|Screenshot courtesy of Langford IC Systems|
Upstart Langford IC Systems claims that it's launching the only system that meets FDA standards for reprocessed medical device cleanliness. Its first buyer is the Ronald Reagan UCLA Medical Center in Los Angeles, which reported two patient deaths and several infections earlier this year due to insufficiently disinfected duodenoscopes, which are a type of endoscope for examining the duodenum.
Langford expects to commercialize its device, which it developed in partnership with medical device consultancy Proven Process, more widely soon.
The FDA held a committee meeting in May to examine the required disinfection processes, which have proven inadequate and resulted in years of patient infections. Earlier this year, the agency said it had disclosed that it has received at least 142 reports of duodenoscope-related patient infections since 2010.
The UCLA Medical Center had previously said that it was purchasing enough extra duodenoscopes that it could take sufficient time to sterilize them, rather than just meet the inadequate disinfection standards.
Langford said that its new device meets improved FDA standards of cleanliness, which requires elimination of all but 6.4 mcg of protein per centimeter squared (6.4 mcg/cm2). It said that no other cleaning machine meets that cleanliness without extensive additional procedures, but that its own has shown to leave an average leftover residue of 2.5 mcg/cm2 and in some cases lower than 1 mcg/cm2.
Unlike other disinfection machines, Langford's uses no connectors and it also both pushes and pulls disinfectant fluids at high velocity to thoroughly clean endoscope surfaces. Reprocessing devices are typically cleaned with a one-way flow and pressure level that may not be sufficient.
"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," Ken Fine, president and co-founder of Proven Process, said 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."
- here is the release