1. SMS POLYPROPYLENE WRAP
WHAT’S THE WRAP ABOUT?
SMS POLYPROPYLENE WRAP
HASSAN BILAL
CRCST, VICE PRESIDENT
OPERATING ROOM DIVISION
MEDLINE INDUSTRIES INC

2. 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

3. 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”

4. 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

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 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”

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 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

12. 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

13. 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)

14. 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

15. 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

16. 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!

17. 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

18. 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 minutes
How do you check the load after one item is found wet
Recalling a load
Documentation (Department, Infection Prevention, Risk Management)

19. 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

20. 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

21. AAMI ST79: Wrapping Technique

22. 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

23. 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

24. 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

25. Quality Assurance and sterilization process monitoring
According to AAMI ST , 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).

26. 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

27. Conclusion Future of the Wrap Industry -Muslin wrap -Polypropylene
-Biodegradable
Shelf Life and Event Related Sterility
Newer Technologies

28. Questions

29. References AORN Perioperative Standards and Recommended Practices 2011
ANSI/AAMI ST79: Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities
ANSI/AAMI ST41: Ethylene Oxide Sterilization in Health Care Facilities
CDC: Guidelines for Disinfection and Sterilization 2008
ANSI/AAMI ST46:2002 Steam Sterilization and Sterility Assurance
Wet Loads presentation © Tim Galekop Abstract 2006

30. QUESTIONS?
We are what we repeatedly do. Excellence, then, is not an act, but a habit.
Aristotle