Scope steriliazation tough due to time constraints and complex devices
by Karin Lillis

Make it snappy, but make it clean.That bit of advice is something Lamont Holliday wishes he didn’t hear so often when it comes to reprocessing flexible endoscopes. Crowded schedules put a daily squeeze on scope supplies, says the manager of central sterile services at University Hospital, Newark, NJ. But despite the hectic pace, the risk of infection associated with an improperly cleaned and disinfected scope is a matter the hospital and the CS staff has in mind and takes very seriously.

“We are always under the gun to turn cases around. The pressure is on. We’re trying to meet customer demand and trying to clean the scopes properly,” Holliday says. “But you need a certain amount of time to get it done right.”

Many of the endoscopes at University Hospital are used for just-in-time procedures, so certain sterilization techniques like ethylene oxide – which can take 16 hours to process – aren’t a viable option. Holliday’s department relies on a product called Cidex OPA, manufactured by Advanced Sterilization Products, an Irvine, CA-based Johnson & Johnson company. Cidex OPA is a high-level disinfectant that the manufacturer says makes the scope ready for use in 12 minutes. Standard glutaraldehyde soaks – like ASP’s Cidex — take about 20 minutes to process, Holliday says.

The high cost of the endoscopic apparatus demands efficiency in sterilization that allows the facility to take best advantage of the equipment on hand. “Turnaround time is the reason a lot of hospitals do high-level disinfection like Cidex or Cidex OPA,” Holliday says. “The scopes are typically very expensive – costing as much as $10,000 or $20,000, so the hospital can’t buy that many of them.”

A tiny margin for error
“The greatest challenge to the cleaning process is the intricacies of the instrumentation,” notes Ray Taurasi, business development director for Case Medical Inc., Ridgefield, NJ, and an authority on sterilization. “It’s tough to be able to clean all of the moving elements. Many of the instruments aren’t capable of being disassembled and sometimes the ability to get total exposure to all working mechanisms is difficult and questionable when you’re working with these long, lumened instruments. But if something isn’t cleaned adequately, the success of the sterilization process is questionable.

“The instrumentation is very expensive, but at the same time technology is advancing and the demand is greater than ever,” he adds. “Many hospitals have inadequate inventory levels of the instruments to allow for adequate turnaround time. Wherever there is pressure to turn it over faster there is a risk factor. There have been instances of cross-contamination as a result of inadequate cleaning.”

There are approximately 15 million endoscopic procedures every year in the U.S., a figure that includes colonoscopy, sigmoidoscopy and bronchoscopy, according to Citizens Against Cross Contamination, an Albertson, NY-based patient watchdog group. Of those procedures, as many as 2.7 percent – about 270,000 a year — result in cross-contamination due to nonsterile endoscopes, CACC says. The margin for error is small indeed.

There are a litany of common diseases that can be transmitted through endoscopic cross-contamination, including hepatitis B and C, tuberculosis, salmonella, human papoloma virus, pseudomanus aeroginosa, flu viruses and other common bacteria. HIV, E. coli and Creutzfeldt-Jakob disease can possibly be contracted through flawed endoscopic procedures, the group says.

Flexible endoscopes are rife with valves and joints that are virtually impossible to reach, and some channels are two- to six feet long and only a few millimeters wide. Says Holliday, “A lot of times it’s difficult to clean the instruments. We have tools in decontamination, like brushes that we can put through the lumens and ports we can run water through. We also do a leak test on the flexible endoscopes to make sure there are no holes or any air coming out of the chamber.”

Times are tough
“I’m hearing a lot about the demand for instrument turnaround. Hospitals that are reprocessing with a 20-minute glutaraldehyde soak face significant demand to reduce that time even more,” says Lawrence Muscarella, Ph.D., an infection control expert with Custom Ultrasonics Inc., Ivyland, PA. Cidex OPA has helped hospitals reduce the time to 12 minutes. But even 12 minutes can be too slow, he says. A recently released “elevated glutaraldehyde product,” Muscarella says, can cut that time even shorter – to as short as five minutes at an elevated temperature of 95 degrees Celsius. Glutaraldehyde is usually set at approximately 20 to 25 degrees Celsius for reprocessing, he says.

“When staff is faced with getting quick turnaround, these germicides look good. Even for an endoscopy unit that’s reprocessing in the next room, cutting that time can really produce money for the facility – they’re turning around more patients, especially in procedures like a GI endoscopy,” Muscarella says. “Can these few minutes make a difference? Yes. The hospital doesn’t have to buy more instruments and the facility can be more profitable.”

Caution with chemicals
Muscarella cautions that while products like Cidex OPA are purportedly less dangerous than glutaraldehyde, hospital staff should remain mindful of precautionary measures. “There is the potential for the staff to have a false sense of security,” he says. “The users don’t feel as much irritation, and we’re not finding the problems with vapors. But I’m wondering if there’s a sleeping snake there waiting to wake up and bite. I have said to treat Cidex OPA like it’s glutaraldehyde – you don’t smell carbon monoxide either.”

Heating an already toxic chemical like glutaraldehyde can compound the effects of the noxious vapors, Muscarella warns.

Taurasi agrees. Misunderstanding or misusing such chemical disinfectants compromise the product’s effectiveness or, worse, the safety of staff reprocessing the instruments. “There is sometimes a lack of understanding to a lot of these products and the appropriate use of them. The claims that some have can be misleading or misinterpreted,” he explains. “For instance, a product might say it’s both a disinfectant and a cleaning agent. But if you read the fine print, that doesn’t mean you can eliminate the cleaning process before the instrument is disinfected. In most instances, you would have to apply the product twice – once as a cleaning agent and again at the prescribed [soak] time for the disinfectant. It’s not a magical, wipe-off, quick fix-it-all.”

He stresses that staff must carefully read instructions regarding any chemical disinfectant, and follow the manufacturer’s recommendations to the letter. “It is imperative that people follow the chemical manufacturer’s recommendations completely,” Taurasi says. “And to also remember that the heating of any chemicals, unless there are precise instructions for monitoring that process, can be extremely hazardous to employees.”

Break it, buy it
“Another challenge we face is the care and handling of the endoscopes. The end users don’t take care of them and the scopes break, get crushed or are bent,” says Holliday. “Once that happens, because of the fiber optics inside the scopes, we have to send them out for repair. Linked with that is the financial challenge – the scopes cost anywhere from $3,000 to $6,000 to get fixed. Some are sent out so often, we have to weigh if it’s more feasible to purchase a new one.”

Richard Schule, who is manager of surgical processing at The Cleveland Clinic Foundation, faces similar issues. “In our case, it’s not only the end users but the people reprocessing as well. It’s a shared responsibility,” Schule says. “Just the other day, we had a scope come in where a stainless steel base and wire were stacked on top of the scope. Sometimes when we get the flexible scopes back, they’re coiled up in a spaghetti mess.”

It’s the policy at Cleveland Clinic to track the damaged scope back to the department in question and reeducate the perioperative staff or surgical techs who broke down the case, Schule says. “We’ll take pictures of the scope and contact the nurse manager in charge of service,” he explains. “It takes a lot of education.”

Schule expects to have in place this year a project that will track how and why scopes are damaged, and break down the repair costs for analysis. “Communication and working as a team are key to taking care of those issues,” he says. 

HPN

April