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New Prion Decontamination System for Surgical Instruments Presented at Sterilising Meeting
Manchester, UK, 26 Oct 2007: Breakthroughs in prion decontamination and detection were presented at the Central Sterilising Club meeting, in Manchester this week, by Dr Graham Jackson, Head of Molecular Diagnostics at the Medical Research Council (MRC) Prion Unit and a consultant to D-Gen Ltd., an academic spin-out company whose founders include the MRC, Imperial College, the Wellcome Trust and the University of Bristol, in addition to founder inventors.
Developed through a collaboration between D-Gen and DuPont, Rely+On (TM) Prevention Solutions, the new prion disinfectant Rely+On (TM) Prion Inactivator will significantly and rapidly reduce the potential risk of variant CJD (vCJD) transmission via surgical instruments and medical devices in UK hospitals with a convenient single-step, pH neutral, 10-minute pre-soak procedure.
Launched this week, Rely+On (TM) Prion Inactivator provides hospital sterilisation units with a truly effective treatment for sterilisation-resistant prions in an easy-to-use format. The remarkable efficacy of Rely+On (TM) Prion Inactivator means that an equivalent of a 1,000,000 fold reduction in prion infectivity could be achieved on surgical instruments. This equates directly to a potential reduction in the risk of accidental transmission of vCJD of up to a 1,000,000 fold.
The need for an effective prion decontamination method has become a formidable public health challenge. Recent NICE Guidance and a CMO letter have emphasised the DoH’s concerns for the potential of secondary vCJD infections occurring in the NHS. CNS and posterior eye surgery carry the greatest risk of infectivity although individuals silently carrying vCJD infection are known to harbour infectivity in a range of so-called lymphoreticular tissues which are present all over the body. A recent DoH survey of hospital SSD units showed that despite carrying out full decontamination and sterilisation procedures, surgical instruments retain relatively large amounts of residual protein. Prion proteins bind avidly to steel and such steel surfaces are known to be still infectious after conventional sterilisation and decontamination procedures.
Of most concern, infective prions can resist both extensive autoclaving and treatment with formaldehyde and alcohol. In one notable case, an accidental transmission of CJD occurred via an EEG brain electrode confirming that prions retain infectivity even after numerous routine sterilisation procedures.
Groundbreaking work at the MRC Prion Unit, directed by Professor John Collinge, and funded by the UK Department of Health, led to the development of novel enzymatic methods to destroy prions on metal surfaces1. This laboratory research work has now been developed into a practical system for easy use in hospitals in a collaboration between D-Gen and DuPont.
Dr Jackson presented the new data on Rely+On (TM) Prion Inactivator and a new Cell Bioassay developed in collaboration by D-Gen and the MRC Prion Unit for the assessment of prion decontamination/infectivity. The new Cell Bioassay uses prions sourced from the RML strain which are more resistant to proteolytic enzymes than vCJD prions and therefore a more stringent model for the assessment of enzymatic decontamination methods.
D-Gen’s extensive assessment of Rely+On (TM) Prion Inactivator and various experimental formulations using the new highly sensitive Cell Bioassay demonstrated that two proteolytic enzymes are most effective at prion destruction. Dr Jackson will present data demonstrating that the new Cell Bioassay is 100 times more sensitive than the previous gold standard mouse bioassay which has the added disadvantage of taking more than four months to complete.
Commenting on the Rely+On (TM) Prion Inactivator launch, the Technical Director at DuPont, Dr Vince Croud explains, “With activity against prions and conventional microbial pathogens, plus the key advantage of the single-step procedure, the new product is formulated to provide good instrument compatibility having a neutral pH, a reasonably low temperature of use and a short contact time.
We are delighted that Rely+On (TM) Prion Inactivator has been developed and tested under such exacting conditions by D-Gen and DuPont. Under normal in-use conditions the new Cell Bioassay has confirmed that Rely+On (TM) Prion Inactivator will reduce protease-resistant RML prions and the risk of accidental transmission of vCJD by more than 1,000,000 fold. The public health benefits of using Rely+On (TM) Prion Inactivator will result in a quantifiable and significant reduction in the risk of accidental transmission of vCJD.”
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