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The Application of Plasma for SUMD. Non-thermal Atmospheric Plasma (NTAP) Electrode. MEM-031 Shawn Anderson William Borrell John Mattero Joseph Neal Royston Rodrigues. Advisors : Dr. Y. Cho Dr. A. Fridman. OVERVIEW. Background Information Market Analysis Experiments Conducted
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The Application of Plasma for SUMD Non-thermal Atmospheric Plasma (NTAP) Electrode MEM-031 Shawn Anderson William Borrell John Mattero Joseph Neal Royston Rodrigues Advisors: Dr. Y. Cho Dr. A. Fridman
OVERVIEW • Background Information • Market Analysis • Experiments Conducted • Design of Prototype • General Progress of Winter Term • Future Goals
BACKGROUND INFORMATION • Bacterial Contamination – widespread problem • “Sterilization” • A vital process • According to FDA1 – process that shows 106 endospores killed – define Sterility Assurance Level • Low Temperature Sterilants with High Efficacy2 • Current Medical Sterilization methods • Electron Beam (E Beam) Sterilization3 • Ethylene Oxide • Steam Sterilization (Autoclaving)
NON-THERMAL PLASMA • Plasma – 4th state of matter • Depending on energy provided can be thermal or non-thermal (cold) plasma • Non-thermal can be formed by • Electron Beam5 • Dielectric Barrier Discharge (DBD) • Dielectric barrier discharge • Created when high voltage is applied6 • Charge builds up on surface • Electrons that enter region form electron avalanche • Advantage as produces high energy electrons directly
REPROCESSING SINGLE-USE MEDICAL DEVICES • Single-Use Medical Devices (SUD) • Scalpel handles, forceps, scissors, speculums, etc. • Defined as used, open, or expired • FDA and MDUFMA • Validated sterilization procedures must accompany 510K submissions • Requires similar standards as OEMs
WHY REPROCESS • If 1-2% of all SUDs were reprocessed, savings of $1,000,000,000/yr • Up to 50% savings when reprocessing once • 500 Million tons of waste diverted from landfills each year
3rd PARTY GOLD STANDARD • Ascent Healthcare Solutions • 1,700 hospitals and surgery centers • Typically utilize EtO sterilization • Provides complete process • Receiving, tagging, reprocessing, repackaging, tracking
COMPETITIVE ADVANTAGES • Size • Scalable to large container size • Possible conveyor belt mechanism with automated sterilization • Efficacy • Proven to kill D. radiodurans, B. subtilis, E. coli • Short duration exposure times • Safety • Runs off 110V wall power supply • Non-thermal plasma safe to touch • Speed • Sterilization times reduced to 30sec. from 10hrs
Design Overview • Market Driven – changing target = changing design • Maintain Simplicity • Uses DPI Technology
Design Constraints • Size – fit to existing power source • Minimize moving parts • Plasma dictates suitable materials and other requirements
Design Basics • Simple • Low Cost • Easy to manufacture
GOALS FOR SPRING TERM • Completion of validation activities • PTFE, Ceramic, Nylon • Implementing the NTAP Electrode and Protocol into sterilization box • Testing actual medical devices in box contaminated with D. radiodurans and E. coli
Dr. Young Cho Dr. Alexander Fridman Dr. Greg Fridman Moogega Cooper The Drexel Plasma Institute
REFERENCES 1 http://www.myendosite.com/cms/files/July_1998_ID478.pdf • http://www.unc.edu/depts/spice/dis/ICHE-1996-Feb-p87.pdf • http://www.devicelink.com/mddi/archive/02/09/003.html • http://books.google.com/books?id=3f-kPJ17_TYC&pg=PA351&lpg=PA351&dq=plasma+sterilization+medical+devices&source=bl&ots=KkCpEv8PFZ&sig=hvTIRX2UtewsEEo0qgKqcfs8ugQ&hl=en&ei=7P2tSfHpCIiSngeElojDBg&sa=X&oi=book_result&resnum=7&ct=result • http://www.swri.org/3pubs/ttoday/Spring96/ttoday2.htm • http://www.gregfridman.com/publications/documents/STAR-RyanRobinson.pdf