Getting Wrapped Up in Packaging Choices

June 1, 2003

Getting Wrapped Up in Packaging Choices

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 isstill the standard today for wrapping medical devices to be sterilized. There isa new face on muslin as it takes the form of Goretex and syntheticspunbond-meltdown-spunbond (SMS) and polyester/cotton blend materials. Thearrival 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 medicaldevice(s) that go in them. Adding to that is the challenge of whichsterilization method must be employed: Steam: gravity, dynamic air removal, dryheat, convection heat, hydrogen peroxide gas plasma or EO/ETO.

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

Medical DeviceSterilization MethodSuggested Packaging Material
Stainless steel instrument(s) Instrument set(s)Steam140-count muslin  SMS Woven cotton/polyester-blend fabrics Pouches
Endoscopic instrument(s) Instrument set(s) plasma EO/ETOLow temperature: Hydrogen peroxide gasHydrogen 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 glassSteam EO/ETO Hydrogen peroxide gas plasmaSteam: 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 tobe difficult if a few considerations are made before making definitive choicesfor purchase. The investigation of packaging material/system(s) should includethe properties of the medical devices to be sterilized and the sterilizationmethod required. Charting the different packaging material(s)/system(s) andtheir 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 thegrowing number of complex, innovative, odd shapes of new medical devices and thestandard application of basic instrumentation/medical devices. Medical packagingmanufacturer(s) have risen to the challenge for new packaging requirements; howto choose from so many sizes can be daunting when faced with budget constraintsthat 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 representativecall 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 packagingmaterial/system manufacturer(s). A good rule of thumb is to include threemanufacturer(s) in the investigation process for best product/pricing) to set upa time to discuss the options and solutions available. Concise information onthe real needs of the healthcare facility can decrease the purchase of packagingmaterial/systems that will sit on a shelf not used and eventually become(s) adonated or discarded corporate expense. Consideration of all applications canavoid purchase of a multitude of sizes and configuration(s) bringing theselection(s) for warehouse stock or containers systems down to a few standardmanageable sizes.

Choosing the wrong packaging material/system can be devastating to a budgetby (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 formedical devices, instrumentation/medical devices are then protected andsterilized in packaging material/system(s) specific to the sterilizationmethod(s) approved and the budget responsibility to target/cut cost and useresources more effectively are met.

Materials management departments can help sort through and recommenddirection but should not be the sole researcher or decision maker in thepurchase of sterilization packaging material(s)/system(s). Cheaper is not alwaysbetter and does not always meet the needs of clinical use. If a less expensiveproduct can be found with equal or better properties than a marginally moreexpensive product, then certainly proceed with the less expensive product.Likewise, more expensive does not mean better. Weighing all options, cost andapplication sits on the shoulders of clinical end users, management of CPD/SPDdepartments and purchasing. While contract-buying groups are on the rise, beforechoosing a buying group, consideration must be given to products that will bestserve the patient population. Personnel and departments that should be involvedin 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 forhealthcare and more importantly for patients. As in every case in any healthcarefacility, the patient and his or her well-being should be considered first, lastand everywhere in between. Cost reduction, while it is a very real concern andmust be handled delicately to meet the rising cost of healthcare, should notsupercede the best practice adhering to the best standards holding to thehighest moral and ethical responsibility to protect patients from potential andactual risk to their health and bodies.

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

Medical DeviceSterilization 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.