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Making sure that your sterilizer is working for you.

Today, more than any other time in history, mankind is putting an inordinate amount of faith in machines and technology. We are awakened in the morning by a machine, a machine prepares our coffee, we take another machine to get to work where we utilize machines all day long. Technology and modern machinery undoubtedly make our fives easier ... as long as the machines are running properly.

Perhaps one of the most often used machines in the healthcare setting is the sterilizer. This marvelous device delivers high level antisepsis to surgical and medical equipment, eliminating or at least reducing the risks of infection to both the patient and the hospital staff. This is one machine for which proper and optimal function is imperative.

Fortunately, mankind's faith in machinery only goes so far, and in cases of equipment as critical to human wellbeing as the sterilizer, certain checks and balances have been put in place to ensure that proper sterilization is achieved for every load. Sterility assurance products come in a variety of configurations and like most other medical equipment, are held to very high standards. Currently, there are a number of companies manufacturing and marketing test packs, indicators and integrators that ensure that sterilizers are functioning to their fullest capacity and helping to keep patient and staff safe in the OR and beyond.

STERIS Corporation, located in Mentor, OH, provides several sterility assurance products for steam, ethylene oxide (EtO), and dry heat sterilization systems, as well as for its SYSTEM 1[R] Sterile Processing System. The STERIS family of products includes Bowie Dick Tests, Biological Indicator Test Packs, Class 5 integrators and external process chemical indicators that, when used as a system, ensure that the sterilization process is working at effective levels.

In sterile processing, time is very important, especially sterilizer uptime. STERIS's Verify[R] Bowie Dick Test Packs can help to reduce the downtime associated with sterilizer residual air failures through its indicative failure patterns. When reviewed by a trained technician, the distinctive patterns can help identify the source of the residual air as either an air leak or as non-condensable gasses. This is advantageous as non-condensable gases are normally introduced from the steam supply and are not typically associated with the steam sterilizer.

While most sterility assurance products are typically geared to a specific sterilization process, STERIS has developed a line of biological indicators that can work across the entire sterilization spectrum. The Verify Dual Species Self-Contained Biological Indicators can be used for multiple sterilization processes, including steam sterilization, flash sterilization and EtO sterilization. In addition, container data cards and load record cards can be used for both steam and EtO systems.

Among the most exciting new products in the STERIS family are the Verify Class 5 Integrators. These chemical integrators and integrator challenge packs are easy to use and show clear, easy to read color changes that provide immediate assurance that all the critical parameters of sterilization (exposure time, temperature, steam quality) were achieved.

STERIS is also introducing a new Verify Biological Indicator for the widely used SYSTEM 1 Sterile Processing System, which the company developed to provide a safe method for processing endoscopes and other temperature-sensitive medical devices. The current biological indicator for this system requires seven days to incubate, but the new product allows a final reading after 48 hours of incubation, saving significant time for SYSTEM 1 users.

Another supplier of chemical and biological indicators is Healthmark Industries Company in St. Clair Shores, MI, offering indicators for each method of sterilization commonly in use within healthcare facilities: steam, EtO and Gas-Plasma. These indicators feature dramatic, easily interpreted color changes that make it simple for the user to determine the success or failure of a sterilization cycle.

Unlike many products currently on the market, Healthmark's Gas-Plasma indicator is not sensitive to light and will only change color in the conditions necessary for sterilization. Also, the company's robust 5-level integrator requires over three minutes of optimal sterilization conditions in order to change, among the highest level available.

To complement the sterility assurance products, Healthmark also has a complete line of products for monitoring the effective cleaning of instruments. The ProFormance[TM] family of products help users determine if their decontamination equipment is functioning properly and if items are clean of residual soils. Products include the TOSI blood soil test, HemoCheck residual blood soil test, EndoCheck biopsy channel test for flexible endoscopes, SonoCheck ultrasonic cleaner test, Aquatest water quality test strips and the TempaChek line of temperature monitoring devices.

The SteriScan[TM] Steam Integrators from Stow, OH-based Spectrum Surgical Instruments Corporation provide biological indicator accuracy and chemical indicator convenience. They integrate time, temperature and steam, assuring accuracy at all times and temperatures. The integrators can be used in flash, gravity and vacuum steam sterilization processes.

The Class 5 SteriScan Steam Integrators are designed to provide an additional margin of safety over and above biological indicators, significantly reducing the risk of a non-sterile pack. These economical indicators come conveniently in 250-count packages, and are available in case quantities of eight packages of 250 integrators each.

Raven Biological Laboratories in Omaha, NE has been manufacturing biological indicators since 1949 and offers three types of self-contained indicators to offer a broader range of possibilities and solutions for the users. Raven makes biological indicators for several different processes including steam, EtO, Dry Heat, Peracetic Acid and several industrial processes. For those using steam sterilization, final results are available in 24 hours. Raven also offers Class 5 chemical integrating indicators that provide immediate results and can be used to release non-implantable items in an urgent situation. Ideally these products would be used together to provide the greatest sterility assurance level. All Raven indicators provide very vivid color changes, taking the guesswork out of indicator interpretation.

In addition to supplying quality sterility assurance products, Raven is dedicated to providing the training to its clients. Realizing that it is often difficult to keep training current across an entire hospital staff, Raven has begun offering training on CD to help technicians hone the skills they need to do their job with confidence. A training program is also in the process of being setup on the company's website.

SPSmedical Supply Corporation in Rush, NY provides cost effective and easy to use chemical integrators and biological indicators for use with all approved sterilization processes (Steam, EtO gas, Gas plasma, Peracetic acid, Dry heat, and Chemical vapor). The STEAMPlus Class 5 integrating indicator offers an immediate readout equivalent in performance to a biological indicator. Certified for use in gravity, pre-vacuum and flash sterilization cycles, it is also validated for use in a variety of extended steam cycles.

SPSmedical also offers the SporViewPlus Steam Biological Indicator Test Pack, a dual indicator system that offers immediate release of processed loads via the STEAMPlus device with final results available after 24-hour incubation. This test pack is approved for use with both standard steam cycles and extended cycles. The SporView PA Culture Set for peracetic acid sterilization monitoring is also approved for a 24-hour incubation, compared to other products currently on the market that require seven days of incubation.

Based in Englewood, NY, Qosina has recently added a few new sterilization indicators to its already extensive product fine. These indicators show a color change to signify proper exposure to various sterilization processes. The latest additions to the Qosina family of products are an EtO Sterilization Indicator that changes from purple to green, a Steam Sterilization Indicator that changes from blue to pink and a Radiation Sterilization Indicator (Gamma or E-Beam) the shifts from yellow to red.

These self-adhesive labels can be applied by hand. By the observable color change, it is easy to determine whether or not a particular sample has been through a qualified sterilization process. After exposure to the sterilization process, the indicators retain their color change indefinitely. These convenient labels are approximately one-half inch in diameter and are available in rolls of 5,000.

While no sterility assurance product can actually prove that a medical device is sterile, it can verify that the equipment is functioning in a manner that should sterilize the device, ensure that sterilized packages achieved conditions that could sterilize, and ensure that procedural errors have not occurred that would result in non-sterile items being used on a patient. Having faith in machinery is fine, but it's nice to have a little security to base that faith upon.

For Information on The Companies In this Article

Healthmark Industries Company

Info LINK 025-60601-701 or Call 800-441-6180


Info LINK 025-60601-702 or Call 800-441-6180

Raven Biological Laboratories

Info LINK 025-60601-703 or Call 800-441-6180

Spectrum Surgical Instruments Corp.

Info LINK 025-60601-704 or Call 800-441-6180

SPSmedical Supply Corporation

Info LINK 025-60601-705 or Call 800-441-6180

STERIS Corporation

Info LINK 025-60601-706 or Call 800-441-6180
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Title Annotation:Technology Solutions: Sterility Assurance Products
Author:Ritsma, Rich
Publication:Surgical Products
Date:Jun 1, 2006
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