Proven Process Medical Devices, a manufacturer of Class II and Class III medical devices, announced that its client, Langford IC Systems, has successfully launched a cleaning machine that significantly improves sanitation of surgical instruments, endoscopes and implantable devices. The new “LIC” machine will considerably reduce the probability of reusable medical devices spreading disease between patients in clinical settings.
Improvements were desperately needed. In February 2015, U.S. health officials issued a safety warning on a specialty endoscope that was linked to transmission of a drug-resistant superbug known as carbapenem-resistant Enterobacteriaceae (CRE). CRE infections contributed to the deaths of two patients at the Ronald Reagan UCLA Medical Center in Los Angeles who had undergone a procedure with this particular type of endoscope, known as the duodenoscope. Eleven patient deaths were also linked to CRE at Virginia Mason Medical Center in Seattle after duodenoscope procedures between 2012 and 2014.
In both cases, the hospitals were found to have cleaned the scopes properly, according to approved protocol. However, that protocol has proven insufficient to protect patient safety, due to inadequacies in the best available cleaning equipment.
The new device, invented by Langford IC Systems and developed in partnership with Proven Process, uses a different cleaning mechanism than medical device cleaning systems currently on the market.
Until now, endoscopes and other reusable medical devices have been cleaned in machines that push water and disinfectants through them at high pressure in a one-way flow, like using a garden hose. It is ineffective in eliminating all residues because the instruments’ geometries are complex, and the water did not push through all the curves and corners with sufficient force to scrub them clean. Any bacteria remaining can infect a patient undergoing a procedure where the instrument is reused, even after cleaning.
Langford’s new LIC cleaning device operates on a different basis. The only endoscope cleaner in the world that uses no connectors, it is engineered to generate a fluid dynamic that pushes and pulls fluid at fierce velocity, reversing direction thousands of times through the scope and its channels, inside and out. The LIC’s unique, patented technology creates a pressure-controlled, powerful mechanical shear that removes the toughest of soils from both the inside and outside of an instrument. The effect is a powerful scrubbing action on all of the endoscope’s surfaces, corners and crevices.
Testing of the LIC product has demonstrated performance far beyond anything achievable using currently available equipment. The FDA has developed a standard for acceptable levels of cleanliness (measured by the amount of protein left on surfaces after cleaning). The standard requires cleaning to eliminate all but 6.4 mcg of protein per centimeter squared (6.4 mcg/cm2). None of the machines currently available can achieve that level of cleanliness without extensive additional procedures. In validation studies for the FDA, the Langford machine reduced leftover residue to an average of 2.5 mcg/cm2 and in some cases lower than 1 mcg/cm2. No comparative equipment comes close.
Because of the recent “superbug” infections associated with duodenoscopes, the FDA now requires a new test protocol for processing duodenoscopes with the inoculum to be used in the testing changed from ATS to British soil. The British soil is considered by the FDA to be more difficult to remove and will present a greater challenge to the cleaning capability of the automated cleaning machines. A few of the manufacturers of Automated Endoscopic Reprocessors (AER) conceded their equipment could not meet this challenge but the LIC machine had no problem meeting and beating the cleaning endpoint of 6.4 mcg/cm2.
“Proven Process specializes in developing complex medical devices from concept to reality,” said Ken Fine, president and co-founder of Proven Process. “Partnering with Langford Systems, we applied all our engineering expertise and our experience with testing, verification and FDA approvals to bring the LIC machine to market. 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.”
The first, new LIC cleaning machine will ship to UCLA as soon as the hospital has installed the necessary utilities. Commercialization is imminent.
Proven Process Medical Devices
Langford IC Systems