A startup company in Arizona claims its washer may be the solution to preventing more deadly duodenoscope infections.
While most automated endoscope reprocessors push liquid one-way through scopes, Langford says its machine forcefully moves water and detergent back and forth through endoscopes thousands of times. This dislodges debris hidden behind curves and crevices, says the company.
The device is making its debut at the UCLA Ronald Reagan Medical Center in Los Angeles, which is trialing the washer as an adjunct to its duodenoscope reprocessing.
After its outbreak of scope-related CRE infections last year, UCLA began sterilizing its reusable duodenoscopes with ethylene-oxide gas. But, ridding the hard-to-clean scopes of debris — which caused the outbreak in the first place — still posed a problem. The hospital says adding the Langford machine to its reprocessing could be the solution.
The powerful 2-way force of the liquid is enough to clean the scopes on its own without manual cleaning or additional steps, Langford claims. While the FDA standards of cleanliness require elimination of all but 6.4 mcg of protein per centimeter squared, the new machine leaves an average leftover residue of 2.5mcg/cm2, and can even get as low as 1mcg/cm2. Following cleaning, the company says the scopes can be subjected to high-level disinfection, as required by the manufacturer.
Though the FDA first approved the washer in 2011, only recently has it been considered for endoscopes. The company says it can also be used for the sanitation of surgical instruments and implantable devices. According to the Los Angeles Times, there are no upfront capital costs for the washer. Instead, the company charges $35 each time it is used.
The device currently isn't on the market, but Langford — which partnered with medical device consultancy Proven Process to create the device — says that commercialization is "imminent."
"Partnering with Langford Systems, we applied all our engineering expertise and our experience with testing, validation/verification, and FDA approvals to bring the LIC machine to market," says Ken Fine, president and co-founder of Proven Process, in a statement. "Collaborating with Langford on this initiative is really exciting, because its deployment will drastically improve patient safety and reduce their risk of infection during medical procedures."