Using single-use towels to wrap instrument sets

AORN Journal,  April, 2008  by Downing Denise

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QUESTION: When reprocessing instruments sets, our Sterile Processing Department personnel wrap towels around the sets or places towels in the bottom of the instrument tray. The towels have been laundered for reuse even though they are labeled as "single use." Our facility sometimes uses new sterile towels for the same purpose. What is AORN's recommendation about using new, sterile towels or reusing single-use towels to wrap around instrument sets or to line the bottom of instrument trays for sterilization?

ANSWER: Towels labeled as "single-use" should not be laundered for reuse. When a manufacturer labels a medical supply as single-use, the device is intended to be used on one patient for one procedure. "The device is not intended for reprocessing or use on another patient and/or on the same patient at another time." (1(p238)) AORN's "Guidance statement: Reuse of single-use devices" states that any company or hospital that is reprocessing items, including all operations to render a contaminated item reusable or a single-use device patient-ready, is considered by the US Food and Drug Administration (FDA) to be a manufacturer and, therefore, must comply with statutory and regulatory requirements. (1,2)

The procedure for reprocessing a single-use device, whether it is a towel or a vascular graft, is complex and is governed by the FDA under the Federal Food, Drug and Cosmetic Act (3) and the Medical Device User Fee and Modernization Act (MDUFMA). (2)

   Government protocols that hospitals must
   comply with are time consuming and expensive,
   requiring additional staff members,
   equipment, and the services of an independent
   laboratory. (4(p110))

If your facility launders single-use towels for use in or around instrument trays your facility must comply with the FDA's registration processes, premarket 510(k) requirements, fees, package labeling, quality processes, inspections, and reporting requirements?

Reusable towels should be laundered, delinted, and inspected for holes, worn spots, breaks in or separation of the fabric, and stains. The towels should allow proper air removal, steam penetration, and evacuation of steam during the sterilization process for the items that are being processed. Several quality tests can confirm that the towels allow for the proper steam sterilization process to occur. The tests help to ensure that the wrapped instrument trays, in their specific configuration, will be acceptable for steam sterilization.

The test may include placing a biological indicator (BI) in a sample pack of instruments wrapped with new, reusable, unlaundered towels and instruments wrapped with reusable, laundered towels. The test will ensure that proper steam penetration has occurred for the sample pack. Placing a dynamic air removal test sheet (ie, a Bowie-Dick-type indicator) in a sample pack will assess for proper air removal from within an instrument tray during the sterilization process. More sophisticated testing that records real-time and temperature profiles, known as thermocoupling, is used infrequently.

Several rules should be followed when pack testing is performed.

* For an instrument set, the BI and chemical indicator (CI) should be placed at each end of the instrument tray and among the instruments that are placed on stringers.

* For a multilayered instrument set in a rigid containment device, the BI and CI should be placed in the locations determined by the product manufacturer to create the greatest challenge to the sterilization process. (2)

According to the Association for the Advancement of Medical Instrumentation,

   Textile products and wrappers should be made
   of materials that will allow for adequate air removal,
   steam penetration, and steam evacuation
   (for drying) when the package has been
   properly assembled. The textile product manufacturer
   should be consulted for recommendations
   on the pack size and density that have
   been validated using hospital steam sterilization
   cycles. (6(P64))

Absorbent materials, such as towels, provide efficient drying by wicking condensate away from instruments and dispersing it over a greater surface area. "The judicious use of tray liners or other absorbent material can alleviate drying problems." (6(p64))

Excessive numbers of towels or the incorrect type can impede air removal and steam penetration, which will interfere with proper drying of the instrument set. Before using new or reprocessed towels, the facility should verify with the towel manufacturer that the product being used is not labeled as "single-use" and can be sterilized using a steam sterilization cycle. When using new towels, the organization should launder them first. Laundering new towels will help prevent dye release onto the instruments or the container during the sterilization process. To ensure that the towels being used are steam-permeable, simple tests should be conducted in the health care facility to demonstrate their compatibility with the organization's sterilization process. (2)