Sterile processors continue to see contamination in lumens designated as clean, according to recent research.

Patient Safety

Exploring the World of Decontaminated Instruments, Up Close

“This is why they’re passionate about their inspection, because a tech who packages instruments for sterilization is held responsible for making sure that they’re clean and in good repair."

Why would sterile processors reprocess single-use suction tips?

Maybe because the metal devices looked like reusable instruments and not like something that should be discarded after one use.

But it was what the insides revealed that was even more troubling, according to experts.

When Dr. Jahan Azizi and his team at the University of Michigan cut open devices like bone shavers and suction tips with a band saw in 2012, they found a variety of contaminants inside.

Cori Ofstead, president and CEO of Ofstead & Associates Inc., decided to follow up with new research. So, more than a decade after those initial findings, she asked sterile processors a new round of questions about decontaminated instruments and discussed them in a YouTube video.

“We got an earful,” said Ofstead, who leads a multidisciplinary team that specializes in designing and conducting real-world studies to validate healthcare guidelines, treatments, and product claims.

In the new research, for example, sterile processing techs report finding contamination in lumens as often as once a day.

“This is why they’re passionate about their inspection, because a tech who packages instruments for sterilization is held responsible for making sure that they’re clean and in good repair,” Ofstead said.

Scrutiny was heightened starting in 2009, after seven patients in Texas were infected following joint surgery, Ofstead said. Bone shavers were found to contain tissue and brush bristles, prompting the FDA to call for routine inspection of lumens to make sure there is nothing inside them before sterilization.

That inspired Azizi and his team to pioneer the use of borescopes to look inside devices.

Currently, a variety of techniques are used to test for cleanliness including forced air, sterile water or alcohol, brushes, swabs, pipe cleaners and borescopes, Ofstead said.

Use of forced air for cleaning, however, concerns Ofstead. That’s because whatever is in the lumen gets aerosolized, and the instruments may also be damaged in the process. Using fluids to clean can result in splashing and aerosolization, can expose staff to contaminants and may not be effective.

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