This article is from in the February 2008 issue of DOTmed Business News. A list of registered users that provide sales & service can be found at the end.

Louis Pasteur popularized the sterilization of medical equipment the 1860s.

As a result of sterilizing infections and using antiseptic techniques in operating rooms, patient survival rates soared. Pasteur was an ardent advocate, preaching adherence to the sterile surgical practices also followed by Lister in England.

But if he were alive today, Pasteur would most likely revel in the magnitude of how far his methods have evolved into the advanced capabilities of modern-day sterilization and the state-of-the art equipment that goes along with it.

On a global basis, the medical sterilization systems and equipment market is pushing north of $2 billion. The US is the largest market for medical sterilization systems at about half of that, with Europe and Japan trailing. One form, steam sterilization is a $250 million business while another, Ethylene Oxide, is nearer to $300 million.

So why is there increased government and private pressure on the healthcare community to do something about the widespread problem of acquired infections (HAIs), which has affected 2.3 million hospital and ambulatory patients, causing as many as 99,000 deaths yearly.

If everything's so sterile, why is the FDA, citing strict standards for product quality control and assurance, legislating medical device producers to upgrade and expand sterilization and disinfection systems? The Joint Commission of Medical Standards (JCAHO) requires hospitals to document performance testing of all sterilizers found in surgery, central service, and other departments. Usually, the departments that have sterilizers are responsible for verifying proper sterilization performance and for keeping a record of the testing. Each department's data must be aggregated and reported.

Common Methods of Sterilazation

Common methods of sterilization include physical and chemical methods. Physical ugtilizes dry heat, steam, radiation and plasmas. Radiation relies on gamma radiation, electron beam, X-ray, ultraviolet, microwave and white (broad spectrum) light. Chemical methods include ethylene oxide, propylene oxide, chlorine dioxide, ozone gases and a variety of chemicals in liquid and vapor form, such as glutaraldehyde, hydrogen peroxide and peracetic acid.




According to Raef Warzynski, President of Eagle Technical Services, Eagle, WI, sterilizing equipment must pass a Bowie Dick test to verify that it is able to maintain a vacuum without any air leaks. "This test is mandatory in the health care market and performed daily," says Warzynski. He says that even though a sterilizer passes a Bowie Dick test, it could still have an internal steam leak causing poor vacuum levels, one of man reasons why qualified technicians must inspect sterilizers.

Eagle sells both new and refurbished sterilizers. Warzynski says reputable sterilizer remanufactures clean and test the unit, paint the exterior and frame and install new plumbing, with the cost dependent on what is done in the rebuilding process. "Some rebuilders install new electronics, while others reinstall the old electronics," says Warzynski. "This is where sale price differs. New controllers typically cost about $8,000 to 10,000 out cost." Warzynzki believes that the advantages of buying a new sterilizer are a 15-year vessel warranty and knowing that you are not buying a plugged or defective vessel. "I've had a lot of success in marketing and selling Primus Sterilizers," says Warzynki. "

Sterilization Equipment Market

STERIS Corporation, with revenues of $1.2 billion in fiscal 2007, offers a mix of capital products including sterilizers. A provider of infection prevention and surgical products and services, STERIS' primary focus is on the critical markets of healthcare, pharmaceutical production and research.

Stephen Loes, Vice-president of Marketing, Sterile Processing, believes that STERIS is a leader in the industry because, he says, "We offer the highest levels of value and quality in our products and services and provide the broadest array of solutions based on what our customers actually need. This includes STERIS project design professionals who work with healthcare organizations to develop practical and scalable sterile processing and surgical suite layouts and plan for optimal efficiency and future growth; instrument tracking capabilities, a full-line of sterilization and high level disinfection equipment including steam, ethylene oxide, low-temperature liquid and vaporized hydrogen peroxide systems."

As for the company's main products, Rick Gurley, Director of Low-Temperature Reprocessing and Applied Infection Control for Sterile Processing says, "In addition to our well known Amsco® and Century® steam sterilizers, STERIS has recently launched some new sterile processing and high-level disinfection systems such as the Reliance™ Endoscope Processing System; the Amsco® V-PRO™ 1 Low Temperature Sterilization System and the VaproSure™ Sterilizer, which uses an EPA registered sterilant to sterilize all the surfaces in ORs, ERs and other enclosed spaces and is. The company says, the only sterilization process designated and certified by the Department of Homeland Security as an anti-terrorism technology."

Another key player in the sterilization equipment market is PRIMUS Sterilizer Company, LCC. Since 1990, PRIMUS has been designing simple yet versatile and easily serviced line of steam sterilizers. With corporate headquarters located in Omaha, NE, and production facilities in Omaha, as well as Great Bend, KA. PRIMUS sterilizers are designed and manufactured according to Quality Management System, which is compliant with ISO 9001:2000 and 13485:2003, FDA Good Manufacturing Devices: General Regulation (21 CFR Part 820) and UL listed through dealers, representative and authorized service agents for both domestic and international markets.




According to Connie L. Mansfield, Manager of Marketing Services, "PRIMUS is the only major US manufacturer with their own ASME certified pressure-vessel factory. It is our only business." The company takes pride in the unique Pri-Mirror® finish, which produces the most sanitary of all vessels." The PRIMUS clinical line includes 10 standard 316L stainless steel pressure vessels, from two to 72 cubic feet and custom sterilizers of virtually any size.

David L. Counley, Vice-President of Sales and Marketing says, "Quality and integrity is the core belief of our company since inception 20 years ago. The quality of our product is paramount ensuring we deliver the most cost efficient sterilizer with simplistic functionality and ease of operation, thus reducing 'Total Cost of Ownership' (TCO). Our ability to provide a complete 'turn key application' from design to post service and support enables us to consistently meet the unique challenges of steam sterilization." And board member, Peter Huff says PRIMUS is one of the rare healthcare companies that has grown at double-digit rates over multiple decades in good markets as well as bad.

L & R Services is a medical equipment and repair service company that sells refurbished tabletop sterilizers. President, Randy Lowers says the amount of refurbishing a sterilizer needs depends on how the previous owner took care of the unit. "Some units can be rebuilt by replacing common consumable parts like gaskets and filters, while others need rebuilding or replacing solenoids," says Lowers, adding "I've rebuilt tabletop sterilizers for $100 up to $2000." As far as finding service and parts for sterilization units, Lowers says it's fairly easy, especially if you have been in the field for a while and have number of resources to turn to. "As far as parts go," he says, "it is all up to the manufacture - most sterilizers in the field today are still honored by the manufacturer, though you come across a unit that is now obsolete and this can cause some problems."

Chris Miller, President of Zoetek Medical sells both new and refurbished sterilizers. "Our market seems to demand equal amounts of both new and refurbished sterilizers," he says. Zoetek Medical services and installs sterilizers almost every day. Miller said that his technicians do a complete electrical safety inspection, as well as replace common failure parts and do detailed cleaning and calibration of the temperature and pressure. Finally, a spore test is performed and brought back to the Zoetek lab for testing.

Sales support person, Terra Stumbo of Zoetek said that a refurbished unit, depending on the condition of the unit, can range in price from $5,800 (low end) to $12,000 (high end). A new unit runs from $18,000 to $14,000. "We estimate the cost of a refurbished unit to be about 50 percent the cost of a new unit," says Stumbo. She went on to say when Zoetek refurbishes a sterilizer, technicians replace the external tubing and steam traps, then rebuild the safety valve. "They replace common parts like filters and door gaskets, and verify all connections. If needed, they replace the heater and calibrate the temperature controllers," states Stumbo. "When refurbishing a steam generator, our technicians clean the inner chamber and replace the heater if necessary."

Sterilizer Services, Inc. sells new Midmark, SciCan and Tuttnauer sterilization products. Steve Beno, President of Sterilizer Services said that the company sells used autoclaves to other refurbishing companies and end users. "Our main line is service, which accounts for 95 percent of the business," says Beno, "Sales is the other five percent." Beno said that from a budgetary standpoint, the lifespan of a sterilizer is about 15 years. "There are some units that we service that are 30 years old," he says. "They run and do their job, but parts that were common 15 years ago are no longer available."

Beno gets his parts from OEMs (STERIS or Getinge) or other suppliers like RPI or PartsSource. Beno feels that STERIS and Getinge control the sterilizer market, but "with STERIS moving manufacturing out the US, PRIMUS might move up as a main US producer of autoclaves." He said that STERIS sells remanufactured units and he promotes Medequip and Continental because, "our company gets the warranty work for selling their units."

Bob Reindel is a Biomedical Technician II at Sodexho, Inc., which is an integrated food and facilities management service company in the US, Canada and Mexico with $7.3 billion annual revenue and 125,000 employees. Reindel said that their healthcare environmental services division helps ensure that a facility is consistently clean and comfortable for patients. Staate Hayward is an imaging specialist under the Sodexho,Inc. umbrella. He feels that the lifespan of a sterilizer can be 20 years plus. He said that Sodexho strictly services sterilizers and has seen units that are old but still able to perform flash sterilization modes. Sodexho services hospitals and clinics sterilization equipment by cleaning, checking and replacing what is necessary and by testing all safety valves and operational features. "The newer models have many self-checks built-in via feedback sensors - pressure, temperature, water flow, etc," says Hayward.

North American Medical is a used medical equipment liquidation company. President Mitchell Guier says, "we buy and sell a wide variety of medical equipment. We sell anything from CT scanners and MRI's to autoclaves and stretchers." He sells used sterilizers and does not refurbish any of his equipment. Guier says that before he sells a sterilizer, it has been checked by a hospital's biomedical department to make sure it meets guidelines for certification. His units run anywhere from $4,000 to $8,000 depending on the age and model.

Biomedical Technical Specialties offers per diem consulting, JCAHO survey preparation, cost savings initiatives, inventory certification, complete physical inventory, review quality of inventory data and equipment risk assessment, program development, equipment inventory review and assessment, maintenance inspections, per diem contract maintenance and equipment repair and sales. President of the company, Jeovanni Rivas said that Biomedical Technical Specialties sells mostly refurbished sterilizers - about 95 percent refurbished and five percent new. Rivas said that in order to ensure proper operation, sterilizer equipment should have spore test done on a daily basis and chambers should be cleaned at least once a year. He always recommends using distilled water in tabletop sterilizers.

On a slightly different note, but still in the sterilization market, SPSmedical Supply Corp. is the largest sterilizer laboratory in North America and a corporate member of numerous healthcare organizations, including standard setting organizations like AAMI and CSA.

"With a dedicated staff and over 50 sterilizers, SPSmedical provides sterilization test results to thousands of customers each year, and we manufacture a comprehensive line of sterilization monitoring, packaging and record keeping products," says Mariann Pierce, Director of Sales & Marketing. "SPSmedical shares a passion for infection prevention as we assist healthcare facilities and medical device manufacturers meet their sterility assurance needs."

SPSmedical has a quality system in place and complies with the Federal Food and Drug Administration. "The system we are regulated with is compliant with QRSs (Quality Systems Regulations) as listed in the United States Code of Federal Regulations. 21 CFR Part 820. Pierce said that the company's market involves all healthcare industries where instruments and devices are reprocessed, e.g. hospitals, private offices and clinics as well as dentist's offices. "There are other companies out there that are competitors who offer testing services and those who offer sterility assurance products," says Pierce. "However, we are the only company that offers both testing services and a full-line of sterility assurance products."

The Future of Sterilization

The need to improve sterilization methods and machinery has created ongoing research in order to produce better and more complete sterilization performance. Steve Beno thinks the new Ozone Sterilizer by TSO3 could replace ethylene oxide and hydrogen-perioxide units in the near future. Raef Warzynski feels that Ozone may also be the answer to Prion sterilization and be a low cost alternative to Plasma and ETO sterilization. He feels that it still needs to be a proven method but it does have potential. The challenge, however, in developing Prion deactivation technologies is that there is no appropriate standard for a company to measure the effectiveness of sterilization technique against Prions. Whatever the challenges, the sterilization equipment industry is alive and well and has evolved over the years - driven by consumer demand and competition in the marketplace. As medical devices become more intricate, and regulatory and sterilization standards become more demanding, sterilizer manufacturers and companies are working to develop and maintain advanced systems and features to meet the challenges.

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DOTmed Registered Sterilization Sales & Service Companies
Names in boldface are Premium Listings.

Domestic
Michelle Booth, Booth Medical Equipment, AR
DOTmed Certified
Randy Lowers, L & R Services, FL
DOTmed Certified
Gil King, Remarket Medical, Inc., GA
DOTmed Certified
Mitchell Guier, North American Medical, MO
DOTmed Certified/100
Boyd Campbell, Southeastern Biomedical Associates, Inc., NC
DOTmed 100
David Ogren, OMED of Nevada, NV
Jeovanni Rivas, Biomedical Technical Specialties, NY
Chris Miller, Zoetek Medical, NY
DOTmed Certified
Bob Mighell, World Medical Equipment, WA
DOTmed Certified
Raef Warzynski, Eagle Technical Services, WI
Staate Hayward, Sodexho, WI
Steve Beno, Sterilizer Services, Inc., WI
DOTmed Certified/100

International
Yasser Elsayed, Direct Response, Egypt

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