Instrument Cleaning Inconsistent, but Crucial

Cleaning instruments properly so they don’t transmit infections to patients is clearly an important component in the practice of otolaryngology, but how this cleaning is done remains open to question. Oversights can lead to harm, but some measures can be pointless and wasteful. A panel of experts discussed instrument cleaning at the Triological Society Combined Sections Meeting in January 2017, bringing big-picture considerations into focus while discussing their own experiences.

Moderator Natasha Mirza, MD, director of the University of Pennsylvania Penn Voice and Swallowing Center in Philadelphia, said that what she learned as she prepared for the panel was eye-opening. “Most of the data is more than 10 or 15 years old, and it’s been done in a very disparate way all over the country, whether we are trying to be in compliance with our hospital policies or in clinics,” she said. “Everything’s done in a very different way, which isn’t good for us, or for our patients.”

In 2015, researchers at Mayo Clinic in Rochester, Minn., found that viable microbes were collected from 64% of flexible endoscopes after high-level disinfection, even though the researchers observed the cleaning process and saw that guidelines were followed (Am J Infect Control. 2015;43:794–801). Dr. Mirza said it was important to note that the study pertained to gastroscopes and colonoscopes, not non-channel scopes used in otolaryngology.

The following month, the Centers for Disease Control issued an advisory on an “immediate need” for healthcare facilities to review their procedures for cleaning, disinfecting, and sterilizing equipment.

Dr. Mirza said that the risk of infection from an endoscope is just one in 1.8 million, a number she calls “extremely, extremely low.” There is potential for an infection, she added, but noted that some measures, such as excessive use of peel packs, can be a significant waste of time and resources.

Biofilm

Julio Figueroa, MD, acting chief of infectious diseases at Louisiana State University in New Orleans, drew particular attention to biofilm, the glue organisms make to stick to instruments. “That’s one of the reasons it’s important to disinfect,” he said. “Even though they might look clean, you might have this biofilm to deal with.” The endoscope, with its hooks and joints, is full of “nooks and crannies and crevices” from which it can be difficult to remove biofilm.

When facilities are found to be noncompliant, commonly cited problems are a lack of knowledge of procedures, a process that is not well defined or is not followed, and a poor design of the sterilization space, which needs to include a “dirty” area and a “clean” area where instruments dry.

Overkill

Soly Baredes, MD, chair of otolaryngology-head and neck surgery at Rutgers New Jersey Medical School in Newark, N.J., said literature on the cleaning of instruments is sparse in otolaryngology, but one in vitro study suggests that general recommendations might be more aggressive than needed.

When instruments are cleaned with the most commonly used disinfectant, ortho-phthalaldehyde (OPA), they’re supposed to be used for a minimum of 12 minutes. But in a 2012 study in which flexible endoscopes were contaminated with S. aureus and Candida albicans and then cleaned in a variety of ways, researchers found that even a 30-second scrub with OPA and isopropyl alcohol eliminated all of the staph and Candida (Arch Otolaryngol Head Neck Surg. 2012;138:119–121).

At his center, he said, cleaning practices vary, depending on the unit. But at the main hospital, he said, one of the key parts of the process—which also includes passing cleaned parts through a small window to the “clean” area for drying—is the enzymatic wash that’s done immediately after use. “This is probably, in my view, the most important part of the whole process,” he said. “This is how you eliminate the bio-burden.”

State and Federal Regulations

Sigsbee Duck, MD, an otolaryngologist at Memorial Hospital of Sweetwater County in Rock Springs, Wyo., said his research into the oversight of instrument cleaning across states found that centers generally follow manufacturer recommendations, often with government hoops involved.

In New York, some practices have “Article 28” status, which gives them higher reimbursement after they’ve gone through a rigorous, complex process of certification. But, in the end, this designation doesn’t appear to mean much in terms of how instruments are cleaned, he said. “When you get through all the layers, it depends on the facility as to how you sterilize your scope,” he added. “You either use manufacturers’ recommendations or you use gas sterilization.”

In California, Title 22 is used on a state level in conjunction with federal regulations. In the end, he found, centers tend to simply follow manufacturers’ recommendations. But at Stanford, where instruments used to be sterilized in house, university policy dictates that couriers pick up scopes needing to be cleaned and then return them to the center, a process Dr. Duck said was described to him as “very costly.”

In Wyoming, as everywhere, a policy for instrument cleaning is required by the Joint Commission. Dr. Duck’s center follows the standard four-step method of clean-disinfect-rinse-dry. Essentially, they’re just following manufacturers’ recommendations, he said. “Everybody does the same thing but in a different way,” Dr. Duck said.

OSHA

Will Harrill, MD, president and CEO of Carolina Ear, Nose and Throat in Hickory, N.C., said his experience in private practice is a lot different than those found in hospitals regulated by the Joint Commission. As an employer, the clinic is overseen by the Occupational Safety and Health Administration (OSHA). Every year, his center performs a mock OSHA inspection because “that’s the standard of care we believe in.”

He said they’ve recently decided to invite OSHA to their campuses. This approach fosters a better relationship with the agency and is a chance to “clean up what you’re not doing right.”

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Thomas Collins is a freelance medical writer based in Florida.