Presented by: Healthmark Industries Low Temperature Sterilization “Do you have Gas or are you just Vaping?” Presented by: Healthmark Industries Presented by Fred Alston, CSPDT Director of Clinical Sales and Services, Eastern Region December 2, 2017

Low Temperature Sterilization Hydrogen Peroxide (VHP)

Low Temperature Sterilization Hydrogen Peroxide (VHP) STERIS introduced the V-PRO™1Sterilizer in 2007 Other companies also offer VHP sterilizers. Uses V H2O2 in 4 phases within 2 half cycles. Much Safer than EtO Process by-products are Oxygen and Water. Much quicker process than EtO Only utility needed was electrical power (200-230V 3Ø) H2O2 is a surface sterilant and does not penetrate as effectively as EtO. Kills by Oxidation

Low Temperature Sterilization Hydrogen Peroxide (Vaporized) Shorter Cycle times (roughly 1 hour) No Aeration needed. Biological used for testing is Geobacillus stearothermophilus Sterilant is 59% hydrogen peroxide. Self-contained cartridge. 15 cycles per cartridge.

Low Temperature Sterilization Steris Vpro H2O2 (VHP) Cycle Phase

Low Temperature Sterilization H2O2 (VHP) Pro’s and Con’s PRO’s Non-Toxic Low Temp Shorter complete process CON’s Not a great penetrant for lumens and cannulas Not compatible with traditional packaging materials Not as sensitive to moisture but additional drying could be necessary. Layout 1 Image + text

Low Temperature Sterilization Hydrogen Peroxide and Ozone (VH2O2 + O3)

Low Temperature Sterilization Hydrogen Peroxide and Ozone TSO3 in Qubec, Canada received FDA clearance in 2014 for the STERIZONE® VP4 Sterilizer So unique, FDA created a new category for this Dual Sterilant Sterilizer. Utilizes Vaporized H2O2 and Ozone (O3) the process. Process by-products are Oxygen and Water. Much quicker process than EtO Only utility needed is electrical power (208 or-240V 1Ø) Does need Medical grade Oxygen (to create the Ozone) Kills by Oxidation

Low Temperature Sterilization Hydrogen Peroxide and Ozone Shorter Cycle times. (Dynamic Exposure based on load size. Runs about 45 min to 70 min) No Aeration needed. Biological used for testing is Geobacillus stearothermophilus Sterilant is 50% hydrogen peroxide. Self-contained package. 8-12 cycles per bottle. Bottle has a 24 month shelf life.

Low Temperature Sterilization H2O2 + O3 Cycle Phase

Low Temperature Sterilization H2O2 + O3 Pro’s and Con’s PRO’s Non-Toxic Low Temp Shorter complete process Medical Grade O2 flush (x2) in the vent phase Much better lumen and cannula penetration (not quite as good as EtO Does not require Extra Drying before processing. (in fact not recommended) CON’s Not a perfect penetrant for lumens and cannulas Not compatible with traditional packaging materials Layout 1 Image + text

Low Temperature Sterilization Comparisons

Low Temperature Sterilization VH2O2 Product Comparison

Low Temperature Sterilization VH2O2 Product Comparison   STERIZONE® VP4 Sterilizer V-PRO® MaX STERRAD® 100NX STERRAD® 100NX DUO Cycles / System 1 3 4 Cycle Parameters Variable based on load configuration and TORR pressure Fixed cycles Fixed cycle Cycle Time\min 46-60 minutes based on load configuration 35 for flexible 55 for lumens 28 non lumen 42 for Flexible 47 for Standard 24 for Express 60 for DUO 60 for flexible H2O2 Concentration 50% 59% 90% Standard & Flex Number of Pulses 2 Chamber Size 125L 136L 82.3L Maximum Load 75 lb + 25lb 3 tier loading rack 24 lb 21.4 lb 13.2 lb

Low Temperature Sterilization Summary EtO still the most effective “All around” low temperature sterilant New technologies and processes are always on the come. H2O2 currently offers the best alternative to EtO. As new technology is introduced, Use your Critical Thinking Skills to determine the best process and procedures for your applications. IFU’s may not immediately reflect the use of the new technology but AAMI does address new Technology in Section 12, New Product Evaluation.

Low Temperature Sterilization Summary Our field is evolving and the only constant going forward will be change. Don’t be afraid of the change. Embrace, Understand, Employ, Improve. Ask the WHY.

Low Temperature Sterilization Why are we here? We are professionals. We are dedicated. We are the experts in what we do. We help insure patient safety. We help insure quality patient outcomes. We take pride in what we do. We need to be recognized. WE ARE THE HEART OF THE HOSPITAL Layout 2 image + text

PATIENT The circle of life Pre-Cleaning at point of use Proper Biohazard transport Patient Use PATIENT Cleaning per device IFU and Cleaning Verification Proper Transport-Storage Visual Inspection-Enhansed Optical Inspection DOCUMENTATION HLD or Sterilization

Thank You! Questions? On behalf of Healthmark, I would like to thank you all for the opportunity to be here today. THANK YOU!