Several safeguards exist to minimize the risk of introducing bovine-derived xenographic materials with bovine spongiform encephalopathy (BSE) prions to medical devices. The safeguards range from geographic locations to validation protocols.
Considering Geographic BSE Risk is certainly a simple safeguard. GBR was established based on a calculation of the risk of BSE in certain geographic areas. Countries that have had major breakouts of BSE receive the lowest rating, and those that have not had any breakouts receive the highest (GBR 1).
However, GBR makes no differentiation between open and closed herds. It takes no account of any other quality, safety or handling issues. GBR is simply a matter of place.
At Prather Ranch, the cattle herds have been closed for generations. The handling protocols, traceability procedures, feed and water sources and every other aspect of the ranch is geared toward raising healthy, wholesome, humanely treated cattle that yield materials of optimum quality and safety.
The ANSI/AAMI/ISO 22442-2 standard establishes the requirements of a closed herd for sourcing xenographic materials. When it comes to safeguards, a closed herd is far more important – and far more reliable – than a geographic location.
What’s more, Prather Ranch goes beyond industry standards and requirements – even beyond ISO 22442-2. Above “certified fit for human consumption.” Well past geography.
The entire operation is dedicated to safety and quality – and to the peace of mind of the clients and the people around the world who benefit from their medical devices.