2 What is SMS Wrap? SMS stands for Spunbound Meltblown Spunbound Spunbound which means it is tightly woven = Security/BarrierMeltblown = Filter to allow steam penetrationSpunbound = Security/BarrierThis gives protection from microbial penetration
3 What is Polypropylene?The most widely used wrap is made up of PolypropylenePolypropylene is used in making many items:Plastic chairsRubbermaid and Sterilite container productsFace masks, filters, diapers, wipesNon absorbable suture called ProleneUS Military “ Polypros”
4 Why use Polypropylene? Can withstand heat in autoclaves It has a melting point of 171 C (370 F)FlexibleToughEconomicalTranslucentGood resistance to fatigue
5 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)
6 How is wrap used?Creates a protective barrier around and protects the sterility of:Linen and towel packsInstrument(s) and Instrument setsRetractorsScopesCreates a sterile field in the O.R. to keep the field and the “tools” as sterile as possible”
7 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.
8 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 )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 )
9 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.
10 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 )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.
11 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 daysDouble layered muslin wrap and two way crepe paper were found to become contaminated in 21 to 28 days when stored on shelvesJoint Commission decided shelf life should have an expiration date
12 History and Use of WrapIn 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 eventsIn later years the phase “Event Related Sterility” was coined
13 Event Related Sterility Movement from one area to another i.e. sterilization rack to shelfDustHumidity and temperature in storage areasPlacing heavy items on top of wrapped itemsWater on packageMoisture or water in package (wet load)
14 Event Related Sterility Sterility tape or seal is brokenHole(s) or tearing of wrapMajority of Holes in wrap come from event related activitiesRock Paper ScissorsScissors always trumps paperMetal always trumps wrap
15 Wet Load Issues What is a wet load? Wet in Wet out Steam pressure issuesSteam Vacuum issuesSteam Trap issuesDrain cleaning should be conducted once a week
16 Problem Solving of Wet Loads Identifying the problemCan be seasonal with humidity or altitudeSteam trap issuesSterilizer problems e.g. vacuumSterilizer problems…..OLD!
17 Problem Solving of Wet Loads Identify the Key PlayersSet up meeting(s) with OR, SPD, Engineering, Sterilizer company or personDiscuss facility policy concerning wet loadsIdentified when the problem startedSolve the problem and follow-up periodically
18 Wet Load Issues Where to start solving the problem Tray liners- help, but masks the problemDry time-does extending the dry time help i.e minutesHow do you check the load after one item is found wetRecalling a loadDocumentation (Department, Infection Prevention, Risk Management)
19 Problem solving with holes/tears Manufacturer or facility personnel can conduct an in-service to explain proper handling techniqueIn-service must be conducted in CSSD as well as the ORConduct wrap audits and determine what is the percentage of holes versus wrapped itemsCorner protectorsTransport TraysReplace wrap items with Rigid Containers
20 Problem solving with holes/tears Avoid too much handlingDo not put trays on top of other traysResterilize if rotation does not happen in a timely manner i.e. six months on shelf with reoccurring movementExamine regularly for holes and defects
22 Wrapping Techniques Sequential Technique Wrapping in sequence or wrapping the item once and then applying a second wrapperDouble SimultaneousWrapping two wrappers as oneCan be two single wrappers or one single bonded wrapper
23 Wrapping Techniques Envelope Technique Wrapped with two single or one bonded wrap in an envelope designMost popular way to wrapRectangular or Square TechniqueCan be used sequentially or simultaneouslyUsed to make packs
24 Sterilants Used with Wrappers ETO or Ethylene OxideHydrogen Peroxide- used with the Sterrad and VPRO sterilizationSteam SterilizationPre-vacuum SteamGravity DisplacementOzone Sterilization
25 Quality Assurance and sterilization process monitoring According to AAMI ST , an essential element of sterility assurance is sterilization process monitoring, which consists ofmonitoring 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); andperiodic product quality assurance testing (see Table 7 and 10.9).
26 Conclusion Purpose -Use wrap for its proper purpose Preparation –ensure proper handling of product before, during, after sterilizationPrevention- consistently check for wrap integrity in CSSD and OR
27 Conclusion Future of the Wrap Industry -Muslin wrap -Polypropylene -BiodegradableShelf Life and Event Related SterilityNewer Technologies