1 AST Standards of Practice for Packaging Material and Preparing Items for Sterilization Introduction arched and authored by the AST Education The following Standards of Practice were rese and Professional Standards Committee and ha ve been approved by the AST Board of Directors. They are effective October 19, 2009. re facilities in the ice to support healthca AST developed the following Standards of Pract reinforcement of best practices related to th e selection and use of packaging material for the sterilization of items, incl istics that are important to uding evaluation of the character the selection of the packaging material. recommendations are Additionally, general ms for sterilization. The purpose of the provided regarding the preparation of ite rtified Surgical Technologists (CSTs) and Standards is to provide an outline that Ce Certified Surgical First Assistants (CSFAs) can use to development and implement ackaging material a policies and procedures for p nd preparing items for sterilization. The Standards are presented with the understandi ng that it is the responsibility of the healthcare facility to develop, approve, and establish policies and procedures for evaluating packaging material according to esta blished healthy care faci lity protocols. Rationale d to the evaluation, selection and use of The following are Standards of Practice relate tting, including general recommendations for packaging material in the perioperative se the preparation of items for sterilization. The four overall purposes of any type of packaging system is to ensure the packagi ng material allows the penetration of the sterilant, maintains the sterility of the contents until opened for use, and allows ease of nd are cost effective. There are a variety of use in order to open in an aseptic manner, a packaging systems, including woven fabric s, nonwoven materials, plastic-plastic pouches, paper-plastic pouches (commonly ca lled peel packs), and rigid instrument containers. Standard of Practice I Packaging materials should be evaluated prior to adoption and purchase. This includes receiving samples of the packaging material as test products to ensure it will meet the performance standard s of the healthcare facility. 1. Packaging materials and seals should ha ve the following general characteristics: A. Allow the sterilizing agent to penetr ate and reach all surface areas of the item(s) to be sterilized. B. Maintain the sterility of the item up until its use; perform as a reliable barrier to microorganisms.
2 C. Permit the package to be opened in an aseptic manner that allows for ansferred to the sterile field without sterile items to be easily removed or tr contamination. Conform to the size and D. shape of the item(s). E. Cover the contents in their entirety. F. Provide for maximum amount of use. Allow air to be completely removed G. during the sterilization process. Withstand the physical conditions pr oduced by the autoclave, including H. moisture, pressure and high temperatures. I. Be permeable to the sterilizing agent and moisture. Allow the escape and removal of the st erilizing agent at the end of the J. sterilization process. K. Allow the contents to be dried afte r sterilization with no presence of also have the characteristic of moisture. The packaging material must t packages upon removal from the being able to be dried to avoid we sterilizer. This is particularly important when using ethylene oxide sterilization, since water comb ined with EtO can produce toxic byproducts. Allow ethylene oxide gas and moisture to escape during the aeration cycle, L. when using ethylene oxide sterilization. M. sterilization and normal handling. Resist tears and punctures, during N. Should not easily degrade when the sterile packages are stored. O. Provide a barrier to the penetration of dust and particles, and resist moisture penetration. P. Woven fabrics should be lint free and also free of loose fibers. or dyes that could produce a chemical Q. Must not contain any toxic material reaction during the sterilization proc ess. The toxic residue could be harmful to the patient and the members of the surgical team, who are handling the packaging material, an d sterile team members, who are handling the contents. Reusable packaging materials should be free of bleaches and detergents R. during the steriliz ation process. that could produce a chemical reaction The toxic residue could be harmful to the patient and the members of the surgical team, who are handling the p ackaging material ,and sterile team members, who are handling the contents, as well as cause instrument discoloration. S. Promote integrity of the seal that is used to secure items, so that content sterility is maintained. The seal shou ld not spontaneously open, when the package is in sterile storage. T. Incapable of being re-seale or package is opened. d, once the seal is broken Specific characteristics related to rigid container systems are: 2. A. Easily open and provide for excellent sterile presentation of contents. B. Contain a removable lid that is sealable with some type of locking device. C. Broken locking device should be readily apparent. D. Manufactured of a sturdy anodized alum inum, stainless steel, plastic or plastic-metal combination.
3 E. Allow removal of all moisture and prevent collection of water in bottom of container. F. Be permeable to the sterilizing agent and moisture Allow complete removal of the steriliz ing agent and drying of the contents G. and container itself. H. Allow for easy, aseptic removal of the st erile contents for use on the sterile field. 3. paper-plastic peel packs are: Specific characteristic related to Thickness of the plastic layer must be a minimum of 2 mm. A. B. Plastic side should allow visu alization of the content(s). C. Pouch should be commercially heat sealed along the edges lengthwise. One end may be commercially heat sealed with the other end open for zed, and the open end is either heat- placement of the item(s) to be sterili sealed, adhesive self-seale d or sealed with chemical indicator tape. Or the at must be heat-sealed. pouch may have two open ends th D. The peel pack must allow the open e nd to be easily sealed to prevent tunneling (incomplete contact) of the seal. E. Peel pack material must allow for total air removal. F. Be permeable to the sterilizing agent and moisture. G. Peel pack material must allow for complete removal of the sterilizing agent. H. Peel pack material must allow for complete drying of the contents and drying of the packagi ng material itself. I. be opened in an aseptic manner that Peel pack must permit the package to erile items without contamination. allows for easy removal of the st When evaluating packaging material or a packaging system, the healthcare 4. facility should request and review the manufacturer’s information to ensure it is appropriate for the method of sterilization to be used, and to review and maintain ation validation studies. a written copy of the steriliz 5. mple of the packagin g product to evaluate Healthcare facilities should request a sa and test the efficacy prior to making a selection and purchasing. The product should be tested in a manner to determine that it meets all the general and specific performance characteristics unique to the packaging material, including sterilization parameters with the use of a biological indicator and recording of the results. Standard of Practice II Rigid containers, including instrument cases and plastic-metal combination instrument organizing trays, should be eval uated for design and construction prior to final selection and purchase. 1. When evaluating the rigid container system , the healthcare facility should request and review the manufacturer’s informati on to ensure it is appropriate for the method of sterilization to be used, and to review and maintain a written copy of the sterilization validation studies. 2. Biological and chemical i ndicator testing of the c ontainer system should be performed according to the Associa tion for the Advancement of Medical
4 Instrumentation (AAMI) standards. The c ontainer should be tested according to the type of sterilizing agent(s) that will be used and the cycles to be used. 3. Evaluation of the container system should include: Verifying manufacturer’s test A. and validation study results. B. Verifying that the container syst em meets all the prerequisite penetration of characteristics, including allowing co mplete air removal, the sterilizing agent, dr ying, ease of opening in an aseptic manner, user friendly sealing, ease of changing filters, ease of disassembly and decontamination. C. Verify container system has been approved by the US Food and Drug Administration for ster ilization purposes. D. Verify efficacy of single use filters and valve systems. 4. As recommended by AAMI, the manufactur er should provide instructions and documentation related to the tested performance qualifications and written instructions for the use of the container system including: A. Manufacturer’s recommendations relate d to the type of sterilization method can vary. Example, a manufacturer may indicate that a container system should only be used with pre-vacuum cycle because of the difficulty of air removal associated with gravity cycle. B. Methods for verifying sterilization c onditions including penetration of the sterilant, time, placement of the biologi cal and chemical indicators, drying times and aeration times. Example, a manufacturer may recommend extended sterilization and drying times for a container system. C. Recommendations related to the placem ent and uniform distribution of the instruments/contents, including weight and density. D. Methods recommended by the manufact urer for verifying testing the intenance of filters and valves. barrier effectiveness and sterility ma Manufacturer’s recommendations for di sassembly of container system for E. decontamination, including recomme nded type of cleaning agents; inspection, maintenance and re-assembly of gaskets, filter covers, and ces; placement of the cont valves; use of sealing devi ainer on the sterilizing cart; handling, transportation and stor age after sterilization process. Selection factors to consider when 5. evaluating a container system include: A. Content visibility. If container lid is not semi-transparent, visibility of the contents and inner basket upon removal of the lid. B. an easy manner employing aseptic Removal of contents can be done in technique. C. s of container system, if needed. Manufacturer can provide varying size D. Estimated life expectancy of the container system. E. Cost analysis, including cons ideration of the following: (1) Comparison of rigid containe r system to CSR wrappers, including costs relate d to labor, capital and materials for both. (2) Labor costs associated with contai ner systems, related to the time required to clean, inspect and assemble
5 (3) supplies for the container system, Analysis of cost of ancillary bels and specific cleaning agent, including seals/locks, filters, la and cost of replacement parts such as worn out gaskets. Availability of manufactur er’s refurbishing services. F. G. Ease of assembling container. H. Ease of identifying worn out parts that need replacing, such as worn out gaskets and filter-retention-plates. Manufacturer recommended maximu m weight of container with I. instruments. J. Manufacturer recommended guidelines, related to how the containers should be handled when loading and removing from autoclave. K. available for cool-down of the Manufacturer’s recommendations are container, after removal from the autoclave. the manufacturer, concerning L. Any special recommendations from necessity to preheat load prior to in itiation of the ster ilization cycle in order to ensure a dry set at the end of the cycle. Manufacturer recommendation for lengt h of time load with containers M. ber to dry before removal. should be left in the autoclave cham Standard of Practice III Packaging and container systems should only be used with the sterilization process for which it was manufactured. 1. Packaging and container systems for st eam sterilization should be able to withstand the physical conditions without breaking down and also allow adequate drying. A. Healthcare workers (HCWs) should follo w the manufacture r’s instructions 4 for the use of the steam sterilization packaging and container systems. B. Several factors should be considered by the healthcare facility that can and container systems. Appropriate affect the efficacy of the packaging aring items for steam sterilization. adjustments should be made when prep Factors include: Altitude (1) (2) Humidity of environment (3) Size of package or container (4) Contents of package or container (5) Weight and density of the package or container Paper-plastic combination peel packs should be used for steam C. sterilization. Tyvek® combination peel packs should not be used for steam D. sterilization. (1) Tyvek is a flammable material in steam sterilization; steam melts and/or burns the material. able to withstand Packaging and container systems for EtO st erilization should be 2. the physical conditions wit hout breaking down as well as allow penetration of 2 EtO and moisture, and allow for proper aeration.
6 A. instructions for the use of the HCWs should follow the manufacturer’s 2 EtO sterilization packaging and container systems. Paper-plastic combination peel packs can be used for EtO sterilization. B. used for EtO sterilization. Tyvek combination peel packs can be C. 3. Packaging and container systems for gas plasma sterilization should be able to withstand the physical conditions, wit hout breaking down as well as allow plasma sterilizing agent. penetration of the hydrogen peroxide A. The manufacturer’s written instructions should be followed for the use of packaging materials and container systems that are compatible for gas plasma sterilization. Not all packagin g materials and container systems can be used with gas plasma ster ilization. HCWs should refer to the nd results of studies verifying the manufacturer’s written information a ’s use in gas plasma sterilization. packaging material or container system The use of absorbable packagi (1) ng material should be avoided; paper material and textiles can absorb the gas plasma ecreasing the effectivene sterilization, thus d ss of the sterilization 3 process. (2) Only peel pack pouches that are entirely plastic (no paper is 6 present) should be used in gas plasma sterilization. For container systems that requir (3) ilter should be e a filter, the f 6 made of non-cellulose material. 4. Packaging and container systems for oz one sterilization should be able to withstand the physical conditions wi thout breaking down and also permit sterilizing agent. penetration of the ozone The manufacturer’s written instructions should be followed for the use of A. ems that are compatible for ozone packaging materials and container syst sterilization. Not all packaging mate rials and container systems can be used with ozone sterilization. HCWs should refer to the manufacturer’s written information and results of studies verifying the packaging material or container system’s use in ozone sterilization. 6 material for ozone sterilization. B. Tyvek is the recommended packaging Standard of Practice IV Reusable packaging materials should be laundered, inspected and properly stored between every use to preserve the packaging properties of the mate rial. Single-use packaging materials should be properly st ored to preserve the packaging properties of the material. 1. Reusable woven packaging materials must be laundered and inspected between each use. Laundering aids in rehydration of the packaging material. Experience has shown that if the packaging produc t is too dry, superheating during steam 5 ogical indicators can result. sterilization and positive biol A. All woven packaging material should be de-linted prior to use. B. All woven packaging material should be inspected for holes, tears, and thinning of the material each time af ter laundering. It is recommended the inspection take place with the use of a lighted table. Defects should be
7 repaired with the use of a vulcanized patch that is heat sealed onto the on each side of the defect. woven material. A patch should be placed Defects should not be sewn. The needle from sewing creates multiple C. multiple routes of microbial entry holes in the woven material, producing to the sterile field. Multiple laundering and defect repairs eventually cause the woven D. material products failure to meet the criteria for performance and must be 3 retired. The healthcare facility should have a tracking system in place, (1) such as a marking grid or bar c ode system to track the number of times a woven product is la undered and sterilized. (2) products should provide written The manufacturer of the woven recommendations for the number of times the product can be 3 processed and used. 2. To further aid in the prevention of supe rheating, all types of packaging materials should be stored at the proper temperat ure and humidity for at least two hours ure and humidity permits adequate steam before use. Storage at room temperat 4 penetration and prevention of superheating. Room temperature and humidity should be monitored and recorded on a daily basis. The recommended temperature and humidity are 20° C to 23° C (68° F to 73° F); 30% to 60% 5 humidity. Standard of Practice V Wrapped packages should be prepared to fa cilitate ease of opening the package and intaining the sterility of the contents. transferring to the sterile field, while ma The correct size wrapper should be chosen in order to ensure complete coverage 1. of the contents and sterilization. The wrapper should not be too large in order to prevent air pockets from A. ion and release of the sterilant. forming, which can inhibit the penetrat to not allow adequate coverage of However, it should not be too small as the contents and possibly tear at the corners. B. Wrappers that will be used to esta blish a sterile field should be large enough to extend a minimum of six inches below the four sides of the 8 table or basin ring. C. Wrappers must be large enough to cover the hand of the individual opening it, if the package is to be handed to the CST in the scrub role, using sterile technique or transfer red (tossing) to a sterile field. Before wrapping an instrument tray, an absorbent lint-free linen towel D. the tray and wrapper to cushion should be placed between the bottom of the corners of the tray a nd prevent tearing, as well as serve to absorb the condensation during steam sterilization. E. Density is a key factor related to the sterilization of items. The more densely items are packed, the greater the percentage that the sterilant will not contact the surface areas of all ite ms, and drying will be inadequate. (1) AAMI has recommended that instrument sets should not exceed 5 25 pounds.
8 Standard of Practice VI n begins after decontamination and the The preparation of items for sterilizatio lized: inspection, reassembly, d for all items to be steri three steps should be complete and preparation. 1. Items should first be inspected for blood and soil that could be left after decontamination. Instrument function should be tested to 2. determine if the instrument needs repair, sharpening or replacement. A. Cutting edges of scissors and other sharp instruments such as trocars should have no burs, cracks, scratche s or bends and have not become dulled. The blades of scissors should close smoothly and be sharp enough 8 to easily cut two 4 x 4 gauze sponges. B. Instrument ratchets must lock properly and not spring open. The instrument should be tested by lightly tapping the ring handle in the palm of the hand; if the instrument remains closed, the ratchet is assumed to be working properly. Ratchets on self-reta ining retractors shoul d be tested to ensure they remain C. and easily release when closing. locked in the open position and smoothly The jaws of clamps should close evenly with no gaps and the tips aligned. D. E. Forceps should close evenly and the tips aligned. The teeth of tissue forceps should be aligned and fit sm oothly and evenly into the groove of the opposite side when closed. F. Manufacturer’s inst ructions must be followe d for the proper inspection and testing of powered instruments. (1) The powered instrument may re quire lubricati on and operation ndicated in the manufacturer’s for a specific amount of time as i instructions. (2) The power hose should be inspected in detail for cracks or cuts. Manufacturer’s inst ructions must be followe G. d for the proper inspection and testing of endoscopic equipment. (1) The endoscope may require testing according to the manufacturer’s instructions. (2) The light cord should be inspecte d for breaks in the integrity of the cord and function should be tested. Instruments with multiple parts usually should not be reassembled in order to 3. make sure the sterilant contacts all su rface areas. Manufacturer’s instructions should be followed related to the disassembly and assembly of instruments with multiple parts, including if the instrument should remain disassembled for sterilization purposes. 4. The three principles that should be fo llowed in the prepar ation of items to facilitate effective sterili mes into contact with all zation are: the sterilant co surface areas, instruments ar e positioned in a protective manner, and instruments 8 are evenly distributed. A. Instruments should be placed in a mesh-bottom or wire mesh basket.
9 (1) An absorbent linen towel should be used to line the bottom. A should not be used to line the tray nonwoven disposable wrapper due to its water-repellent characteristic, causing the moisture to collect at the tray bottom. (2) It is recommended that instrument s with ring handles be placed on a “stringer” to maintain the instruments in an open (ratchets fully unlocked) manner and prevent scattering of the instruments in the tray. Instruments of lik e size, length, shape and function stringer as an aid to the CST should be grouped together on the in the first scrub role to quickly identify instruments during counts and when setting up for the surgical procedure. (3) When using steam sterilization, a residual amount of water with a lumen to facilitate the should be left inside instruments ter boils during st displacement of air, when the wa erilization. ter should be left inside the When using EtO sterilization, no wa lumen; EtO combines with water to produce the toxic by- 8 products ethylene glycol and ethylene chlorohydrin. Instruments with concave surfaces should be positioned on their (4) side to allow the sterilant to contact the entire surface and allow the concave portion to drain. for moisture that collects in (5) Loose instruments, such as re tractors, should not be tightly grouped together or wrapped. Instrument grouping and disproportionate metal contact inhibi ts the contact of the sterilant with all surface areas and may a llow condensate to collect. (6) Heavier instruments should be placed on the bottom or end of the more delicate instruments. An tray to avoid damaging small, absorbent towel can be used to separate layers of instruments and facilitate the absorption of moisture. (7) Instruments should not be held together with rubber bands. The rubber bands can deflect the sterilant and prevent it from contacting the surface areas of the instruments. (8) ners should be placed flat on the Instrument trays and rigid contai shelves of the sterilizing cart. B. Microsurgical instruments should be placed in special trays designed specifically for the sterilization of these delicate instruments. C. Basins that are nested within each other and/or contain other metal items should be assembled to allow the ster ilant to contact all surface areas and allow the complete remova l of air and condensate. (1) Nested basins should differ in diameter by a minimum of one 5 inch. (2) An absorbent linen towel should be placed between two nested basins to facilitate the sterilant contacting all surface areas, aid in air removal and absorb condensate. (3) Hollow OR lights should be placed in the basin handle down to 8 allow the condensate to drain out.
10 (4) should not be placed inside a basin; Sponges and woven fabrics t, thus inhibiting the ability to the material can deflect the sterilan contact all surface areas. The maximum recommended weight of wrapped basin sets is (5) 5 seven pounds. (AAMI, 2006). (6) Basins should be placed on the ster ilizing cart on their side with the fold down to aid in the re moval of air and prevent the 5 accumulation of condensate. The basin sets should be placed all facing the same direction. 5. The healthcare facility should establis h policies and procedures for wrapping techniques and should reflect the manufacturer’s recommendations. The two recommended wrapping met hods are the envelope (diagonal) A. l double-wrapping and simultaneous fold and square fold. Sequentia hods of packaging. double-wrapping are acceptable met The diagonal fold is recomme nded for use when wrapping (1) individual items and small to medium-sized instrument trays. The square fold is recommended for use when wrapping large (2) instrument trays, basin sets and large packs. 6. and decontaminated after each use and Rigid containers should be disassembled assembled according to the manufact urer’s written instructions. All components of the rigid container, A. eg lid, container, filter retention plates, should be disassembled a nd decontaminated prior to clean instruments being placed in the container for sterilization. (1) The manufacturer’s instructions for decontaminating, inspecting, performing preventative mainte nance and repair should be followed. B. ype of filter, internal and external The manufacturer’s instructions for t 4 chemical indicators, and security locks should be followed. (AAMI, 2006). C. The manufacturer’s instructions fo r assembling the instrument trays 4 should be followed. tions related to whether or not other objects can D. The manufacturer’s instruc as linen towels, should be followed. be placed in the rigid container, such Protective organizing baskets or trays should not be placed inside a rigid E. container system, unless the manufactu rer provides written verification that these devices can be safely used with the rigid container system. Protective organizing baskets or trays can inhibit air removal, (1) nt evacuation and drying. sterilant penetration, sterila Surgical supplies, such as cotton ba lls, dressings and needles should be 7. 5 to healthcare facility policies. individually packaged, according A. Canisters with lids should not be used for the sterilization of surgical 5 supplies. It is necessary to remove the can ister lid for sterilization of the contents and therefore, the sterility of the items is compromised once the sterilizer door is opened. Additiona lly, the canisters usually have solid bottoms, which do not allow for the removal of air and are conducive to condensate collecting at the bottom.
11 8. ior to being sterilized. Packages should be labeled pr Labeling must be performed in order A. to allow the user to identify the contents of the package, in pa rticular when woven and non-woven ould also be performed as wrappers are used. It sh an aid for purposes of rol, and rotation of stock. quality assurance, inventory cont 5 B. wrapped packs, it should be non-toxic. If a marking pen is used to label (1) avoids toxins adhering to the The use of a non-toxic marking pen packs or instruments. C. Information should be written on the chem ical indicator (CI) tape or on the front, plastic portion of p eel packs. The following information should be included: (1) Package contents (2) Date sterilized (for purposes of rotating packages) Identification of the sterilizer (3) Sterilization cycle number (4) (5) Initials of the employee who prepared the package D. The use of a label gun that discharges printed labels can be used as a e information. The label should be substitute for providing some of th or plastic of a peel pack. Printed placed on the chemical indicator tape labels may contain the following information: (1) Julian date to indicate date of sterilization (2) Identification of the sterilizer (3) Cycle number 9. Devices used to close a package should al low the sterilant to penetrate, maintain 5 the integrity of the package and pr event constriction of the package. A. re packages; no other type of tape Only CI tape should be used to secu should be used. (1) e not designed to withstand the Tapes, other than CI tape, ar sterilization cycle and may lose th eir ability to keep the package closed. B. t be used for package closure. Staples or other sharp items should no (1) Sharp items, such as staples do not fully secure th e closure of the package, thus compromising the ster ility of the enclosed items. (2) Sharp items can puncture the p ackaging material, causing the enclosed items to be contaminated. 10. e manufacturer indicates are sterilant Only instrument tip protectors that th permeable should be used and should fit loosely. A. al or fit too tigh tly can inhibit the Tip protectors made of the wrong materi sterilant from making contact with the instrument surface. B. Latex tubing should not be used as a tip protector due to the sterilant- inhibiting property of the material. Standard of Practice VII Paper-plastic peel pouches or peel pack s should be used for small items or lightweight items that require sterilization. 1. The open end of the pouch should be sealed by heat seal, CI tape, or self-seal.
12 A. should not be used to close a peel pack. The staples cause small Staples amination of the contents. holes, creating entry for microbes and cont Rubber bands, tape or paper clips should not be used to bind package contents 2. together. contact of the sterilant with the A. The binding material can prevent the surface of the contents. An item or items should be placed inside th e peel pack that allows the circulator 3. sterile technique. to present the contents to the CST in the first scrub role using A. The item should be placed in the peel pack so the portion of the item that has the most surface area for the CST to grasp should be first presented when the pack is opened, eg clamp or scissors placed with ring handles at the end of the pack that will be opened. 4. The correct size pouch must be selected. Pouches that are too small may prevent adequate air removal, penetration A. of the sterilant, and drying. Additio nally, the contents may tear a pouch that is too small. B. Pouches that are too large allow exce ssive movement of the content(s), which may cause tears. 5. ced from the pouch prior to sealing to As much air as possible should be for prevent the pouch from bulging during sterilization and brea king the heat seals. 6. Sharp edges and tips of items should be pr otected with a tip protector or foam sleeves to prevent the pouch from tearing. A. Latex tubing should not be used as a tip protector due to the sterilant- inhibiting property of the material. Multiple items or items with multiple pi eces should be kept together by double 7. peel packs. The items should be placed in a pouch that A. can be inserted inside a larger the outer pouch without having to pouch. The inner pouch should fit inside be folded; folding can cause entrapment of air which can prevent penetration of the sterilant. The inner pack should not be sealed; sealing can cause en trapment of air B. ion of the sterilant. which can prevent penetrat 8. Paper-plastic pouches should not be placed within wrapped sets or rigid container 5 systems. A. The pouches cannot be properly positione d within the wrapped set or rigid air removal, sterilant contact and container system to ensure adequate drying. B. The practice of placing pouches in wr apped instrument sets or rigid container systems has not been validated as appr opriate and effective by 5 any paper-plastic pouch, ri wrap manufacturer. gid container system or 9. Pouches should be placed on their edge, paper side to plastic side when positioned on the sterilizer cart to en sure air removal, sterilan t penetration, and drying. Standard of Practice VIII
13 Chemical indicators (CI) should be used in combination with mechanical monitors and biological indicators as part of the healthcare facility quality assurance sterilization program . The manufacturer’s written instructions 1. for the use of CIs should be followed. 2. An external CI should be used on all hea lthcare facility prepared packages with the exception of those packages, such as paper-plastic pouches that allow visualization of the internal CI. External CIs that are acceptable for use include, CI tape, CI label or CI A. printed legend that are affixed to or printed on all healthcare facility prepared packages and rigid container systems. 5 Only Class 1 CIs should be used. B. 3. An internal CI should be used within all healthcare facility pr epared packages and rigid container systems. 5 See Table 1. Class 3, 4 or 5 CI may be used. A. The internal CI should be placed in the area of a wrapped package, B. instrument tray or rigid container sy stem where there can be the greatest chance of entrapped air. 1 Table 1: Five Classes of Chemical Indicators CI Name Definition CI Class 1 Process indicators External CIs. Used with individual wrapped packages, trays and rigid container systems to demonstrate package has been exposed to the sterilization process. Specific-test indicators Bo wie-Dick type indicators 2 Single-parameter indicators 3 Indicator that reacts to only one of the parameters of sterilization. Multi-parameter indicators 4 I ndicator that reacts to two or more of the critical parameters of sterilization. 5 Indi cator that reacts to all Integrating indicators critical parameters of sterilization. Standard of Practice IX Sterilized wrapped packages, instrument tr ays, peel pouches and rigid container systems are considered sterile until an event occurs causin g a break in the integrity of the wrap, pouch or ri gid container system. 1. Healthcare facilities should follow the concept of event-related sterility for economic purposes.
14 A. related to how sterile packages are The concept of event-related sterility is t related rather than time related. handled and that contamination is even Items are considered to be indefinite ly sterile until an event occurs that compromises the sterility. Standard of Practice X licies and procedures for evaluating the Healthcare facilities should have written po competencies of surgical personnel respons ible for preparing items for sterilization as well as completion of continuing education. 1. itten policies and procedures for the Healthcare facilities should have wr items to be sterilized. preparation and packaging of A. Written policies and procedures should address the following: Inspection, assembly and prepara (1) tion of rigid container systems (2) Inspection, assembly and prepara tion of items for sterilization (3) Use of various types of pouches (4) Use of various types of wraps Handling and use of CIs (5) (6) Labeling packages 2. The competencies of CSTs and other surgical personnel, who are responsible for preparing items for steril ization and using CIs, should be evaluated and documented. A. Training and/or continuing educ ation should be documented and periodically reviewed. (1) Continuing education should be co mpleted by surgical personnel their knowledge of packaging in order to remain current in systems and use of CIs. (2) Continuing education should be co mpleted by surgical personnel any time the healthcare facility implements new policies and ation equipment or surgical procedures, when new steriliz instrumentation is purchased. (3) Documentation of completion of continuing education and d in ensuring the personnel have verification of competencies ai ing of the packaging systems the basic knowledge and understand and use of CIs; potential hazards to the patient, self and other healthcare workers in the event of a product or process malfunction; and actions that s hould be taken to correct the malfunction. The completion of continuing educ ation contributes to meeting (4) the competency standards that are a part of The Joint Commission’s National Patient Sa fety Goals and providing safe quality patient care. B. Competency verification should be performed during the following time 7 periods. (1) New hire (2) End of orientation period (3) Annually
15 (4) Healthcare facility revise s policies and procedures New sterilization equipment or supplies is purchased (5) (6) New surgical instrumentation is purchased Competency Statements Measurable Criteria Competency Statements rds as established by 1. Educational standa 1. The CST and CSFA have the Core Curriculum for Surgical Assisting the knowledge and skills for participating in Core Curriculum for Surgical and the evaluation of packaging systems, Technology . including rigid container systems, wraps, and pouches. 2. The subjects of the evaluation and use of packaging systems and CIs is included 2. The CST and CSFA have the knowledge in the didactic studies as a student. and skills for participating in the evaluation skills in the use of of CIs, as well as the 3. The subject of properly preparing items CIs. in preparation for sterilization is included s as a student. in the didactic studie have the skills in 3. The CST and CSFA the use of various packaging systems, 4. Students demonstrate knowledge of the including rigid container systems, wraps, above listed didactic subjects in the and pouches. lab/mock OR setting and during clinical rotation. 4. The CST and CSFA have the skills for properly preparing items for the various 5. As practitioners, CSTs and CSFAs methods of sterilization. participate in the evaluation and use of packaging systems and CIs. 6. CSTs and CSFAs complete continuing education to remain current in their knowledge of packaging systems, CIs, and preparation of items for sterilization. References 1. Association for the Advan cement of Medical Instru mentation. ANSI/AAMI ST60:1996 Sterilization of healthcare produc ts – chemical indicators – part 1: General requirements. 1996. Arlington, VA. 2. Association for the Advancement of Medical Instrumentation. ANSI/AAMI ST41:1999/(R)2005 Ethylene oxide sterilization in healthca re facilities: Safety and effectiveness. 2000. Arlington, VA.
16 3. Medical Instrumentation. ANSI/AAMI Association for the Advancement of textiles for use in healthcare facilities ST65: 2000 Processing of reusable surgical . 2000.Arlington, VA.. 4. Association for the Advancement of Medical Instrumentation. ANSI/AAMI gh-level disinfectio n in healthcare ST58: 2005 Chemical sterilization and hi facilities.2006 . Arlington, VA. 5. Association for the Advancement of Medical Instrumentation. ANSI/AAMI ST79:2006 Comprehensive guide to steam ster ilization and sterility assurance in healthcare facilities. 2006. Arlington, VA: AAMI. th Central Service Technical Manual. 6. 7 ed. International Association of Healthcare Central Service Material Manage ment. Chicago, IL; IACSMM; 2007. Chobin N. (2008). Verifying compet 7. Biomedical encies in sterile processing. Instrumentation & Technology. 2008; 42(6): 474-476. 8. Frey KB, Price BD, Ross T. (2008). Asep sis and sterile technique. In: KB Frey, T Ross (eds.). the Surgical Technologist: A Surgical Technology for rd Positive Care Approach . 3 ed. Clifton Park, NY: Delmar Cengage Learning; 2008: 139 – 184. Tyvek is a registered trademar k of the Dupont Corporation.