selection and use of packaging systems. presented by spsmedical largest sterilizer testing lab in...
TRANSCRIPT
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 [email protected]
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