This report originally appeared in the August 2009 issue of DOTmed Business News

Sterilization is a well-known, critical procedure done in any clinical setting to prevent infections that, unfortunately, occur in hospital and medical care facilities all over the world.

In hospital settings, the most common sterilizer is the steam autoclave. Many hospitals also own an ethylene oxide unit. Advances have been made using Sterad systems (ozone and liquid systems), while cold sterilization using liquids also have proponents.

EtO Sterilizer Update
The Deadline for Compliance Reports to EPA has Passed

Many hospital facilities using the Ethylene Oxide (EtO) Sterilizer are facing close scrutiny and review. The 1990 Clean Air Act labeled EtO as a hazardous air pollutant and consequently directed the Environmental Protection Agency (EPA) to regulate its emissions. In 2007, the EPA delivered a final ruling regulating these sterilizers stating users must adhere to rules in terms of work practices rather than device replacements. For example, a facility using an EtO sterilizer must run the machine fully loaded or have air pollution control devices (APCD).




Most will agree that running a fully-loaded sterilizer is more economical, and the EPA's take is - the fuller the sterilizer, the less times it runs; therefore, less EtO gases are emitted into the air. Exceptions to this rule are medically determined circumstances that require the sterilizer to run less than full or if the EtO has an APCD. The rule applies to hospitals, which are deemed to be a major source of hazardous air pollutants but does not apply to health care providers that see patients on an outpatient basis.

To ensure these rules are enforced, hospitals must keep records every time an EtO sterilizer is used and if, for a medically determined reason, the sterilizer is used less than full, a special administratively signed note must accompany the report indicating why the sterilization was run at less than capacity.

Compliance to these rules is determined by whether the sterilizer is existing or new. An 'existing' source would be considered a sterilizer installed or rebuilt before November 6, 2006, and a Notification of Compliance Status (INOCS) report had to be recorded with the EPA by June 2009. EtO sterilizers installed after November 6, 2006 are referred to as 'new' and must report to the EPA 180 days from the date the sterilizer was put into use. Copies of these reports must be maintained by a hospital for each EtO sterilizer in use.

Sterilizers on the Market

Michael Parnell, CEO and President of EquipStat Medical Equipment, sells new and refurbished sterilizers. The company also repairs sterilizers under warranty. His opinion about the best sterilizers on the market is, "Amsco, Midmark and Tuttnauer because they provide the best value to a customer." Parnell's business is doing well on the 'refurbished sterilizers' side, "due to budget constraints and because buyers save money on refurbished units." He says the most common problems he sees with sterilizers occur because "the operator is not following the manufacturer's instructions and/or buying a refurbished unit that has not been refurbished."

When an EquipStat technician works on a sterilizer, it is completely refurbished - replacing the entire PM kit including gaskets, bellows, heating elements, temperature gauges and filters.

STAT Bio-Medical Sales & Service is experiencing a positive increase in business as well because, says Alda Clemmey, Vice President of Sales and Marketing, "We are a lot less expensive (usually half of what the manufacturer charges), whether a customer is looking to have their units serviced, or looking to purchase a new or pre-owned unit." STAT Bio-Medical Sales & Service sells Midmark, Pelton & Crane and Tuttnauer equipment. She too believes that the main problems affecting sterilizers are not usually in the equipment, but instead caused by the user of the device. Major problems seen at STAT are devices not heating properly, not draining properly, leaking and error codes.

Lisa Vanasco, Sales/Marketing, Ready Medical agrees blaming, "operating misuse," as the most common fault with sterilizers. Ready Medical sells refurbished and on occasion, new sterilization equipment with popular brands being Amsco, Steris, Midmark and Pelton Crane.

Sterilizers Need Maintenance

The fact that human error does seem to account for a majority of sterilizer breakdowns is concerning, considering that people's health can be severely affected by improperly sterilized equipment. Is lack of funding for proper maintenance the reason, or are those controlling the maintenance or handling of sterilizers not paying close enough attention to caring for the equipment?

Obviously there are people watching. Aside from the EPA rulings, the FDA has cited strict standards for product quality control and assurance, and have legislated medical device producers to upgrade and expand sterilization and disinfection systems. As reported in last year's industry report on sterilizer sales and service [search for dm5373 on DOTmed.com], "The Joint Commission of Medical Standards (JCAHO) requires document performance testing of all sterilizers found in surgery, central service and other hospital departments."

"The lack of daily, weekly, monthly and yearly maintenance is a big problem," says Darren Walker, Sales Consultant for Duraline Systems. "Sterilization equipment is a lot like a vehicle, if it is well-maintained it could last decades, if not - it may only last a year or two before major problems occur." Duraline carries many makes and models of sterilizers, and when their factory certified technicians refurbishes one - it is taken apart and each piece is inspected. Parts are replaced if there are any questions as to their condition. When all parts are cleaned, painted or replaced, the device is reassembled and run though a series of tests to insure the unit is running like new. All Duraline sterilizers are checked by quality control, and "if all is well, it is made available for use."

Gregory Drinkwater, President of remanufacturedsterilizers.net, places blame of sterilization problems on poor maintenance of machines as well. "The lifespan of the machine is shortened because of this oversight," says Drinkwater. "Simple maintenance will add years to a machine."

Drinkwater's company remanufactures sterilizers and has a factory certified technician "gut the core machine and replace all the parts." He says, the machines will last another ten years once they've been refurbished. The most popular brand's his company services are Statim 2000 and 5000 for dentists, ophamologists and tattoo artists.

When it comes to pricing, according to Krista Kalweit, MT (ASCP), Vice President and Senior Field Service Technician, MERCO, "a refurbished sterilizer can sell for $2,000, while a new model can go for $6,000." With the current economic climate, price is important. "Business is down due to the economy and companies not wanting to spend money." She goes on, "We are also seeing the dramatic growth of hospital managed field sites (sites other than the main hospital), which run small independents out of the market."

Dave Waterman, President of MRSBiomed says that business in the sterilizer sector is up. MRSBiomed services several surgicenters that have relatively low usage, but "scheduled maintenance has increased my work load a great deal in this area," he says.

What's New and Different?

Waterman notes one recent innovation that has helped hospitals save money is the Water-Mizer, which he describes as "a water-saving device that eliminates the "tempering" water consumption during the non-sterilizing portion of a sterilizer's cycle, thereby substantially reducing overall water consumption." Waterman says this device is a great value and can pay for itself in a year.

Carlos Rosado, President of Lone Star Medical says, "non-heat and pressure technology is making a name," and he sees STERIS as one of the contributors. STERIS offers several innovative systems including the Amsco® V-Pro™ 1 Low Temperature Sterilization.

Advanced Sterilization Products (ASP), a division of Ethicon, Inc. a Johnson & Johnson Company introduced the EVOTECHTM System in December 2008. This system eliminates the risk of human variation in endoscope cleaning by automatically cleaning and disinfecting the device at standards comparable to professional society guidelines. The system uses dual, independent basins that clean and reprocess endoscopes in 33 minutes or less and a single-use, high-level disinfection is performed using glutaraldehyde-free CIDEXR OPA concentrate solution. It also features automated leak detection at the beginning and end of the cycle, helping to ensure the integrity of the endoscope.

Karen Borg, Worldwide Vice President of Marketing at ASP says, "EVOTECH system's automation and technology is exceptional, and with the system, you can be confident that endoscopes are reprocessed safely and consistently." The system does not require that manual cleaning of an endoscope be done prior to using it, when selecting the cycles that have a wash stage; however manual washing is required when selecting the disinfect only of the disinfect/alcohol flush cycle. ASP also offers the STERRAD CYCLESURE - 24 Biological Indicator, which allows users to record biological indicator results in 50% less time, helping to speed up instrument throughput in sterilization departments. It can be used with all ASP's low-temperature, hydrogen peroxide systems including STERRAD 100NX, STERRAD NX, STERRAD 1005, STERRAD 200 Systems, as well as the STERRAD 50 System.

PRIMUS Sterilizer Company, LCC, is a unique, innovative company designing and manufacturing sterilizers since 1990, for both domestic and international markets. It is their only business.

Connie L. Mansfield, Manager, Marketing Communications and Regulatory Compliance said, "PRIMUS Sterilizer is the only major US manufacturer with their own ASME Certified pressure vessel factory, manufacturing sterilizer for clinical, dental, biopharmaceutical, laboratory and animal research and decontamination applications."

PRIMUS products offer a PRI-MIRROR (R) finish, which produces the most sanitary vessels. Through the use of non-proprietary parts, PRIMUS sterilizers reduce the total cost of ownership. The PRIMUS line includes 19 standard sizes from 4 to 261 cubic feet and 12 standard sizes FDA approved for clinical market. Besides the standard sizes they offer custom sterilizers of virtually any size plus four different control systems to meet the needs of all applications.

For other innovations, Bryan Crawford, President of Crawford Diversified Services, Inc. says, "Some of the sterilizer controls have changed, but they still pretty much work the same way as they have since the late 1970s." Darren Walker sums it up by saying "There have been some great innovations in sterilization, but there could be more!"

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

Domestic
G. John Oggel, Green Cross Medical/ GOMED, CA
DOTmed Certified
Lisa Vanasco, Ready Medical, CA
Judy Engle, Frontier Medical, Inc., CO
DOTmed Certified
Calixto Barja, Barja Medical Equipment Corp, FL
DOTmed Certified
Michael Parnell, EquipStat Medical Equipment, FL
DOTmed Certified/100
Jeff Fisher, Fisher BioMedical, Inc., FL
Charles Moore, CMoore Medical Sales & Service, GA
Dave Waterman, MRSBioMed, GA
Gil King, Remarket Medical, Inc., GA
DOTmed Certified
Alda Clemmey, STAT Bio-Medical Sales & Service, MA
DOTmed 100
John Gladstein, Medical Device Depot, MD
Asif Bhinder, tekyard, MN
Bryan Crawford, Crawford Diversified Services, Inc., MO
Anwar S. Syed, MDIC, MO
DOTmed Certified
Connie L. Mansfield, PRIMUS Sterilizer Company, LLC, NE
Darren Walker, Duraline Systems, NY
Gregory Drinkwater, remanufacturedsterilizers.net, NY
Mark Ragus, Foremost Equipment, NY
Abe Sokol, Absolute Medical Equipment, NY
DOTmed Certified/100
Dawn Nightshade, Medequip Engineering Service, Inc., OR
DOTmed Certified
Carlos Rosado, Lone Star Medical, TX
Krista Kalweit, MERCO, VA
Steve Beno, Sterilizer Services, Inc., WI
DOTmed Certified

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