The Application of Plasma for SUMD

1. 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

2. OVERVIEW • Background Information • Market Analysis • Experiments Conducted • Design of Prototype • General Progress of Winter Term • Future Goals

3. 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)

4. 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

5. BUDGET

6. 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

7. 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

8. 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

9. 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

10. Results

11. Results

12. 3 Phases of Inactivation

13. 3 Phases of Inactivation

14. Design Overview • Market Driven – changing target = changing design • Maintain Simplicity • Uses DPI Technology

15. Design Constraints • Size – fit to existing power source • Minimize moving parts • Plasma dictates suitable materials and other requirements

16. Design Basics • Simple • Low Cost • Easy to manufacture

17. Inside View

18. Component / Assembly Drawings

19. Component / Assembly Drawings

20. Test Electrode

21. 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

22. Dr. Young Cho Dr. Alexander Fridman Dr. Greg Fridman Moogega Cooper The Drexel Plasma Institute

23. 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