Selection and Use of Packaging Systems

Presented by SPSmedical

• Largest sterilizer testing Lab in North America with over 50 sterilizers

• Develop and market sterility assurance products that offer advanced technologies

• Provide full day sterilization Seminars and on-site Facility audits for compliance with best practices

• Corporate member: CSA and AAMI, serving on numerous sterilization working groups

Association for the Advancement of Medical Instrumentation

Meets in Washington, DC throughouteach year and establishes guidelines for sterility assurance which become our National standards.

Membership includes: • Health care facilities• Health care organizations• Government agencies• Medical device manufacturers• Testing Labs and Consultants

Program Objectives

At the end of this program, participants will be able to…

• identify the different packaging systems.• explain guidelines for evaluation, selection,

and use of packaging systems for items to be sterilized.

• understand how each system ensures and maintains the sterility of the package contents.

Packaging Systems

Should…• be appropriate to item(s)

being sterilized• permit closure of items• resist tears, punctures• be free of holes, toxic

ingredients and low linting• permit aseptic delivery

Packaging Systems

Should…

• maintain sterility until point of use

• be appropriate to method of sterilization

• have favorable cost/benefit ratio

• be used in accordance to mfg’s instructions

Packaging Systems

for steam sterilization should…

• provide adequate air removal• permit steam penetration and

direct contact with surfaces• permit adequate drying• permit use of material

compatible with the process• maintain the integrity of the

system

Packaging Systems

for ethylene oxide sterilization

should…

• be permeable to EO, moisture and air

• permit aeration• maintain material

compatibility • maintain the integrity

of the system

Packaging Systems

for Gas plasma sterilization should…

• be permeable to the process• maintain material

compatibility• be made of a material

recommended by the mfg. and used according to the mfg. recommendations

• maintain the integrity of the system

Packaging Systems

Wrapped items should…• be assembled, handled, and

wrapped in a manner that provides for aseptic presentation.

• be wrapped with the appropriate size material to prevent gapping, billowing and air pockets from forming.

Packaging Systems

Wrapped items should…• be sequentially wrapped

using two barrier-type wrappers (or one fused or bonded, double layer) disposable, non-woven wrapper according to the mfg’s FDA’s clearance.

Packaging Systems

Indicator tape (not safety pins,

paper clips, staples or other

sharp objects) should be used

to secure wrapped items.

Rubber bands may be used

only if authorized by the

wrap manufacturer.Lead/Latex Free Steam Indicator

Tape now available from SPSmedical

Sterilization Packaging (Peel Pouches)

Should…• have as much air removed as possible,• provide a proven integrity seal, and be

hermetically sealed.• Double peel packaging is not necessary for

routine sterilization; however, double packaging may facilitate containment of multiple items to facilitate aseptic presentation.

Caution: Some pouches contain peel off chemical indicator strips.  Check with the manufacturer for the specific Class of CI as not all comply with AAMI recommendations for a Class 3, 4 or 5 internal chemical indicator.

Sterilization Packaging(Peel Pouches)

Should be used for small, lightweight, low profile items and placed on edge

in the sterilizer.

If you choose to double pouch items, place plastic to plastic – paper to paper and select proper size(s).

Inexpensive pouch dividers for both small and large sterilizers are

available from SPSmedical

Packaging Systems

Rigid containers should…• be used in accordance with

mfg.’s recommendations,• have approved sterilization

parameters,• be designed/constructed of materials compatible with

sterilization processes, • and have filters and/or valve

systems that are secure and in proper working order.

Packaging Systems

Rigid containers should…

• have filter plates that can be inspected for proper working condition before and after sterilization,

• have their integrity evaluated periodically, and should be tamper proof.

Packaging Systems

Newly purchased systems should be cleaned and decontaminated per mfg’s recommendations before initial use and between uses prior to sterilization.

Follow mfg’s instructions for choice of detergent and be sure to RINSE thoroughly after cleaning.

Packaging Systems

Wrapped packs…

• should be labeled prior to sterilization.

• labeling should include, but not be limited to:– a description of package contents– initials of packager, and a lot

control number. – labeling should be done on the

indicator tape and not on the wrapper itself.

AORN Recommends labeling all packages PRIOR to sterilization

Packaging Systems

• Peel pouches may be labeled on the plastic portion or on self-sealing tab.

• Markers should be indelible, non-bleeding and nontoxic.

Industrial Sharpie® pen (Item No. 13601) is specially formulated for Steam sterilization

Packaging Systems

The shelf life of a packaged sterile item is “event-related.” The length of time a product is considered sterile is dependent on the…

• type and configuration of

packaging materials used,• number of times an item is

handled before it is used,

and• the number of personnel

who handled the package.

Packaging Systems

• 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.

The length of time a sterile product can maintain sterility is dependent on the…

Packaging Systems

Policies and procedures for the selection and use of packaging systems should be written, reviewed periodically, and readily available within the practice setting.

These recommended practices should be used as guidelines for the development of policies and procedures for packaging.

Packaging Systems

Policies and procedures establish authority, responsibility, and accountability for the selection and use of packaging systems within the practice setting.

Policies and procedures also establish guidelines for performance improvement activities to be used in monitoring packaging system efficacy.

THANK YOU!!

SPSmedical Supply Corp.

Sterilization Products & Services6789 W. Henrietta RoadRush, NY 14543 USAFax: (585) 359-0167Ph: (800) 722-1529

Website: www.spsmedical.com

© SPSmedical Supply Corp.

Certificate is available after viewing by calling SPSmedical

or e-mailing education@spsmedical.com

Selection and Use of Packaging Systems

Purchasing AAMI Standards

If your organization is not a member of AAMI, you may purchase the Standards directly from SPSmedical at our member discount. The member discount saves you 40-50% depending on the document.

For example:

ORDER CODE: AAMI ST:79List Price: $220 Member Price: $110

References & Resources

Association for the Advancement of Medical Instrumentation 1110 North Glebe Road, Suite 220, Arlington, VA 22201-4795703-525-4890 Fax: 703-276-0793 www.aami.org

Association of periOperative Registered Nurses 2170 South Parker Road, Suite 300 Denver, CO 80231-5711800-755-2676 www.aorn.org

Canadian Standards Association5060 Spectrum Way Mississauga, Ontario L4W 5N6 CANADA800-463-6727 Fax: (416) 747-2510 www.csa.ca

Certification Board for Sterile Processing & Distribution2 Industrial Park, Suite 3 Alpha, NJ 08865 908-454-9555 www.sterileprocessing.org

International Assoc. of Healthcare Central Service Materiel Management 213 W. Institute Place, Suite 307 Chicago, IL 60610312-440-0078 Fax: 312-440-9474 www.iahcsmm.org