Transcript WHAT’S THE WRAP ABOUT? - NJHCSA Upcoming Seminars

SMS POLYPROPYLENE WRAP
HASSAN BILAL
CRCST, VICE PRESIDENT
OPERATING ROOM DIVISION
MEDLINE INDUSTRIES INC
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
AAMI ST79: Wrapping Technique
21
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
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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
Questions
References
 AORN Perioperative Standards and Recommended Practices 2011
 ANSI/AAMI ST79: Comprehensive Guide to Steam Sterilization
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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
 http://en.wikipedia.org/wiki/Polypropylene
 http://www.infectioncontroltoday.com/articles/2000/05/choosi
ng-a-sterilization-wrap-for-surgicalpacks.aspx
QUESTIONS?
We are what we repeatedly
do. Excellence, then, is not
an act, but a habit.
Aristotle