Case Medical (South Hackensack, N.J.) announced that it was awarded a U.S. patent for a cleaning solution designed to reprocess medical devices affected by prion contamination.
Prions are misfolded proteins that can cause unfolding in normal prion proteins most commonly found in the brain, but also in the spine, eye, spleen, and lymphoid tissues, according to Case. Prion diseases are described by the U.S. Centers for Disease Control and Prevention as “…a family of rare progressive neurodegenerative disorders that affect both humans and animals. They are distinguished by long incubation periods, characteristic spongiform changes associated with neuronal loss, and a failure to induce inflammatory response.” The CDC also indicates that “the abnormal folding of the prion proteins leads to brain damage… Prion diseases are usually rapidly progressive and always fatal.”
Prions are transmitted by the eating of meat infected with prions, but also in healthcare settings from blood transfusions and from medical devices, especially from surgical instruments, even from apparently cleaned devices, having residual prion contamination. The patent is a significant step for the company toward commercializing cleaning products that will enable prion contaminated devices and surfaces to be processed without resorting to the extraordinary methods required today, according to Case Medical.
“The challenge with prions is that they are almost impossible to detect before a fatal occurrence of the disease and they are also extremely hard to remove from contaminated devices and surfaces,” said company CEO Marcia Frieze in a news release. “The logical solution would be to make prion decontamination a standard part of medical device processing but the current options are extremely time-consuming and so harsh that they significantly reduce the useful life of the devices themselves.”
Currently, prion contaminated materials are either incinerated or pre-treated with sodium hypochlorite, sterilization, oxidizing agents, peracetic acid or pre-treatment at temperatures above 100°C for extended periods of time. These methods and materials are environmentally unfriendly and excessively corrosive to the materials being cleaned, the company said. The cleaning solution patented by Case Medical uses a multi-enzymatic formulation
Case Medical’s biodegradable formula uses specific enzymes combined with a surfactant. The enzymes effectively digest or inactivate prions, rendering them ineffective, and the surfactant lowers the level of friction to allow easy rinsing. The process is more thorough result and requires much less time and effort, suggesting a feasible process for healthcare settings and the food processing industry, the company said.
“While prion diseases are currently rare and a much bigger issue in Europe than in the U.S., the coronavirus pandemic has hopefully taught us the value of being prepared,” said Frieze. “We still have many regulatory steps before we can fully commercialize this product and process, but we are continuing to work as fast as we can.”
Testing and validation were performed in conjunction with the U.S. Geological Service (USGS) through their National Wildlife Health Center at the Class III prion lab in Madison, Wis.