Case Medical is pleased to announce that it was awarded a U.S. patent for “compositions and methods for handling potential prion contamination.” The patent is a significant step toward commercializing cleaning products that will enable potential prion contaminated devices and surfaces, such as surgical instruments and implements used in the food processing industry, to be processed without resorting to the extraordinary methods required today.
Collaboration and research
Case Medical collaborated with the US Geological Service’s (USGS) National Wildlife Health Center on a multi-year Chronic Wasting Disease research project to help manage and mitigate the effect of CWD on wildlife. Case Medical joined the project with three patient safety focused goals in mind:
- First, determine whether enzymatic cleaners can be antimicrobial and show potential for inactivating even the most challenging infectious agent—prions.
- Second, as a U.S. EPA Safer Choice partner, our mission is to develop a formulation and process that is sustainable, biodegradable, and meets the requirements for safer chemistries.
- Third, the resulting process is intended to fit within everyday decontamination and cleaning protocols.
In collaboration with USGS, we tested various solutions based on our current enzymatic formulations to understand their effect on infectious prions. Results demonstrated degradation of prions under certain process parameters, including increased contact time, water quality, and temperature.
Currently, prion contaminated materials are either incinerated or pre-treated with sodium hypochlorite, extended sterilization cycles, oxidizing agents, peracetic acid, or pre-treatment at temperatures above 100°C for extended periods of time. These methods and materials are not environmentally friendly and are excessively corrosive to the materials being treated.
In contrast, the cleaning solution patented by Case Medical uses a multi-enzymatic formulation to achieve a safer, more thorough result and requires much less time and effort, suggesting a feasible process for healthcare settings and the food processing industry.
Prion diseases and prevalence
Prion diseases are fatal, transmissible neurological diseases characterized by the abnormal folding of prion proteins, found primarily in the brain and central nervous system. Examples of diseases caused by prions are Creutzfeldt-Jakob Disease in humans and Chronic Wasting Disease in the deer family (cervids). CWD has been confirmed in at least 26 U.S. states, three Canadian provinces, with a notable increase in the past 5 years. In heavily affected areas of Wyoming, Colorado, and Wisconsin, more than 40% of free-ranging cervids are infected.
We have much to learn about prion diseases, but we do know they can be spread from animals to humans by eating meat from infected animals. They can also be transmitted through medical procedures via contaminated human growth hormone, dura mater, and corneal grafts or neurosurgery procedures with instruments previously used on someone with an undetected prion disease.
Healthcare challenges and infection prevention
Unlike viruses, bacteria, and fungi, these abnormal proteins are highly resistant to typical methods of surgical instrument processing. That is why it is so important to continue searching for new ways to combat the spread of these diseases.
“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 Marcia Frieze, CEO of Case Medical. “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.”
With evidence that enzymatic cleaners can degrade prion protein in lab tests, there is potential for a new approach. Case Medical is continuing to work through the many regulatory steps required to fully commercialize this product and process.