HIGHPOWER Validation Testing & Lab Services

Chuck Hughes

The purpose of sterilization packaging systems (i.e. wraps, peel pouches and rigid containers) in health care facilities is to maintain sterility until point of use. While this is well understood by health care users, Guidelines are not always accessible and therefore not always understood by health care teams responsible to carry out this critical task. In this article, we will highlight an important document that should be purchased and used by all U.S. health care facilities responsible for the sterilization of reusable medical devices.

The document is titled “Guideline for Selection and Use of Packaging Systems for Sterilization” published by the Association of periOperative Registered Nurses (AORN) in their Guidelines for PeriOperative Practice. This document is approved by the AORN Recommended Practices Advisory Board and lists twelve (12) Recommendations which are intended to be achievable and represent what is believed to be an optimal level of practice.

Recommendation I states: “Packaging systems and packaging materials should be evaluated before purchase and use”. This recommendation provides a detailed list of what packaging systems should have, should be and what they should allow in order to be considered for selection and use in health care facilities. FDA clearance, written instructions for use (IFU), resistant to tears and resistant punctures to name a few. A proper pre-purchase evaluation ensures the health care facility will have right product for the right use will be provided wherever sterilization occurs.

Recommendation II states: “Packaging Systems should be compatible with the specific sterilization method for which they will be used.” This recommendation discusses the most common sterilization methods used in health care facilities (steam, EO gas, hydrogen peroxide gas plasma, hydrogen peroxide vapor and ozone) and emphasizes process and sterilizer manufacturer compatibility.

Recommendation III states: “Packaging materials should be processed and stored in a way that maintains the qualities required for sterilization.” This recommendation discusses temperature and/or humidity requirements prior to use, single-use product disposal or recycling if suitable and supports event-related shelf life.

Recommendation IV states: “Items to be sterilized should be packaged in a manner that facilitates sterilization and provides and aseptic presentation of the package contents. Packaging should be used according to the packaging manufacturer’s and sterilizer manufacturer’s written IFU.” This recommendation discusses issues that can occur when incorrect or defective packaging is used, i.e. prevent sterilization, loss of integrity post sterilization and making aseptic delivery difficult or impossible. Proper size is emphasized when using wrapping material to cover contents, along with maximum weight of instrument trays (25 lbs), proper assembly of instruments, use of towels, racks or stringers within instrument sets and the use of sequential wrapping to facilitate sterility maintenance and aseptic presentation of contents.

Recommendation V states: “Chemical indicators specific to the sterilization method selected should be used with each package.” This recommendation emphasizes that a chemical indicator (CI) should be placed and outside and inside of every package to verify processing has occurred. While not a sterility indicator, these devices are critical to visible show users that sterilization parameters were achieved. The different classes (recently changed to“types”) of chemical indicators are described, along with proper placement.

Recommendation VI states: “Reusable woven packaging materials should be inspected and monitored throughout the life of the product.” This recommendation discusses how to inspect reusable textiles used for sterile packaging, along with the importance of delinting after washing and the importance of establishing a method to monitor, control, and determine the useful life.

Recommendation VII states: “Peel pouches (i.e., paper-plastic, Tyvek, Mylar) should be used in according to manufacturers’ written IFU).” This recommendation discusses using peel pouches for small, light weight, low profile items and not placing them within other packaging systems unless validated. Proper method of double pouching is explained when the pouch has been validated by the manufacturer for this purpose. Proper placement of pouches when loading the sterilizer, the use of racks, labeling and proper use of markers is also covered.

Recommendation VIII states: “A rigid sterilization container should be used, cleaned, inspected, repaired, and maintained according to the manufacturer’s written IFU”. This recommendation discusses using containers that have been FDA cleared and validated for specific sterilization methods and cycle exposure times. User evaluation of sterilization efficacy and drying effectiveness prior to use is emphasized, along with use of cassettes or organizing trays within rigid containers. Cleaning and inspection after each use is important and a list of what each inspection should include is provided. The use of additional materials (e.g. silicone mats or towels) should be used in accordance with the rigid container manufacturer’s IFU.

Recommendation IX states: “Packages to be sterilized should be labeled”. This recommendation discusses what information should be documented prior to sterilization which allows items to be identified or retrieved in the event of a processing error or sterilizer malfunction.

Recommendation X states: “Perioperative team members with responsibilities for selection and/ or use of packaging systems should receive initial and ongoing education and competency verification on their understanding and use of packaging systems.” This recommendation discusses the need and importance of education and competency verification of periOperative team members.

Recommendation XI states: “Policies and procedures for selection and use of packaging systems should be developed, reviewed periodically, revised as necessary, and readily available in the practice setting in which they are used.” This recommendation discusses what should be included in your policies and procedures, along with why they are important.

Recommendation XII states: “Perioperative personnel should participate in a variety of quality assurance and performance improvement activities that are consistent with the health care organization’s plan to improve understanding and compliance with the principles and processes of selection and use of packaging systems.” This recommendation discusses the establishment of quality assurance and performance improvement programs to monitor the workplace environment and practices associated with selection and use of packaging systems. A list of activities is provided for inclusion in the health care facility’s policies and procedures. Product testing is recommended whenever there is a major change in packaging systems, i.e. a change from using wrapping materials to using rigid sterilization containers, or when there are changes to materials, tray configuration, or content density. The use of biological and chemical indicators is explained during product testing, along with the need for visual inspection for wet packs.

As reported by the CDC, The Joint Commission and the national media; recent infection control lapses due to non-compliance with recommended reprocessing procedures highlight a critical gap in patient safety. Sterilization is a critical aspect of patient safety and the selection and use of packaging systems plays a vital role in achieving and maintaining sterilization of reusable medical devices. For this reason, health care facilities are encouraged to implement each of these important recommendations.