What Is Sterilization?
• Sterile = free from any viable
micro-organisms *
• Sterilization is a validated process used to
render a product free from viable micro-
organisms.*
• It is the terminal kill or inactivation of all
micro-organisms with a probability of 10-6.
* ISO
Overall Goal of Sterilization
Produce sterile goods in a
cost effective, timely
manner for the use at or
on a patient.
It’s all about…
Keeping
the
Patients
Safe
Today’s Processing Challenge
• Removing evolving
microorganisms
from complex
instrumentation
Each instrument set component is
critical to the success of each
procedure
Sterilization
• Instruments,
implants, supplies,
and utensils often
require different
types of sterilization
technologies
Processing Decisions
are more Complex
Instrument Stewardship
• In addition to protecting
patients, good
processing work
practices protect the
facility’s investment by
protecting and
maintaining its
instrument system
Surgical Implants
• Many of today’s
surgical implants
require on site
sterilization
• Those processes
require an
understanding of
manufacturers’
processing
requirements and
sterilization and
monitoring concepts
The Sterilization Challenge
• Provide Instruments
Quickly
• Provide Correct and
Functional
Instruments
• Keep Patients Safe
• Keep Staff Safe
Today’s Sterile Processing
• Complex Instruments
• Fiberoptics, Computer
Chips, Imaging
Systems, etc.
• Sophisticated
Sterilization Methods
• More Infection Control
Decisions
• Many, Many More
Challenges
Good Sterilization Work Practices
include
• Compliance with
Industry Standards,
Regulations, and Work
Practice Guidelines
– EPA
– FDA
– OSHA
– State & Local
Governments
– International …
Poor work practices can cause
• Infections
• Delay of Treatment
• Equipment Incidents
• Infection Control and
Safety Issues
• Financial Loss
Sterilization Quality Assurance
Each facility must
• conduct and record several
measurements to assess the quality of
its products
• keep records on every item sterilized
Steps in Sterile Processing
• Decontaminate
• Inspect
• Assemble
• Package
• Sterilize
• Store
• Transport
Every Step Protects the Patient
Decontamination...
• …is the FIRST Step
in any Sterilization
Process
Inspection & Assembly
• Visual Inspection
for Cleanliness
• Positioning and
Placement to
Facilitate the
Sterilization
Process
Packaging
• Create a Bacterial
Barrier
• Allow Sterilant
Penetration
• Allow Aseptic
Opening
Sterilization
• The complete
destruction of
microorganisms on
an object
Routing of single use instruments in a hospital
Medical Hospital
devices
Use on a patient
Storage
Disposal
Instrument processing CSSD
Transporting
CSSD
Receiving
Washing Packing sterilising
Disinfecting Storing
Transporting
room
cleaning
cleaning/ desinfection
equipment
CSSD route
packaging room
sterilization equipment
room
Storage
room
cleaning
cleaning/ disinfection
equipment
CSSD route
packaging room
sterilization equipment
room
Storage
Receiving and cleaning
Carwash
room
cleaning
cleaning/ desinfection
equipment
CSSD route
packaging room
sterilization equipment
room
Storage
Packing
Sterilizers loading side
room
cleaning
cleaning/ disinfection
equipment
CSSD route
packaging room
sterilization equipment
room
Storage
Sterilizers unloading side
Process registration
Sterile storage
Instrument Chain CSSD / Decontamination cycle
Washing desinfecting loading
Wrapping
Sterilising loading
WEAKEST LINK Storing
Transporting
Sterilization Options
• High Temperature
• Low Temperature
Steam Sterilization, Mode Of Action
To transform water into steam, energy
has to be added.
This energy is released, when hot steam
hits on colder surfaces and thus
condenses and leads to the kill of the
micro-organisms (denaturation).
Water + Energy = Steam
Advantages of Steam Sterilization
• Fast
• Effective
• Inexpensive
• Technologically well
understood
• Relatively easy to use
• Items can be packaged
and maintained sterile
• No hazardous residues
after sterilization
Disadvantages of Steam
Sterilization
• Need to eliminate air
from the chamber
• Control steam quality
to prevent super
heating and
introduction of air or
other gases
• May damage moisture
and heat sensitive
items
• May cause dulling of
sharp instruments
Low Temperature Sterilization
Low Temperature Sterilization
Processes
Ethylene Oxide
LTSF
Gas Plasma
H2O2
Ethylene Oxide Sterilization
Processes
• Used in sterilization of heat & moisture
items since 1950’s
• Approximately 4,000 EO sterilizers in U.S.
hospitals
• Gas mixture or 100% systems
Current Status of EO
• NOT BEING BANNED, (nice try STERRAD, get your facts
right)
• 18th most commonly used chemical in the world
• EPA regulated, registered as a pesticide
• Major volume used by food industry
• 5% used for hospital sterilization
– Over 6000 - 100% systems
• Available in every country of the world
• Listed as toxic controlled substance
– …along with Hydrogen Peroxide and Peracetic acid!
• Best sterilant chemical for reprocessing medical devices
– EO Penetrates --Non oxidizing --No residue
EtO Influential Factors
• Humidity
– at least 35%
• Gas concentration
– > 400 mg/l
• Temperature
– the higher the shorter
• Time
Mode Of Action
• Alkylation process
– Forms new carbon bonds with proteins
NH 2 NH - CH 2CH 2OH
SH
CH 2 - CH 2 S - CH 2CH 2OH
Bacterial O Bacterial
cell EO cell
O - CH 2CH 2OH
OH
COOH COO - CH 2CH 2OH
LIVE DEAD
Ethylene Oxide
Sterilization Processes
• Advantages
– Sterilizes complex devices
– No lumen restrictions
– Non-corrosive
– Penetrates packaging
material
• Disadvantages
– Aeration required for
sterilant residue removal
– Longer processing times
– OSHA worker exposure
limits
– EPA compliance
requirements
Packeging
• Paper (Kraft, crepe)
• Paper-plastic pouches
• Tyvek-plastic pouches
• Textile wraps (cotton, linen, muslin,
treated fabric
• Non-woven wraps (Kimguard®,
Spunguard®)
• Rigid sterilization containers
Vapor Phase Hydrogen Peroxide
Plasma
(Gas Plasma)
• Advantages
– Cycle is short
– No aeration time
– No installation
requirements
Vapor Phase Hydrogen Peroxide
Plasma
(Gas Plasma)
Disadvantages
– Lumen restrictions
– May be corrosive
– Packaging
restrictions
– Items must be
completely dry,
including lumens
– Labor intensive
– OSHA worker
exposure limits
– EPA compliance
requirements
Liquid Peracetic Acid
• Advantages
• Cycle is short
• Non-toxic end products
• Small space requirements
• Water hook-up requirements
Liquid Peracetic Acid
• Disadvantages
• Limited to immersible devices
• Internal channels must be correctly connected to
ports for sterilant to contact all surfaces
• May be corrosive
• Items must be used immediately, cannot maintain
sterility
• OSHA worker exposure limits
• EPA compliance requirements
Sterilant Penetration
Property Ideal EO
H2O2
vapour pressure
High 600 2
(mmHg)
boiling point (°C) Low 10 150
molecular stability
High High Low
Biological Kill
Property Ideal EO H2O2
concentration (mg/l) Low 650 0.5
temperature (°C) Low 50 25
time (min) Low 30 10
Sterilant Removal
Property Ideal EO H 2 O2
non toxic Yes No Yes
end products
Low 10 150
boiling point (°C)
molecular stability High High Low
Comparative Toxicity
OSHA NIOSH NFPA
Sterilant PEL (8 hr. TWA) IDLH (Health)
EO 1 ppm 800 ppm 3
H2O2 1 ppm 75 ppm 3
H2O2 and 1 ppm 75 ppm 3
Peracetic acid mix
(Acetic Acid)
from Peracetic Acid
OSHA – Occupational Safety and Health Administration
IDLH – Immediate Danger to Life and Health (the lower the
PEL – Permissible Exposure Limit value the greater the concern for health and life)
TWA – Time Weighted Average NFPA – National Fire Protection Agency (Health Hazard:
0=normal material; 4=deadly)
NIOSH – National Institute for Occupational Safety and health
Results of NIOSH Study Mortality Rates
Among EO Exposed Workers
36
Hematopoietic Cancers 33,8
6 Actual number of deaths
Brain Cancer 11,6
among EO workers
80
Digestive Cancer 85,6
Respiratory Cancer
96 Expected number of deaths
101,7
in similar segment of general
42
Breast Cancer 49,6 population
17
Urinary Cancer 12,4
358
Heart Disease 430
61
Monmalignant Digestive Disease 76,4
48
Nonmalignant Respiratory Disease 9,4
12
Nonmalignant Genitourinary Disease 18,8
0 100 200 300 400 500
Source: New England Journal of Medicine (1991; 324;1402-7)
3M SteriVac system
100% EO Sterilizer/Aerator
3M SteriVac EO Sterilizer/Aerator
• Works with 100% EO - no risks of gas stratification.
• Uses single dose cartridges directly placed into the sterilization
chamber - No risks of EO spill through tanks or external gas
lines.
• Negative pressure cycle - No risk of EO spill through the
sterilizer door gaskets.
• Equipped with an exhaust hood - Maximum protection for the
operator unloading the sterilizer after the cycle.
• Pre-selected cycle parameters - the operator has only to chose
the temperature and start the cycle.
• At the end of the cycle the sterilizer turn automatically in
Aeration mode - cost saving and use friendly.
Engineering Controls
Local Exhaust Hood
EO Personnel Monitors
EO Area Monitors
Gas Mixture Cylinders
Single Use 100% EO Cartridge
EO in the Environment
• The primary fate of ethylene oxide in the
environment is degradation by a process called
hydrolysis:
• Ethylene oxide → ethylene glycol
• EO → CO2 + H2O + heat
• 99.9% efficient
• Question: What are your top three suggestions for selling Steri-Vac?
• Answer:
• Position EO as the “Gold Standard” by referencing the long term and wide spread use of
it in the industry.
– Use the fact that J&J is one of the largest users in the US of EO contract
sterilization!
• Point out the efficacy of EO technology as an alkylation of proteins process rather than an
oxidative technology. As a penetrating sterilant EO has no lumen, material, or device
limitations.
• 3. Address the time issue with EO and the necessity of aeration by discussing
the recognized benefits of a penetrating sterilant.
– Bring to light that the time issue is much larger than STERRAD makes it out to be.
4. Highlight the cost differential between EO and H2O2 technologies when comparing the systems
head to head.
– Included utility costs, BI/CI's, PM's, packaging, etc... Head to head cubic foot
comparison.
• .
• Thank you for your attention
