Wrap It Up, I'll Take It (to Surgery)!
By Bryant C. Broder, ACSP
"Wrap it up, I'll take it!" sounds like the lyrics from an old Thunderbirds song, but I'm actually referring to a Class II medical device regulated by the Food and Drug Administration (FDA). Many well-known experts have written about wraps during the last 50 years. The most readily recognizable individuals to central service professionals are John J. Perkins, V. Greene, Dan Mayworm, William Rutala, David Weber, C Hunstiger, Martha Spaulding and Barbara Stanewick. Several organizations have published articles and guidelines in reference to wraps as well, including the FDA, the Association for the Advancement of Medical Instrumentation (AAMI), the Association for Professionals in Infection Control and Epidemiology (APIC), the Association of periOperative Registered Nurses (AORN) and the Joint Commission on the Accreditation of Healthcare Organizations, and I'm sure I'm missing a few.
The Pros and Cons
There are several advantages to sterilization wraps; they are reusable and don't retain memory, they are easily drapable and they can be configured in many different sizes and shapes. Some disadvantages of their use are that the laundering, repair and the inspection process required can dramatically add to costs, sequential wrapping is essential, and most importantly, it is the least effective packaging practice with regard to maintaining sterility; cloth wraps cannot support all methods of current sterilization practices.
Even considering the advent of newer fabrics in the last half of the 20th century -- fabrics made from non-woven materials, barrier cloth (272 to 288 thread count), spun-bonds, micro fibers -- and manufacturing methodologies that have increased effectiveness and lowered costs, cloth wraps still are not appropriate for all sterilization methodologies.
A Brief History of Wraps
Sterilization wrappers have been around for about 80 years. They were first made out of 140-count (140 threads to the inch) muslin. Non-woven materials that produced an effective tortuous path were introduced in the 1960s. Non-woven materials are generally suitable for steam and ETO sterilization because they resist wicking, have little memory and can be opened aseptically.
Barrier cloth, which is the equivalent of two 140-count muslin wrappers, also allows for adequate use of steam and ETO sterilization. Barrier cloth, as with muslin and non-woven fabrics, must be laundered, inspected, and de-linted between uses and has the propensity to retain some moisture in the process.
With the advent of polypropylene came the development of spun-bond wraps that produced superior strength, permeability and barrier properties. The wraps possess adequate wicking capabilities, but may require increased drying times. They retain little or no memory, have good barrier qualities and are not reusable.
The FDA classification of Class II medical devices 21 CFR #20 Quality System Regulation and Good Manufacturing Processes puts wrappers in a category along with surgical lasers, physical/chemical sterilization process indicators, sterilizers, general and plastic forceps, some fiber optics and surgical cutting tools.
Key Characteristics of Sterilization Wraps
Most experts and organizations agree on several key characteristics of wrapping and packaging:
- Barrier effectiveness prevents contamination and maintain sterility.
- Permeability/penetrability allows for the effective penetration of sterilants (steam, ethylene oxide, plasmas, irradiation, ozone and moisture).
- Aeration allows for the post-sterilization dissipation of moisture and the sterilants used.
- Efficiency of use means the product can be easily inserted, maintains "seal integrity," has the ability to conform to the contents and has ease of presentation to the sterile field maintaining aseptic technique.
- Drapability means the wrap conforms to the contents and contours of the product/instrument and can opened on a flat surface or held out of the sterile field during presentation. (Drape stiffness test ASTM D 5732-95)
- Flexibility accommodates any size or shape article.
- Durable package integrity means the wrap resists punctures, tears and abrasions. Conforms to measurement standards for tensile strength, porosity and moisture vapor transmission rates. (Grab Tensile strength ASTM test method D 5034-90)
- Toxin free means non-toxic and non-fast dyes prevent adverse physical reaction of handler or change/coloration of the contents or wrapper.
- Odor free characteristics prevent any allergic reactions from inhalation of chemical processes used in manufacturing or laundering.
- Lint free/minimal linting means the wrap is devoid of or contains minimal linting properties (Gelbo Lint INDA Standard testing method 160-1-92)
- Cost effectiveness ensures the wrap is economical, saves time and reduces waste without compromising aseptic technique.
- Content verification means the ability to identify the internal contents of the product produced visually or by labeling.
Diversify Your Options
The AAMI, FDA, AORN, JCAHO and groups such as American National Standards Institute (ANSI), the American Society for Healthcare Central Service Professionals (ASHCSP), the International Association of Healthcare Central Service Materiel Management (IAHCSMM) and textile industry all have standards, recommended practices and requirements dealing with wrappers and packaging. I have found that it is best practice to make use of multiple wrapping and packaging options, as well as utilize several methods of sterilization.
So, before you "wrap it up and take it" to be sterilized, check out your options. Make sure you chose the appropriate wrapper or packaging method best suited for the sterilization method to be employed.
The author wishes to acknowledge Sandy Buhler, manager of professional relations, and Clarita Lewis, product manager, of Kimberly Clark Healthcare, for providing technical material for this article. Additional background information came from "The Principles and Methods of Sterilization in Health Sciences" by John J. Perkins, IAHCSMM, 3rd edition of "The Central Service Technical Manual," ASHCSP's 4th edition "Technician Training Manual," Dan Mayworm's 1984 article titled, "Sterile Shelf Life and Expiration Dating," Martha Spaulding's 1999 article in Infection Control Today magazine titled, "Breakthrough Still Needed for Sterilization Wraps," "Choosing a Sterilization Wrap for Surgical Packs" by William Rutala and David Weber, and Barbara Stanewick's presentation, "Surgical Textiles: Expectations and Outcomes," at the 2000 ASHCSP conference in Denver.
Bryant C. Broder, ACSP, is the manager of surgery processing at Saint Mary's Mercy Medical Center in Grand Rapids, Mich. and president of the American Society for Healthcare Central Service Professionals (ASHCSP).