by Julie E. Williamson

Case Medical's Flashtite containers

With the cost of surgical instrument sets totaling in the tens of thousands of dollars – and as much as $60,000 or more for orthopedic sets — taking steps to properly care for the devices both inside and outside the operative room becomes imperative.

Fortunately, manufacturers are offering a slew of container systems that promise to reduce damage to delicate instruments, enhance the sterilization process, organize and transport sets, and maximize storage space. Container systems come in various sizes to accommodate different sets and unique facility requirements, and range from stainless steel or aluminum rigid models to those made of lighter, high-density polymers and composites. Cutting-edge models are also available to safely transport flashed instruments, transport and sterilize delicate cameras, scopes and lenses, and serve as soaking systems to eliminate spillage and protect personnel from contaminated instruments during transfer.

Sources agree that durability, versatility, safety and ease of use are the primary factors driving today’s purchasing decisions.

"Construction is very important. Not only is it necessary to have a reliable container, it’s also important to have one that can be easily serviced, maintained and repaired," said Alex Vrancich, operations manager for Spectrum Surgical Instruments Corp., Stow, OH.

Vendors appear to be meeting those demands with systems that feature durable bases, latches, lids and handles that can withstand the rigors of repeated use and various sterilization methods.

A case for rigid containers

In recent years, there’s been a growing trend toward the use of rigid container systems. Such systems provide numerous benefits. Not only does their rigidity offer superb protection and permit easy stacking of sets, they are also known to simplify set-up and identification of instruments in the operating room, and help maintain sterility of surgical devices until they are used.

Another key benefit is that they eliminate the need for woven and nonwoven wrapping materials, which can cost facilities thousands in labor, material and expenses associated with reprocessing due to tears or punctures in the wrapper and the accumulation of condensate on the internal "wet packs" and external surfaces of the case following sterilization. The elimination of wrapped cases can prove particularly beneficial when managing heavy orthopedic trays because of improved handling and identification of contents. Furthermore, some sealed container systems are designed to package multilevel trays, which avoids the expense and time required to wrap each individual level, noted Marcia Frieze, chief executive officer, Case Medical Inc., Ridgefield, NJ.

An orthopedic set can have as many as 12 trays for one procedure. In addition, there is a time factor involved. Some orthopedic companies are recommending extended processing times up to 40 minutes for these systems. "A sealed container system constructed of thermoconductive materials, such as aluminum, can facilitate the sterilization process," she said.

To further maximize user benefits, manufacturers of rigid containers are incorporating even more value-added features into their systems. The SterilContainer System by Aesculap Inc., Center Valley, PA, for example, consists of various sizes of lids and bottoms, along with assorted accessories such as baskets, filters, indicator cards and tamper-proof locks. Color-coded lids are also available to facilitate grouping and coordination of different instrument sets. The SterilContainer System is made of a "specially formulated aluminum alloy," with the surface protected by a layer of adonized oxide to prevent corrosion.

Perhaps the most unique feature of Case Medical’s SteriTite rigid reusable sealed container is that is can be used in universal sterilization applications; that is, the system is fully validated in steam, prevacuum and gravity displacement, ethylene oxide and gas plasma sterilization. The company’s perforated bottom container has been validated for all current methods of sterilization; solid bottom containers are limited to dynamic air removal systems, such as pre-vacuum steam.

"Having a universal container system is very important because of the complex devices and various methods of sterilization options being used today," Frieze explained. "The SteriTite container was designed to handle small and delicate instruments, such as scopes and cameras, all the way up to robust orthopedic devices. A universal system is extremely cost-effective because it contributes to standardization and eliminates the need for multiple products." The fact that SteriTite containers have been cleared for up to 22 pounds of instruments further adds to the savings because it reduces the need for additional containers.

Case Medical states that adopting an event-related sterility policy using SterilTite containers can save facilities approximately $3,600 annually. Specifically, facilities that use the SteriTite container system can save an average of $200 per container in refurbishing costs and reduce labor costs by 28%. In addition, Case Medical’s organizational system of protective inserts and snap in Back Bone brackets can save thousands of dollars in expensive repair and replacement costs associated with scopes, cameras and other delicate and complex devices.

Cysto container before conversion                                                Cysto container after conversion

"These labor and cost savings can fully justify initial investment within one to two years," Frieze noted.

The Genesis rigid container system from V. Mueller, a division of Cardinal Health, is also suited for a broad range of sterilization applications. In addition to the Genesis STERRAD System Compatible Container, which is indicated for use with STERRAD 50,100 and 100s systems, ethylene oxide systems and prevacuum steam sterilizers, V. Mueller has recently added the Genesis Extra-Long Container System to accommodate longer instruments, such as laparoscopic devices. The Genesis line is also backed by a lifetime warranty for materials and workmanship.

The power of polymer

Manufacturers of container systems made of durable composite material and plastic polymers are also experiencing a surge in business, thanks to an extensive product portfolio and a wide array of unique value-added product features.

Container systems engineered from composite material are not only resistant to pitting, corrosion, denting and distortion, vendors contend their lighter weight also makes it easier for staff to transport and stack instrument sets. STERIS Corp.’s Amsco Sterilization Container System, for example, is engineered from a "tough composite material," which the vendor says offers unparalleled advantages over aluminum, stainless steel and ordinary plastic. Chemicals that will pit and corrode aluminum will not harm Amsco containers, the manufacturer notes, and the containers will also stand up to blows that can render aluminum containers unusable.

Some vendors also insist that their products can accommodate more instruments by maximizing space inside the container.

Riley Medical Inc., Auburn, ME, for example, has carved out a niche in the non-rigid container business by offering an array of customizable products and accessories tailored to specific devices and sterilization and transport applications. Those products include the MultiPak, which was designed for organizing and protecting delicate surgical instrumentation; ScopePak, which comes in a variety of sizes, offers engineered protection for the handling and storage of endoscopes and can withstand steam sterilization, ethylene oxide and cold sterilization conditions; MicroPak, which comes in a range of sizes to accommodate sterilization and storage of packs for single microsurgical instruments and full sets; TransPak, a lightweight plastic soaking system that reduces splashing and protects staff during transport; and the StackPak, which allows users to easily handle, transport, organize, sterilize, stack and secure delicate surgical instrumentation. The StackPak features a patented latch that makes it possible to combine complex instrument sets into one package.

"The StackPak’s latching system is located on the base, which allows three to four different levels to be stacked within the same system. This allows for greater organization and flexibility," noted Fred Finocchiaro, manager of distribution sales and international business development, Riley Medical.

Another benefit of the system, he said, is that it requires only one lid — unlike systems in the past, where different levels were placed in a large container and required their own lid. "Obviously, when you reduce the number of required lids, that also saves money."

The FlashPak, Riley Medical’s flagship product, also continues to be a big draw thanks to its unique closed system design that achieves effective sterilization in five- or ten-minute flash cycles, seals flashed instruments, and allows them to be safely transported and stored for up to 24 hours.

"The completely sealed system prevents contamination during transport, which is a big concern when flash sterilizing instruments," he continued, noting that a pressure-activated valve is the key to sealing off the instruments and avoiding contamination once the sterilizer door is opened.

Modularity maximizes value

Hospitals in the market for new container systems will find today’s models are increasingly modular and more flexible, regardless of their manufacturing materials.

Vendors of both rigid and composite containers are relying on innovative accessories, such as inserts and instrument holders, to provide greater customization, protection and organization. Their products are also becoming easier to clean, disassemble and maintain – critical factors given that container systems are medical devices and must function properly to protect the instruments from contamination and damage.

                                           Container conversion to a flash sterilizer

"Our goal is to offer a range of products that meet the critical needs from an application and budgetary standpoint," noted Ralph Basile, vice president of marketing, Healthmark Industries Co., St. Clair Shores, MI. "Our products come in many different sizes to accommodate small instruments all the way up to a full basket of instruments. Not only do they improve oraginzation, they are also extremely durable and easy to maintain." Healthmark’s SST Instrument Retrieval System is a three-part container system for collecting, pre-soaking, transporting and processing reusable contaminated instruments and sharps.

Case Medical’s SteriTite container comes with a full range of modular inserts that can be wrapped or serve as accessories to the device. According to Case Medical, its "Lego-like" MediTray inserts provide an organizational system to protect delicate and costly surgical instrumentation during decontamination, sterilization and transport, and also facilitate the instrument count process. What’s more, the system allows hospitals to containerize virtually all instruments, drills, scopes and lumens.

To help facilities further standardize their container systems and garner additional savings, Case Medical has also developed the FlashTite valve plate that easily converts an existing SteriTite sealed container into one that can be used in pre-vacuum flash and gravity displacement flash cycles.

"No filtered system can be safely used for sealed flash sterilization. The FlashTite valve has been cleared by the FDA for the intended purpose of flash sterilization," Frieze explained. "Containers are medical devices. It’s extremely important that healthcare professionals are using them for their intended purpose."

More than ever, vendors are offering services to tailor containers systems to the unique needs of a facility. Through its CustomPak program, a Riley Medical sales service specialist will bring a design kit to a facility and configure the ideal sterilization case onsite to meet its needs. Case Medical, V. Mueller and Aesculap also offer customization services.

"Customers are looking for more options that are best suited to their own needs," noted Robert Edelstein, president of Millennium Surgical Corp., the Haverford, PA-based distributor of surgical devices and supplies. Millennium works closely with customers to determine the best fit for their sterilization tray needs, whether the need is to protect one expensive eye instrument or a specialized endoscopic set.

"The goal is to offer a range of options, while at the same time, reducing confusion and easing use by keeping the systems simple," Edelstein said. "Healthcare facilities are not one-size-fits-all, so their container systems shouldn’t be, either." HPN