Convert to Rigid Reusable Sterilization Containers
All PIM content was independently developed and reviewed to be vendor-, product-, and service provider-neutral.
Rigid reusable containers provide a durable, long-lasting, reusable packaging system for sterilization, storage, and transport of medical devices. Switching from disposable blue wrap to rigid reusable sterilization containers saves substantial amounts of money, reduces waste, decreases energy requirements, increases storage space, improves patient safety and instrument reprocessing turnaround time, and has been demonstrated to help the health care organization's bottom line.
Project Talking Points
All rigid reusable containers contribute to hospitals’ short- and long-term sustainability initiatives to reduce waste, increase productivity, reduce energy requirements, and contribute to a safer, healthier environment.
Most rigid reusable containers are compatible with pre-vacuum steam sterilization. Some are compatible with more than one sterilization modality such as low temperature sterilizers including hydrogen peroxide reducing the need for duplication for excess inventory.
Most are manufactured from corrosion-resistant materials to meet reprocessing needs for decontamination and sterilization over a long useful life.
The best are composed of extremely durable metals that are light in weight and thermo-conductive, usually anodized aluminum with passivated stainless steel hardware.
Anodized aluminum containers must be cleaned with pH neutral instrument cleaners which are in most cases environmentally preferred and increase the useful life of the product which can then be decontaminated and sterilized for many years.
In addition, pH neutral detergents used can be rinsed off into the waste water stream without contaminating our planet with hazardous chemicals.
While the acquisition cost for containers is more expensive than disposable wrap initially, after weeks or months it generates income for the facility by reducing the ongoing expenses for wrap and the accessories needed to secure the wrap and avoid handling damage.
Disposable blue wrap is paid for twice: once to purchase, then after single use to be disposed of properly as non-biodegradable waste.
A major advantage to containers is the reduction in consumables required for instrument processing.
Rigid reusable containers are constructed from metal or plastic materials that are not penetrable, whereas wrap can tear and results in unnecessary reprocessing and delayed surgical cases.
Some container systems require inspection of their filters prior to surgery. Other containers are designed with an offset filter retention plate vent pattern to avoid strike-through. Such containers do not need to be inspected at the OR, saving valuable time and increasing productivity.
Wrap, whether disposable or linen, is inconsistent from hospital to hospital. Some use various layers and brands including non-woven polypropylene disposable wrap, resulting in loads that are inconsistent. Wet packs may occur and absorbent liners or towels may be necessary to wick moisture. Additional dry time or exposure time may be required, or sets may need to be reprocessed if moisture is observed.
Sterilization containers are designed to be dry after sterilization for storage and handling.
Reusable sealed container systems, particularly ones with universal compatibility, are ideal for standardization, resulting in huge savings in inventory reduction over wrap, and other containers with limited compatibility with multiple methods of sterilization.
Reusable container systems by virtue of their hard case provide better protection for delicate, valuable instrumentation, leading to substantial savings in repair and replacement costs, as well as a reduction in excess instrument inventory.
Some sterilization containers have modular inserts for instrument organization to facilitate the instrument count and to protect of valuable instrumentation and delicate devices.
Reusable containers and trays cut down labor due to the reduction of time spent wrapping trays and then rewrapping and reprocessing torn wrapped trays.
An instrument set that is containerized increases surgeon satisfaction and contributes to patient safety by reducing procedure delays.
Reusable container systems have handles for lifting and may be pulled from shelves, whereas wrapped sets can tear and adhesive tape can separate.
Containers are designed for identification, including label slots and a location designated for load cards to identify the instrument set and load information; some contain bar-coding for set tracking.
Containers, for the most part, come with handles for transport and lifting. Wrapped sets are hard to identify which is top and bottom, creating handling problems for staff as there are no handles for ergonomic lifting and transport.
All containers provide a tamper-proof seal to secure contents.
Many reusable containers are designed to be stacked to reduce inventory storage space. Wrapped sets cannot be stacked one on top of the other for storage or sterilization.
Some sterilization containers have been validated for internal and external stacking within the sterilizer, thus reducing product needed as a cost savings feature and waste reducer.
The ergonomic design of reusable containers maximizes usable interior space while still being able to be handled and transported effectively.
Reusable container systems provide superior sterility maintenance over wrapped trays as most are event-related.
Rigid reusable container systems have been shown to reduce pre-vacuum steam sterilization cycles over wrapped trays, saving energy, creating efficiencies, and increasing turnaround time.
A rigid reusable container that has been validated for compatibility with various sterilization cycles is cost-effective, avoids excess inventory, and is ideal for standardization while meeting health care sustainability goals.
Triple Bottom Line Benefits
Cost benefits: Converting from disposable wrap to reusable sterilization containers is an enormous opportunity for savings in all of the following: inventory reduction, increased OR utilization, decrease in repair and replacement of surgical devices, reduced labor, reduced consumables, energy and waste disposal reductions as well as increasing hospital efficiencies and OR turnaround time. Generally switching from wrap to containers generates a return on investment in less than one year. The most significant savings are realized over the long term, over the useful life of the containers placed in service and the number of instrument sets containerized. The greatest ROI is found with the most frequently used instrument sets and those with the most delicate and costly instrumentation. Over a ten year period or longer, rigid reusable containers can provide an annual cost savings of thousands of dollars for each year of use over the disposable wrap alternative.
Environmental benefits: Rigid reusable containers reduce hospital waste. Hospitals report that up to 20% of hospital waste is blue wrap. Many communities do not have access to recycling programs, and as a result wrap may be added to local landfills. Rigid reusable containers are durable and do not contribute to unnecessary material waste and in fact reduce consumption of single use products. While sterilization containers have filters and other consumables for reprocessing, the footprint is minimal, the cost significantly less, and some of the accessories are biodegradable. Also rigid reusable containers decrease reprocessing cycle times, thus reducing energy consumption. When cycles are reduced, water in the form of steam may be reduced as well. Furthermore, as rigid reusable containers reduce unnecessary reprocessing, net waste, water consumption, and energy. This project is in alignment with nationwide hospital group sustainability goals.
Social and satisfaction benefits: Rigid reusable sterilization containers contribute to improved and more efficient sterilization of critical devices needed for surgery. Therefore, they contribute to patient safety, reduce surgical delays, and increase surgeon satisfaction. Additionally, hospital staff often report ergonomic issues due to handling of wrapped trays, and experience frustration at having to reprocess sets that were properly prepared when tears or wet packs are discovered in the OR. In addition, wrapping sets requires more time and the possibility of human error. These factors are significantly reduced when assembling trays into containers. OR staff appreciate the protection of the instrumentation, and the efficiencies created when sets are received on time and do not require reprocessing. Facilities managers may be concerned about the volume of waste generated by daily disposal of blue wrap and the costs incurred for resources such as energy, water and inventory space required for various wrap products and accessories. This program is a win-win to satisfy healthcare personnel and contribute to the health and safety of patients.
Review alternatives in the marketplace and develop specifications
Sustainability considerations such as compatibility, reusability, and inventory reduction are important factors to be considered when acquiring rigid reusable container systems. Further consideration should be assessed as to need for part replacement, service contacts and actual useful life of the product. While there are several rigid reusable containers to choose from, few are compatible with all current sterilization modalities.
1. Materials of Construction:
a) Rigid reusable sterilization containers are composed of materials that can withstand the autoclave, and some chemical sterilants.
b) Container materials include shells that are manufactured from anodized aluminum, non-anodized aluminum, and plastics that are autoclavable or composites, and are anodized for corrosion resistance, can also be used in low temperature sterilization modalities, and can be properly decontaminated without discoloration and becoming “rusted” or corroded over time.
c) Anodized metals fare better long term over non-anodized metals and plastics, which may degrade over time and may not be able to be properly cleaned and reprocessed.
d) Hardened passivated, stainless steel hardware for latches, locking mechanisms and handles have significant durability over plastic components. Not all container systems use hardened materials that contribute to useful life and designed to reduce damage, dents requiring repair or replacement.
e) Gaskets may vary as well. Some require scheduled replacement; others may be composed of platinum-cured silicone for durability. All gaskets require inspection, but not necessarily replacement.
f) Most rigid reusable containers have been reviewed by FDA for material compatibility and tested to ensure that no chemical sterilants have been retained after processing. Special consideration should be placed on containers that have been validated for ethylene oxide and also undergone a residual analysis study.
2. Design Considerations:
a) Container configuration should accommodate the proper arrangement of the instruments for sterilization, inspection, sterilant removal, and storage (per AAMI ST 77 4.3.1).
b) Some container systems are DIN sized, meeting global standards for size and fit. Other containers may vary and may not fit into all equipment, nor accommodate inserts such as “loaners” which are DIN sized.
c) Rigid reusable containers vary in volume available for content placement. While most container manufacturers recommend at least 2+ inches of interior clearance, a lower profile container with only 1 inch of clearance allows for maximum use of interior space, lowers inventory requirements, and addresses ergonomic issues for safe handling.
d) A lower profile container is lighter in weight than an equivalent model that needs greater clearance.
e) Rigid reusable containers may be provided with filter retention plates to secure a disposable filter or have a reusable filter or a valve system which is filter-less. When considering which container system to acquire, a container with interchangeable filter retention plates is preferable over those specifically designed for top and bottom.
f) Interchangeable components such as filter retention plates, lids, and bases can reduce inventory and contribute to ease of assembly.
g) Disposable filters provide consistent bacterial filtration. Reusable filters need to be laundered, inspected, and may degrade over time in a similar manner to reusable wrap. While all reusable materials should be cleaned after each use, reprocessing reusable filters can create issues from wear and detergent residuals.
h) Containers with reusable filters are limited to steam sterilization only and may require an extended cycle.
i) Valve systems are limited to steam sterilization, specifically pre-vacuum or dynamic air removal and may be wet after sterilization if extended dry times are not provided. Filtered containers are broader in scope and drier, as steam can exit through the filter after pressure is equalized. Thus dry loads are a consistent outcome with filtered containers.
j) Containers having moisture within the load must be reprocessed. Wet instruments can contaminate the sterile field. Corrosion can occur during storage. Moisture is a breeding ground for microorganisms. The only exception when wet items are acceptable is for immediate use (IUSS).
k) One container system has an interchangeable valve available for IUSS and recommends its disposable filter for terminal sterilization and storage for later use. This design feature contributes to sustainability and reduction in duplicate inventory and reduces wet loads and increases patient safety.
l) Containers are designed to protect the contents after sterilization until point of use. However, not all have a recessed knife-edge fit between lid and base for ideal seal and protection of contents.
m) Furthermore, not all containers provide an off-set filter vent pattern to avoid strike-through and chance occurrence of contamination from the environment.
n) Perforations should permit the sterilant to enter and be removed from the containment device. Number as size of perforations should be sufficient to support the mode of sterilization and drying process (per AAMI 77 4.3.3).
o) Latching mechanisms vary as well in material and functionality. Metal stainless steel latches are strongest and most durable. Some latches clamp for secure fit. Others close horizontally and have plastic components which wear over time, require replacement.
p) Handles are included in most container systems as an ergonomic feature. However, some containers do not provide handles at all, nor assemble handles at center point so that the container is balanced when transported by personnel.
q) Some containers come with silicone handle sleeves which will need replacement for wear.
r) Disposable seals for sterility maintenance are required to avoid tampering. While most provide a plastic padlock, at least one manufacturer provides an arrow whereby the plastic material may project or stick within the latching assembly.
s) Some containers are designed for safe ergonomic transport of contents by providing nesting dimples to secure one unit above the other. This avoids handling injuries and secures the product during transport from slipping and potential damage.
t) Rigid reusable containers are required to have labeling for system identification. Some manufacturers are now offering paperless systems with 2D barcodes for set identification, traceability, and reference. Others are exploring RFID to avoid human error, extensive input of data by personnel, and to reduce mistakes and inaccuracies.
u) While all rigid reusable containers contribute to sustainability initiatives, consideration must be taken in deciding which products are sustainable, will provide a longer useful life, are durable, and can help eliminate duplication, reduce inventory, and can be decontaminated for patient safety while truly lasting over time.
3. Manufacturer’s Instructions and Validations:
a) Prior to considering a container system, review the manufacturer’s instructions, validations, and claims.
b) Review the container manufacturer’s 510ks and claims. All rigid reusable containment devices, not only container systems, must have pre-market clearance from FDA.
c) Obtain IFUs. Determine if the information provided is accurate and that the instructions are clearly written, provide visuals, and are reproducible by staff in your department.
d) All rigid reusable container systems, as well as containment devices, are Class II medical devices designed for reuse and reprocessing. However, not all sterilization containers or containment devices have FDA 510k and meet sterilizer and device manufacturer’s claims.
e) It is important to request current validation testing information and a listing of the company’s 510ks for its product.
f) While FDA has always required sterilization validation for containment devices, they are now requiring validation of the manufacturer’s reprocessing instructions.
g) As mentioned previously, not all container systems can be properly decontaminated. Thus the company’s reprocessing instructions need to be thoroughly reviewed for accuracy and reproducible in healthcare facilities.
h) Furthermore, review manufacturer’s IFUs and claims for compatibility with various sterilization modalities. Consider whether the container system you are planning to purchase is compatible with the sterilizers in your facility.
i) Manufacturers validate their devices. Hospital personnel need to verify that the containment device is compatible with the hospital sterilizer and consistent with standard hospital settings.
j) Ensure that the rigid reusable container system can be cleaned, rinsed, and dried after use, as a medical device used in surgery.
i. Warning: some container manufacturers are recommending environmental cleaners or germicides instead of washing, rinsing, and drying. Consider the effect this will have on patient safety and the environment.
k) Review manufacturer’s claims to determine if the sterilization container has been cleared for blades and lumens, and if the lumen claims cover flexible endoscopes in your preferred method of sterilization.
4. Storage and transport:
a) Sterilization containers provide for efficient storage for further use of sterile items.
b) Most are event-related, meaning that time dating is not a factor once a containerized system is sterilized.
c) Handling events can impact a container system if the tamper evident seal has been compromised, if the filter is missing or has been punctured, and if the set has been opened. These are rare events which would require reprocessing.
d) Shelving is required for placement of stock and sterilized sets.
e) One significant advantage is the fact that items stored in sealed containers can be stacked one on top of the other. This minimizes the footprint required for storage of wrapped sets which can only be placed singly on a shelf.
f) Case carts have become important vehicles for transport of necessary supplies and containers to the operating room for procedures. While in the past open case carts were used for this purpose, closed case carts have become the standard for protection of sterile sets and containment of items after use.
g) Some case carts have been designed for supplies only, and may not be deep enough for full size or long containers, which need to be placed horizontally on shelves.
h) Perforated stainless steel shelving has been introduced to address tears and damage to instrument sets when wire shelving is used.
i) Some case carts are now DIN sized to correspond with sealed container systems, thereby providing the correct footprint for properly securing containerized sets. Be sure to select the right cart for the service based on the quantity and sizing of the sets to be placed within.
j) When purchasing case carts or mobile shelving, ensure that the materials of construction are durable and that the cart itself can be cleaned.
k) Most case carts are constructed of stainless steel.
l) Some case carts come with rubber bumpers, which can retain moisture and separate from the structure. Newer case carts have stainless steel bumpers which are longer lasting.
m) There are various wheels and castors to take into consideration. For example, some castors are made of stainless steel facilitating reuse and avoiding rusting when cleaned. This enables housekeeping to clean the area in storage for infection prevention. Some shelving has wheels as well to retrieve items placed behind other instrument sets.
Cost Benefit Analysis
Sterilization containers can provide a significant cost savings to healthcare facilities when compared to the ongoing expense of using wrap for reprocessing instrument sets. Savings can be obtained when instrumentation is protected and sets do not require reprocessing. While most containers can be a cost savings to hospitals and surgical centers, some containers are more durable than others, compatible with more sterilization methods, and designed to reduce inventory and contribute to sustainability goals.
First, gather all current expenses for wrap, including labor, supplies, acquisition cost of wrap and accessories, and projected cost for container budget. Obtain data relating to OR surgical delays. If currently wrapping, the cost information can be received from purchasing or department budgets for operating costs. In addition, determine all expenses associated with the costs of the transition. If currently using containers, determine the useful life based on replacement schedule, and take into consideration the cost of repair, replacement, and service contract, if required to maintain container inventory.
1. Determine required number of containers, this can be done by identifying:
a) Number of sets processed per month; and
b) Average utilization rate of wrapped instruments and containerized instrument sets
2. Compare container system costs vs. disposable wrap costs.
a) Container Costs
i. Initial container purchase price
ii. Lifetime upkeep of containers based on cleaning, repair, and replacement (figure should be much less than wrap)
iii. Expenses related to reprocessing sets due to tears or wet packs
iv. Container disposable costs (filters, seals, load cards)
v. Service contract price (if applicable)
b) Disposable Wrap Costs
i. Wrap purchase price
ii. Wrap accessories’ material costs per use—these include indicator tape, dust covers, corner protectors, tray liners, paper bags, and towels
iii. Labor costs associated with wrapping based on time to wrap vs. time to containerize
iv. Expenses related to reprocessing for wrap when extended cycles are required
v. Costs of blue wrap disposal including how blue wrap is handled, whether as regulated medical waste or solid waste. That will impact your cost saving opportunities.
3. Track repair and replacement of instruments that could be avoided if rigid reusable containers are in place. Make sure you only include the costs for those devices that will not require blue wrap after conversion.
4. OR Delays. Determine the percent of disposable wrap packs that are torn and must be reprocessed and re-wrapped. Determine costs of OR suite delayed procedures, anesthetized patients, operating room costs per minute, canceled cases, etc.
5. Perform Total Cost of Ownership analysis
a) Total Cost of Ownership (TCO) analysis should consider the decontamination and washing impact of cleaning X number of rigid sterilization sets per hour. SPD leadership should perform a time/effort analysis to understand the impact of rigid instrument sterilization containers on SPD instrument set throughput production. SPD leadership may need to add washing equipment capacity to deal with increased space/time demand from reusable instrument containers.
b) Refer to ANSI/AAMI document ST79 for more detail.
6. ROI – Return on Investment is based on:
a) Average number of uses: usage per set per week or per month. Note the more frequent the set is used, the quicker the return.
b) Instrument protection: calculate the costs for repair and replacement of delicate instruments and the savings to be obtained when instruments are protected in sealed container systems with protective inserts.
c) Layers: ability to stack internal tray layers increases ROI as additional containers will be needed for single level trays.
d) Universal attributes: costs associated with need for duplicate inventory when container is not universal.
e) Corrosion resistance: not all containers for low temperature sterilization are treated for corrosion resistance, thus impacting the ability to reprocess and greatly decreasing the useful life of the product.
f) Projected useful life of container: while most container systems are paid off within 1 – 1 ½ years, some earlier. The substantial savings is seen in years two through fifteen once the acquisition cost is covered within year one.
7. Set your cost reduction targets and review periodically with vendor to track savings.
1. Determine your stakeholders. The sourcing and implementation team includes OR Nurses, team leaders and director of surgical services, Supply Chain and Materials Management, Central Sterile, infection control, sustainability director, risk management, and your vendor(s).
2. For purchasing and sourcing considerations, refer to the field above. Take into consideration the following:
a. Durability of the container system
b. Ease of use
c. Compliance with current standards
d. FDA clearances
e. Projected useful life of the container system
f. The value proposition for instrument protection
g. Container sterility maintenance claims (i.e. event-related or real time dated)
h. The compatibility with various sterilizers
i. The ability to clean and reprocess after an extended useful life
j. Universal attributes including interchangeable components
k. Functionality of latches and hardware
l. Percent target of instrument sets to transition to hard cases
m. Percentage of blue wrap reduction
n. Number of items to remain in blue wrap or peel pouches such as basins and single items
o. Shelving and inventory requirements
p. Transport and handling
q. Reprocessing instructions for containers
r. Manufacturer’s IFUs
s. Implementation plan
t. Set customization services
u. Range of customizable components
v. Availability of product and service
w. Origin of manufacture
x. Acquisition cost of the product
y. Sustainability of the product and its accessories
3. Determine the key performance indicators for the project.
a. Cost savings over current wrap budget
b. Cost savings over existing container repair and replacement budget
c. Cost savings from decreased instrument repair and replacement budget, e.g. scopes
d. Calculate ROI from initial purchase in time and in savings over the useful life of product
e. Productivity improvements over wrap in time
f. Reduction in time for training staff
g. Increase in productivity and efficiencies
h. Inventory reduction
i. Increased turnaround time
j. Increase in user satisfaction
k. Patient safety improvements
l. Reduction in infection rates
m. Improvements in reprocessing procedures
n. Changes in waste handling operations
o. OR efficiencies
4. Become a reusable sterilization container product expert:
a. Sterilization containers are designed to hold medical devices for sterilization, storage, transportation, and aseptic removal of contents. They generally consist of a bottom/base with carrying handles and a lid secured to the base by a latching mechanism. A basket/tray holds instruments or other items to be sterilized inside. A filter or valve system is incorporated into the lid and/or base for air evacuation and sterilant penetration during the sterilization cycle (per AAMI ST 77).
b. Sterilization containers have a vented area with either filter mechanism or valve designed to facilitate air removal, and permit the sterilant penetration. The filter acts as a microbial barrier. Filters are designed to completely cover the sterilization port/vents and are held in place with a tight uniform seal by the retention plate. The filter and retention plate combination form a microbial barrier against recontamination of contents post-sterilization.
c. Most sealed container systems are designed for terminal sterilization and extended storage. Some containers have a filter-less system equipped with a pressure sensitive or thermostatic valve which opens and closes within the sterilizer. Such devices are cleared for pre-vacuum steam sterilization only, and few for sealed IUSS or “flash” immediate use steam sterilization, including gravity displacement steam. Some rigid reusable containers have been validated for pre-vacuum IUSS using a cellulosic filter and an abbreviated dry time.
d. All sealed container systems require an inner basket or tray to secure the contents of the load. The basket may contain accessories including instrument brackets, partitions and posts to secure and to organize and protect contents. Some may include stackable trays to separate contents into levels and protect contents from damage during transport.
e. Peel pouches may not be used within sealed or wrapped container systems as they are not able to stand on their sides for sterilization. Small perforated trays or insert boxes are recommended in lieu of pouches.
f. A sealed container is virtually impossible to penetrate or puncture. If the filter is protected by an offset retention plate, the assurance of safety is enhanced and chance tampering is further reduced with the use of a tamper-evident seal.
g. Some containers are designed to stack multiple layers of trays within the container, and maximize the interior space of the container.
h. Dry outcomes matter. Moisture has always been considered a breeding ground for bacteria, although the inside of the container should be free of microbes after sterilization, and a dry outcome is critical for storage. Pre-vacuum steam sterilization is the method of choice for rapid sterilization. Sterilization containers should be as dry and sealed after sterilization before being shelved for later use. The only exception to this is “flash” immediate use steam sterilization where small amounts of moisture can remain in the sealed container for the brief period of time between processing and use.
i. Plastic sterilization containers have a history of problems with wet packs because of the accumulation of condensate on the internal and external surfaces of the case after the sterilization process has been completed. As a result, some manufacturers have added metal inserts, incorporated metal parts or a composite material of plastic and metal in the case design.
j. Wet packs are a problem with some metal container systems as well, although far less than plastic. In the past, an absorbent towel had been used to absorb moisture and to protect instrumentation. If the purpose of the towel is to provide protection, examine other options including instrument mats that provide drainage or perforated instrument baskets with secure adaptable inserts.
k. If the sterilization container requires a towel because of moisture, check to see if the sterilizer is properly functioning and that parameters for dry time are met.
l. Some containers are designed with a greater ability to conduct heat than others, a necessary component for steam sterilization. This is particularly true of anodized aluminum containers with anodized aluminum inner baskets, as aluminum has greater thermo-conductivity than other metals and certainly plastics with very low thermo-conductivity. Thus, an assessment of the design of a particular container should be reviewed by the team for the purpose of determining the probability of wet packs. More importantly, invite a representative from the company to meet with the team to answer questions and demonstrate effectiveness of the tray system in your sterilizer.
m. Some container vendors provide customization assessment services to facilitate purchasing decisions, thereby helping hospitals to only acquire what is actually needed to reduce unneeded spare parts and duplicate inventory, and to ensure that instrumentation is protected and the correct product selected.
n. Modular inserts are available for tray organization and instrument protection. Such inserts may be modular in nature, and reduce inventory as parts can be reconfigured to make new sets.
5. Understand different types of sterilization and how they relate to the use of rigid reusable containers for reprocessing.
a. Pre-vacuum: dynamic air removal process that suck air from the sterilizer chamber during the condition phase of the sterilization cycle. The advent of pre-vacuum steam sterilization facilitated the use of rigid reusable containers for efficiencies, secure transport, and sterility maintenance, and to reduce labor and energy required when items were wrapped. Containerized items in pre-vacuum steam can be processed at a faster rate, meeting standard hospital cycles.
b. Gravity Displacement Steam: downward air displacement process uses gravity to remove air from the sterilizer chamber, and steam forces the air down and out of the chamber drain. Not all containers are cleared for gravity displacement steam sterilization, and additional time is required over wrapped items.
c. Sealed “flash”, now called Immediate Use Steam Sterilization (IUSS): can now be achieved using sealed containers designed for the purpose. All IUSS containment devices can retain moisture because of short-to-no drying times. Containers with thermostatic or pressure-sensitive valves can reduce exposure times especially in gravity cycles. Some containers with paper filters can be utilized in pre-vacuum immediate use sterilization with no dry time when necessary.
d. Ethylene Oxide (EtO or EO): low temperature method that is suitable for heat and moisture-sensitive devices, and the EO gas penetrates the sterilization chamber. It is a relatively long sterilization cycle and it needs to aerate for a specified amount of time.
e. Ozone: low temperature sterilization method using ozone gas. This modality can be corrosive to devices and the provider is transitioning to a hybrid system with hydrogen peroxide.
f. Hydrogen Peroxide: uses vaporized hydrogen peroxide in three sterilization cycles, including two lumen cycles designed for flexible endoscopes and other lumen devices.
g. Hydrogen Peroxide Plasma (STERRAD): low temperature sterilization method dispersing hydrogen peroxide solution in vacuum chamber. Various models are available in differing sizes. Containers have been validated for use in the system, some with no anodizing or corrosion resistance at all.
6. Understand the quantity and type of items that are not conducive for hard surgical trays. For those items, blue wrap will still be required. The goal is to minimize these wrapped items as much as possible. Sets or devices infrequently used do not make economic sense for containerizing. For example, if a set is not used at least once a month, it should not be put in a container. Basins still need to be wrapped, as well as small single use items which may be placed in peel pouches or small insert boxes that can be wrapped. In addition, certain devices are oddly shaped or too long or too wide to be placed in existing containers, and thus must be wrapped.
7. Select and purchase rigid reusable sterilization containers, and case carts for transport as needed. See purchasing considerations for details.
8. Develop storage and transportation procedures
i. Determine storage space for all aspects of the sterilization process including long term storage. Ensure heavier cases have space on lower shelves. Cases shouldn’t weigh more than 25 pounds (per AAMI recommendations for ergonomic considerations). However, shelving may require greater strength for holding multiple cases.
ii. Wire racks for shelving are not recommended as they may scratch the cases and tear the wrappers.
iii. Wrapped sets cannot be stacked. Sealed containers may be safely stacked for storage. No product can be placed on the floor, nor within 18 inches of the ceiling.
iv. Avoid pull-out shelves at high levels, as shelving can tip with heavy loads when pulled out.
i. Case carts are designed to hold and transport multiple sets. Some are deep for proper transport of bariatric sets.
ii. If transporting to and from multiple facilities in vehicles, make sure case carts have locking wheels and swivel wheel to get around corners.
iii. Push handles on case carts are needed for movement. Some case carts have hitches for moving several carts at one time to a set location.
iv. Case carts may need a secure locking mechanism on the door, or a tamper-proof mechanism.
v. Contents of the case cart need to be identified and documents can be placed in a document holder, or a barcode may be attached to include content information and traceability.
vi. Some case carts may be designed to be placed in mobile vehicles. These may need to be secured with locking wheels or mechanism so that the carts will not move during transport.
vii. Furthermore, case cart selection should be based on the dimensions of the lift, doorways, and corridors through which it will move.
viii. Containers can be used to transfer contaminated items to the decontamination area.
ix. Placement of used sets and devices are safely transported within closed systems. At such times proper PPE should be worn.
x. Clean/dirty items should be labeled for transport and safe handling.
9. Operations - Train CS/SPD staff on reusable container sterilization best practices
i. Rigid sterilization systems should be cleaned and inspected after each use.
ii. The disposable filter should be discarded and the components disassembled prior to cleaning.
iii. Filter retention plates should be removed and placed in a basket or tray for cleaning.
iv. Valve type closures must be decontaminated following manufacturer’s written instructions. Some may need to be calibrated.
v. pH neutral cleaners must be used to preserve the metal surface and functionality of the container.
vi. Particular attention should be given to type of the detergent used as alkaline cleaners and those followed by acid neutralizers can damage the passive layer of sealed systems. Check manufacturer’s recommendations to see if pH neutral and/or multi-enzymatic cleaners are suggested to preserve container integrity.
vii. Check machine settings for automated washing or sink setup for manual to ensure correct detergent dosing occurs during cleaning.
viii. Containers may be cleaned in cart washers under certain conditions: that a pH neutral cleaner is used, that wash/rinse water is not reused, and that rinse agents of low or high pH are eliminated.
ix. There are special racks designed specifically for cleaning containers in cart washers.
x. Container components should be separated and placed on a rack to ensure that detergent reaches all surfaces.
xi. Ready to use enzymatic pH neutral wipes may be used for manual cleaning of containers. A thorough rinse must follow.
xii. Ensure that all detergent residue is rinsed off all surfaces of the containers, and that the container and its components are thoroughly dried.
xiii. Alcohol may be used as a drying agent and provides some disinfection.
xiv. Air dry or dry with a lint-free cloth if manually cleaning.
xv. If using automated washers or cart washers, ensure that the container is completely dry before prep and pack or assembly.
xvi. Moisture is not only a vehicle for microbial growth, but moisture itself on devices can abort low temperature sterilizers.
b. Care and Handing:
i. All rigid reusable containers must be decontaminated before being used for reprocessing of surgical devices after each use.
ii. Each sealed container system is required to have an inner tray or basket to secure the load.
iii. According to AAMI ST 79 recommendations, no instrument set should exceed 25 lbs.
iv. Container systems must be placed flat on sterilizer shelves or in inventory.
v. Ensure that container is properly sealed and labeled for storage and future use. A tamper evident seal, as well as a load card with indicator, must be present and intact before opening.
vi. All container systems that are placed in storage must be thoroughly cooled to room temperature prior to transport.
vii. Some containers may be stacked inside the sterilizer. Most are designed to be stacked in the storage area.
viii. Cracking the door of the sterilizer for a minimum of ten (10) minutes will facilitate drying post-steam sterilization by reducing condensation and equalizing the temperature.
ix. Sealed container systems are available for immediate use (IUSS) steam sterilization. Review manufacturer’s instructions.
x. Wet packs are not acceptable under any conditions, except in emergency situations for IUSS sterilization.
xi. Sterilization containers are reusable devices, and if properly cared for and cleaned with pH neutral detergent or enzymatic cleaners, designed to last for many years of continuous service.
xii. It is important for staff to be instructed in proper care and handling, and understand that rough handling can damage a container and interfere with its seal and function.
xiii. Inspection procedures should include verification that gaskets are intact and latches are properly functioning. If the hardware is riveted to the container, such devices may become compromised over time as rivets loosen and create pathways for entry of microorganisms.
xiv. Valve systems are filter-less. However, some valve systems require daily calibration and “burping” after each use to express the steam and may retain moisture.
xv. Train staff on correct container assembly for use including inspection for damage, filter retention plates and filter placement (or filter-less valve plates for some containers), the appropriate baskets are inside the container, and process indicator strips are within the baskets placed in opposing corners on each level of the load.
xvi. Make sure correct disposables are employed: tamper-event locks and seals, load cards, and labels. Consider employing ID plaques with barcodes if applicable for instrument set tracking purposes.
xvii. At point of use ensure that tamper evident seals are intact, disposable filter is visible, load card results are correct, and it is the correct set before breaking tamper-evident seals and opening container. After opening scrub person should check end point response of chemical indicator inside for acceptable results before removing basket straight upwards and then into sterile field. Implants must be monitored with biological indicators.
xviii. Containers may be used after procedure to transport soiled instruments to decontamination and labeled as such or placed within closed case carts.
i. Update count sheets, pick lists, etc. to include containers as well as tray layouts.
ii. Consider pairing digital tracking system with reusable containers to monitor movement of instrument sets and reprocessing productivity, to cut down redundant inventory, and to subsequently reduce OR procedure delays.
- MetroWest Medical Center, Wyoming, MI, 2011. The transition to reusable rigid containers saved MetroWest 5,606 pounds of blue wrap waste and $29,800. Perioperative staff at MetroWest highlight the rigid sterilization containers used in the OR and Sterile Processing.
- St. Luke's Hospital, Duluth, MN. Based on a college study, St. Luke's undertook a project on transitioning from wrap to reusable containers. The MnTAP analysis revealed St. Luke's achieved an ROI of less than one year and reduced waste by 50 lbs. per year.
- Gundersen Lutheran's website on Greening the Operating Room has several case studies on blue wrap reduction and recycling.
- Sarasota Memorial Hospital, Sarasota, FL, 2001.
Sarasota Memorial Hospital changed from disposable wrap and plastic composite containers to a universal anodized metal container system, resulting in a 95% reduction in repair costs, saving time and money, and elimination of wet packs.
- Mills-Peninsula Medical Center, a 413-bed hospital in Burlingame, CA, purchased rigid sterilization containers for the organization in 2006 at a cost of $34,987. They were able to avoid blue wrap purchases of $25,173 and save $26,000 in rewrapping costs for torn blue wrap sets, making the pay-back 8.2 months with an additional cost-savings of $16,186 in one year without even tallying waste avoidance costs into the equation. Gail Lee, past Director, Environmental Health & Safety, Mills-Peninsula Medical Center, Burlingame, CA.
- Boulder Community Hospital purchased $150,000 of rigid sterilization containers for the OR in 2003 and over two years, reduced blue wrap purchase from $250,000 to $60,000 annually - less than a two year pay-back. BCH has saved over $1 million in avoided supply costs since 2003 as a result of the program. Kai Abelkis, Sustainability Coordinator, Boulder Community Hospital, Boulder, CO.
Regulations, Codes and Standards, Policies
- The FDA must clear sterilization containers and other containment devices for a 510k clearance before they can be placed into market.
- Ensure your vendor has FDA clearance for your type of sterilization.
- Some containers are cleared for steam sterilization only, others for low temperature sterilization. Only one brand is universal and corrosion resistant cleared by FDA for all current sterilization methods from steam to various low temperature methods.
- “All containment devices whether sealed containers or wrapped trays are considered Class II medical devices and must be cleared by FDA for their intended use. According to AORN Recommended Practices, ‘Packaging systems should be evaluated before purchase and use to ensure that items to be packaged can be sterilized by the specific sterilizers and or sterilization methods to be used and should be compatible with the specific sterilization process for which it is designed.’ AAMI ST 77 provides guidelines for manufacturers of containment devices for reusable medical devices. Many international standards have been adopted in the U.S. document with the goal of providing minimal labeling, safety, performance, and validation requirements. Manufacturers are required to validate their containment devices and provide the data to FDA for clearance. However, health care personnel bear the ultimate responsibility for ensuring that the containment device or sterilization packaging is compatible with or can be effectively sterilized within the health care facility.” see Resources
- AAMI ST 79 Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities provides standards for steam sterilization, as well as guidelines for selection, proper care and handling, and parameters for use.
- International standards include ISO 868-8, which defines the requirements for use of sealed container systems.
Cross References: LEED
- LEED Existing Building version 9; Operations Materials and Resources Credit 6. MRc6 - Solid Waste Management – Waste Stream Audit. 1 credit.
- Blue wrap can account for almost 20% of the waste in a hospital. A waste stream audit will identify the actual generation and the opportunities to reduce the waste.
- LEED Existing Building version 9; Operations Materials and Resources Credit 1.1 -1.3. Sustainable Purchasing: Ongoing Consumables. 1 -3 credits; and related Credit 7.1 and 7.2: Solid Waste Management: Ongoing Consumables, 1-2 credits
- Eliminating disposable surgical wrap will significant reduce the volume of consumables.
- LEED Existing Building version 9; Operations Materials and Resources Credit 6. MRc6 - Solid Waste Management – Waste Stream Audit. 1 credit.
- Recycling Blue Wrap
- Multi-Enzymatic Cleaners (in progress)
Case Medical's Case Academy online at www.casemed.com has continuing education tutorials with CEU credits available on rigid reusable sterilization containers, reprocessing best practices, sustainable cleaning methods, etc.
ANSI/AAMI ST77, 2013.
ANSI/AAMI ST79, 2014.
Central Service Technical Manual Seventh Edition IAHCSMM 2008  Case Academy-Case Medical. Sterilization Container Systems- Tutorial. Website. Accessed on March 12, 2011.
Carlo, A. Sterilization cues for containers. Materials Management Health Care. 2007 Apr;16(4):40-2
Laustsen, G. Greening in Healthcare. Nursing Management. November 2010. Vol. 41, Issue 11. Pp: 26–31. Accessed on March 11, 2011.
Brannen, L., Guity, A. and DeLoach Lynn, C. Improving Sustainability Performance in a High-Paced, “Big” Cost-Center, and Resource-Constrained O.R. Setting. ASHE International Summit and Exhibition on Planning, Design and Construction. March 15, 2011.
McGurk, J. Greening Healthcare Through Pollution Prevention: Overview of Waste Management. Greening of Hospitals Workshop. Accessed on Mar 11, 2011.
Flynn, S. Considerations for use of rigid sterilization containers. Healthcare Purchasing News. October 2010. Accessed on March 18, 2011.
Case Academy-Case Medical. Sterilization Container Systems- Tutorial. Website. Accessed on March 12, 2011.
Considerations for use of rigid sterilization containers. Flynn, S.; Healthcare Purchasing News. October 2010. Accessed on March 18, 2011.
Case Academy-Case Medical. Sterilization Container Systems- Tutorial. Website. Accessed on March 12, 2011.
Carlo, A. Sterilization Cues for Containers. Materials Management in Healthcare. Accessed on March 18, 2011.
Heller, Jim. "Revising Instrument Processing Practices.” Managing Infection Control. (Nov 2001), 28-31.
Berry, Nancy. “From Blue to Green.”Greenhealthmagazine.org. (2012). Accessed August 20, 2014.
Lahd, Holly. “Reduce Blue Wrap Waste with Sterilization Containers." Minnesota Technical Assistance Program, University of Minnesota (2008). Accessed August 20, 2014.
Supply Chain, Waste
- Medical Products
- Source Reduction
- Waste and Recycling
- Waste Reduction
- Source Reduction
- Waste Minimization
- Central Sterile
- Operating Rooms/Surgical Suites
- Purchasing/Materials Management/Supply Chain
- Comment, and please add information, tools, or additional resources you think should be added to the PIM.
- Write a case study or a PIM to contribute to the Roadmap (links are to instructions).