By Susan Klacik, BS, CRCST, CIS, CHL, FCS, AAMIF
The Association of periOperative Registered Nurses (AORN) has revised its Guideline for Sterilization Packaging Systems, which provides guidance for evaluating, selecting and using sterilization packaging systems, and packaging items to be sterilized for subsequent use in surgical and other invasive procedures. This article summarizes some of the significant changes regarding peel pouch use and package preparation.
Peel Pouch Guidance
The importance of using peel pouches correctly was emphasized in Recommendation 6 of the revised guideline. Based on research that showed seal defects were related to overweight instruments and paper-plastic pouches that were too small for the item being packaged, the revised guideline recommends choosing peel pouches based on the size and durability needed to accommodate each item undergoing packaging.
A peel pouch’s integrity is compromised if the seal is broken. Therefore, it is recommended that all peel pouch seals should be smooth and closed completely. A peel pouch with gaps, folds, bubbles or wrinkles indicates that the seal has been compromised and the package cannot be used. Interestingly, research based on a root cause analysis of peel pouch defects revealed human factors that caused seal defects; such human factors included distraction, neglect, insufficient training, insufficient inspection, poor vision, and incorrect equipment use. Further, there were environmental factors, including insufficient lighting and lack of space; material factors, such as using a small-sized package for a larger item; and equipment factors like obsolete equipment and abnormal machine performance. The study led to improvements to correct the findings from the root cause analysis; after the improvements were made, the sealing defect rate improved from 0.15% to 0.07%.
The guideline does not recommend placing peel pouches within wrapped sets or rigid sterilization containers unless doing so is stated in the pouch manufacturer’s instruction for use (IFU). The pouch manufacturer’s IFU should be consulted regarding the positioning of the package within the sterilizer. It is also important to note that if the impervious plastic side of a peel pouch is in contact with instruments within sets, the sterilant cannot contact the surfaces.
Double pouching, which entails placing an instrument within one pouch and then placing that pouch inside another, is addressed in Recommendation 6.3. Double pouching is not recommended unless it is permitted by the pouch manufacturer and included in the IFU. The packaging manufacturer performs sterilization validation studies to confirm that the pouch will perform as intended when two pouches are used in a single package. If the pouch manufacturer does permit double pouching (as stated in the IFU), Recommendation 6.4 of AORN’s revised guideline provides recommendations for performing double pouching to allow for complete surface sterilant contact.
Some types of peel pouches require the use of a heat sealer. Recommendation 6.5.2 recommends using heat sealers in strict accordance with the manufacturer’s IFU to ensure the correct temperature for the pouch material is used. Note: Using a heat sealer incorrectly can result in incomplete seals that jeopardize the integrity of the seal and sterility of the peel pouch.
Using an inappropriate method to label a sterile package can also render a package unusable. A new recommendation was added (Recommendation 8.1.1) stating that if a marker is used to label the package, the ink should be nontoxic, nonbleeding and indelible. Ballpoint pens and pencils should not be used because the force of writing with wither can cause perforation or puncture the pouch. The labeling location is another important consideration. The paper side of the pouch should not be used for labeling because doing so can damage the package and compromise the barrier. It is recommended to only write on the indicator tape, affixed label, or plastic side of peel pouches.
Recommendation 5.2.1, which is closely tied to the AORN Guideline for Sterile Technique, states that all single-use sterilization wrappers are to be inspected for defects and cleanliness before use. Research was performed on polypropylene wrappers with holes ranging in size from 1.1 mm to 10.0 mm. The findings showed that bacterial transmission occurred in all holes, regardless of their size. This recommendation recognizes that visually inspecting sterilization instrument wrappers by holding them to the light does not reliably identify holes or tears. In addition, packaging tears may be more easily identified than holes. Note: Defective packaging materials should not be used. Inspection for holes is also recommended under Recommendation 7.3.3, since non-intact filters can result in microbial ingress and failure to maintain sterility within a sterilized package. Both single-use and reusable sterilization container filters should be inspected to ensure they are intact. If a filter is not intact, the sterilization container should not be used.
Set Standardization Emphasized
Some instrument sets contain a number of devices that are often unused during the procedure. The updated AORN guideline (Recommendation 10 on Quality) includes a conditional recommendation to employ the use of quality assurance (QA) and performance improvement (PI) initiatives to identify and remove underutilized instruments from sets.
Removing instruments from a set should be performed using common QA and PI initiatives such as Lean, Kaizen and Six Sigma. Instrument utilization data may be used to identify and remove underutilized instruments from sets, and an interdisciplinary team of users and key decision-makers should be assembled to further evaluate instrument utilization and determine which instruments can be removed from sets. There are many benefits of streamlining sets, including improved efficiency, reduced instrument processing and set-up time, and a reduction of instrument set weight, costs and energy and water consumption. There is some evidence that having a surgeon champion the standardization initiative can be critical to its success.
Also recommended is the establishment of a process for updating and reviewing instrument count sheets to ensure the required devices for a procedure are included in the set. Inaccurate count sheets also contribute to communication problems between Surgery and Sterile Processing. Updating count sheets in a standardized format streamlines Sterile Processing workflows and helps ensure that end users have the appropriate devices for each procedure.
This article summarized some of the significant updates to AORN’s revised Guideline for Sterile Packaging Systems. It is important to review the entire guideline, which is available at https://aornguidelines.org/guidelines/content?sectionid=173737249&view=book#180198250
