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Ed first joined Ô°ÇøÒùÂÒin 1987. Since that time, Mr. Arscott progressed to the role of Manager of Microbiology and In vitro Toxilogy before leaving to take a role with Depuy/J&J, where he stayed for 14 years. Ed then returned to Ô°ÇøÒùÂÒin 2013—first, in a Validation Group technical position before taking on his current role as a Principal Strategy Consultant. In this role, he consults in medical devices with experience in all terminal sterilization methods (traditional and novel), Biological Indicator (BI) development, packaging shelf-life studies, medical device reprocessing validations, environmental monitoring and cleanroom qualifications.Ìý

CORE COMPETENCIES

• Technical Advisor for a worldwide orthopedic company, including projects that are focused on biocompatibility, aseptic processing, ethylene oxide, gamma, electron beam, gas plasma and laboratory operations
• Implementation of GLP and GMP practices for all phases of microbiological testing, BI production and In Vitro biocompatibility testing
• Consultation on ethylene oxide, gamma and e-beam sterilization validations and disinfection efficacy, steam sterilization, packaging shelf-life studies and cleaning efficacy validation studies for reusable devices
• Subject matter expert for auditing of external contract laboratories and sterilization vendors
• Regular interactions, on multiple levels, with regulatory agency submissions and regulatory compliance audits
• Active participant in many AAMI Sterilization Standards Committees since 1992

RECENT PROJECTS

• Coordinated the design, layout, equipment procurement and validation of a new ISO Class 7 cleanroom, allowing for regulatory inspection and approval
• Conducted an epidemiological risk assessment for a reusable oral medical device to justify the appropriate cleaning and disinfection levels in a regulatory submission
• Managed multiple, full EO sterilization validation studies, which were being conducted at the same sterilizer for three separate clients during the same period

PUBLICATIONS

• Validating Reusable Medical Devices: An Overview. Susanne Anderson, Ed Arscott, John Broad, and Dave Parente. Medical Device & Diagnostic Industry, January 1996.
• Validating Radiation Sterilization in a Global Marketplace. Ed Arscott, Susanne Anderson, John J Broad and Dave Parente. Medical Device & Diagnostic Industry February 1999.
• A Practical Guide to ISO 10993-5: Cytotoxicity. Richard F. Wallin, Ph.D, Edward F Arscott. MDDI. 1998;20:96–8