CRCST
Technical Continuing Education (TCE)
SELF-STUDY PLANS

This series of self-study lessons on Central Service topics was developed by the International Association of Healthcare Central Service Materiel Management (IAHCSMM). The lessons are administered by Purdue University’s Continuing Education Division.

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Lesson Plan CRCST 102
Sterility Maintenance: Sterile Storage and Transport Standards
[Reprinted from Communiqué: September/October 2008]

It does little good to carefully clean, decontaminate, disinfect, and sterilize medical instruments if they do not remain sterile until the moment of use. Two very critical steps—storage and distribution—occur after sterilization, and procedures to maintain sterility during these activities are the topics of this Self-Study Lesson.¹

Objective 1: Explain that the objective of the packaging process is to maintain the sterility of packages until they are opened.
One objective of the Central Service packaging process requires that package contents remain sterile until they are opened. The U.S. Food and Drug Administration (FDA) classifies sterilization packaging as Class II Medical Devices because they present a potential risk to patients and healthcare workers. The consequences of using a non-sterile item during a surgical procedure can be life-threatening. Central Service technicians must prepare packages that allow the sterilization process to be successful and which will then protect the package contents from contamination after processing is completed. During the sterilization process, the package must then allow the sterilant to effectively enter and exit the package. Finally, sterilized packages must maintain their content sterility until they are intentionally opened.

Objective 2: Review the concept of event-related sterility and indicate factors that affect it.
Traditionally, package sterility was thought to be time-related; packages were considered sterile until a specific expiration date was reached. The package was then taken out of inventory to be reprocessed.

Today, the Association for the Advancement of Medical Instrumentation (AAMI) and the Association of periOperative Registered Nurses (AORN) recognize that sterility is event-related, where microbial contamination of a sterile package is caused by an event, such as improper handling or transport, rather than by the expiration of time, alone. Examples of events that can compromise package sterility include multiple handling before use (which can break seals or cause a loss of package integrity), moisture penetration, and exposure to contaminants in the air.² Other factors (including storage and transport conditions, which are discussed in this self-study lesson) can also affect package sterility.

By closely controlling the storage environment and the events to which sterile packages are exposed, rather than only the time packages are in storage, Central Service personnel can minimize the probability of package contamination. Note: expiration dates on commercial products are still of concern because they indicate usability or stability rather than content sterility. Packages that contain dated products must be labeled with the earliest expiration date, and they should be used before, or discarded on that date.

Objective 3: Explain basic procedures for maintaining package sterility during storage.
The storage environment for sterile packages should be clean, dry, and easily accessible by authorized personnel. Storage areas should also be well-lighted so package labels can be easily read. There should be no dark corners or blind spots which could lead to improper product identification and misplaced or forgotten inventory. Adequate lighting is also critical to personnel safety.

All storage areas should be cleaned routinely with a hospital-approved germicidal agent. Housekeeping procedures should specify concentrations of cleaning chemicals to be used and specific details for cleaning these areas.

Cleaning tasks for sterile storage shelves should be scheduled by section, moving into areas where supply packages have been removed. Shelving units should be damp-dusted routinely. Be careful to avoid excess handling of sterile supplies, and be sure that storage surfaces are dry before supplies are returned to the cleaned shelves.

Air supply to storage areas should be as clean and dust-free as possible, which usually requires filtration. The room should be under positive air pressure to reduce airborne contamination from air outside the storage area. Storage temperatures should be kept between 64ºF to 75ºF (18ºC to 24ºC), with less than 75 percent relative humidity (the amount of water vapor in the atmosphere). Very dry air can affect package seals and cause plastic materials to become brittle. Excessive humidity can cause tapes and labels to lose their adhesion, loosen seals, and affect the identification of package contents. Moisture can also condense on the packaging material and seep (or “wick”) through it, carrying microorganisms that will create wet packs and compromise pack sterility. The presence of moisture also provides an excellent opportunity for fungal growth in the packages.

Store packages at least two inches away from windows, window seals, and the interior surfaces of exterior walls, where condensation can form. Sterile packages should not be stored near exposed water pipes, sewage lines, or air conditioning drains, or near or under sinks. Packs should be kept eight to ten inches above the floor to prevent contamination from floor cleaning agents, spills, and accidental contact by Central Service personnel. The bottom shelf of storage shelving or carts should be solid to help protect sterile packages.
The ANSI/AAMI ST79 standard specifies, and fire safety codes may require that sterile packages be stored at least 18 inches from sprinkler heads.³ Spacing must also be planned and maintained to prevent packages from being touched, bumped, or leaned upon when the room is cleaned or when packs are being stored or retrieved.

Storage areas should be located away from areas with heavy traffic, and access to these areas should be restricted. Authorized individuals entering a storage area must follow hand hygiene policies, wear proper attire, be in good health, and use proper personal hygiene practices while in the area.

All Central Service personnel should maintain a high level of personal hygiene, including clean hair, body, nails, and clothing at all times. Frequent hand washing is important, fingernails should be kept short, and artificial nails should be prohibited. These practices will reduce the microbial load under the fingernails, which will help to minimize contamination of packages and pouches through accidental rupturing.

Stored items should be arranged so that packages are not crushed, inappropriately stacked, bent, or compressed. If the air inside the package is forced out, it can potentially rupture closures and seams in the process. Additionally, when air is forced out of the package, a void is created. When the source of compression is released (the weight on top of the package is removed), a slight suction can then be created by the void. This can, in turn, potentially establish conditions for the packs to “suck in” contaminated air.

Open shelving is convenient and less expensive than closed (enclosed) shelving. Shelves usually have open racks to prevent dust accumulation. Packages on open shelves, however, are more vulnerable to physical hazards (usually accidental) and environmental challenges, including those from cleaning solutions and microorganisms. Many facilities devote some, or all of their storage space to closed shelving units, to protect sterile packages from microbial, environmental, and physical challenges from the outside environment. Doors should be opened slowly when accessing the packs to minimize air rushing into the storage unit, which may contaminate the packs stored in it.

Sterility maintenance covers can be used to protect and extend the shelf life of items that have been properly packaged and sterilized. Only products specifically designed and labeled for this purpose, however, should be used. Covers are designed to protect packages against outside elements such as dust; they do not provide a barrier against microorganisms. The cover wraps should be clearly designated so they are not mistaken for sterile wrap. Covers should be applied to sterilized packages as soon as possible after items have dried and cooled.⁴

Sterile storage areas are also used to store pre-sterilized products received from outside vendors. Products are typically delivered in cardboard shipping containers that should be removed in the receiving department or other break-out area. These containers have been exposed to the environmental challenges of transportation, and they may be dirty, insect-infested, and contaminated with microorganisms, including fungus and bacterial spores.

After removal from shipping containers, externally purchased sterile items must be placed in clean transport containers for transfer to the sterile storage area. A covered or enclosed cart, with solid bottom shelves, should be used. Written procedures are needed to outline steps to help maintain the cleanliness and sterility of vendor-purchased sterile products and to prevent damage or contamination during break-down and transport. The procedure needs to address product expiration dating that may be indicated only on the exterior shipping carton. Storage containers may require labeling with the product’s expiration date. Alternately, labels or stickers may be applied to each item. Use care when applying stickers, to avoid covering other vital product information.

Objective 4: Discuss the logical arrangement of sterile stock.
Properly arranged stock improves staff efficiency, decreases injuries, and facilitates stock rotation. Sterile items should be arranged so they are easy to locate. They can be organized alphabetically by name, functionality, specialty (related items are shelved together), or numerically using stock codes. Shelves should have a label specifying where packs should be stored, along with information needed for reorders. Heavier items should be placed on lower and middle shelves, and lighter and less cumbersome items can be placed on higher shelves.

Sterile packages should be arranged and maintained so stock can be rotated on a first in, first out (FIFO) system. This is important because the longer an item has been in storage, the longer it has been exposed to the environment and physical abuses, and the more likely it will be compromised. Note: items with expiration dates should be used in the order of their expiration dates, with items that will expire the earliest being used first.

Many Central Service facilities use a left-to-right storage system: newest items are placed on the left and older items moved to the right. Packs on the far right, then, should be the first packs used. Other facilities place new packs into storage from the back of the shelf and use the oldest items, which are located at the front of the shelf, first. Remember, to avoid damage to the packages’ integrity, packs must be lifted correctly rather than sliding them over shelf surfaces.

Objective 5: Explain methods for maintaining the sterility of packages during transport from Central Service to sites of use.
Transportation of sterile packages from receiving areas to the Central Service department, or later to the site where they are used, involves the use of covered or enclosed carts. Bottom shelves should be of solid construction because, as the cart wheels turn, they pick up dirt and dust and sling it onto the underside of the solid shelves. Therefore, it is important to wash the tops and bottoms of shelves on carts used to transport sterile packages.

Policies and procedures help to assure cleanliness and proper maintenance of equipment. Damaged cart doors may not close securely, which can allow air to enter as the cart is moved. This “wind” effect can force dirty air, under pressure, against the packs, potentially contaminating them.

Avoid contact with sterile packages, whether by bumping or backing into them, touching them when counting, or excessively rearranging them. When a package is moved or handled, it should be supported with one’s hands, but it should not be held against the body.

Any sterile items that are dropped to the floor should be considered contaminated and removed, even if there is no noticeable damage to the pack. The jarring and compression on landing can force dust and airborne microorganisms into the package. The floor could be wet, sharp edges of trays could puncture the packing wrap, and dirt could be carried onto the storage shelf and contaminate the next pack that is placed in that position on the shelf.

Central Service technicians must be able to recognize evidence of sterility compromise. A log of sterile package contamination events should be maintained and analyzed so that corrective and preventive actions can be implemented.

When removing a sterile package from the shelf, the front should be lifted from underneath with one hand. The other hand should be placed midway under the package, and the unit should then be lifted off the shelf. Packages should not be dragged or pushed against any surface because friction or abrasions may result, which can cause a pressure cut or snag that will compromise sterility. Shelf liners can help create a cushion between the hard surface of the shelf and the bottom of the packages. These are especially helpful if the facility experiences tears on the bottom of packs. This is usually a greater concern with heavy packs, procedure sets and, especially, instrument trays. The edges of the metal trays and weight of the instruments increase the negative effects of friction. Burrs or sharp edges on the shelves themselves may also damage sterile packs.

When packs are removed from storage, they must be observed carefully for expiration date (if any), tears, abrasions, tracks, fuzzy (“worn”) areas, punctures, compromised seals, dirt, and evidence of moisture. The sterilization process indicator must be checked to ensure that the package was properly subjected to the sterilization process. If any problems are noted, the pack should be considered contaminated. If the contents are reusable, they should be removed from the package and completely reprocessed. If the contents are disposable, they should be discarded. Single-use wrap should not be reused.

In Conclusion
No single packaging method meets the packaging and sterilization needs of all medical devices required for all patient care procedures. Written policies and procedures are required to establish the authority, accountability, and responsibility for the selection and use of packaging materials. Procedures should be developed jointly by Central Service personnel and user department staff members, and protocols must be reviewed and approved by the facility’s infection control and quality assurance/improvement committees.

Endnotes

1. Except where otherwise referenced, this Self-Study Lesson is based on: Sterile Packaging and Storage. Chapter 13 in: Central Service Technical Manual. Seventh Edition. Chicago, Illinois. International Association of Healthcare Central Service Materiel Management. 2007.
2. See, for example: Association of periOperative Registered Nurses (AORN). Recommended Practices for Sterilization in the PeriOperative Practice Setting. Standards, Recommended Practices, and Guidelines. 2007. (See “Recommended Practice xii.”)
3. Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities. ANSI/AAMI ST79: 2006. (See Section 8.9.2)
4. See reference 3 (Section 8.9.1).