What is SMS Wrap? SMS stands for Spunbound Meltblown Spunbound Spunbound which means it is tightly woven = Security/Barrier Meltblown = Filter to allow steam penetration Spunbound = Security/Barrier This gives protection from microbial penetration
What is Polypropylene? The most widely used wrap is made up of Polypropylene Polypropylene is used in making many items: Plastic chairs Rubbermaid and Sterilite container products Face masks, filters, diapers, wipes Non absorbable suture called Prolene US Military “ Polypros ”
Why use Polypropylene? Can withstand heat in autoclaves It has a melting point of 171 C (370 F) Flexible Tough Economical Translucent Good resistance to fatigue
Wrap FDA 510K What is the wrap approved for? What is the wrap validated for? What is the proper “intent for use? Instructions for Use (IFU)
How is wrap used? Creates a protective barrier around and protects the sterility of: Linen and towel packs Instrument(s) and Instrument sets Retractors Scopes Creates a sterile field in the O.R. to keep the field and the “tools” as sterile as possible”
Why is SMS used? Barrier effectiveness prevents contamination and maintains 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.
Why is SMS used? 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)
Why is SMS used? 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. 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.
Why is SMS used? 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.
History and Use of Wrap Two layers of wrap are Use In the 70’s and early 80’s microorganisms were found to penetrate single muslin wrap in as little as 3 days Double layered muslin wrap and two way crepe paper were found to become contaminated in 21 to 28 days when stored on shelves Joint Commission decided shelf life should have an expiration date
History and Use of Wrap In 1984 author, educator and speaker, Dan Mayworm wrote an article questioning the scientific basis for dating items which were sterile. He stated that items were contaminated by events In later years the phase “Event Related Sterility” was coined
Event Related Sterility Movement from one area to another i.e. sterilization rack to shelf Dust Humidity and temperature in storage areas Placing heavy items on top of wrapped items Water on package Moisture or water in package (wet load)
Event Related Sterility Sterility tape or seal is broken Hole(s) or tearing of wrap Majority of Holes in wrap come from event related activities Rock Paper Scissors Scissors always trumps paper Metal always trumps wrap
Wet Load Issues What is a wet load? Wet in Wet out Steam pressure issues Steam Vacuum issues Steam Trap issues Drain cleaning should be conducted once a week
Problem Solving of Wet Loads Identifying the problem Can be seasonal with humidity or altitude Steam trap issues Sterilizer problems e.g. vacuum Sterilizer problems…..OLD!
Problem Solving of Wet Loads Identify the Key Players Set up meeting(s) with OR, SPD, Engineering, Sterilizer company or person Discuss facility policy concerning wet loads Identified when the problem started Solve the problem and follow-up periodically
Wet Load Issues Where to start solving the problem Tray liners- help, but masks the problem Dry time-does extending the dry time help i.e. 30 45 90 minutes How do you check the load after one item is found wet Recalling a load Documentation (Department, Infection Prevention, Risk Management)
Problem solving with holes/tears Manufacturer or facility personnel can conduct an in-service to explain proper handling technique In-service must be conducted in CSSD as well as the OR Conduct wrap audits and determine what is the percentage of holes versus wrapped items Corner protectors Transport Trays Replace wrap items with Rigid Containers
Problem solving with holes/tears Avoid too much handling Do not put trays on top of other trays Resterilize if rotation does not happen in a timely manner i.e. six months on shelf with reoccurring movement Examine regularly for holes and defects
Wrapping Techniques Sequential Technique Wrapping in sequence or wrapping the item once and then applying a second wrapper Double Simultaneous Wrapping two wrappers as one Can be two single wrappers or one single bonded wrapper
Wrapping Techniques Envelope Technique Wrapped with two single or one bonded wrap in an envelope design Most popular way to wrap Rectangular or Square Technique Can be used sequentially or simultaneously Used to make packs
Sterilants Used with Wrappers ETO or Ethylene Oxide Hydrogen Peroxide- used with the Sterrad and VPRO sterilization Steam Sterilization Pre-vacuum Steam Gravity Displacement Ozone Sterilization
Quality Assurance and sterilization process monitoring According to AAMI ST79 10.4, an essential element of sterility assurance is sterilization process monitoring, which consists of monitoring of every package and sterilization load (see Table 7 and 10.6); routine monitoring of sterilizer efficacy (see Table 7 and 10.7); qualification testing of the sterilizer after installation, relocation, sterilizer malfunction, major repairs, and sterilization process failures (see Table 7 and 10.8); and periodic product quality assurance testing (see Table 7 and 10.9).
Conclusion Purpose -Use wrap for its proper purpose Preparation –ensure proper handling of product before, during, after sterilization Prevention- consistently check for wrap integrity in CSSD and OR
Conclusion Future of the Wrap Industry -Muslin wrap -Polypropylene -Biodegradable Shelf Life and Event Related Sterility Newer Technologies