Endoscopes are contradictions. Designed to simplify surgical procedures, the instruments themselves are complex. They look sturdy—blame the stainless steel body—but they are actually as delicate as the thin glass rods found inside. This means breakage is just as likely to occur—perhaps even more so—when they are not being used for a procedure. “One of the big problems in hospitals is damage to the scopes that occurs somewhere between the end of [one] surgery and the start of the next one. Often, it’s not discovered until the scope has already been inserted into the patient,” says Dennis Leiner, PhD, president of Lighthouse Imaging Corp, Portland, Me.

Because of the fragile nature of endoscopes, damage occurs easily, and repairs can be expensive. Everyone who handles them must do so with care. Unfortunately, that includes a lot of people. Endoscopes are surgical instruments and will pass through the hands of nurses, surgical teams (surgeons, physician assistants, etc), professionals in postprocessing and sterilization, transport, and biomeds.

Biomeds are often responsible for the preventive and corrective maintenance of these instruments, meaning they are called whenever anything goes wrong. Because parts and expertise are difficult to obtain (systems are frequently proprietary and well-protected by manufacturers), many biomeds find they are most effective when they focus on preventive maintenance (PM).

Sterilization methods are guided by the manufacturer’s recommendations and include units that use chemicals to sterilize flexible endoscopes that cannot be autoclaved.

This means not only regular inspections but also ongoing user education. The more biomeds can inform their colleagues about the instruments and their proper care, the more damage can be prevented, resulting in better patient care and less cost. This is as true for those who use the system as those who clean it.

Cleaning Up an Act

Geoffrey Smith, CBET, a BMET II at Universal Hospital Services, Eenah, Wis, has spent the last 5 years studying sterilization procedures in addition to managing his biomed responsibilities. He has measured the impact of sterilization processes on patient care and budget and found that it can be significant.

“We had been using a peracetic acid system for sterilization but were finding a spider web–like material on the endoscopes,” Smith says. Research uncovered that the mystery matter was the end product of a reaction between the peracetic acid and a human bowel protein. So the facility decided to try an automatic endoscope reprocessor (AER), which uses a different sterilant, OPA, or orthophthalaldehyde. “The peracetic acid system is a good system, which is still used to clean uteroscopes, but not endoscopes,” Smith says.

Critics claim the AER is not ideal since it merely “highly disinfects” rather than “sterilizes.” Sterilization standards defined by the Association for the Advancement of Medical Instrumentation (AAMI, Arlington, Va) set the rate limit of microbial survival to less than 1 in 1 million, according to David Stiles, CBET, manager of biomedical engineering at Long Beach Memorial Medical Center, Long Beach, Calif.

However, Smith suggests that in 90% of cross-infection cases, the cause is generally poor preprocessing rather than ineffective disinfection/sterilization. Preprocessing refers to the immediate postsurgical cleaning, when debris and the majority of bacteria are removed from the endoscope. “Preprocessing can get 90% of the bacteria out,” Smith says. Even if the new AERs do not get every last bacterium in that last 10%, his facility has experienced no problems with cross infection since the new reprocessors were installed.

In addition, money spent on repairs has decreased significantly, more than 75%, from $60,000 to $13,000. “The OPA solution is more gentle on the scopes. We have fewer problems with the sheets, bending rubbers, and image tubes,” Smith says.

A Clean Slate

Sterilization methods ultimately should be guided by the manufacturer’s recommendations, which will often include specifics on biocides, detergents, and processes. “It is important to consult and follow the endoscope manufacturers’ sterilization guidelines,” Stiles says. Methods include steam under pressure (such as autoclaving), dry heat, ethylene oxide gas (ETO), low-temperature hydrogen peroxide plasma, gluteraldehyde-based, and automated peracetic acid systems.

Setting Limits

Prevention is one way to reduce repair bills for endoscopes. Deborah Barker, vice president of sales and marketing at MedServ International Inc, Beltsville, Md, a third-party repair service, suggests another: a capitated program. “It works like an insurance program,” Barker says.

Facilities can purchase an annual contract for a negotiated price, which takes into account the inventory, and the vendor agrees to complete all repairs, even if the total sum rises above the agreed-upon amount. “We take on 100% of the risk,” she says.

Companies differ in the items they will include in a contract, and no two contracts are alike. MedServ offers all-inclusive agreements, meaning that even endoscopes damaged by user error are repaired within the capitation program. Other terms may address turnaround times, preventive maintenance, and in-house loaners.

Barker notes the company has seen its biggest growth occurring in this category. “Facilities no longer have to worry about fluctuations in their budget in any given fiscal year,” Barker says.

Naturally, automated systems permit greater efficiency since they typically handle multiple tasks such as cleaning and drying, but there is no one method that dominates the industry. “There really isn’t a gold standard at this time,” says Robert Purtell, director of business development for Mobile Instrument Service and Repair in Bellefontaine, Ohio.

Autoclaving might have been the gold standard—if endoscopes could withstand the heat and pressure—but until recently, few could. Potential damage includes irreversible fogging of the optics and misalignment of the lens. Horror stories exist in which multiple endoscopes have been damaged during one run in the autoclave because one staff member didn’t know the scopes should not go in there.

“Autoclaving would be best for hospitals because they can sterilize endoscopes along with other instrumentation, but autoclaving is hard on the optics,” Leiner says.

Technological advances have permitted progress in this area. “Only in the past few years have the majority of rigid scopes become autoclavable,” Leiner says. Flexible scopes will be next.

Purtell notes that a fully autoclavable flexible endoscope was recently introduced. “I would expect other OEMs to follow suit,” he says.

Come Clean

Whatever method of disinfection and/or sterilization is used, preprocessing is required. “Because of the many channels and orifices present in endoscopes, improper precleaning and flushing of the scopes could result in debris remaining in the devices. The potential of foreign body introduction in subsequent cases is a possibility,” Stiles says. Immediately following surgery, endoscopes should be thoroughly cleaned to remove blood, tissue, and other secretions before they dry and become more difficult to wash away.

This is accomplished with flushing and brushing. The channels are flushed with detergent—often an enzymatic solution—and air to remove debris and microorganisms. Brushes are then run through to eliminate what remains. The process is specific, and manufacturer guidelines indicate the materials that should be used and accessories that must be employed or removed. “This is needed to ensure proper distribution of disinfectant, rinse, and cycling processes,” Stiles says.

The manufacturer often supplies the brushes for this purpose as well. The brushes are designed to fit perfectly and can clean the scope without damaging it. They may be single use or sterilizable, but if worn or kinked, they should be abandoned to avoid damage to the instrument. Brushes for use on the outside of the instrument are not so specific, but should also be used with care. The Gastroenterological Nurses College of Australia Inc (GENCA) recommends soft toothbrushes for the distal tip and grooved control handles.

Smith has encountered situations where the usual procedure was not enough to remove debris and clean the scope completely. He recalls one instance when six brushes were used and the scope was still not clean. An investigation revealed that the patient had eaten legumes (beans, peas, and lentils) the night before; the same situation occurred with patients who consumed Olestra products, such as Wow potato chips.

“A protein in the matter caused it to stick to the channel, making the endoscope difficult to get clean,” Smith says. He turned to the manufacturer, who recommended running one brush back and forth lightly with soap and then following with one more brush pulled through. It worked. “If you don’t clean the scope properly, you’re doing the next patient a disservice,” Smith says.

Purtell concurs, “Cross-contamination is the most significant problem that occurs if a scope is not cleaned properly. Improperly cleaned equipment can cause harm to the next patient,” Smith says.

A Clean Break

Improper cleaning can also cause harm to the scope itself. “The most significant damage from improper cleaning is fluid invasion,” Purtell says.

Fluid can invade the scope through an opening that should have been capped or through a leak, such as a hole, tear, or crack in the scope’s outer housings. Once in the scope, liquid can cause expensive damage to electronic components, fiber bundles, and steel components; it also increases the risk of cross infection. Thorough inspections can catch these openings and thereby avoid the related damage.

“We implemented PM measures within processing and sterilization to reduce damage,” Smith says. Recommendations include wrapping the scopes (“They can’t just be tossed around,” Smith says) and close inspections during cleaning. “We found the majority of breaks on the bending rubber, and so instructed the processing professionals to check that carefully,” he adds.

The program has been working. Recently, one staffer noticed an abrasion on the bending rubber and called Smith to follow up. “We sterilized the scope by hand to make sure the break wasn’t open and discovered that it was, so we sent it to the manufacturer for repair. It cost $120. Had the scope gone through cleaning [resulting in fluid invasion], the repair would have been $3,300,” Smith says.

Leak testing is a more direct form of checking for breaks and is recommended before submerging an endoscope. Both GENCA and the Society of Gastroenterology Nurses and Associates Inc recommend strongly that users follow the manufacturer’s instructions for leak testing.

Squeaky Clean

Leak testing is beneficial in that it helps to detect damage before significant harm is done to either the patient or the scope. Leiner believes endoscopes need more regular testing and feels that too often the endoscope has been reprocessed, is wrapped and ready to go, but may actually be broken. “No one knows until the doctor places it in the patient’s body and can’t see properly,” Leiner says. This introduces a host of problems, including patient safety, backup availability, rescheduling issues, and increased cost.

“It’s my opinion that many biomeds don’t get involved with endoscopes because they don’t have any tools to measure or troubleshoot,” Leiner says. Leak testing is one tool, but it is more useful in preventing damage than identifying it.

A new tool from Sonora Medical Products Inc, Longmont, Colo, (pictured at right) can help in this regard. The Firefly is a handheld instrument designed to measure the luminous radiation of standard medical endoscopic light sources, fiber optic cables, and endoscopes. It features an integrating sphere, light meter, and adapters for common endoscopic equipment. “It’s really hard with the human eye to tell whether a light source is bright enough. There has been no way to quantify it, so it’s often left up to the surgeon to identify a problem. And then it’s too late and the physician gets cranky,” Leiner says.

Although angry doctors are a challenge for biomeds, Leiner says he understands that they have a procedure to perform that impacts someone’s health, and it is not unreasonable for them to want and expect the equipment to work.

For more information on endoscopes, see the October 2006 article, “Protecting Your Endoscope Investment.”

Regular checks of the scopes, as often as every 1 to 3 months, are intended to catch problems before they manifest during surgery. That still may not be enough. Because there are so many opportunities for damage and because endoscopes are in such great demand, problems are sometimes diagnosed by the surgeon before the biomed. And so much comes down to user training.

“Teamwork is key to reducing damage,” Smith says. He spent time in preprocessing to see how the department cleaned scopes and worked with them to enhance inspections and identify early damage. “They would notice the little things and call me, and we saved thousands of dollars in repair,” he says, proving that providing a clean bill of health for endoscopes need not come with a large repair bill.

Renee DiIulio is a contributing writer for  24×7. For more information, contact .