1. The Evolution of Low Temperature Sterilization
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2. Presented by Pika N Lynch, MSN, RN Clinical Specialist TSO3
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Objectives
Review of Sterilization History
Discuss Industry Drivers
Review of Low Temperature Sterilization Options.
What’s in the Future for Low Temperature Sterilization.
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4. Brief History of Sterilization
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5. 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

6. 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

7. 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
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8. 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
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9. 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
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10. 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.
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11. 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.
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12. 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.
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13. 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.
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14. 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.
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15. 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
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16. 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
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17. Drivers for Low Temperature Sterilization
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18. 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
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19. Market Growth Drivers
Growing global population Growing aging population Growth in minimally invasive surgeries (MIS) Prevalence of “superbugs”
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20. 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

21. 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

22. Review of Current Low Temperature Sterilization Options
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23. 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.
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24. 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 *
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25. 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.
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26. Gas Plasma (Vaporized Hydrogen Peroxide)
Gas plasma sterilization was patented in 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.
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27. 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
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28. 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

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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
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30. 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
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31. 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.
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32. 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.
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33. 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 VAC
External oxygen supply via tanks or oxygen generator
Issued new product code by the FDA – PJJ
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34. 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
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35. 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
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
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36. 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
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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
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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
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39. 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
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40. 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 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.
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41. What’s the Future of Low Temperature Sterilization?
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42. 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.
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43. Modified Spaulding Classification
Reprinted with permission from Guidelines for Perioperative Practice. Copyright © 2016, AORN, Inc, 2170 S. Parker Road, Suite 400, Denver, CO All rights reserved.
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44. 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.
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45. 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 /CNW Telbec/ - TSO3 Inc.
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46. The Future of Sterilization
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47. The Future Of Sterilization
ERCP Scope in a Aptimax Tray
ERCP Scope Prepared for VP4
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48. Copyright ©
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.

49. Thank-you! Questions?