ASP Sterrad Technology Approved by AFSSAPS for Total Inactivation of Prions
By Advanced Sterilization Products, PRNEMonday, April 26, 2010
French Health Products Safety Agency AFSSAPS Approves STERRAD(R) Hydrogen Peroxide Gas Plasma Technology for Total Inactivation of Protein-based Infectious Agents Linked to Fatal Brain Diseases
PARIS, April 27, 2010 - Advanced Sterilization Products (ASP) announced today that the French
Health Products Safety Agency, AFSSAPS, will approve the low-temperature
hydrogen peroxide gas plasma STERRAD(R) NX(TM) and the STERRAD(R) 100NX(TM)
Sterilization Systems for total inactivation of prions.
Prions, which are protein-based infectious agents, cause
neurodegenerative brain diseases characterized by the formation of "holes" in
brain tissue. Prions are highly resistant to the commonly used procedures for
inactivating them, and until recently, only the most severe sterilization
processes had been proven effective.
"The effectiveness of low-temperature STERRAD(R) technology against the
prion threat confirmed that 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, SPI-BIO, CEA,
Fontenay-aux-Roses, France. "This is a great milestone for healthcare
facilities who 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
ASP by two independent laboratories in France and Germany, the STERRAD(R)
NX(TM) Advanced Cycle and STERRAD(R) 100NX(TM) System Flex and Standard
Cycles successfully provided prion inactivation and proved to be more
effective on the prion threat than steam sterilization at 134degrees C for 18
minutes, which is the steam cycle recommended by the World Health
Organization.
"The AFSSAPS approval of STERRAD(R) System sterilization technology for
total inactivation of prions is another example of ASP's commitment to
developing innovative infection prevention solutions that help raise the
standards of care," said Chuck Austin, WW President of ASP. "STERRAD(R)
Sterilization Systems are used by thousands of healthcare facilities across
the globe and this new approval by the French Health Products Safety Agency
is a significant benefit for customers and patients alike."
About STERRAD(R) Sterilization Systems
Engineered using ASP's breakthrough low-temperature gas plasma
technology, STERRAD(R) Sterilization Systems terminally sterilize surgical
instruments and medical devices safely and effectively, without the
limitations or risks associated with peracetic acid, steam, formaldehyde and
ethylene oxide gas systems. With thousands of units in use at hospitals and
healthcare facilities around the world, STERRAD(R) Sterilization Systems
produce a measurable return on hospital's sterilization investment by
reducing instrument repair costs, offering rapid cycles, reducing instrument
inventories and enhancing safety.
About Prion Diseases
Prion diseases, or proteinaceous infectious particle only agents, are
able to induce abnormal folding of normal cellular prion proteins in the
brain and can develop into neurodegenerative disorders including
Gerstmann-Straussler-Scheinker Syndrome, fatal familial insomnia and
Creutzfeldt-Jakob Disease (CJD) in humans. Such prion diseases can have long
asymptomatic incubation periods but will result in fatality in all cases.
Unlike infectious agents in other difficult-to-treat infectious diseases,
prions exhibit an unusually high level of resistance to common sterilization
methods and disinfection methods, including steam, and pose a threat to
infection prevention in healthcare facilities.
About the Data
ASP, through the use of several independent laboratories in France and
Germany produced a set of comprehensive studies on prion inactivation. 61
tests (41 in vivo and over 20 in vitro controls) evaluating and comparing
disinfection, washing and sterilization procedures were performed. In these
studies, the STERRAD(R) NX(TM) Advanced Cycle and STERRAD(R) 100NX(TM) System
Flex and Standard Cycles proved to be more effective in prion inactivation
than a steam cycle at 134degreesC, 18 minutes- a special optimized steam
cycle recommended by the World Health Organization against prions.
About Advanced Sterilization Products (ASP)
Advanced Sterilization Products (ASP), a Division of Ethicon, Inc., a
Johnson & Johnson company is a leading developer of innovative instrument
sterilization, high level disinfection and cleaning technologies. The company
is dedicated to protecting patients, healthcare workers, and the environment
with products that focus as much on safety as they do on efficacy and
cost-effectiveness. Utilizing advanced instrument processing technologies,
these products help customers to promote positive patient outcomes while
controlling costs, increasing productivity and enhancing safety. The company
is based in Irvine, California with offices around the world.
Media: ASP - UK Johnson & Johnson Media Relations Komel Bajwe APCO Worldwide +44(0)20-7526-3616 kbajwe@apcoworldwide.com
Media: ASP - UK Johnson & Johnson Media Relations, Komel Bajwe, APCO Worldwide, +44(0)20-7526-3616, kbajwe at apcoworldwide.com
Tags: Advanced Sterilization Products, April 27, France, Paris