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Medical advances make cleaning more complex

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Patient safety depends on properly cleaned, disinfected and sterilized medical instruments and devices — any slip-up can result in cross-contamination of patients.

It’s a critical and complex task, entrusted to sterile processing technicians who may be among the least educated and lowest-paid hospital employees. They can process as many as 15,000-20,000 surgical instruments in a day at a busy acute care hospital.

“You can see the numbers that you’re up against. You only need one that’s contaminated to go back up to the OR, and you suddenly have the risk of a patient infection or even worse,” said Jim Schneiter, president of America’s MedSource Inc., a Chicago-area company that designs and patents surgical instruments.

A contaminated instrument “is like a loaded gun in the OR,” Schneiter said, because of its potential to spread deadly pathogens. Yet employees can be tempted to skip steps in the cleaning process. Some instruments may be in short supply, putting pressure on technicians to turn the job around quickly.

The problems have become more common in the last 30 years, as operations became less invasive and tiny instruments such as laparoscopic tools became the norm, said Jahan Azizi, a retired clinical engineer for the University of Michigan Health System and an expert on cleaning instruments.

“Thirty or 40 years ago, you didn’t have (surgical instrument) cases with 400 pieces in them,” he said. “They have not hired people to keep up with the explosion in instrumentation.”

Donna Swenson, a Chicago-based sterile processing consultant, said tiny scopes, suction tips and other precise devices can take four hours to clean — and an understanding of science that was unnecessary years ago.

“The job requires a higher level of training and education than many hospitals require,” she said.

Even when carefully processed, some surgical instruments have been proven all but impossible to clean. Hospitals in Houston, Los Angeles and elsewhere have experienced outbreaks of deadly infections caused by antibiotic-resistant superbugs that lurk in the hollows and crevices of tiny scopes and complex devices.

Guidelines are voluntary

The CDC Guidelines for Disinfection and Sterilization in Hospitals, issued in 2008 by the federal Centers for Disease Control and Prevention, contains 158 pages of recommended best practices for cleaning, disinfecting and sterilizing surgical instruments.

The guidelines cover various processes of sterilization, which can include steam, dry heat, gas, hydrogen peroxide gas plasma and various chemicals. Sterilization destroys all forms of microbial life. There is also disinfection, which kills a majority of pathogens with the exception of disease-spreading spores. Disinfection can include pasteurization, ultraviolet radiation and a laundry list of disinfectant chemicals such as iodine, hydrogen peroxide and peracetic acid. The cleaning method chosen depends on the material the instrument is made of, whether it can survive high temperatures, and how quickly it is needed for the next surgery.

According to the guidelines, the cleaning process starts in the operating room, where instruments should be rinsed immediately after use by surgical technicians, assistants who help surgeons during operations.

“Cleaning begins the moment the instrument is taken from a surgeon’s hands,” Schneiter said. “The moment you put it in fluid that stops the coagulation process.”

Instruments are then sent to the hospital’s sterile processing department, where workers — known as sterile technicians — scrub away organic matter, called bioburden, and inorganic matter like sutures, using water and a detergent or an enzymatic cleaner.

Skipping this step can leave blood, bone, tissue or mucus to dry on the instruments, making it harder to remove. Biofilms, communities of microbes that attach stubbornly to instruments’ surfaces, can become resistant to disinfectants.

The instruments then have to be rinsed thoroughly because some detergents and enzymes can interfere with disinfection or sterilization. They should also be inspected and instruments with breaks, holes or cracks discarded or sent for repair.

“Once they have manually cleaned the instrument, the next step is to put it into an ultrasonic machine that uses ultra high frequency sound waves in a water bath, circulating at about 16,000 to 20,000 cycles per second,” Schneiter said, adding this step takes five to 10 minutes. “It’s a very high amplitude and has the effect of knocking everything off.”

Instruments are rinsed and arranged into surgical cases that often involve more than 400 tools. Then the trays are wrapped in a synthetic material that allows steam to penetrate, and loaded on carts to be rolled into a large industrial sterilizer. Inside the sterilizer, moisture is heated to 275 degrees Fahrenheit.

Superbug tied to dirty scope

Blood or tissue is easy to spot on a knife-like scalpel or a pair of scissors. But it’s difficult or even impossible to see inside the flexible tubes and scopes surgeons use to view inside the body or perform laparoscopic procedures.

A superbug outbreak at UCLA’s Ronald Reagan Medical Center early last year was tied to drug-resistant bacteria trapped inside Olympus duodenoscopes, which are threaded down patients’ throats to view inside the gastrointestinal tract.

Eight patients were infected, including three who died. Congressional hearings in April revealed at least 350 people at 41 hospitals in the United States and worldwide were infected by the devices. The scopes were recalled by Olympus.

Azizi was working for the University of Michigan Health System in 2009 when an outbreak at Houston Methodist Hospital in Texas was linked to arthroscopic shavers. University of Michigan Hospital was among a number of institutions that worked with the federal Food and Drug Administration to investigate the cause of the outbreak.

Azizi examined the arthroscopic shavers used at the Houston hospital. He cut them open and took photos of the inside.

Those were “full of gunk,” Azizi said.

He contends the tools can’t be cleaned.

Azizi described how he used a tiny camera to examine the insides of 350 reusable suction tips used to whisk away blood and fluids during surgeries. Magnifying the images revealed tiny ridges inside the hollow suction tubes. Invisible to the naked eye, the grooves were filled with blood, bone and debris.

“Anything ... that you can’t see with the naked eye may have the same problem, so there’s dried blood falling on that patient,” said Azizi, now director of regulatory affairs with HeartSync, an Ann Arbor-based manufacturer of defibrillation electrodes.

Schneiter, the instrument designer, said the FDA should require the industry to prove devices can be cleaned and provide instructions on how to clean and properly sterilize those instruments before being allowed to sell them to health care providers.

“People go into the hospital expecting to get better, not worse,” Schneiter said. “They expect to have whatever the problem is taken care of surgically, and not come out worse off than when they went in.”

kbouffard@detroitnews.com

jkurth@detroitnews.com

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