The Evolution of Low Temperature Sterilization TSO3® Inc. 2017 . All Rights Reserved.

Presented by Pika N Lynch, MSN, RN Clinical Specialist TSO3 TSO3® Inc. 2017 . All Rights Reserved.

TSO3® Inc. 2017 . All Rights Reserved. Objectives Review of Sterilization History Discuss Industry Drivers Review of Low Temperature Sterilization Options. What’s in the Future for Low Temperature Sterilization. TSO3® Inc. 2017 . All Rights Reserved.

Brief History of Sterilization TSO3® Inc. 2017 . All Rights Reserved.

Brief History of Sterilization The use of antiseptics such as pitch, tar and aromatics was used by the Egyptians to embalm bodies Surgical instrument design was radically changed when antiseptic and aseptic surgical techniques became the norm Physician, Earle H Spaulding, proposed how an object should be disinfected or sterilized based on its intended use. The research of Dr. Robert Koch and associates devised the first non pressure flowing steam sterilizer

Low Temperature Technology Timelines Gas Plasma STERRAD is introduced to the market VHP Only Steris introduces VPro line VHP and ozone TSO3 receives 510K clearance. Partners with Getinge ETO ETO becomes standard for low temperature sterilization Add your own dates and event details to the flag markers. Move the flags along the timeline to match your event dates. Copy and paste a flag to add more. 1970 1980 1990 2000 2010 1960 2020

Characteristics of an Ideal Sterilization Method* Consists of: High Efficacy Rapid Activity Strong Penetrability Material Compatibility Nontoxic Organic Material Reistance Adaptability Monitoring Capability Cost Effectiveness * 1994 Dr. William Rutala worked with the CDC to define the Characteristics of an Ideal Sterilization Method TSO3® Inc. 2017 . All Rights Reserved.

Characteristics of an Ideal Sterilization Method* Consists of: High Efficacy Rapid Activity Strong Penetrability Material Compatibility Nontoxic Organic Material Reistance Adaptability Monitoring Capability Cost Effectiveness the agent should be virucidal, bactericidal tuberculocidal, fungicidal. and sporicidal TSO3® Inc. 2017 . All Rights Reserved.

Characteristics of an Ideal Sterilization Method* Consists of: High Efficacy Rapid Activity Strong Penetrability Material Compatibility Nontoxic Organic Material Reistance Adaptability Monitoring Capability Cost Effectiveness ability to achieve sterilization quickly TSO3® Inc. 2017 . All Rights Reserved.

Characteristics of an Ideal Sterilization Method* Consists of: High Efficacy Rapid Activity Strong Penetrability Material Compatibility Nontoxic Organic Material Reistance Adaptability Monitoring Capability Cost Effectiveness ability to penetrate common medical device packaging materials and penetrate into the interior of device lumens. TSO3® Inc. 2017 . All Rights Reserved.

Characteristics of an Ideal Sterilization Method* Consists of: High Efficacy Rapid Activity Strong Penetrability Material Compatibility Nontoxic Organic Material Reistance Adaptability Monitoring Capability Cost Effectiveness produce negligible changes in either the appearance or function of processed items and packaging materials, even after repeated cycling. TSO3® Inc. 2017 . All Rights Reserved.

Characteristics of an Ideal Sterilization Method* Consists of: High Efficacy Rapid Activity Strong Penetrability Material Compatibility Nontoxic Organic Material Reistance Adaptability Monitoring Capability Cost Effectiveness present no health risk to the operator or to the patient and pose no hazard to the environment. TSO3® Inc. 2017 . All Rights Reserved.

Characteristics of an Ideal Sterilization Method* Consists of: High Efficacy Rapid Activity Strong Penetrability Material Compatibility Nontoxic Organic Material Resistance Adaptability Monitoring Capability Cost Effectiveness withstand reasonable organic material challenge without loss of efficacy. TSO3® Inc. 2017 . All Rights Reserved.

Characteristics of an Ideal Sterilization Method* Consists of: High Efficacy Rapid Activity Strong Penetrability Material Compatibility Nontoxic Organic Material Resistance Adaptability Monitoring Capability Cost Effectiveness suitable for large or small (point of use) installations. TSO3® Inc. 2017 . All Rights Reserved.

Characteristics of an Ideal Sterilization Method* Consists of: High Efficacy Rapid Activity Strong Penetrability Material Compatibility Nontoxic Organic Material Resistance Adaptability Monitoring Capability Cost Effectiveness monitored easily and accurately with physical. chemical and biological process monitors TSO3® Inc. 2017 . All Rights Reserved.

Characteristics of an Ideal Sterilization Method* Consists of: High Efficacy Rapid Activity Strong Penetrability Material Compatibility Nontoxic Organic Material Resistance Adaptability Monitoring Capability Cost Effectiveness reasonable cost for installation and for routine operation TSO3® Inc. 2017 . All Rights Reserved.

Drivers for Low Temperature Sterilization TSO3® Inc. 2017 . All Rights Reserved.

Why low temperature sterilization? “Many components of today’s advanced surgical tools cannot tolerate the high heat of steam sterilizers. Demand for low-temperature alternatives has driven manufacturers to create safer, faster low-temperature sterilizers. Markets predicts that the technology will become an essential element of ORs and central sterile processing departments in the next few years.” OR Today 2012 TSO3® Inc. 2017 . All Rights Reserved.

Market Growth Drivers Growing global population Growing aging population Growth in minimally invasive surgeries (MIS) Prevalence of “superbugs” TSO3® Inc. 2017 . All Rights Reserved.

Minimally Invasive Surgery (MIS) is Increasing the Need for Low-Temperature Sterilization of Devices 30 million+ Minimally Invasive Surgery (MIS) operations annually in U.S. MIS offers multiple benefits Speeds recoveries Maximizes surgical suite time Reduces patent trauma However, devices used in MIS are problematic Expensive, complex and delicate Cannot tolerate high-temperature steam sterilization Therefore, many MIS devices are not sterilized between patient use, but only disinfected Disinfection cannot reach all the layered, complex parts Disinfected-only MIS devices are linked to patient illness and death MIS Devices are Complex, Delicate, and Expensive, and Therefore Difficult to Disinfect Completely It is all about improving outcomes, reducing hospital stays

The Problem with Disinfection-only: Superbug & Endoscope Connection SUPERBUG = Antimicrobial Resistant Bacteria At least 2 million Americans suffer from antibiotic-resistant bacteria annually – 23,000 die1 Half of all bugs that cause infections after surgery are antibiotic resistant2 Superbug, CRE, has become resistant to most available antibiotics, resulting in death in up to 50% of patients who become infected1 CRE infections increasingly prevalent and linked to use of endoscopes, including seven incidents and two deaths at UCLA Medical Center3 Settings CRE, which stands for carbapenem-resistant Enterobacteriaceae, are a family of germs that are difficult to treat because they have high levels of resistance to antibiotics. overuse of antibiotics in our healthcare practices, and foods Source: Centers for Disease Control (CD) The Lancet Infectious Diseases journal, as reported by Time, October 2015 Associated Press, February 20, 2015

Review of Current Low Temperature Sterilization Options TSO3® Inc. 2017 . All Rights Reserved.

Approved Low Temperature Sterilization Processes Low Temperature Process Offered By Brand ETO 3M Steri-Vac™ Gas Plasma VHP Advanced Sterilization Products STERRAD® VHP Steris V-PRO®maX VHP and Ozone Getinge Infection Control STERIZONE® We won’t talk about AERs and liquid chemical sterilization which are HLD. Although I do know that Steris has applied for sterility claim on the duodenoscope for System 1E. Just-in-time. TSO3® Inc. 2017 . All Rights Reserved.

Liquid Chemical Sterilization FDA believes that sterilization with liquid chemical sterilants does not convey the same sterility assurance as sterilization using thermal or gas/vapor/plasma low temperature sterilization methods *https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/GeneralHospitalDevicesandSupplies/ucm208018.htm TSO3® Inc. 2017 . All Rights Reserved.

Ethylene Oxide Pros Cons Kills just about everything Excellent Penetration Works well for lumened devices Good compatibility with most materials and packaging Kills just about everything Toxic, hazardous carcinogenic linked to cancer Flammable and at room temperature Requires personnel and room monitoring Takes a really long time due to aeration requirements (12 – 18 hrs) Kills everything - kills through a process called alkylation which destroys the cell structure making it unable to reproduce With ETO there are so many alphabet soup agencies involved. FDA, OHSA, EPA, etc. Excellent penetration – ETO is constructed of really small molecules which allow it to penetrate and get to hard to get places. Because of this it works well with lumened devices. Pretty gentle on materials and able to work with most packaging materials. TSO3 Inc. 2017 . All Rights Reserved.

Gas Plasma (Vaporized Hydrogen Peroxide) Gas plasma sterilization was patented in 1987 and was cleared for market under the STERRAD brand (ASP) in 1993 and is now in more than 60 countries. Often referred to as gas plasma but the kill is accomplished by vaporized H2O2. An electrical charge is applied to the vapor field to generate plasma. Plasma participates in breaking down of the residual hydrogen peroxide. TSO3® Inc. 2017 . All Rights Reserved.

Hydrogen Peroxide (plasma, VHP) Pros Cons Broad material and device compatibility Fast cycle times Better inventory management Non-toxic by products Low temperature, low moisture environment Struggles with long lumens Inability to process liquids, powders, or strong absorbers (e.g., cellulose) Devices/material not compatible with deep vacuum Limited capacity. Multiple cycles necessary to cover full range of devices Gas Plasma and Hydrogen peroxide will have the same pros and cons TSO3® Inc. 2017 . All Rights Reserved.

Why is Hydrogen Peroxide Important? Hydrogen Peroxide Addressed Need for Safer, More Cost Effective Sterilization Chemical Used in Medical Device Reprocessing Relative Market Share Over Time ETO Ethylene Oxide (100%, 90/10, etc. – all forms) Toxic Carcinogenic Slow Environmental pollutant H2O2 Hydrogen Peroxide (VHP, Plasma, etc.) Quick Environmentally safe However, typically expensive, with strict loading limitations and monitoring

TSO3® Inc. 2017 . All Rights Reserved. What might you sterilizer in a Low Temperature sterilizer? Identifying the Ideal Customer Endoscopic Systems Flexible Endoscopes Rigid Telescopes Light Guide Cables Video Cameras Instrument sets for Urology, Gynecology, General Surgery, ENT, Plastics, Thoracic, Pulmonary Orthopedics Rechargeable Batteries Large Bone Power Tools Arthroscopes Video Optical Sets Many Other Devices Ultrasound Transducers Stereotactic Head Screws and Devices Eye Shields Silicone Dilation Bougies Stainless Steel Instruments Doppler Probes Internal Defib paddles Anesthesia Laryngoscope Blades Flexible Intubation Scopes Video laryngoscopes Other intubation devices such as stylets, rigid endoscopes, etc TSO3® Inc. 2017 . All Rights Reserved.

TSO3® Inc. 2017 . All Rights Reserved. VHP Based Sterilizers 1st Generation STERRAD ® 100NX 2 cycles at 90% (original) & 2 optional cycles at 59% STERRAD® 100S 2nd Generation Steris (AMSCO) V-PRO ® maX 3 Cycles STERRAD ® 100NX ALLCLEAR 2 cycles at 90% (original) & 2 optional cycles at 59% Latest Technology STERIZONE ® VP4 Sterilizer 1 Cycle for all devices 75 lb load capacity TSO3® Inc. 2017 . All Rights Reserved.

TSO3® Inc. 2017 . All Rights Reserved. STERIS V-PRO®max Low temperature sterilization process at < 55°C (131° F) Uses vaporized hydrogen peroxide for the terminal sterilization of packaged, resuseable medical devices No secondary means of reducing hydrogen peroxide residual. Returns to atmospheric pressure by use of HEPA filtered room air. Releases only water vapor and oxygen (no drain required). No toxic residues. TSO3® Inc. 2017 . All Rights Reserved.

STERRAD® 100NX® with AllClear Technology Low temperature sterilization process at 50°C (122° F) Uses vaporized hydrogen peroxide for the terminal sterilization of packaged, resuseable medical devices Followed by creation of a low energy plasma field to break apart the peroxide vapor. Returns to atmospheric pressure by use of HEPA filitered room air. Releases only water vapor and oxygen (no drain required). No toxic residues. TSO3® Inc. 2017 . All Rights Reserved.

STERIZONE® VP4 Sterilizer Low temperature sterilization system (41°C ± 3°C) Uses dual sterilants: vaporized hydrogen peroxide (H2O2) and ozone (O3), in a multiphase process. Releases only water vapor and oxygen (no drain required). No toxic residues. Free standing or recessed mounting Minimum Utility Requirements 208V - 240 VAC External oxygen supply via tanks or oxygen generator Issued new product code by the FDA – PJJ TSO3® Inc. 2017 . All Rights Reserved.

STERIZONE® VP4 – Key Differentiators First and only Dual Sterilant sterilizer approved by in U.S.A by the FDA. First low temperature sterilizer with a “load sensitive” Dynamic Sterilant Delivery System™ First documented “wet” cycle with validated micro-condensation conditioning First Biological Indicator Test Pack to survive past the first half-cycle. First low temperature sterilizer validated to sterilize multi-channeled1 endoscopes such as video colonoscopes and gastroscopes. 1 Up to 4 working channels TSO3® Inc. 2017 . All Rights Reserved.

STERIZONE® VP4 Sterilizer Comparing the Systems   Steris V-PRO® MaX STERRAD® 100NX STERIZONE® VP4 Sterilizer # of Selectable Cycles 3 4 1 Cycle Parameters Fixed cycles Variable based on load size and configuration Cycle Time\min 35 for flexible 55 for lumens 28 non lumen 42 for Flexible 47 for Standard 24 for Express 60 for Duo 46 - 60 minutes (varies based on load size and configuration) H2O2 Concentration 59% 90% Standard & Flex 59% for Duo 50% Chamber Size 136L 150L 125L Maximum Load 50 lb. non-lumen load 21.4 lb. 13.2 lb. for Duo Up to 75 lb. + 25lb 3 tier loading rack TSO3® Inc. 2017 . All Rights Reserved.

STERIZONE® VP4 Sterilizer Comparing the Systems   Steris V-PRO® MaX STERRAD® 100NX STERIZONE® VP4 Sterilizer Loading 2 tiered shelves 3 adjustable shelves Maximum Flexible Scope Load 2 flexible scopes 3 flexible scopes Injection Method Single pulse Continuous pulse Injection controlling parameter Quantity Pressure Chamber Temperature 50°C <55 41°C TSO3® Inc. 2017 . All Rights Reserved.

TSO3® Inc. 2017 . All Rights Reserved. STERRAD® 100NX STERRAD® 100NX TIME CAN PROCESS WEIGHT LIMIT Flexible Cycle 42 min 2 flexible scopes Claims: >1mm x < 850mm < 21.4lbs Standard Cycle 47 min Lumen instruments up to 40 lumens/load, cameras, general SS instruments >0.7mm x <500mm <21.4lbs Non-Lumen Cycle 28 min General metal medical devices requiring surface sterilization, <10.7lbs DUO Cycle 60 min 2 flexible endoscope >1mm x<875mm <13.2lbs 37 TSO3® Inc. 2017 . All Rights Reserved.

TSO3® Inc. 2017 . All Rights Reserved. V-PRO® max V-PRO® maX TIME CAN PROCESS WEIGHT LIMIT Flexible Cycle 35 min 2 flexible scopes or 1 flexible scope plus non lumen instruments Claims: >1mm x < 1050mm ≤ 24lbs Lumen Cycle 55 min 1,2 , or 3 lumen instruments up to 15 lumens/load, plus diffusion restricted /non-restricted SS instruments ≤19.65lbs Non-Lumen Cycle 28 min Telescopes, non-lumen flexible scopes, SS instruments, non lumen devices ≤ 50 lbs 38 TSO3® Inc. 2017 . All Rights Reserved.

STERIZONE® VP4 Sterilizer   Inside Diameter Length Single Cycle Single channel flexible endoscopes ≥ 1.0 mm ≤ 850 mm Single and double channel flexible endoscopes ≤ 989 mm Rigid channel devices including single channel and double rigid channel endoscopes ≥ 0.7 mm ≥ 2.0 mm ≤ 500 mm ≤ 575 mm Multi-Channel flexible endoscopes with or without elevator mechanism* ≥ 1.2 mm ≥ 1.45 mm ≤ 1955 mm ≤ 3500 mm *Only the Olympus® EVIS EXERA II Duodenovideoscope TJF-Q180V TSO3® Inc. 2017 . All Rights Reserved.

Process Challenge Comparison STERRAD® Systems (100S, NX, 100NX) H2O2 V-PRO® Systems H2O2 STERIZONE® VP4 H2O2 & Ozone Single BI for 7 different cycle parameters Uses fixed cycle Load restrictions per cycle: up to 10.7/21.4lbs Load restricted by device mix to be processed Single BI for 6 different cycle parameters Uses fixed cycles Load restrictions per cycle: up to 19-50 lbs Load restricted by device mix to be processed Single BI/Test Pack for 1 cycle Uses a variable injection cycle* Can process loads up to 75 lbs. Load not restricted by load mix** * Dynamic Sterilant Delivery SystemTM that delivers H2O2 through microburst injections to adapt the total amount of hydrogen peroxide introduced to the composition (surface area, weight and temperature) of the sterilizer load. ** Load exception for multichannel scope. No more than 1 multichannel flexible endoscope packaged in a compatible container placed on the lower shelf without any additional load. TSO3® Inc. 2017 . All Rights Reserved.

What’s the Future of Low Temperature Sterilization? TSO3® Inc. 2017 . All Rights Reserved.

TSO3® Inc. 2017 . All Rights Reserved. FDA Guidance Updates Effective August 8, 2017 IFUs clear and predictable = more efficient review of 510(K)s New 510(k) must include validation data regarding cleaning, disinfection and sterilization. Table 1 – Pose a greater risk of transmission and infection E.g., endoscopes, arthroscopes, laparoscopic, etc… Table 2 – Pose a challenge to adequate reprocessing E.g., lumens, esp. flex. & multi internal lumens, hinges, stopcocks etc. Please make sure we give Rose Seavy credit for this slide. TSO3® Inc. 2017 . All Rights Reserved.

Modified Spaulding Classification Reprinted with permission from Guidelines for Perioperative Practice. Copyright © 2016, AORN, Inc, 2170 S. Parker Road, Suite 400, Denver, CO 80231. All rights reserved. TSO3® Inc. 2017 . All Rights Reserved.

Professional Organizations “Strong Evidence for Sterilization of Endoscopes Presented at Stakeholder Meeting” IAHCSMM’s Endoscope Reprocessing Manual 2017 New AORN guidelines - changes that should be implemented immediately for example: no longer disinfecting flexible endoscopes manually (e.g., soaking in a pan of high-level disinfectant solution) Posted September 13, 2017 Evidence indicating that sterilization is a superior method to high-level disinfection (HLD) for the reprocessing of endoscopes was reported during a meeting held on Sept. 11 at AAMI headquarters in Arlington, VA. More than 40 stakeholders representing healthcare professional organizations, manufacturers, testing labs, independent research groups, academia, patient and clinical end user interests, the Food and Drug Administration (FDA) Center for Devices and Radiological Health, and the Centers for Disease Control and Prevention, among others, attended the meeting in person or by teleconference. http://www.aami.org/newsviews/newsdetail.aspx?ItemNumber=5243 TSO3® Inc. 2017 . All Rights Reserved.

Industry TSO3 Files for an Extended Claim for Duodenoscopes “Company has filed a 510(k) submission with US regulators for its STERIZONE® VP4 Sterilizer for the terminal sterilization of duodenoscopes used in endoscopic retrograde cholangio-pancreatography (ERCP) procedures.” * TSO3 Provides an Update on Recent Activities “Company announced that the second largest hospital in Canada has completed the installation of multiple STERIZONE® VP4 Sterilizers and is now using these sterilizers to terminally process duodenoscopes used on patients undergoing endoscopic retrograde cholangio-pancreatography (ERCP) procedures.” QUEBEC CITY and MYRTLE BEACH, SC, July 20 2017 /CNW Telbec/ - TSO3 Inc. http://www.newswire.ca/news-releases/tso3-provides-an-update-on-recent-activities-643080913.html STERIZONE Technology ™. 2016 . All Rights Reserved. TSO3® Inc. 2017 . All Rights Reserved.

The Future of Sterilization STERIZONE Technology ™. 2016 . All Rights Reserved. TSO3® Inc. 2017 . All Rights Reserved.

The Future Of Sterilization ERCP Scope in a Aptimax Tray ERCP Scope Prepared for VP4 STERIZONE Technology ™. 2016 . All Rights Reserved. TSO3® Inc. 2017 . All Rights Reserved.

Copyright © 2014-2017 TSO3 Inc. All rights reserved for all countries. No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form, be it electronically, mechanically, or by any other means such as photocopying, recording or otherwise, without the prior written permission of TSO3 Inc. The TSO3 logo and STERIZONE® are trademarks registered with the US Patent and Trademark Office. The STERIZONE® VP4 Sterilizer is patented in the US under US Pat. 9,101,679; in Canada under Pat. 2,767,726; and in Europe under Pat. EP 2,601,976. Other patents applications pending. Corresponding foreign patents and patent applications pending. The information contained in this presentation is subject to change without notice.

Thank-you! Questions?