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SELF-STUDY SERIES

LearningObjectives1) Explain the various types ofsterilization packaging.

2) Discuss the advantages anddisadvantages of each type of

packaging.

3) Select appropriate packaging forspecific instruments andapplications.

January 2008The self-study lesson on t his central service top ic was

developed by STERIS and AAMI (Association for the

Advancement of M edical Instrum entation). The lessons

are administered by KSR.

Earn CEUsThe series can assist readers in maintaining their CS

certification. After careful study o f t he lesson, complete

the examination at the end of this section. Mail the

complete examination and scoring fee to Healthcare

Purchasing News for grading. We will notify you if you

have a passing score of 70 percent o r higher, and you

will receive a certificate of completion within 30 days.

Previous lessons are avai lable on the Internet at

www.hpnonline.com.

Certif icationThis in-service has been pre-approved by the CBSPDfor 1 Contact Hour. Follow the CBSPD CEU Protocols

for p re-approved in-services. The prot ocols can be found

on CBSPD website sterileprocessing.org or by calling

CBSPD office at 908-454-9555.

For m ore informat ionDirect any questions to Healthcare Purchasing News

(941) 927-9345, ext 202.

S

ELF-STUD

YSERIE

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The shield is a universal symbol ofprotection. Shields protect their us-ers from harm and defend against

invasion by an enemy. In the world of ster-ile processing, sterile packaging acts as ashield against bacterial invasion, protect-ing patients from harm. And like anyshield, proper selection, care and use en-

sure that the items being protected remainsafe until needed.

Packaging usesSterile processing depart-ments sterilize thousands ofinstruments daily. Eachsuccessful sterilization pro-cess ensures that bacteria,viruses and other disease-causing agents left on in-strumentation have beendestroyed. These instru-ments remain sterile as long

as they are not exposed tosources of bacteria or vi-ruses such as counters,hands, and even the air it-self. This is where packag-ing comes into play. Pack-aging provides a barrierthat shields sterile instru-ments from recontamina-tion after sterilization.

Packaging also serves to organize instru-mentation. For example, rigid sterilizationcontainers provide compartments, posts

and stringers that help segregate and orga-nize instruments, and smaller pouches canbe placed in larger pouches or container sys-tems to manage small components. Whenused properly, packaging ensures that theorganized and packaged instrumentationremains sterile until it is needed.

Types and materialsPackaging is defined in three categories:wraps, pouches and rigid sterilizationcontainers. Each type of packaging hasadvantages and disadvantages. A clearunderstanding of packaging pros and

cons will help SPD professionals opti-mize their use of packaging and ensure

that sterile devices are delivered each andevery time.

WrapsThe simplest of packaging materials isthe reusable wrap often referred to as mus-lin wrap. Muslin wraps are made of cottonand come in various forms. Muslin is a wo-

ven material. This means that cotton fibersare intertwined in a pattern resulting in acrisscross of fibers creating a weave. Thestrength of the fabric comes from the fibers

thickness and theweave pattern. Thetypical muslin wrapused by medicalprofessionals todayis 140-thread countmuslin in a varietyof sizes and colorsthat allow color cod-ing of wrapped

items.Muslin wraps re-

quire launderingand over time be-come worn and un-usable. As an alter-native, non-wovenwrap materials areavailable for wrap-

ping instrument trays. Non-woven wrapsserve the same purpose and are used in thesame manner with one important difference:these wraps are disposable. Non-woven

wraps are typically constructed from a pulpor spun-bound synthetic material that ismade of a single continuous fiber. The non-woven wraps come in a variety of strengthsthat offer better tear or puncture resistance.Synthetic materials are generally preferredfor their greater consistency and better per-formance. All non-woven wraps are de-signed for one-time use.

Both muslin and synthetic wraps are usedtoday. Both require double-wrapping,which is accomplished either individuallyor simultaneously. When done individu-ally, the first sheet is wrapped and secured,

and then a second sheet is wrapped overthe first and secured. When done simulta-

Instrument packaging:The basics for sterileprocessing professionalsby Heide Am es

A w rapped load for steam ster i lizat ion

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SELF-STUDY SERIESneously, two wraps are wrapped and se-cured as one process. Double wrapping of-fers additional protection from tears andholes. If the first layer is torn or puncturedduring storage and transport, the secondlayer maintains the packages sterility.

PouchesPouches are sealable envelopes that instru-ments are placed in before sterilization.Pouches are available in a variety of materi-als, sizes and designs.They are used forlightweight instru-ments, and some canbe placed within otherpackaging systemssuch as rigid steriliza-tion containers ortrays.

The most commonpouches are con-structed from a paperbonded to a transpar-ent plastic material.Pouches used withinother packaging mate-rials are constructed of a paper bonded topaper. The paper allows for air removal andpenetration of sterilant during a cycle. Pa-per-backed pouches are used in ethyleneoxide and steam sterilization processes.They are not used in hydrogen peroxide

or plasma processes, however, becausepaper will react with the hydrogen perox-ide and prevent the sterilant from penetrat-ing the pack.

Some pouches are made of Tyvek* ma-terial bonded either to a transparent plasticor to more Tyvek. This material is not reac-tive to ethylene oxide or hydrogen perox-ide and is the material of choice forhydrogen peroxide and plasma sterilizationprocesses.

Pouches may also have a chemical indi-cator printed on the pouch. Chemical indi-cators use chemicals that, when they are

exposed to a sterilant, will change color.These chemical indicators can also beprinted on the interior side of the pouch toact as an internal indicator. External indica-tors confirm that the pouch has been pro-cessed. Internal indicators are designed toprove that the sterilant penetrated thepouch.

Pouches come in two basic styles: heat-sealed and self-sealed. The most commonpouch used in sterile processing depart-ments is the heat-sealed pouch. After the in-struments are placed into a pouch, heat isapplied to the open side to fuse the pouch

together. Heat seal pouches are an economi-cal solution and are available in a flat pouch,a gusseted pouch and roll tubing. Flatpouches consist of two pieces of materialthat have been sealed on three sides. Gus-seted pouches have expandable sides that

allow bulkier instruments to be enclosedand sealed. Roll tubing has two open ends.The desired length is measured and then cut.Both ends of roll tubing must be sealed toenclose the instruments.

The second style of pouch is the self-sealedpouch. These are flat pouches that have three

factory sealed sides. The fourth seal ismade with a wide adhesive strip. Self sealpouches do not have gusseted or tube-style versions.

Rigid sterilizationcontainersSterilization containers aremade of durable rigid ma-terials such as metal, plasticor composites. These rigid,reusable types of packagingprovide a good physical bar-rier to protect instruments.

Each container includes at least one basketto hold the instruments and allow asepticremoval and presentation of the contents.

Rigid sterilization containers house a fil-ter that allows the sterilant to enter the con-tainer and contact the instruments. In order

to prevent recontamination, the filters pro-vide a microbial barrier. Filter systems usedisposable filters typically made of syntheticmaterials, or a reusable porous filter.

Shelf lifeAll packaged items have event-related shelflife. This means that the itemswithin the packagingare consideredsterile until anevent occurs thatbreaks the sterilebarrier. Events include

tears, punctures, moisture,or opening of the package.

Which packaging shouldbe used?Each type of packaging has its place intodays sterile processing environments.The pliable nature and flexible sizes ofwraps allows for odd-shaped instrumen-tation and instrument sets of any size tobe packaged and sterilized. Wraps made ofsynthetic materials have proven perfor-mance in a multitude of sterilization pro-cesses like ethylene oxide, steam, hydrogen

peroxide and plasma sterilization processes.The versatility of wraps makes them a goodchoice for sterilization packaging.

Though wraps are pliable, they are alsofragile. Muslin wraps become worn andthreadbare over time. This weakens the bac-

terial barrier. Synthetic wraps can be proneto tears, rips and punctures during handling.These compromise the sterile barrier mak-ing the items unusable. Both types can dis-charge lint when opened, which allowscontaminated debris to come into contactwith the sterile instrumentation. When us-ing wraps, it is important to select materialsthat are low-linting and puncture-resistant.Wrapped items should be stored on linedshelves to prevent accidental tears or punc-tures. Each package must be inspected priorto use for tears or punctures that may havepenetrated both layers of the wrap.

Pouches offer a convenient method forpackaging small lightweight items. Theycan also be a convenient means of orga-nizing small items within a larger con-tainer or tray. For example, they can beused to contain items like cords for easierhandling and presentation in the OR withthe instrument set.

Like wraps, pouches are susceptible topuncture and tears. It is important to evalu-ate the appropriateness of the instrumentsbeing placed in a pouch. Devices withsharp tips can easily puncture pouch ma-

terials. However, it is possible to double-pouch instruments to protect against tearsand punctures.

Its important to remember thatpouches are designed for specific steril-ization processes. Using the wrong pouchin a particular sterilization cycle can re-sult in non-sterile and/or damaged in-strumentation. For example, the Tyvek

pouches used for hydrogen peroxideand plasma sterilization will

melt onto instrument sur-faces if processed in asteam sterilization process

by mistake.Rigid sterilization con-

tainer systems provide thebest physical protection forinstruments. In addition,multiple trays, compart-ments and a variety of ac-cessories make it easier toorganize the instruments.Rigid container systems

also allow for several instrument piecesand whole instrument sets to be processedwithin one container, which can simplify

Self-TestAnswers:1.B,2.C,3.D,4.A,5.E,6.A,7.B,8.D,9.B,10.C

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SeeSELF-STUDYon page 42

STERISCorporat ions

Vis-U-All pouch fam ily

Amsco r igidcontainer made

of compositemater ial

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CONTINUING EDUCATION TEST JANUARY 2008

SELF-STUDY SERIES

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aseptic presentation in the OR and reducethe amount of space required for storage.

Rigid container systems do have someconstraints. Depending on the containersdesign, it may have sterilization limita-

tions. For example, some container sys-tems cannot be used in hydrogen peroxideor plasma sterilization systems. Some de-signs should not be used for gravity steamsterilization but can be used in dynamicair removal steam sterilization processes.When choosing a rigid sterilization sys-tem, it is important to ensure that the con-tainers will be appropriate for the typesof sterilization processes that are used bythe facility.

Typically, a combination of all threepackaging methods is the best choice for

1 . Wha t a r e the two uses fo r packaging?a. M icrob ia l bar r ier and physica l protec t ionb . M ic r ob ia l bar r ie r and o rgan iz a ti onc . Ster i le storage and moisture protec t ion

2 . Wh ich o f t he fo llow ing ma te r ia ls i s no t used toconstruct w raps?

a. Co t tonb . Ce llu lo sec. A lu m in um fo il

3 . Why a r e syn the t i c w r aps p r efe rr ed over mus linwraps?a. Synthet ic w raps prov ide consistent per formance

and bet ter puncture resistanceb. Synthet ic wraps are more p l iab le than musl in

wr apsc . Sy n t het i c w r aps a r e d isposab led . a. an d c.

4. Pouches are used to package smal l l ightweightitems.a. Tru e

b . False

5 . Wha t a r e chemica l ind icato r s used fo r whenpr in ted on pouches?a . Ex t er na l ind i ca t o r shows t ha t t he pouc h has

been through a ster i l izat ion processb. In terna l ind icator shows that ster i lant

penet ra ted the pouchc . Co lo r c od ing i den t if i es whe r e t he inst r um en t s

should be used.d . b . an d c.e . a. an d b .

6 . Wha t a r e the tw o w ays tha t pouches a r e sealedbefore ster il ization?

a . A dhesi ve st r ips and hea tb . I nd i ca to r t ap e an d h e atc . Safety p ins and adhesive s t r ipsd . Sa f et y p in s a n d h ea t

7. Rig id ster i l izat ion conta iners provide the w orstphysical protectio n of all packaging choices.a. Trueb . False

8. Al l r ig id ster i l izat ion systems can be used for :a . A l l t ypes o f st eam st e ri li za t ion

b. Hydrogen perox ide or p lasma ster i li zat ionc . Grav i t y s team ster il i za t iond . N o ne of th e a bo ve

many facilities because of the variety ofitems they must process each day. For ex-ample, wraps are best for odd shapeditems and loaner sets. Pouches are greatfor those single items typically foundmissing from sets or for organizing cords

and small items. Rigid container systemsprovide the best physical protection andorganization for the most common surgi-cal sets.

Wrapping it upPackaging offers a variety of choices to pro-tect sterile instrumentation from contami-nation. Proper care to select and use theappropriate packaging system for the de-sired application will ensure that sterility isachieved and maintained. As with any medi-cal device, the packaging manu-facturers in-

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structions for use must be reviewed and fol-lowed to assure proper function and results.When used correctly, packaging is an effec-tive shield of protection for instruments, andultimately, for the patients on whom thesedevices are used. HPN

*Tyvek is a registered trademark of DuPont.

9. Pouches and w raps share which d isadvantages?a . O n l y used f o r sm a l l l igh t we igh t i t em sb . Pr o ne t o t e ar a n d p un c t ur esc . L imi ted ster il i za t ion processes

10. Which advantage do r ig id ster il izat ioncontainers provide over pouches and wraps?a. Can be used in mul t ip le ster i li zat ion processes

b . Can be us ed as a m ic rob ial ba rr ie rc . Prov ide the best physical protec t ion of

ins t rumentat ion

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SELF-STUDY f rom page 41

Instrument packaging: The basics for sterile processing professionals

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References:

ANSI/ AA M I ST79:2006 Comprehensive guide to s team steri l -ization an d sterility assurance in healt hcare facilities

ICT Infect ion Cont rol Today M agazine; Thats a w rap; KathyD ix; 11 /7 / 2006

ICT Infection Cont rol Today M agazine; Choosing a Steriliza-tion W rap for Surgical Packs; William A. Rutala, PhD, MPH,and David J. Weber , M D, MPH; 05/0 1/ 2000

Centers for Disease Control and Prevention; Sterilization Pack-aging and Storage; 8/7/ 2007

Healthcare Purchasing New s; Routine inspection and repairof r ig id s ter i lizat ion conta iners; L inda Clement, M ichael E.Russell, John W heeler; March, 20 06

M aterials M anagem ent in Healthcare; Sterilization cues for con-ta iners; Ar lene Carlo; 12/ 3/ 2007