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:
Low-temp SMS pouches
Some crepe-type papers
Thermoplastic polymers (Tyvek)
|Glass syringes or other medical devices made of glass||Steam
Hydrogen peroxide gas plasma
Low-temp SMS pouches
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
- 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)
Alloy combination instrument(s)
Low temperature sterilization
Low temperature sterilization/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.