[Insert facility name or a header]

Competency Verification Tool—Perioperative Services

Practice: Packaging Systems for Sterilization – RN or Non-RN

Competency Statements/Performance Criteria / Verification Method
[Select applicable code from legend at bottom of page] / Not Met
(Explain why)
DEM/
DO/DA / KAT / S/SBT/
CS / V / RWM/
P&P / O

Name: ______Date: ______

Competency Statement: The perioperative RN ornon-RN team member has completed facility- or health care organization-required education and competency verification activities related to packaging systems for sterilization.1

  1. Guideline for selection and use of packaging systems for sterilization. In: Guidelines for Perioperative Practice. Denver, CO: AORN, Inc; 2016:809-822.

Outcome Statement: The patient is free from signs and symptoms of infection.2

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

Competency Statements/Performance Criteria / Verification Method
[Select applicable code from legend at bottom of page] / Not Met
(Explain why)
DEM/
DO/DA / KAT / S/SBT/
CS / V / RWM/
P&P / O
  1. Participates inprepurchaseevaluationofpackagingsystemsasapplicable.

  1. Participates in testing the performance of each packaging system as applicable.

  1. Recognizes that sterility is event-related.

  1. Verifies that the total weight of instrument containment devices do not exceed 25 pounds, including contents and containment method.

  1. Stores packaging materials at room temperature and at a relative humidity that is in accordance with the packaging manufacturer’s instructions for use (IFU).

  1. Discards wrapping materials labeled for single-use after one sterilization cycle.

  1. Packages items to be sterilized in a manner that facilitates sterilization, maintains sterility, and provides for an aseptic presentation of the package contents.

  1. Inspects packaging materials, including filters for rigid sterilization containers, for defects and extraneous materials before using and does not use packaging materials with defects or extraneous materials that cannot be removed.

  1. Selects the size of wrapping material to achieve adequate coverage of the items to be packaged.

  1. Wraps the items securely in a manner that prevents gapping, billowing, or formation of air pockets.

  1. Positions the items to be sterilized within the package to allow sterilant content with all surfaces.

  1. Disassembles instruments composed of more than one part unless the manufacturer’s IFU specifies that disassembly is not required.

  1. Positions items to be sterilized that have concave or convex surfaces within packages in a manner that prevents those surfaces from retaining water.

  1. Places towels in instrument sets only if they are lint-free and laundered in the health care-accredited laundry facility.

  1. Places items to be sterilized in the package or tray in an open or unlocked position.

  1. Uses racks or stringers designed and intended for sterilization to maintain instruments in their open position as needed.

  1. Places a chemical indicator on the outside and inside of every package unless the internal indicator is readable through the package material.

  1. Places a class I chemical indicator (ie, process indicator) externally.

  1. Places 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.

  1. Places more than one chemical indicator for multilevel trays according the tray manufacturer’s written instruction for use.

  1. Places chemical indicators in an area within the package that presents a challenge for air removal and sterilant contact.

  1. Follows the chemical indicator manufacturer’s instructions for storage and use and expiration date.

  1. Inspects textiles on a light table for defects (eg, holes, tears, worn spots) and
  2. repairs small defects using a vulcanized patch,

  1. keeps the number of repairs to a minimum, and

  1. discards reusable woven packaging if there is a question about its suitability.

  1. De-lints reusable woven packaging materials after laundering and before using.

  1. Marks 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.

  1. Follows the manufacturer’s IFU for the recommended number of reprocessings.

  1. Uses peel pouches for small, lightweight, low-profile items (eg, one or two clamps, scissors).

  1. Does not use peel pouches within wrapped sets or containment devices unless the pouch manufacturer can supply documented validation for this process.

  1. Does not perform double pouching (ie, placing the item within one pouch and then placing this pouch inside another) without instructions and the pouch in question has been cleared by the FDA for this purpose.

  1. Verifies that the inner pouch
  2. fits within the outer pouch without folding and

  1. faces in the same direction as the outer pouch (ie, plastic or Mylar faces plastic or Mylar,® paper or Tyvek® faces paper or Tyvek) when double pouching is indicated.

  1. Places peel pouches on edge and spaced to permit sterilant contact and drying when loading the sterilizer.

  1. Uses racks designed and intended for sterilization to separate and hold pouches in a vertical position as needed.

  1. Labels peel pouches according to the pouch manufacturer’s IFU.

  1. Places labels on the plastic side of the pouch.

  1. Uses a marker with nontoxic ink for writing on the plastic side of the pouch.

  1. Follows the manufacturer’s recommended sterilization method and cycle exposure times for each rigid sterilization container system.

  1. Evaluates sterilization efficacy and drying effectiveness of rigid sterilization containers before initial use and periodically according to the manufacturer’s IFU.

  1. Refers to the containment device or organizing tray manufacturer’s IFU to determine whether placing cassettes or organizing trays within rigid sterilization containers is acceptable.

  1. Inspects the integrity of the rigid container after each use and verifies that
  2. mating surfaces and edges of the container and lid are free of dents and chips,

  1. lid and container fit together correctly and securely,

  1. filter retention mechanisms and fasteners are secure and not distorted or burred,

  1. latching mechanisms are functioning correctly,

  1. handles are working correctly,

  1. integrity of the filter media is not compromised,

  1. gaskets are pliable, securely fastened, and without breaks or cuts, and

  1. valves are working correctly.

  1. Examines filter plates before and after the sterilization process and
  2. verifying that single-use or reusable and valve systems are secured and working correctly before sterilization,

  1. using only intact filters,

  1. considering the contents unsterile if the filter is damp, dislodged, or has holes, tears, or punctures.

  1. Removes damaged items from service for repair or replacement.

  1. Cleans rigid sterilization containers after each use.

  1. Disassembles and cleans all components (eg, filter retention plates) unless otherwise specified in the manufacturer’s IFU.

  1. Does not place additional materials (eg, silicone mats, towels) within rigid sterilization containers unless the container manufacturer has provided directions for their use.

  1. Reviews the manufacturer’s IFU to determine limitations related to density of materials, weight, and distribution of contents before placing devices within rigid sterilization containers.

  1. Labels packages to be sterilized with the sterilizer number, cycle or load number, date of sterilization, description of the contents (eg, Kerrison rongeur), and identification of the assembler.

  1. Verifies that package labels are visible and securely fixed to the package.

  1. Writes on the indicator tape or affixed label of wrapped packages or on the plastic side of peel pouches and not on the packaging material.

  1. Verbalizes a review offacility or health care organization policies and procedures related to packaging systems for sterilization.

  1. Participates in quality improvement programs related to packaging systems as assigned.

Concurrent competency verification of the following is recommended
  • [Additional competencies related to packaging systems for sterilization as determined by the facility or health care organization]

Editor’s note: Mylar is a registered trademark of DuPont Teijin Films. Tyvek is a registered trademark of E. I. du Pont de Nemours and Company.

DEM/DO/DA=Demonstration/Direct Observation/Documentation AuditKAT=Knowledge Assessment Test

S/SBT/CS=Skills Laboratory/Scenario-based Training/Controlled SimulationV=Verbalization

RWM/P&P=Review of Written or Visual Materials/Policy/Procedure Review (Specify P&P #s ______)O=Other: ______

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