The French Health Products Safety Agency (AFSSAPS) has approved Advanced Sterilization Products’ (ASP) low-temperature hydrogen peroxide gas plasma Sterrad NX and Sterrad 100NX sterilization systems for the total inactivation of prions.
Prions, which are protein-based infectious agents, cause neurodegenerative brain diseases characterised by the formation of ‘holes’ in brain tissue. They are resistant to the commonly used procedures for inactivating them, and until recently, only the most severe sterilisation processes had been effective.
“The effectiveness of low-temperature Sterrad technology against the prion threat confirmed that it is possible to eliminate these deadly pathogens while helping to preserve the integrity of medical devices, including heat-sensitive surgical instruments,” said Dr Pascal Clayette of SPI-BIO in France. “This is a great milestone for healthcare facilities which use an increasing number of sophisticated and costly surgical instruments and for patients who demand the most stringent infection prevention practices.”
Following a number of in vivo and in vitro studies conducted on behalf of US-based ASP by two independent laboratories in France and Germany, the Sterrad NX Advanced Cycle and Sterrad 100NX System Flex and Standard Cycles successfully provided prion inactivation and proved to be more effective than steam sterilisation at 134˚C for 18min, which is the steam cycle recommended by the World Health Organization.
“This new approval by the French Health Products Safety Agency is a significant benefit for customers and patients alike,” said Chuck Austin, worldwide president of ASP.