The evolution of low temp sterilization13650861(1).ppt

The evolution of low temp sterilization

1. The Evolution of Low Temperature
Sterilization
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®
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2. Presented by
Pika N Lynch, MSN, RN
Clinical Specialist TSO3
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®
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3. 3
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. 5
Brief History of Sterilization
The use of antiseptics
such as pitch, tar and
aromatics was used by
the Egyptians to
embalm bodies
The research of Dr.
Robert Koch and
associates devised the
first non pressure
flowing steam
sterilizer
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.

6. Low Temperature Technology Timelines
1
9
6
0
1
9
9
0
2
0
1
0
ETO
ETO becomes
standard for low
temperature
sterilization
VHP Only
Steris
introduces
VPro line
Gas Plasma
STERRAD is
introduced to
the market
VHP and ozone
TSO3 receives
510K
clearance.
Partners with
Getinge
2
0
0
0
2
0
2
0
1
9
7
0
1
9
8
0

7. 7
Characteristics of an Ideal
Sterilization Method* Consists of:
High EfficacyRapid 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. 8
Characteristics of an Ideal
Sterilization Method* Consists of:
High EfficacyRapid 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. 9
Characteristics of an Ideal
Sterilization Method* Consists of:
High EfficacyRapid Activity
Strong
Penetrability
Material
Compatibility
Nontoxic
Organic Material
Reistance
Adaptability
Monitoring
Capability
Cost
Effectiveness
ability to achieve sterilization quickly
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®
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10. 10
Characteristics of an Ideal
Sterilization Method* Consists of:
High EfficacyRapid 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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®
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11. 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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®
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12. 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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®
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13. 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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®
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14. 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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®
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15. 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. 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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®
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17. Drivers for Low Temperature
Sterilization
17 TSO3
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18. 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. 19
Market Growth Drivers
G
row
ing global population
G
row
ing aging population
G
row
th in m
inim
ally invasive surgeries (M
IS)
Prevalence of “superbugs”
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20. MIS Devices are Complex, Delicate, and
Expensive, and Therefore Difficult to Disinfect
Completely
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

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
die
1
•Half of all bugs that cause infections after
surgery are antibiotic resistant
2
Superbug, CRE, has become resistant
to most available antibiotics, resulting
in death in up to 50% of patients who
become infected
1
CRE infections increasingly prevalent and linked
to use of endoscopes, including seven incidents
and two deaths at UCLA Medical Center
3
1)Source: Centers for Disease Control (CD)
2)The Lancet Infectious Diseases journal, as reported by Time, October 2015
3)Associated Press, February 20, 2015
21

22. Review of Current Low
Temperature Sterilization Options
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23. 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
®
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®
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24. 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
*https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/
GeneralHospitalDevicesandSupplies/ucm208018.htm
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25. 25
Ethylene Oxide
ConsPros
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)
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26. 26
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 H
2
O
2.
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. 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
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28. Chemical Used in Medical Device
Reprocessing
28
Why is Hydrogen Peroxide Important?
ETO
H
2
O
2
Relative Market Share
Over Time
Ethylene Oxide (100%, 90/10, etc. – all
forms)
•Toxic
•Carcinogenic
•Slow
•Environmental pollutant
Hydrogen Peroxide (VHP, Plasma, etc.)
•Quick
•Environmentally safe
•However, typically expensive, with
strict loading limitations and
monitoring
Hydrogen Peroxide Addressed Need for Safer, More Cost Effective Sterilization

29. 29
What might you sterilizer in a Low Temperature
sterilizer?
Endoscopic Systems
•Flexible Endoscopes
•Rigid Telescopes
•Light Guide Cables
•Video Cameras
•Instrument sets for Urology, Gynecology,
General Surgery, ENT, Plastics, Thoracic, Pulmonary
Anesthesia
•Laryngoscope Blades
•Flexible Intubation Scopes
•Video laryngoscopes
•Other intubation devices such as stylets, rigid
endoscopes, etc
Many Other Devices
•Ultrasound Transducers
•Stereotactic Head Screws and Devices
•Eye Shields
•Silicone Dilation Bougies
•Stainless Steel Instruments
•Doppler Probes
•Internal Defib paddles

Orthopedics
•Rechargeable Batteries
•Large Bone Power Tools
•Arthroscopes
•Video Optical Sets

Identifying the Ideal Customer
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30. 30
VHP Based Sterilizers
1st
Generation
2
nd

Generation
Latest
Technology
STERRAD
®
100S
STERRAD
®
100NX
•2 cycles at 90% (original) &
2 optional cycles at 59%
Steris (AMSCO) V-PRO
®
maX
•3 Cycles
STERIZONE
®
VP4
Sterilizer
•1 Cycle for all
devices
•75 lb load
capacity
STERRAD
®
100NX
ALLCLEAR
•2 cycles at 90% (original)
& 2 optional cycles at
59%
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31. 31
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. 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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®
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33. 33
STERIZONE
®
VP4 Sterilizer
•Low temperature sterilization system
(41°C ± 3°C)
•Uses dual sterilants: vaporized
hydrogen peroxide (H
2O
2) and ozone
(O
3), 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
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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-channeled
1

endoscopes such as video
colonoscopes and gastroscopes.
1
Up to 4 working channels
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35. 35
Comparing the Systems
 
Steris
V-PRO
®
MaX
STERRAD
®

100NX
STERIZONE
®

VP4 Sterilizer
# of Selectable
Cycles
3 4 1
Cycle ParametersFixed cycles 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)
H
2
O
2

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. 36
Comparing the Systems
 
Steris
V-PRO
®
MaX
STERRAD
®

100NX
STERIZONE
®

VP4 Sterilizer
Loading 2 tiered shelves2 tiered shelves
3 adjustable
shelves
Maximum
Flexible Scope
Load
2 flexible scopes2 flexible scopes3 flexible scopes
Injection Method Single pulse Single pulseContinuous pulse
Injection
controlling
parameter
Quantity Quantity Pressure
Chamber
Temperature
50°C <55 41°C
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37. 37

STERRAD
®
100NX
STERRAD
®

100NX
TIMECAN 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 min2 flexible endoscope >1mm x<875mm <13.2lbs
37
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38. 38

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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®
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39. STERIZONE
®
VP4 Sterilizer
39
   
Inside Diameter Length
Single Cycle
Single channel flexible endoscopes≥ 1.0 mm ≤ 850 mm
Single and double channel flexible
endoscopes
≥ 1.0 mm ≤ 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. 40
Process Challenge Comparison
STERRAD® Systems
(100S, NX, 100NX)
H
2O
2
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
V-PRO® Systems
H
2O
2
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
STERIZONE® VP4
H
2
O
2
& Ozone
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 System
TM
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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®
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41. What’s the Future of Low
Temperature Sterilization?
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®
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42. 42
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.
42
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43. 43
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.
43
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®
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44. Professional Organizations
44
•“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)
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®
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45. 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.”
STERIZONE Technology ™. 2016 . All Rights Reserved.

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46. 46
The Future of Sterilization
STERIZONE Technology ™. 2016 . All Rights Reserved. TSO3
®
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47. 47
The Future Of Sterilization
STERIZONE Technology ™. 2016 . All Rights Reserved.
ERCP Scope in a Aptimax Tray
ERCP Scope Prepared for VP4
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48. Copyright © 2014-2017
TSO
3
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 TSO
3
Inc.

The TSO
3
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?
49