Getting Wrapped Up in Packaging Choices

June 1, 2003

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Getting Wrapped Up in Packaging Choices

By Becki Harter, CST, RCST, CRCST

Packaging material has come a long way since the 140-count muslin that is
still the standard today for wrapping medical devices to be sterilized. There is
a new face on muslin as it takes the form of Goretex and synthetic
spunbond-meltdown-spunbond (SMS) and polyester/cotton blend materials. The
arrival of pouches, self-seal, low temperature, pouch rolls, Glassine papers,
thermoplastic polymers, paper-plastic combinations and sterilization trays,
cassettes, containers and container systems are as varied as the medical
device(s) that go in them. Adding to that is the challenge of which
sterilization method must be employed: Steam: gravity, dynamic air removal, dry
heat, convection heat, hydrogen peroxide gas plasma or EO/ETO.

Deciding what goes where can be exhausting and frustrating. Certainly the
manufacturers of sterilization packaging materials/systems can be of great help;
however, if the right questions are not asked, the information that may be
gleaned may then be of no use in deciding which packaging material/system(s) to
choose.

Table 1: Woven Textiles
Medical Device Sterilization Method Suggested Packaging Material
Stainless steel instrument(s) Instrument
set(s)
Steam 140-count muslin  SMS Woven
cotton/polyester-blend fabrics Pouches
Endoscopic instrument(s) Instrument set(s)
plasma EO/ETO
Low temperature: Hydrogen peroxide gas Hydrogen peroxide gas plasma:
SMS
Polyester-blend fabrics
Low-temp SMS pouches
EO/ETO:
140-count muslin
SMS
Polyester-blend fabrics
Some crepe-type papers
Thermoplastic polymers (Tyvek)
Glass syringes or other medical devices made
of glass
Steam
EO/ETO
Hydrogen peroxide
gas plasma
Steam:
SMS pouches
EO/ETO
Hydrogen peroxide gas plasma
Low-temp SMS pouches
Thermoplastic polymers

Wrapping material

Evaluating the options for packaging material(s)/systems(s) does not have to
be difficult if a few considerations are made before making definitive choices
for purchase. The investigation of packaging material/system(s) should include
the properties of the medical devices to be sterilized and the sterilization
method required. Charting the different packaging material(s)/system(s) and
their respective uses in relation to the healthcare facilities medical device(s)
can aide in making the right material choice. For example, see Tables 1 and 2.

Packaging material(s) come in varied sizes and shapes to accommodate the
growing number of complex, innovative, odd shapes of new medical devices and the
standard application of basic instrumentation/medical devices. Medical packaging
manufacturer(s) have risen to the challenge for new packaging requirements; how
to choose from so many sizes can be daunting when faced with budget constraints
that will only allow a few standard choices to be made.

How to Choose

The first step in any purchasing practice is always investigation.
Information required, but not limited to, before the first sales representative
call is:

  • FDA approval for the packaging material (Class II 510(k)) to be used in
    the claimed sterilization processes. This information can be found on the
    FDA Web site or sometimes on the packaging material manufacturer(s) Web
    site. A site search can be done for all packaging material by searching
    using key word(s): sterilization packaging material.
  • Properties of the packaging material to include: tensile strength, flash
    point, thread count or fiber ratio, microbial barrier ratio
  • Approved sterilization methods for the material (including sterilization
    trays, cassettes, container and container systems)
  • What is the smallest device application that the packaging material will
    be used for?
  • What is the largest device application that the packaging material will be
    used for?
  • Which sterilization method is required?
  • What are the care and handling requirements of the device for damage
    control?
  • Can the packaging material support the 16-20 weight limit set by
    manufacturer(s) of sterilization equipment.2 Investigate the
    weight and number of level(s) approved in steam, EO/ETO and hydrogen
    peroxide gas plasma units.
  • Can the packaging material/system support good body mechanics?
  • Can the packaging material/system support clinical standards of practice
    for decontamination/disinfection, processing/re-processing, sterilization
    specific to method and storage and distribution?
  • Can the packaging material/system support care and handling requirements?
  • What kind of holding device(s) is available for this application? Is this
    a custom feature that will come with custom prices? Is this a standard
    feature available?
  • What size/configurations of packaging material/systems are available?

Now it is time to call the local sales representative of the packaging
material/system manufacturer(s). A good rule of thumb is to include three
manufacturer(s) in the investigation process for best product/pricing) to set up
a time to discuss the options and solutions available. Concise information on
the real needs of the healthcare facility can decrease the purchase of packaging
material/systems that will sit on a shelf not used and eventually become(s) a
donated or discarded corporate expense. Consideration of all applications can
avoid purchase of a multitude of sizes and configuration(s) bringing the
selection(s) for warehouse stock or containers systems down to a few standard
manageable sizes.

Choosing the wrong packaging material/system can be devastating to a budget
by (but not limited to):

  • Increasing the probability of medical device damage if not held properly
    during sterilization, transport and use, thus driving up repair cost.
  • Inventory rendered not usable and is now a fiscal liability
  • Compromising SAL if not approved for use in a sterilization process,
    therefore, increasing risk of infection that can drive up patient care cost.
  • Compromising SAL if used in a sterilization process outside of what the
    packaging material is approved for, thereby increasing the risk for
    infection and healthcare facility liability that can drive up patient care
    cost.

If fully informed choices are made concerning packaging material/systems for
medical devices, instrumentation/medical devices are then protected and
sterilized in packaging material/system(s) specific to the sterilization
method(s) approved and the budget responsibility to target/cut cost and use
resources more effectively are met.

Materials management departments can help sort through and recommend
direction but should not be the sole researcher or decision maker in the
purchase of sterilization packaging material(s)/system(s). Cheaper is not always
better and does not always meet the needs of clinical use. If a less expensive
product can be found with equal or better properties than a marginally more
expensive product, then certainly proceed with the less expensive product.
Likewise, more expensive does not mean better. Weighing all options, cost and
application sits on the shoulders of clinical end users, management of CPD/SPD
departments and purchasing. While contract-buying groups are on the rise, before
choosing a buying group, consideration must be given to products that will best
serve the patient population. Personnel and departments that should be involved
in choosing products/buying groups are:

Central sterile and sterile processing department personnel

  • Clinical end-users
  • Members of management/administration
  • Physician/surgeons
  • Purchasing personnel

Good choices do not come easy but bad ones can be a hard burden to bear for
healthcare and more importantly for patients. As in every case in any healthcare
facility, the patient and his or her well-being should be considered first, last
and everywhere in between. Cost reduction, while it is a very real concern and
must be handled delicately to meet the rising cost of healthcare, should not
supercede the best practice adhering to the best standards holding to the
highest moral and ethical responsibility to protect patients from potential and
actual risk to their health and bodies.

Becki Harter, CST, RCST, CRCST, is president/CEO of Indianapolis-based
consulting firm Sterilization By Design.

Table 2: Trays, Cassettes,
Containers and Container Systems
Medical Device Sterilization Method
Stainless steel instrument(s)
Endoscopic instrument(s)
Glass instrument(s)
Polymer (plastic)
Carbide instrument(s)
Alloy combination instrument(s)
Steam
Low temperature sterilization
Low temperature sterilization/Steam
instrument(s)
Steam
Steam
Steam
Note: trays, cassettes, container and container systems must be approved
for use in hydrogen peroxide gas plasma applications. Radel trays,
cassettes, container or container systems are not approved for use in
hydrogen peroxide gas plasma applications.