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Sterile Processing University, LLC Module 17:

Preparation and Packaging of Instruments and Devices – Part I [Technician]

Copyright Sterile Processing University, LLC – 2016 – All Rights Reserved. This material may not be copied or used without permission of SPU.

LEARNING OBJECTIVES:

1. Review dress code requirements.

2. Review the physical environment of the preparation and packaging area.

3. List the basic principles of packaging.

4. Describe the various types of packaging materials.

5. Describe the structure, use, and testing of rigid sterilization container systems.

6. Understand the organization of instruments sets and the preparation of basins and textile packs.

INTRODUCTION

The packaging of medical devices requires a thorough knowledge of the types of packaging materials available, the packaging materials validated for the various sterilization methods, the methods of packaging or wrapping devices and sets, and the methods of closing and labeling packages. Each of these knowledge areas has a direct impact on the sterility of the product.

Surgical instruments represent a large portion of the healthcare facility’s budget. They are the tools that surgeons rely on to help ensure a positive outcome of a surgical procedure. Regardless of the skill of the surgeon, surgical procedures cannot be effectively performed without properly cleaned, complete, functional, properly packaged, and sterile surgical instruments and devices.

PREPARATION AND PACKAGING AREA The preparation and packaging area is a clean area where surgical instruments and other medical devices are inspected, tested, assembled, and packaged for sterilization. In most facilities, the preparation and packaging area is adjacent to the sterilization area (not physically separated).

The area used for the preparation, inspection, testing, and sterilization of instruments and devices should be physically separated from the decontamination area. This is known as a physical barrier. According to ANSI/AAMI ST79, “if physical separation of these areas is not possible (as could be the case in ambulatory-care or office-based facilities), the preparation area should be thoroughly cleaned and decontaminated before being used for clean preparation and assembly tasks.”

The preparation and packaging area should include space for the supplies used for the preparation of trays and sets (e.g., wrappers, chemical indicators, tape, gauze, cotton balls) and for handwashing facilities. In addition, space should be allocated for the storage of cover attire for visitors (e.g., jumpsuits, head covers).

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Figure 8-1 — Preparation and packaging area

The environmental conditions in the preparation and packaging area must meet certain requirements. The area must have an air exchange rate of at least 10 air exchanges per hour, and it must be under positive air pressure to help keep dust and contaminants to a minimum. The temperature should be maintained between 68ºF and 73ºF (20ºC and 23ºC). The ideal humidity level is 50% and should not be less than 35% for best results in sterilization. Lower humidity levels can adversely affect packaging, sterilization process indicators (chemical indicators, biological indicators), and other materials (ANSI/AAMI ST79). The temperature and humidity in the preparation and packaging area should be documented daily. If the levels are too high or too low, the department responsible for maintaining the correct temperature and humidity should be notified, and the actions taken should be documented in the SPD log.

Traffic must be kept to a minimum. Anyone entering the preparation area must wear proper attire (a hospital-laundered scrub suit or disposable jumpsuit and a hair covering). Human skin is naturally colonized with many bacteria; personnel shed microorganisms into the air around them. Wearing long-sleeved attire helps contain skin squames shed from bare arms. (AORN, 2016a). All facial hair (except for eyebrows and eyelashes) must be covered.

Shoes worn in the department should be clean, should have non-skid soles, and should be sturdy enough to prevent injury if an item drops on the foot. Shoe covers are only needed to cover shoes that do not remain at the facility.

Good housekeeping is very important to maintaining the integrity of the preparation and packaging area. Workstations should be cleaned with an approved disinfectant at the end of each shift, or more frequently as needed, by the SPD technician assigned to the area. Floors should be wet-mopped daily by Environmental Services staff. Walls, vents, ceiling fixtures, cabinets, and shelving should be cleaned according to a prescribed schedule and as needed. The schedule should indicate the cleaning frequency and designate the responsible person. Cleaning schedules should be kept in a log and dated and signed each time the cleaning is performed. SPD personnel should enforce the dress code when Environmental Services staff or other visitors enter the area.

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NOTE1: Vacuum cleaners should not be used in SPD. They cause dust to become airborne by exhausting air that is not completely filtered. This dust can settle on trays, instruments, and sterile packages and could even cause health issues for the operator, who ends up inhaling dust, which is also redeposited on the area being cleaned. As noted earlier, floors should be wet-mopped daily. If use of a vacuum cleaner is noted, you should report it to your supervisor, who should follow up with Environmental Services.

NOTE 2: Materials used in floors should not be of a particulate- or fiber-shedding composition, because particulates and fibers can be shed into the environment.

PACKAGING PRINCIPLES OF PACKAGING

The main purposes of sterile packaging are to allow proper sterilant penetration and removal and to maintain the sterility of an item until it is intentionally opened or used. The generic term “package” (also referred to as “sterile barrier system”) refers to wrappers, paper–plastic pouches, and rigid sterilization container systems. The proper type of packaging is needed for sterilization compatibility and for the protection of sterile items during sterilization, handling, storage, and transport. It is important to obtain and read the packaging manufacturer’s written instructions and technical data for the packaging material. This information should include the intended use of the packaging (the sterilization method, including cycle type [e.g., gravity-displacement or dynamic-air-removal steam sterilization]), the storage conditions and shelf life, and the results of sterilization testing. “Documentation of the manufacturer’s test data provides assurance that the packaging system selected meets the criteria required, such as linting level, barrier efficacy, puncture resistance, fluid resistance, and sterilant penetration and removal. Not all packaging systems are suitable for all types of sterilization methods.” (ANSI/AAMI ST79) The manufacturer’s IFU and technical data should be kept on file for as long as the packaging product is in use. All instructions for use should be followed.

NOTE: See Chapter 12 for a more detailed discussion of shelf life. There are three basic principles of packaging: the type of material used must allow the sterilant to reach the contents of the package, the material must provide a good barrier to all types of microorganisms and other contaminants (e.g., moisture), and the package must be able to be opened without contamination of the contents (i.e., allow aseptic presentation). In addition, an ideal packaging material has several characteristics:

• Strong physical changes—such as rapid moisture, vacuum, and temperature changes—occur during most sterilization processes. Therefore, a packaging material must be able to withstand such changes without burning, tearing, or opening.

• The removal of air from packages is essential to the sterilization process, because air will not allow contact with steam and it could prevent EO from diffusing quickly into the sterilization chamber. Therefore, a packaging material must allow air removal.

• For sterilization to take place, the sterilant must contact all surfaces of the item to be sterilized. Therefore, a packaging material must allow the sterilizing agent to enter the package. For example, nylon and aluminum foil cannot be used as packaging materials for items to be EO sterilized, because these materials cannot be penetrated by EO.

• A packaging material must allow easy removal of the sterilant. After steam sterilization, water vapor must be removed to allow drying. After EO or gas plasma sterilization, excess sterilant must be removed to minimize residuals on sterile items.

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• Microorganisms are everywhere, and it is important to ensure that sterile items will remain sterile. A packaging material must not allow microorganisms to enter the package and contaminate sterile items.

• Moisture will contaminate sterile items by wicking microorganisms into the package. Therefore, a packaging material must repel fluids.

• Various types of closures (e.g., tape, seals, and locks) are used in packaging. It should not be possible to open closures and then reseal them. In other words, packaging and/or closures must be tamper-evident.

• Items to be sterilized come in all shapes and sizes. The packaging material must be adaptable and neither too large nor too small.

• Some instruments are very fragile and must be protected from physical damage during handling and transport. One type of protection for these items is a specialty container made of plastic or metal (Figures 8-2, 8-3, and 8-4).

• After sterilization, drying, and cooling, sterilized items are placed in the sterile storage area or transported to another department. Therefore, a packaging material needs to be durable and to resist tearing and puncturing.

• The OR staff must be able to remove instruments or supplies from a package without contaminating them, so a packaging material must allow for aseptic presentation.

It is important to understand that a wrapper that is too large can prevent steam contact with the device, air removal, and revaporization. In addition, extended sterilization cycles can have an impact on the packaging materials used. Therefore, the wrappers used for devices requiring extended cycles should be able to withstand exposure to those cycles.

Figure 8-2 — Metal specialty container

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Figure 8-3 — Plastic specialty container

Figure 8-4 — Dental specialty container

TYPES OF PACKAGING MATERIALS

Two basic types of packaging materials are used for wrapping: woven textiles and nonwoven materials.

Woven Textiles: Woven textiles are made of either 100% cotton or a cotton blend, and they are reusable. At one time, muslin wrappers were the most widely used packaging material. Muslin is unbleached, 140-thread-count, 100% cotton. The use of muslin for wrappers and for protective garments such as surgical gowns has been virtually abandoned because of muslin’s poor barrier properties. Newer types of woven materials have much better barrier properties through the use of various blends and treatments. Woven wrappers must be laundered between uses and inspected each time for holes and tears, using a lighted work table. Also, they must be delinted after each laundering. If the wrapper is one-ply, two wrappers must be used for each package. Most woven materials used as wrappers are considered outdated at 30 days. The manufacturer’s instructions for the number of reuses should be followed, and the number of

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reuses should be tracked (there is usually a grid on the material for marking uses). “The barrier qualities of new textile wraps are diminished by repeated laundering and sterilization cycles.” (ANSI/AAMI ST79) A quality assurance process should be in place for woven textiles to ensure that the barrier quality of the material is still effective and that there are no defects (e.g., holes).

Figure 8-5 — Unacceptable woven wrapper

The manufacturer’s IFU, including the sterilization cycles and exposure temperatures to be used, should be followed for all textiles sterilized in SPD (e.g., cloth surgical gowns, reusable surgical towels).

Nonwoven Materials: Over the years, packaging materials have changed and improved. One of the biggest changes has been the advent of nonwoven (single-use) materials. Nonwoven materials are made of cellulose fibers, plastic polymers, and/or paper pulp that are bonded together to form a sheet. Nonwoven wrappers, which are intended for single use only, are considered to provide an excellent barrier to microorganisms. They are available in various sizes and thicknesses. Some of the newer nonwoven materials, especially heavy-duty wrappers, can cause difficulty in drying instruments at the end of a steam sterilization cycle. When the heaviest or thickest wrapper is used, it might be necessary to extend drying time in steam sterilization cycles. Some nonwoven packaging materials have an expiration date (use-by date) on the box. It is important to ensure that the material is used by the stated date.

For quality assurance purposes, whenever a new box of single-use packaging material is opened (wraps or paper–plastic pouches), several pieces should be inspected for defects and extraneous matter before the packaging material is placed into use. If any defects are noted, the packaging material should be returned to the manufacturer.

One type of nonwoven wrapper consists of two wrappers bonded together at the edges. This type of wrapper is equivalent to two single wrappers, so the “simultaneous” wrapping technique (wrapping with both wrappers at the same time) can be used. For nonwoven wrappers that are single-ply, two separate wrappers are needed. The “sequential” wrapping technique is generally used; i.e., items to be sterilized are first wrapped with one wrapper, then with the second wrapper. However, it is acceptable to apply two single-ply wrappers at the same time even if they are not bonded together.

One problem with nonwoven materials is that they are prone to damage (tears and abrasion) from improper handling, especially when the set is heavy or when sets are stacked, which is not recommended. (Figure 8-7 shows an abraded wrapper. Figure 8-8 shows improper stacking of sets.) Such damage frequently occurs when trays are pulled off a sterilizer cart or storage shelf

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instead of being lifted off. To reduce the incidence of damage, some manufacturers of nonwoven packaging material provide reusable plastic transfer trays (Figure 8-9). After the set is wrapped, it is placed on the tray and then sterilized, stored, and distributed on the tray. Many facilities are now switching to rigid sterilization containers (see the discussion of rigid containers later in this chapter).

Figure 8-6 — Nonwoven (single-use) packaging materials

Figure 8-7 — Abraded wrapper on tray

Figure 8-8 — Improper stacking of sets

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Figure 8-9 — Plastic transfer tray

Some facilities have adopted “green” standards and recycle used wrap. The wrapping material manufacturer should be consulted for recycling guidelines and for information about the costs associated with recycling.

WRAPPING METHODS

Instruments and supplies are wrapped to keep them sterile until used. This is why proper wrapping technique is so important.

The wrapper must be of the correct size. Sets with multiple and specialty instruments may be contained in trays or containers specifically designed for them. As with any item being wrapped, using a wrapper that is too large creates too many layers of material, which can inhibit sterilant penetration. Using a wrapper that is too small will not enclose the item entirely and can cause the item to become contaminated. If the wrapper will be used as a sterile field in the operating room, it must be large enough to extend at least 6 inches over each side of the table it will cover. The packaging manufacturer’s IFU should always be consulted.

The two most common methods of wrapping are the square fold (Figure 8-10) and the envelope fold (Figure 8-11). The square fold is used for large packs such as laparotomy linen packs and is often used to create a sterile field. The envelope fold is used for smaller packs and trays and is the method most widely used in SPD today.

Figure 8-10 — Square fold (first fold should cover item inside)

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Figure 8-11 — Envelope fold (first fold should cover item inside)

No matter which method is used, it is important to use a wrapper of the correct size and to ensure the integrity of the package by securing it properly. Chemical indicator tape is commonly used to secure wrapped packages. It is important not to use excessive amounts of tape to secure packages or to wrap tape around a package, because it will interfere with steam contact and penetration. During the sterilization cycle, the package expands and contracts. Any closure that restricts this action will interfere with air removal, steam penetration, and steam removal. (Figure 8-12 illustrates excessive tape used on a package; the appropriate amount of tape in shown in Figure 8-13. Figure 8-14 shows proper wrapping of a large set.) Pins, staples, paper clips, and similar items should never be used, because they can damage the wrapping material and thereby cause contamination.

Figure 8-12 — Excessive tape used for small set

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Figure 8-13 — Correct amount of tape used for small set

Figure 8-14 — Proper wrapping of larger set

For the envelope fold, the following procedure is used (see Figure 8-15):

1. Arrange the wrapper in a diamond shape on the table. Center the tray, set, or instrument on the wrapper(s).

2. Take the edge of the bottom and bring the wrapper up and over the instrument so that the wrapper completely covers the instrument/device being wrapped.

3. Fold an edge over the item so that there is a tab that the opener of the package can use to secure the contents.

4. Fold in the right (or left) corner fold and fold the tip back on itself to form a tab.

5. Fold in the left (or right) corner fold and fold the tip back on itself to form a tab.

6. Fold the top edges over the package. Tuck in the edges of the open folds and bring over and around the set. Make a fold so that the edges are even with the pack or bring the fold to the back of the tray (although the latter method sometimes causes issues with aseptic opening of the pack).

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7. Secure the package with sterilization tape. One piece should be sufficient for smaller packages; two can if used if necessary. Just enough tape should be used to keep the packaging material secured.

Step 1 Step 2

Step 3

Step 4 Step 5

Step 6 Step 7

Figure 8-15 — Procedure for envelope-fold wrapping

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PACKAGE CLOSURES

Closures used to secure packages should be selected to allow the steam sterilization process to occur, avoid constriction of the package, and maintain package integrity. Sterilization tape is the common method of closure for wrapped packages. The tape should be specific to the sterilization process for the tray or package. Sterilization tape is available in several widths; the size used is determined by the size of the tray and facility preference. The sterilization tape manufacturer’s IFU should always be checked before the tape is used. Some sterilization tapes have an expiration date; it is important to check this date before the tape is used and to rotate the tape stocked in SPD. (The expiration date is usually found inside the roll where the lot number information is printed.) Some states and municipalities limit the amount of lead that can be placed in the waste stream. Because some types of sterilization tape contain lead, it is important to obtain the manufacturer’s IFU and SDS before purchase.

When reusable textiles are wrapped, a tab should be created with the tape to facilitate its removal. For single-use wrappers, the tab is not required because the sterilization indicator tape is torn. No other form of tape (e.g., masking tape) should be used to secure packages. Some elastomer bands have been validated for use as outside closures for sterile packaging, but they should be used only if the wrapper manufacturer specifically recommends their use. Care must be taken to use the correct size (relative to the length and width of the package) so that the band fits snugly but does not constrict the package or create wrinkles or folds.

**NOTE: The Quiz for this topic is given AFTER you complete Module 20. Please click on the link below to go to Module 18. https://www.spdceus.com/modules/sixth/tech/module18_pay.htm