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Low temperature sterilization with hydrogen peroxide vapour; V-PRO TM applications & best practice Dr. Georgia Alevizopoulou MD Senior Manager, Clinical Education STERIS Infection Prevention Technologies 2018 STERIS Corporation
What is low temperature sterilization? By low temperature, we typically mean below steam sterilization temperatures and typically below 80 C; in practice this is chemical Why low temperature sterilization? Historically, needed to be able to sterilize heat sensitive devices Today, explosion in MIS surgery and endoscopy: Demand to expand utilization of low temp inventory through rapid processing Restrictive regulatory climate for EO Gas Desire for process that requires minimal safety precautions Change in guidelines and standards
Evolution of Low Temperature Sterilizers Ethylene oxide (EO) Low-temperature steam-formaldehyde (LTSF) Liquid chemical sterilization Vapor Hydrogen Peroxide With plasma Without plasma Hydrogen peroxide/ozone
Hydrogen Peroxide H 2 O 2 Clear liquid, water-like, odorless Powerful antimicrobial especially in the gaseous phase Practical use: 0.1-60% in water Greater efficacy as concentration increases Balance with material compatibility Environmentally safe: Decomposes to form water and oxygen STERIS Corporation 2018
V-PRO TM Low Temperature Sterilization Systems
Intended Use Rapid, low temperature terminal sterilization of properly cleaned, rinsed and dried reusable metal and non-metal medical devices used in healthcare facilities. The sterilization cycles operate at low pressure and temperature, suitable for processing medical devices sensitive to heat and moisture. Utilize STERIS VHP technology 7 Technical Data Monograph V-PRO max, Low Temperature Sterilization System STERIS Corporation 2018
The VHP principle of operation Hydrogen Peroxide (Liquid) H Hydrogen Peroxide (Gas) O O H O + H 59% Vaporization H Catalytic converter O O Non-Toxic Residues 9 STERIS Corporation 2018
The Plasma sterilization process 59% Energy Electromagnetic field Positive Ions (O +, O 2+, O +2 ) Electrons (e - ) Negative Ions (O -, O 2- ) Other Reactive Species (O 3, Free radicals) Liquid Gas Plasma
STERIS Corporation 2018
Example Cycle Description (V-PRO 1, 1 Plus, and max Non Lumen Cycle) Condition Sterilize Aeration 1000.0 Pulse 1 Pulse 2 Pulse 3 Pulse 4 5 1/2 Cycle 100.0 1 Pressure (Torr) 10.0 3 4 1.0 2 6 7 0.1 0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 Time (min) 1. Evacuate chamber 2. Moisture check 3. Prepare for injection, Inject 4. Post injection hold 5. Transition to 500 Torr, hold 6. Evacuate, prepare for next pulse 7. Evacuate chamber to Aerate
The V-PRO family- Continuous innovation Cycle (Minutes) V-PRO 1 V-PRO 1 Plus V-PRO max V-PRO 60 Lumen 55 55 55 60 Non Lumen --- 28 28 28 Flexible --- --- 35 38 VAPROX HC Sterilant 59% hydrogen peroxide solution used in all V-PRO Sterilizers STERIS Corporation 2018
Q: What are the key factors in choosing your low temperature sterilization process?
Safe profile 16 STERIS Corporation 2017
V-PRO Low Temperature Sterilization Delivering Safety Embed safety video 17 STERIS Corporation 2017
Prion inactivation* *V-PRO Sterilizer, Technical File, Section 7 STERIS Corporation 2018
Material Compatibility* Extensive testing has shown VAPROX HC Sterilant to be compatible with materials commonly found in surgical, endoscopic and other devices Typical examples include: Aluminum Delrin acetyl resin (polyacetal) Ethylvinyl acetate (EVA) N Glass KRATON Polymers Neoprene Noryl (Polyphenylene oxide) Non-mated Nylon (polyamide) Polymethyl methacrylate (PMMA) Polycarbonate ULTEM Polymers (Polyetherimide) Polyethylene Polypropylene Polystyrene Polyurethane Polyvinyl chloride (PVC) Radel (Polyphenylene sulfone) Silicone Stainless Steel Teflon (Polytetrafluoroethylene) Titanium 19 * International Technical Data Monograph STERIS Corporation 2018
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A device is suitable for V-PRO when: Device: Is moisture/heat intolerant Requires sterilization User: Requires fast turnaround Sterile storage is required Transport off site Value for money: Improve instrument quality/shelf life Reduce repair/replacement costs 23 STERIS Corporation 2018
Q: Which reusable instruments are used which cannot be sterilized in an autoclave?
Change in the guidance Sterile scopes The choledochoscope The intubation scope The urology scopes NEW STERIS Corporation 2018
Example: The intubation endoscope How long is it on the airway trolley for? Do you always have the time to reprocess before used on a patient? Best Practice Wouldn t it rather be sterile and wrapped?
Flexible Cycle Process single channel surgical flexible endoscopes, such as urethroscopes, bronchoscopes and those used in ENT Process dual channel surgical flexible endoscopes STERIS Corporation 2017
Establish compatibility The evaluation may occur either at the time of sales negotiation, or at the time of acquiring the sterilizer, or when new medical devices are purchased, or when medical devices are loaned to the healthcare facility. Key considerations: Material compatibility Lumen compatibility Maximum processing load STERIS Corporation 2018
Using the STERIS Device Matrix STERIS Corporation 2018
STERIS Corporation 2018
STERIS Corporation 2017 Terminal Sterilization
Preparation of Devices Properly cleaned, rinsed and dried Instruments can be assembled into sets or single, wrapped or placed in wrapped trays, pouches or rigid sterilization containers STERIS Corporation 2017
Require specific packaging material
Routine Monitoring - SAP Chemical Indicators Biological Indicators
VH2O2 Low Temp Sterilization is evolving http://aboutmanchester.co.uk/the-future-of-jobs-lies-in-the-creative-sector/ STERIS Corporation 2018
Get on SU online portal http://university.steris.com STERIS Corporation 2018
Continuing to transform the standard of Low Temperature Sterilization STERIS has over 30 years of experience with vaporized hydrogen peroxide and has been the innovator in low temperature sterilization modalities 10+ million procedures across the globe are performed with devices that have been reprocessed with V-PRO sterilizers using vaporized hydrogen peroxide 59 STERIS Corporation 2018
Efharisto!
Get connected to STERIS University and its team of Expert Industry Professionals university.steris.com educationdesk@steris.com STERIS Corporation 2017