Surgical preferences, sites driving sterilization trends - Infection Connection

Despite ongoing challenges and controversies, central service departments seem to be "steaming" along smoothly these days.

Yes, the debate over reusing disposables continues and isn't likely to be resolved anytime soon. Sure, there are concerns about toxic exposure with low-temperature chemical and gas systems. Indeed, a financial malaise hangs over the healthcare industry and is putting a dollar squeeze on some CS budgets.

And of course, the protracted labor shortage and negative stereotypes persist as well.

As CS professional Barbara Aldrich, second shift CS supervisor at Alexian Brothers Medical Center, Elk Grove Village, IL, laments, "The nurses view us as overpaid dishwashers. They don't believe we have a lot of knowledge. What they don't understand is that while they know 100 percent of one specialty, we know 75 percent of everything."

Lingering pockets of disrespect aside, CS prolessionals have good reason to be proud: They have become more sophisticated, more knowledgeable and more valuable than ever, said Cynthia Spry, RN, a New York-based clinical consultant for Advanced Sterilization Products, Irvine, CA.

"There is growing recognition of CS significance," she said. "The professional associations have done a great job in training and promoting standards. Some high caliber people have been involved in increasing CS' visibility. It's becoming a well-known fact that there is more to sterilzation than pushing buttons."

Tom Mc Vaughm president of Lancaster, PAbased Healthcare Strategic Resource, also believes that CS has gained considerable prominence.

"CS has become more visible, as opposed to the old days when it was a behind-the-scenes support service," he said. "There are number of reasons for that, such as the debate of reusables versus disposables and the heightened risk management sensitivities at the hospital."

Sizing up Cs

As an integral part of surgical services, CS methdologies are being driven by the type, frequency and site of the procedures, professionals say. All of these factors have influenced sterilization rends in recent years. Therefore, CS departments are using a diverse array of tools to accommodate the OR's demands,

"There is no perfect method of sterilization -- that's why there isn't just one," Spry said. "There has to be more than one modality."

Physically, many CS departments now resemble manufacturing plants. A confluence of pre-vacuum steam, gravity steam, ethylene oxide and hydrogen peroxide gas plasma equipment has become increasingly necessary to cover all the surgical bases and many of the larger hospitals are able to incorporate them all in CS. St. John's Hospital in Springfield, IL, is one such facility, though CS director Norene Fields says she realizes that the assortment is just not possible in some smaller institutions.

"No single method of sterilizing is able to address all types of devices [being used today]," Fields said. "For larger hospitals serving a broad spectrum of patient care needs, having multiple methods of sterilizing may be the most efficient. However, smaller community hospitals that just don't have the funds to invest may find it impractical to 'have it all."'

Even so, through resourcefulness and improvisation, small CS departments can work out methods to meet their increasingly demanding obligations, she said,

"There are alternatives, such as use of disposable devices, outsourcing the work, or asking another healthcare facility to help," Fields said.

Plasma partiality

CS may be managing multiple sterilization methods, but one in particular has been gaining acceptance faster than you can say STERRAD.

"People have really embraced this new technology," said Spry, whose company manufactures the popular hydrogen peroxide gas plasma unit. "For years there was nothing new in sterilization technology. Ethylene oxide has been around since the 1940s and steam goes back to the 1800s."

Since STERRAD's inception in the mid-1990s, ASP reports it has sold approximately 5,000 units and counts some 17 million cycles in hospitals worldwide to date.

Steve Avalos-Bock, RN, director of infection control and CS at Grinnell (IA) Regional Medical Center, sums up why the process has grown in popularity. "It's quick and easy," he said. "All I have to do is wrap the instruments, put them in the chamber and it's done in less than an hour. It's great."

Fields agrees that the ASP equipment is "a big step forward in the sterilizing and quick turnaround of heat- and moisture-sensitive devices" compared to the longer cycles and aeration times required for EtO.

Still, STERRAD has limitations that prevent it from becoming the standard method of sterilization, she said.

"The FDA has not approved STERRAD for devices with long, narrow lumens," Fields said. "Should it ever receive approval for these items--as well as for a self-contained biological indicator test--the technology might become more popular. However, it would not be cost effective or practical for it to replace steam sterilizers, so I don't foresee hydrogen peroxide gas plasma ever being the end-all of sterilizing methods."

Ionized hydrogen peroxide, which creates highly toxic free radicals during sterilization, also raises some concerns about the method's safety. Spry acknowledges those concerns, but says they are unfounded.

"When people talk about toxicity, they're referring to the hydrogen peroxide. But we use 1.8 milliliters, which is a very small amount." she said. "The byproducts are oxygen and water vapor, which are as safe as you can get."

Keeping pace with progress

As surgical instruments become ever more complex, so do the tenets of sterilization.

"It's not all chromium steel anymore--you now have to deal with plastics and fiber optics," McVaugh said. "You need to have the right tools to process it correctly."

Researchers have found specific surgical trends that are steering sterilization methodologies. In its recent report "Strategic Analysis of the U.S. Disinfection and Sterilization Markets," San Jose, CA-based Frost & Sullivan describes how the increase in minimally invasive surgery is influencing sterilization.

"The medical device industry is witnessing a major shift away from many invasive or open surgical procedures to minimally invasive approaches," said Frost & Sullivan industry analyst Dhiraj Ajmani. "High level disinfection or sterilization of the sophisticated and expensive endoscopes is required in order to control transmission of infections from one patient to another. The growing acceptance of minimally invasive procedures is expected to expand the market for sterilizers and sterilants used for endoscope reprocessing."

The proliferation of new surgical instruments means there's always a new wrinkle to learn, Fields said.

"The greatest challenge is in keeping technicians thoroughly trained for each process and each device," she said. "New devices show up in our department regularly. I could in-service my staff daily and never run out of topics."

Avalos-Bock offers a case in point. Endoscopic device technology has shrunk trocar size in half, from 10mm to 5mm. "The device is much smaller and has less impact on patients," he says, "but there are new [sterilization] practices for it requiring new brushes and clean-up techniques."

With a CS department that has grown more sophisticated and technology speeding up turnaround times, the offshoot is a higher number of surgeries per day, Avalos-Bock said. Surgery is, of course, the biggest money maker for nearly every hospital.

"Our surgical volume has gone up dramatically since we brought in the STERRAD two years ago," he said.

On top of that, Avalos-Bock says that his hospital has gained a reputation as the best facility in Iowa for gastric bypass surgery. The CS department now is processing instruments for three-to-five gastric bypass procedures per week--in addition to the regular docket of general surgeries. In fact, because the surgeon is in demand for gastric bypass, he is being sought out for other procedures as well, Avalos-Bock said.

"It's exciting, but it's really driving up volume," he said. "We haven't yet reached a point where we're overly stressed, but we are definitely looking at how we function."

Location, location, location

Just as important as how CS departments are operating is where they are operating. As surgeries progressively shift from inside the hospital to alternate sites, there is pressure on CS to relocate as well.

"Clearly there is a movement toward multiple sites," consultant McVaugh said. "Almost everywhere I go there are satellite facilities going up where the patients are."

But he points out that opening a remote location puts a strain on the traditional distribution for sterilization. Efficient transportation methods can help keep processing in one central location, but also increases CS inventories, he said.

To compensate, some departments are relying on totally disposable packs for off-campus procedures, McVaugh said. "Remote surgeries are a catalyst for [disposables] because they are easier than setting up satellite facility and even more cost effective," he said. "In some cases, there's no incentive to opening up a satellite service center."

Going one step further, remote surgical sites may find that completely outsourcing CS is a viable option, added ASP's Spry.

"There's been a lot of discussion about this," she said. "It just depends on the situation--sometimes it makes sense to put resources in the hospital and other times it makes more sense to outsource."

'Nice' vs. 'Need'

When it comes down to the essentials for properly equipping a modern central service operation, a basic strategy is to decide between what is "nice to have" and what a department "needs to have."

At St. John's Hospital, Fields says that a "nice to have" item is a computer program for monitoring productivity and tracking instrumentation.

"Actually, I believe this to be 'necessary' for improving efficiencies and the bottom line, but administrators have the tough task of determining priorities with finite funds so this one is often placed in the 'maybe later' stack," she said.

"Necessary" equipment is that which helps to keep patients and employees safe, such as well-maintained sterilizers and automated instrument washers to minimize handling of contaminated instruments, she said.

While Spry asserts that having steam and low temperature processing units is necessary, "What's nice is having enough of them."

RELATED ARTICLE: A hot market

Spurred by dramatic growth in the number of endoscopic surgeries, low-temperature sterilizer and liquid disinfectant usage is expected to grow exponentially, San Jose, CA-based research firm Frost & Sullivan reports. In its recent study, "Strategic Analysis of the U.S. Disinfection and Sterilization Markets," the firm projects revenues for these products - along with the entire sterilization sector - to trend upward over the next five years.

Revenues

                                  2002            2008

Low-temperature sterilizers       $46.6 million   $72.2 million
Liquid disinfectants/sterilants   $105.6 million  $159.5 million
Total disinfection/sterilization  $678.8 million  $928.6 million

Former AbTox executives indicted

Four former executives of AbTox Inc., the Mundelein, IL-based company that for a time in the 1990s sold to hospitals a controversial low-temperature sterilization unit, have been indicted on federal conspiracy and fraud charges involving the manufacture and promotion of the AbTox Plazlyte Sterilization System, the U.S. Attorney's Office for the Northern District of Illinois reports. According to a federal grand jury indictment handed down in February, the defendants "conspired to defraud the United States by impeding and impairing the lawful regulatory functions" of the Food & Drug Administration, and "further committed fraud by selling approximately 160 sterilizers to hospitals around the country...despite the fact that the sterilizer had not been cleared or approved by the FDA as required by federal law.

The defendants are: Ross A. Caputo, 53, former president and chief executive officer of AbTox; Robert M. Riley. 56, former vice president of regulatory affairs; Mark E. Schmitt, 44, former director of marketing, and Marilyn M. Lynch, former director of clinical services.

All four defendants were charged with one count of conspiracy and six counts of introducing a misbranded sterilizer into the market. Additionally, Caputo and Riley were charged with four counts of mail fraud and five counts of wire fraud in connection with sales of the unapproved sterilizers. Riley, Lynch and Schmitt were also charged with one count of making false statements to a FDA investigator.

According to the indictment, the FDA cleared an AbTox request in 1994 to market a small, low-temperature hospital sterilizer. From then until the company filed for bankruptcy in July 1998, AbTox manufactured and marketed "a different, much larger sterilizer, with different design and engineering characteristics than the device that was cleared by the FDA," said U.S. attorney Patrick Fitzgerald.

"The sterilizer Abtox actually marketed was never either cleared or approved by the FDA, while AbTox never marketed the small sterilizer [that did receive clearance]," Fitzgerald continued. "Moreover, AbTox promoted the sterilizer for use on types of instruments for which neither sterilizer was ever cleared."

AbTox reportedly sold the units at prices ranging from $75,000 to $115,000 each. Twelve of the unapproved sterilizers were sold for approximately $1.2 million to unwitting Veterans Affairs hospitals, the indictment states.

If convicted, the defendants could be sentenced to prison, ordered to pay six-figure fines, or both.

COPYRIGHT 2003 Nelson Publishing
COPYRIGHT 2003 Gale Group