PACKAGING SYSTEMS FOR STERILIZATION [INSERT FACILITY NAME OR A

(COMPANY) EMPLOYEE ORIENTATION TRAINING LEADERS GUIDE LOADING UNLOADING PACKAGINGASSEMBLY
ACCESS TO DHSOSPHL ONLINE COURSE “LABORATORY SHIPPING AND PACKAGING”
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AWARDING CRITERIA 20082009 PACKAGING ORDER RPAAWRD LIMITED FUNDS SCHOLARSHIPS
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COTS PEMS PACKAGING DOCUMENT 1 OF 2 NEPP PROGRAM

Policies & Procedures: Other: Packaging

PACKAGING SYSTEMS FOR STERILIZATION

[Insert facility name or a header]

ADMINISTRATIVE APPROVAL

Date Created:

Last Date Revised:

Last Date Reviewed:

Date of Next Review:

Approval signature(s) with title and date of signature:

Signature Title Date

Purpose

To provide guidance to perioperative personnel for using packaging systems for sterilization. The expected outcome is that the patient is free from signs and symptoms of infection.

Policy

It is the policy of [insert name of facility] that:

Packaging systems and packaging materials will be evaluated before purchase and use.
Packaging systems will be compatible with the specific sterilization method for which they will be used.
Packaging materials will be processed and stored in a way that maintains the qualities for sterilization.
Packaging materials will be used according to the packaging manufacturer and the sterilizer manufacturer’s written instructions for use (IFU).
The shelf life of a packaged sterile item will be considered event-related.
The total weight of an instrument containment device, including the contents will not exceed 25 lbs.
Count sheets will not be placed in instrument trays.

Procedure Interventions

Storage and Processing

Launder reusable textiles after every use.
Store packaging materials at room temperature and at a relative humidity that is in accordance with the packaging manufacturer’s IFU.
Discard wrapping materials labeled for single-use after one sterilization cycle.
- Recycle single-use packaging materials suitable for recycling if desired.

Packaging

Package items to be sterilized in a manner that facilitates sterilization, maintains sterility, and provides for an aseptic presentation of the package contents.
Inspect packaging materials, including filters for rigid sterilization containers, for defects and extraneous material before using.
- Do not use packaging materials with defects or extraneous materials that cannot be removed.
Select the size of wrapping material required to achieve adequate coverage of the item(s) to be packaged.
Wrap the item(s) securely in a manner that prevents gapping, billowing, or formation of air pockets.
Position the item(s) to be sterilized within the package to allow sterilant contact with all surfaces.
Disassemble instruments composed of more than one part unless the manufacturer’s written IFU specifies that disassembly is not required.
Position items to be sterilized that have concave or convex surfaces within packages in a manner that prevents those surfaces from retaining water.
Place towels within instrument sets only if they are lint-free and laundered in a health care-accredited laundry facility.
Place items to be sterilized in the package or tray in an open or unlocked position.
- Use racks or stringers designed and intended for sterilization to maintain instruments in their open position as needed.

Chemical Indicators

Place a chemical indicator on the outside and inside of every package to be sterilized unless the internal indicator is readable through the package material.
- Place a class I chemical indicator (ie, process indicator) externally.
- Place a class III chemical indicator (ie, single-parameter indicator), class IV chemical indicator (ie, multiparameter indicator), class V chemical indicator (ie, integrating indicator), or class VI chemical indicator (ie, emulating indicator) internally.
- Place more than one chemical indicator for multilevel trays according to the tray manufacturer’s IFU.
Place chemical indicators in an area within the package that presents a challenge for air removal and sterilant contact.
Follow the chemical indicator manufacturer’s written instructions for storage, use, and expiration date.

Reusable, Woven Packaging Materials

Inspect textiles on a light table for defects (eg, holes, tears, worn spots).
- Repair small defects using a vulcanized patch.
- Keep the number of repairs to a minimum.
- Discard reusable, woven packaging materials if there is a question about its suitability.
De-lint reusable, woven packaging materials after laundering and before using.
Mark the printed area each time the item is used if a printed area (eg, grid system) for marking the number of reprocessings is available on the woven textile.
Follow the manufacturer’s IFU for the recommended number of reprocessings.

Peel Pouches

Use peel pouches for small, lightweight, low-profile items (eg, one or two clamps, scissors).
- Do not package heavy devices, such as weighted vaginal speculums in peel pouches.
Do not use peel pouches within wrapped sets or containment devices unless the pouch manufacturer can supply documented validation for this process.
Do not perform double pouching (ie, placing the item within one pouch and then placing this pouch inside another) without written instructions from the pouch manufacturer indicating that this practice has been validated and the pouch in question has been cleared by the FDA for this purpose.
When double pouching is indicated, verify that the inner pouch
- fits within the outer pouch without folding, and
- faces in the same direction as the outer pouch (ie, plastic or Mylar faces plastic or Mylar, and the paper or Tyvek faces paper or Tyvek).
Place peel pouches on edge and spaced to permit sterilant contact and drying when loading the sterilizer.
- Use racks designed and intended for sterilization to separate and hold pouches in a vertical position as needed.
Label peel pouches according to the pouch manufacturer’s IFU.
- Place labels on the plastic side of the pouch.
- Use a marker with nontoxic ink for writing on the plastic side of the pouch.

Rigid Sterilization Containers

Follow the manufacturer’s recommended sterilization method and cycle exposure times for each rigid sterilization container system.
- Evaluate sterilization efficacy and drying effectiveness of rigid sterilization containers before initial use and periodically according to the manufacturer’s written IFU.
Refer to the containment device or organizing tray manufacturer’s IFU to determine whether placing cassettes or organizing trays within rigid sterilization containers is acceptable.
Inspect the integrity of the rigid container after each use and verify that the
- mating surfaces and edges of the container and lid are free of dents and chips;
- lid and container fit together correctly and securely;
- filter retention mechanisms and fasteners are secure and not distorted or burred;
- latching mechanisms are functioning correctly;
- handles are working correctly;
- integrity of the filter media is not compromised;
- gaskets are pliable, securely fastened, and without breaks or cuts; and
- valves are working correctly.
Examine filter plates before and after the sterilization process.
- Verify that single-use or reusable filters and valve systems are secured and working correctly before sterilization.
- Use only intact filters.
- Consider the contents unsterile if the filter is damp or dislodged or has holes, tears, or punctures.
Remove damaged items from service and repair or replace.
Clean rigid sterilization containers after each use.
- Disassemble and clean all components (eg, filter retention plates) unless otherwise specified in the manufacturer’s IFU.
Do not place additional materials (eg, silicone mats, towels) within rigid sterilization containers unless the container manufacturer has provided directions for their use.
Review the manufacturer’s IFU to determine limitations related to density of materials, weight, and distribution of contents before placing devices within rigid sterilization containers.

Labeling

Label packages to be sterilized before sterilization with the
- sterilizer number or unique identifier if more than one sterilizer is in use;
- cycle or load number;
- date of sterilization;
- description of the package contents (eg, Kerrison rongeur, major abdominal set, Kleppinger bipolar forceps); and
- identification of the assembler.
Verify that package labels are visible and securely fixed to the package.
Use a marker that is nontoxic, nonbleeding, and indelible to enter label information.
- Write on the indicator tape or affixed label of wrapped packages or on the plastic side of peel pouches, and not on the packaging material.

Competency

Perioperative personnel using packaging systems for sterilization will receive education and complete competency verification activities on the principles and processes of packaging systems for sterilization.

Quality

Perioperative personnel using packaging systems for sterilization will participate in quality assurance and performance improvement activities related to packaging systems for sterilization.

Glossary

Chemical indicators: Devices used to monitor exposure to one or more sterilization parameters.

Class I: Process indicator that demonstrates that the package has been exposed to the sterilization process to distinguish between processed and unprocessed packages.
Class II: Process indicator that is used for a specific purpose such as the dynamic air removal test (Bowie-Dick test).
Class III: A single-parameter indicator that reacts to one of the critical parameters of sterilization.
Class IV: A multi-parameter indicator that reacts to one, two, or more of the critical parameters of sterilization.
Class V (integrating indicator): An indicator that reacts to all critical parameters of sterilization.
Class VI (emulating indicator): An indicator that reacts to all critical parameters of a specified sterilization cycle.

Containment device: Reusable rigid sterilization container, instrument case, cassette, or organizing tray intended for the purpose of containing reusable devices for sterilization.

Instrument case/cassette: A container with a lid and a base to sterilize devices that permits air removal and sterilant penetration/removal. The devices require wrapping in packaging material if sterility of the container is to be maintained.

Organizing tray: A reusable metal or plastic tray that permits organization and protection of the contents. Some organizing trays have diagrams for the representative instrument etched onto the surface of the tray to facilitate their identification and location within the tray.

Paper-plastic pouch (peel pouch): A type of packaging made of Mylar® (a polyester film manufactured by Dupont) and paper that is suitable for packaging items to be sterilized in steam or a type of packaging made of Mylar® and Tyvek® (a polyethelene material manufactured by Dupont) that is suitable for packaging items to be sterilized in ethylene oxide, low-temperature hydrogen gas plasma, or hydrogen peroxide vapor.

Rigid sterilization 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.

Woven textile: A reusable fabric constructed from yarns made of natural and/or synthetic fibers or filaments that are woven or knitted together to form a web in a repeated interlocking pattern.

References

Petersen C, ed. Infection. In: Perioperative Nursing Data Set. 3rd ed. Denver, CO: AORN, Inc; 2011:254-276.

Guideline for selection and use of packaging systems for sterilization. In: Guidelines for Perioperative Practice. Denver, CO: AORN, Inc.

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Tags: facility name, sterilization, packaging, [insert, systems, facility

PACKAGING SYSTEMS FOR STERILIZATION [INSERT FACILITY NAME OR A

Policies &amp; Procedures: Other: Packaging

Policies & Procedures: Other: Packaging