1. Low Temperature Sterilization Technology

2. Overview Brief History of Sterilization
Why Low Temperature Sterilization?
Low Temperature Technology Evolution
Vaporized Hydrogen Peroxide Sterilizers
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3. Brief History of Sterilization

4. 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 change 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
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5. Brief History of Sterilization
1994 Dr. William Rutala worked with the CDC to define the Characteristics of an Ideal Sterilization Method
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6. Characteristics of an Ideal Sterilization Method
High efficacy - the agent should be virucidal, bactericidal tuberculocidal, fungicidal. and sporicidal.
Rapid activity - ability to achieve sterilization quickly.
Strong penetrability - ability to penetrate common medical device packaging materials and penetrate into the interior of device lumens.
Material compatibility - produce negligible changes in either the appearance or function of processed items and packaging materials, even after repeated cycling.
Nontoxic - present no health risk to the operator or to the patient and pose no hazard to the environment.
Organic material resistance - withstand reasonable organic material challenge without loss of efficacy.
Adaptability - suitable for large or small (point of use) installations.
Monitoring capability - monitored easily and accurately with physical. chemical. and biological process monitors.
Cost-effectiveness - reasonable cost for installation and for routine operation.
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7. Sterilization Methods
Steam
Flash Sterilization
Ionizing Radiation
Dry-Heat Sterilizers
Formaldehyde Steam
Infrared Radiation
Vaporized Peracetic Acid
Ethylene Oxide "Gas" Sterilization
Hydrogen Peroxide Gas Plasma
Peracetic Acid Sterilization
Vaporized Hydrogen Peroxide (VHP)
Ozone
VHP/Ozone
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8. Why Low Temperature Sterilization?

9. 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 and 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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10. Why Low Temperature Sterilization?
Allows creativity and innovation in device design which allow surgeons to reach places, and create opportunities for less invasive surgical techniques......
By the use of plastics, adhesives, electronic technology and other materials/technologies that are either destroyed or suffer reduced life in steam sterilization technologies.
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11. Market Growth Drivers
Growing global population Growing aging population Growth in minimally invasive surgeries (MIS) Prevalence of “superbugs”
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12. Key Market Driver: Demographics
Global population is aging
65+ age group to grow 35%, from million in 2010 to 54 million by 20201
Globally, 65+ to grow >100% by 20202
Patients age 65+ currently consume 50% of surgical suite time 3
Aging population to result in increasing demand for minimally invasive diagnostic and surgical procedures (MIS)3, as well as for devices used in MIS operations
Aging U.S. Population Expected to Drive Growth in MIS Surgical Services
More of us are living longer and with better health
U.S. Census Bureau
United Nations
Markets and Markets, February 2015
Source: U.S. Census Bureau

13. 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
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14. 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

15. Low Temperature Technology Evolution

16. Timeline 2009 VHP and Ozone 1960s ETO 1993 Gas Plasma VHP
Mid 2000s VHP
2009 VHP and Ozone
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17. Approved Low Temperature Sterilization Processes (Canada and US)
Low Temperature Process
Major Supplier
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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18. Ethylene Oxide Ethylene Oxide (EO) Sterilization: Timeline of Events
1859 ETO is discovered
1920s/1930s ETO is used for fumigation
1940s ETO is developed as a sterilant by the U.S. Military
1950s The McDonald process is patented for medical devices
Used commonly in hospitals since the 1960s
Ethylene Oxide (EO) Sterilization: Timeline of Events
In 1859 First reported by French chemist Charles Wurz
In 1928, EO was combined with dry ice to fumigate grain elevators. In the 1930 it was used to kill microorganisms on cotton, sugar crystals and freshly cut tobaacco.
In the 1940s the US military used it to extend food and spice life is support of WWII. It was during this period that that sterilization parameters were optimized
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19. 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 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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20. 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 sterilization but the kill is accomplished by vaporized is H2O2.
An electrical charge is applied to the vapor field to generate low temperature plasma.
Plasma participates in breaking down of the residual hydrogen peroxide.
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21. Gas Plasma Sterilization
1. Vacuum
2. Injection
3. Diffusion
4. Plasma
5.Vent
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22. Hydrogen Peroxide (plasma, VHP)
Pros
Cons
Broad material and device compatibility
Fast cycle times
Better inventory management (compared to ETO)
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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23. VAPORIZED H202 Sterilizers

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

27. 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.

28. STERIZONE® VP4 Sterilizer
Low temperature sterilization process at 41ºC ± 3°C
Uses vaporized hydrogen peroxide for the terminal sterilization of packaged, resuseable medical devices
Followed by injection of ozone and dwell, to aid in the breakdown of residual H2O2 on device surfaces.
Ozone contributes additional lethality to the process.
Releases only water vapor and oxygen (no drain required). No toxic residues.
Note: Only sterilizer approved to sterilizer multi- channel endoscopes up to 4 channels.
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29. 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
Claims: >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 endoscopes
Claims: >1mm x<875mm
<13.2lbs
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30. V-PRO® max Cycles 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
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31. STERIZONE® VP4 Sterilizer
 Cycles
Time
 Can Process
ID x Dia.
Single Cycle
46 minutes*
Up to 3 single channel flexible endoscopes in the presence of other packaged medical devices or
up to 2 double channel and one single channel for a maximum of 5 total channels
≥1.0 mm id x ≤ 989 mm
Rigid channel devices including single channel and double rigid channel endoscopes
≥ 0.7 mm x ≤ 500 mm
≥ 2.0 mm x ≤ 575 mm
Multi-Channel flexible endoscopes up to 4 channels such as air, water, working, etc. (e.g. colonoscope, gastroscopes)
≥ 1.2 mm x ≤ 1955 m
≥ 1.45 mm x ≤ 3500 mm
Mixed loads of general instrumentation up to 75 lb. consisting of nonlumened endoscopes and instruments.
Cycle time varies based on composition of the load and load conditions.
**Only the Olympus® EVIS EXERA II Duodenovideoscope TJF-Q180V in Canada and EU. The US FDA 510k does not include this scope.
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32. Comparing the Systems STERIZONE® VP4 Sterilizer V-PRO® MaX
STERIZONE® VP4 Sterilizer
V-PRO® MaX
STERRAD® 100NX
Cycles / System 1 3 4
Cycle Parameters
Variable based on load configuration
Fixed cycles
Cycle Time(min)
46 *
35 for flexible
55 for lumens
28 non lumen
42 for Flexible
47 for Standard
24 for Express
60 for DUO
H2O2 Concentration
50%
59%
90%
Standard & Flex
 59% for the DUO and Express
Number of Pulses 2
Chamber Size
125L
136L
150L
Maximum Load
75 lb. (34 kg.)
+ 25 lb.(11.3 kg.) 3 tier loading rack
24 lb.
21.4 lb.
DUO lb.
*Cycle time varies based on load composition, weight and temperature
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33. STERIZONE® VP4 Sterilizer
Comparing the Systems
STERIZONE® VP4 Sterilizer
Steris
V-PRO® MaX
STERRAD® 100NX
Loading
3 adjustable shelve
2 tiered shelves
Maximum Flexible Scope Load
3 flexible scopes
2 flexible scopes
Injection Method
Continuous pulse
Single pulse
Injection controlling parameter
Pressure
Quantity
Chamber Temperature
41°C
50°C
<55
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34. Specification Comparison
STERIZONE VP4®
V-PRO®max
STERRAD®
100NX®
Time
Variable*
Selectable**
Volume of H2O2
Fixed
Pressure
Temperature
Weight Limits
< 75lbs
<24lbs
<21lbs
* Dynamic Sterilant Delivery SystemTM that delivers H2O2 through microburst injections to adapt to the composition of the sterilizer load
** Selectable based on the ability to sterilize a specific type instrument design
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35. Thank you! Questions?

36. 2016