetic fibers or filaments that are woven or knitted together to form a web in a repeated interlocking pattern. A
sterility assurance. ANSYAAMI ST46- 1993,” 19-20. 6. M L Young, “Ethylene oxide sterilization:Recommended practices,’’ in Sterilization Technology for the Health Care Facility, second ed, M Reichert, J H Young, eds (Gaithersburg,Md Aspen Publishers, Inc, 1997) 209-210; Association for the Advancement of Medical Instrumentation, Ethylene Oxide Sterilization in Health Care Facilities: Safety and Effectiveness ANSIIAAMI ST41-1999 (Arlington, Va: Association for the Advancement of Medical Instrumentation, 2000) 27. 7. Eagleton, “Packaging: Selection and use,’’ 85; Nicolette, “Sterilizationand disinfection,” 167. 8. D Alexander, “Packaging: Pouches,” in Sterilization Technologyfor the Health Care Facility, second ed, M Reichert, J H Young, eds (Gaithersburg, Md: Aspen Publishers, Inc, 1997) 69; Eagleton, “Packaging: Selection and use,” 90. 9. Nicolette, “Sterilizationand disinfection,” 169; Association for the Advancement of Medical Instrumentation, “Good hospital practice: Steam sterilizationand sterility assurance. ANSIJAAMI ST46-1993,” 19. 10. Association for the Advancement of Medical
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Instrumentation, “Good hospital practice: Steam sterilizationand sterility assurance. ANSIJAAMI ST46-1993,”20; N Fortunato, Berry & Kohn’s Operating Room Technique, ninth ed (St Louis: Mosby, Inc, 2000) 259; American Society for Healthcare Central Service Professionals,Training Manual for Central Service Technicians (Chicago: American Hospital Association, 1997) 141. 11. Association for the Advancement of Medical Instrumentation,Processing of Reusable Surgical Textilesfor Use in Health Care Facilities ANSIIAAMI ST65-2000 (Arlington,Va: Association for the Advancement of Medical Instrumentation,2000) 2226; Eagleton, “Packaging: Selection and use,” 87; B Stanewick, W Kogut, “Packaging: Textiles,” in Sterilization Technologyfor the Health Care Facility, second ed, M Reichert, J H Young, eds (Gaithersburg, M d Aspen Publishers, Inc, 1997) 82-83. 12. Eagleton, “Packaging: Selection and use,” 85, 87; Stanewick, Kogut, “Packaging: Textiles,” 82,83; “Recommended practices for use and selection of barrier materials for surgical gowns and drapes,” in Standards, Recommended Practices, and Guidelines (Denver: AORN, Inc,
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2000) 267-270; Association for the Advancement of Medical Instrumentation, Processing of Reusable Surgical Textiles for Use in Health Care Facilities ANSIIAAMI ST65-2000,25. 13. N Gorrnan-Annis, “Nonwovens,” in Sterilization Technology for the Health Care Facility, second ed, M Reichert, J H Young, eds (Gaithersburg, Md: Aspen Publishers, Inc, 1997) 60; Eagleton, “Packaging: Selection and use,” 8587. 14. Gorrnan-Annis, “Nonwovens,” 61. 15. Fortunato, Berry & Kohn’s Operating Room Technique, ninth ed, 259; Eagleton, “Packaging: Selection and use,” 90; Alexander, “Packaging: Pouches,” 65-66. 16. Alexander, “Packaging: Pouches,” 62, 65-66; Nicolette, “Sterilization and disinfection,” 169170; Fortunato, Berry & Kohn’s Operating Room Technique, ninth ed, 258-259. 17. Alexander, “Packaging: Pouches,” 65-66; American Society for Healthcare Central Service Professionals, Training Manual for Central Service Technicians, 149150. 18. Eagleton, “Packaging: Selection and use,” 90; Nicolette, “Sterilization and disinfection,” 169170. 19. Eagleton, “Packaging: Selection and use,” 90. 20. American Society for Healthcare Central Service Professionals, Training Manual for Central Sendce Technicians, 149150; Nicolette, “Sterilization and disinfection,” 169. 21. Nicolette, “Sterilization and disinfection,” 169; Alexander, “Packaging: Selection and use,” 67.
22. Alexander, “Packaging: Selection and use,” 62-67; American Society for Healthcare Central Service Professionals, Training Manual for Central Service Technicians, 131; Fortunato, Berry & Kohn’s Operating Room Technique,ninth ed, 258-259. 23. ECRI, “Sterilization containers,” in Healthcare Product Comparison System (Plymouth Meeting, Pa: ECRI, August 1997) 2; J Whitbourne, “Packaging: Rigid containers,” in Sterilization Technologyfor the Health Care Facility, second ed, M Reichert, J H Young, eds (Gaithersburg, Md: Aspen Publishers, Inc, 1997) 70-75; Association for the Advancement of Medical Instrumentation, “Guidelines for the selection and use of reusable rigid sterilization container systems for ethylene oxide sterilization and steam sterilization in health care facilities. ANSI/AAMI ST331996,” in M I Standards and Recommended Practices vol I . I : Sterilization,part I : Sterilization in Health Care Facilities (Arlington, Va: Association for the Advancement of Medical Instrumentation, 1998) 185-186; Nicolette, “Sterilization and disinfection,” 170; American Society for Healthcare Central Service Professionals, Training Manual for Central Service Technicians, 152. 24. Association for the Advancement of Medical Instrumentation, “Guidelines for the selection and use of reusable rigid sterilization container systems for ethylene oxide sterilization and steam sterilization in health care facilities. ANSI/AAMI ST33- 1996,” 181-183; Eagleton, “Packaging: Selection and use,” 88; American Society for Healthcare Central
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Service Professionals, Training Manual for Central Service Technicians, 151. 25. Eagleton, “Packaging: Selection and use,” 85. 26. ECRI, “Sterilization containers,’’ 2; American Society for Healthcare Central Service Professionals, Training Manual for Central Service Technicians, 151; Association for the Advancement of Medical Instrumentation, “Guidelines for the selection and use of reusable rigid sterilization container systems for ethylene oxide sterilization and steam sterilization in health care facilities. ANSI/AAMI ST33-1996,” 181. 27. Association for the Advancement of Medical Instrumentation, “Guidelines for the selection and use of reusable rigid sterilization container systems for ethylene oxide sterilization and steam sterilization in health care facilities. ANSI/AAMI ST33-1996,” 182; American Society for Healthcare Central Service Professionals, Training Manual for Central Service Technicians, 154. 28. “Recommended practices for sterilization in perioperative practice settings,” in Standards, Recommended Practices, and Guidelines (Denver: AORN, Inc, 2000) 347-358. 29. Ibid; Association for the Advancement of Medical Instrumentation, Ethylene Oxide Sterilization in Health Care Facilities: Safety and Effectiveness ANSIIAAMI ST41-I 999,33; N F Japp, “Packaging: Shelf life,” in Sterilization Technologyfor the Health Care Facility, second ed, M Reichert, J H Young, eds (Gaithersburg Md: Aspen Publishers, Inc, 1997) 99.