RSDL General Technical Presentation Presented by: Larry Sproat - - PowerPoint PPT Presentation

RSDL – General Technical Presentation

Presented by: Larry Sproat

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This amount of VX is enough to Kill a normal 77 kg man

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RSDL – The Product

Liquid skin decontaminant that removes or neutralizes all known traditional CW agents:

 GA(Tabun), GB(Sarin), GD(Soman, and GF(Cyclohexyl Sarin)  VX, and VR(Nerve Agent)  HD(Mustard)  T2-Toxin

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Reactive Skin Decontamination Lotion (RSDL)

 Selected as Increment 1, Dec 2004  Approved by FDA as 510(k) predicate device  Milestone C approved 23 Mar 07  Used by US DoD and Major NATO Military agencies  Tested as Effective in Decontaminating or Removing all CW Agents in less than 2 minutes  Approved as safe to use on the Skin by the US FDA, European Union CE Mark, and Australian TGA

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RSDL – The Product

 Only product on the market with clearance as a Medical Device from all three Regulatory Bodies: FDA, EU (MHRA) and Australian TGA.

 Clearance supported by complete Efficacy, Safety, and Toxicity studies

 Active ingredient is potassium 2,3-butanedione monoximate (KBDO).  Decontamination is achieved through removal, hydrolysis and nucleophilic displacement.

 Removal is enhanced by the scrubbing action of the foam applicator.

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List of Test Facilities

 Domestic (USA) independent laboratories and Government entities:

 Battelle Memorial Institute of Research  Hill Top Research Inc.  Southern Research Institute  US Army Edgewood Chemical and Biological Center (ECBC)  US Army Medical Research Institute of Chemical Defense (USAMRICD)  US Department of Energy – Lawrence Livermore National Laboratory  Walter Reed Army Institute of Research, USA Medical Research Institute of Chemical Defense

 International test facilities (list includes but not limited to):

 Canadian Department of National Defence: Defence Research and Development Canada – Suffield (DRDC-S)  TNO Prins Maurits Laboratory; Defense Chemical Biological Laboratory; The Netherlands  FOI Defense Chemical Biological Laboratory; Sweden  Forsvarets Forsknings Instiyutt (FFI); Norwegian Defence Research Establishment; Division for Protection (V)  Defence Science and Technology (DSTA); Singapore

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Product History

RSDL is Licensed to O’Dell Engineering who teams up with EZEM Inc. for GMP manufacturing

Canadian Department

• f Defence

Develops RSDL

RSDL is fielded in Canada and some other EU countries RSDL deployed with Canadian troops to Gulf war RSDL is down- selected as the replacement for M291 by US DoD (Foreign Comparative Testing – FCT) RSDL

• btains FDA

clearance as a Medical Device EZEM Inc. purchases RSDL License from O’Dell Engineering RSDL is approved for procurement by the US DoD US DoD places its first full rate production contract BRACCO Imaging acquires EZEM Inc. RSDL

• btains CE

Mark and TGA clearance as Medical Device 1980 - 1995 1991 - 1992 1997 1998 - 1999 2001 2003 2005 2007 2008

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Customers

 United States  Canada  Belgium  The Netherlands  Slovenia  Greece  UK NBC Team  France  Australia  Germany  Spain  Ireland  Sweden  OPCW

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Countries Using RSDL (Cont)

 Austria  Czech Republic  Denmark  Dubai UAE  Estonia  Finland  Hong Kong  Hungary  India  Israel  Italy  Japan  Jordan  Kazakhstan  New Zealand  Norway

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Countries Using RSDL (Cont)

 Portugal  Saudi Arabia  Singapore  Slovakia  South Korea  Switzerland  Taiwan  United Kingdom  USA

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RSDL vs. Powders (1)

RSDL Powders

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RSDL vs. Powders (2)

Powders

 Absorptive particles can become a respiratory threat.  Following a US DoD FCT study, M291 was shown to off-gas CW agent 24 hours following animal sacrifice – As evaluated by Battelle Memorial Institute.  Powders are likely to compromise respirator seal.  Difficulty assessing complete coverage.

RSDL

 Dissolves CA agents from skin into solution where neutralization can

• ccur. No re-aerosolization.

 Lotion does not off-gas in the presence

• f moisture or water vapor.

 Lotion does not compromise respirator seal – Evaluation done by DRDC - Suffield.  Tactile sensation allows completeness

• f coverage to be felt.

USAMRICD

Objective

• Compare the efficacy of skin

decontamination products recommended by doctrine against challenge by nerve agents

• Decons evaluated

– RSDL – M291 SDK – 1% soapy water – 0.5% bleach

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Conclusion of USAMRICD Study

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In reviewing the test, RSDL offers superior protection against all forms of CW Agents, and even if applied 30+ minutes after exposure can tremendously reduce casualties. Users should also be aware that it takes two packets of M291 to cover the same amount of skin as one packet of RSDL

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RSDL’s Benefits

 Thorough decontamination.  Non-toxic residue – removed with water or soap and water when operational conditions permit.  Logistically easy to manage.  Ease of use for immediate self decontamination.  Field proven – deployed in both Gulf wars with no Adverse Events reported.  Inexpensive Training Lotion available.

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Application

• 1. Identify/Suspect contamination

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Application

• 2. Open packet

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Application

• 3. Wipe exposed skin with applicator

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Application

• 4. Rinse when conditions permit

Conclusions

• RSDL provides superior protection against GD, GF, VX,

and VR compared to other decons tested

• M291 SDK is the least effective

– M291 provided no protection against VX and VR – M291 equivalent to 1% soapy water for GD – Wiping with M291 SDK spreads agent on the skin

• 0.5% bleach and 1% soapy water are less effective than RSDL, but still

provide good protection

• RSDL, 0.5% bleach, and 1% soapy water provide significant

protection against VX even when decon is delayed for extended periods of time

• The window of decon for GD is 3 min or less