New EtO Association Vies for Device Market

Medical Device & Diagnostic Industry Magazine | MDDI Article Index

Originally published April 1996

Sterilization

Gamma sterilizers may be hearing footsteps. After years of experiencing diminishing market share, the makers and users of ethylene oxide (EtO) sterilization technologies have banded together to form a new trade association designed to promote the benefits of using EtO.

"EtO has historically been one of the simplest, safest, and most cost-effective methods of sterilization," says Ron Ahnell, sales manager for sterilants at ARC Chemical (Slate Hill, NY) and president of the new association. "This group intends to reinforce that positive message."

Dubbed the Ethylene Oxide Sterilization Association, Inc. (EOSA), the new association resulted from informal meetings among representatives of about 20 companies with interests connected to EtO sterilization. Founding members include suppliers of EtO and related sterilants, makers of EtO sterilizing equipment, contract EtO sterilizers, and device manufacturers that use EtO sterilization. Election of the association's board of directors took place on January 24.

"Many in the EtO industry have felt that they were not able to have adequate representation through existing trade associations," notes Barry Page, a sterilization specialist and industry consultant based in Garner, NC. "They have needed a forum where they could discuss EtO sterilization issues independently of other considerations, and an organizing body that would enable them to present positive information about EtO--especially to balance some of the negative things that have been said about it."

The new association fits that bill precisely. According to Clark Houghtling, national director of sales and marketing for the Cosmed Group (Queensbury, NY) and EOSA vice president, the organization's objectives include information-sharing, monitoring regulatory activities, advocating policies favorable to the industry, fostering reasonable regulation, and disseminating "truthful communications" about EtO.

The truth about EtO has been a rare commodity in the recent past, says Page. "When they talk about sterilization, those who support and use radiation and newer technologies have tended to slip in negative comments about EtO. Consequently, there has been a lot of misunderstanding about the hazards of EtO."

"The negative impressions are out there," agrees Ahnell, "and in the past the EtO industry hasn't done a very good job of countering them with positive information. That's the mission of EOSA."

Ahnell attributes the need for a sector-specific trade association to the unique circumstances that apply to EtO. "This chemical is regulated by a lot of agencies because it is toxic, carcinogenic, and flammable. So much regulatory activity can be confusing to customers, who then begin to question the safety of EtO. But when it's used properly, the way a sterilizer uses it, EtO is a safe and very effective sterilant. Without it we would all be either very sick or dead."

Members of the organization are uniformly determined that its activities should remain positive in nature, and should not become a means for criticizing other technologies. "When we go to visit clients, the key question is what method best meets their needs," says John Masefield, chairman of Isomedix, Inc. (Whippany, NJ), a contract sterilizer that offers both gamma and EtO services and a founding member of EOSA. "We're very unbiased, but we appreciate the potential for this new society to provide comprehensive, detailed information about EtO and its use. This will enable those in the EtO sterilization industry to develop a uniform response to common problems that can't be handled through existing organizations and committees."

With the new association still in its infancy, gamma sterilizers aren't yet concerned about its long-term impact on the medical sterilization marketplace. "If you have a better mousetrap, you're sure to catch more mice," says Mac Connelly, director of sales and marketing for SteriGenics International (Fremont, CA), a contract gamma sterilizer. "Naturally, we believe that gamma technology is safer and cleaner, and because of its faster turnaround times offers an overall better option for many device manufacturers."

Nevertheless, Connelly admits that EtO is a tough competitor. "Unlike gamma sterilization, the barriers to use of EtO are quite low. Whereas the costs of setting up a gam-ma sterilization facility are affordable only by the largest device companies, the costs of in-house EtO sterilization can easily be borne by medium-size companies. Gamma's advantage comes in contract sterilization use on a regional basis, where faster turnaround times can more than compensate for EtO's lower freight and transportation costs," he says.

According to Ahnell, EtO's key advantage is flexibility. "EtO can be used with 99.9% of medical products, and can even be used when it's necessary to resterilize." Ahnell has conducted an informal survey on EtO use in each of the past three years, and says that EtO is currently edging out gamma radiation in the market for terminal sterilization of medical devices. "The margin is close," he says, "but EtO is still used to sterilize more products annually than is gamma."

Gamma radiation is the largest but far from the only competitor for market share that EOSA will have to face. While the two majors are running neck and neck--each with an estimated 45% of the U.S. market for industrial medical device sterilization--steam, electron-beam, and other technologies account for the remaining 10%. Novel technologies such as gas plasma, which is already eating away at EtO's share in the hospital marketplace, may also become contenders in the industrial market.

Although EOSA intends to serve as a clearinghouse for information about EtO, the organization will not be developing technical guidances or standards. "Those activities are being adequately handled by committees of HIMA [the Health Industry Manufacturers Association] and AAMI [the Association for the Advancement of Medical Instrumentation]," says Ahnell. "Instead, EOSA will be setting up committees to serve as liaisons with those other organizations, so that we can inform our members about what they're doing."

"We'll keep track of relevant activities being conducted by key standards-writing organizations," agrees Houghtling. "If we feel they warrant our input or involvement we'll see that our members know how to follow through."--Steven Halasey