Wrap It Up, I'll Take It (to Surgery)!

September 1, 2002

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 oldThunderbirds song, but I'm actually referring to a Class II medical deviceregulated by the Food and Drug Administration (FDA). Many well-known expertshave written about wraps during the last 50 years. The most readily recognizableindividuals to central service professionals are John J. Perkins, V. Greene, DanMayworm, William Rutala, David Weber, C Hunstiger, Martha Spaulding and BarbaraStanewick. Several organizations have published articles and guidelines inreference to wraps as well, including the FDA, the Association for theAdvancement of Medical Instrumentation (AAMI), the Association for Professionalsin Infection Control and Epidemiology (APIC), the Association of periOperativeRegistered Nurses (AORN) and the Joint Commission on the Accreditation ofHealthcare Organizations, and I'm sure I'm missing a few.

The Pros and Cons

There are several advantages to sterilization wraps; they are reusable anddon't retain memory, they are easily drapable and they can be configured in manydifferent sizes and shapes. Some disadvantages of their use are that thelaundering, repair and the inspection process required can dramatically add tocosts, sequential wrapping is essential, and most importantly, it is the leasteffective packaging practice with regard to maintaining sterility; cloth wrapscannot support all methods of current sterilization practices.

Even considering the advent of newer fabrics in the last half of the 20thcentury -- fabrics made from non-woven materials, barrier cloth (272 to 288thread count), spun-bonds, micro fibers -- and manufacturing methodologies thathave increased effectiveness and lowered costs, cloth wraps still are notappropriate for all sterilization methodologies.

A Brief History of Wraps

Sterilization wrappers have been around for about 80 years. They were firstmade out of 140-count (140 threads to the inch) muslin. Non-woven materials thatproduced an effective tortuous path were introduced in the 1960s. Non-wovenmaterials are generally suitable for steam and ETO sterilization because theyresist wicking, have little memory and can be opened aseptically.

Barrier cloth, which is the equivalent of two 140-count muslin wrappers, alsoallows for adequate use of steam and ETO sterilization. Barrier cloth, as withmuslin and non-woven fabrics, must be laundered, inspected, and de-lintedbetween uses and has the propensity to retain some moisture in the process.

With the advent of polypropylene came the development of spun-bond wraps thatproduced superior strength, permeability and barrier properties. The wrapspossess adequate wicking capabilities, but may require increased drying times.They retain little or no memory, have good barrier qualities and are notreusable.

The FDA classification of Class II medical devices 21 CFR #20 Quality SystemRegulation and Good Manufacturing Processes puts wrappers in a category alongwith surgical lasers, physical/chemical sterilization process indicators,sterilizers, general and plastic forceps, some fiber optics and surgical cuttingtools.

Key Characteristics of Sterilization Wraps

Most experts and organizations agree on several key characteristics ofwrapping 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 StandardsInstitute (ANSI), the American Society for Healthcare Central ServiceProfessionals (ASHCSP), the International Association of Healthcare CentralService Materiel Management (IAHCSMM) and textile industry all have standards,recommended practices and requirements dealing with wrappers and packaging. Ihave found that it is best practice to make use of multiple wrapping andpackaging options, as well as utilize several methods of sterilization.

So, before you "wrap it up and take it" to be sterilized, check outyour options. Make sure you chose the appropriate wrapper or packaging methodbest suited for the sterilization method to be employed.

The author wishes to acknowledge Sandy Buhler, manager of professionalrelations, and Clarita Lewis, product manager, of Kimberly Clark Healthcare, forproviding technical material for this article. Additional background informationcame from "The Principles and Methods of Sterilization in HealthSciences" by John J. Perkins, IAHCSMM, 3rd edition of "The CentralService Technical Manual," ASHCSP's 4th edition "Technician TrainingManual," Dan Mayworm's 1984 article titled, "Sterile Shelf Life andExpiration Dating," Martha Spaulding's 1999 article in Infection ControlToday magazine titled, "Breakthrough Still Needed for SterilizationWraps," "Choosing a Sterilization Wrap for Surgical Packs" byWilliam Rutala and David Weber, and Barbara Stanewick's presentation,"Surgical Textiles: Expectations and Outcomes," at the 2000 ASHCSPconference in Denver.

Bryant C. Broder, ACSP, is the manager of surgery processing at SaintMary's Mercy Medical Center in Grand Rapids, Mich. and president of the AmericanSociety for Healthcare Central Service Professionals (ASHCSP).