Sterilization Methods used in Healthcare Today STERILIZATION What is Sterilization?

Sterilization Methods used in
Healthcare Today
Operating Room Nurses Chapter of Singapore
Nurses Association
16 October 2011
STERILIZATION
What is Sterilization?
The complete destruction of all
measurable forms of microbial life
(including bacterial spores) by a
chemical or physical process
Ideal Sterilant: “Wish List”
ƒ
Effective
ƒ
ƒ
Non – toxic
ƒ
Penetration
ƒ
ƒ
Adaptable Monitoring
ƒ
ƒ
Material compatibility
Fast
Cost Effective
Regulatory approval
1
Most Commonly Used Sterilization
Methods in Hospitals Today:
z Steam
z Ethylene Oxide
z Hydrogen Peroxide
z Peracetic Acid
RESISTANCE OF MICROORGANISMS
CREUTZFELDT-JACOB DISEASE
Extended Sterilization
Sterilization
BACTERIAL SPORES
B. subtilis
Cl. sporogenes
High Level Disinfection
MYCOBACTERIA
Intermediate Level
Disinfection
MTB. var bovis
NONLIPID VIRUSES
poliorhinohi
Low Level
Disinfection
FUNGI
Cryptococcus, sp.
Candida, sp.
VEGETATIVE BACTERIA
Pseudomanas,sp.
Salmonella, sp.
Staphylococcus,sp.
LIPID VIRUSES
HSV
CMV
HBV
HIV
From: Bond WW, Ott BJ, Franke KA, McCracken JE. Effective use of chemical germicides on
medical devices: instrument design problems. In: Block SS. Disinfection Sterilization. and Preservation,
4th ed., Lea and Febiger, Philadelphia, 1951, pp. 1097-1106
SPAULDING CLASSIFICATION
SYSTEM
Spaulding Classification of Devices/Items
Spaulding Classification of
Devices or Items
Level of Disinfection
Interim Disinfection
(to be followed with
separate subsequent
decontamination steps)
Critical (Penetrates the
vascular system or sterile
areas of the body) ex:
surgical instruments
Sterilant (Sporicidal)
Interim Disinfection
can be utilized
Semi-Critical (To be used on
mucous membranes or nonintact skin) ex: flexible
fiberoptic endoscopes
Sterilant/High Level
(Sporicidal or High Level =
100% kill of all vegetative
organisms)
Interim Disinfection
can be utilized
Intermediate (Tbcidal)
Interim Disinfection
can be utilized
Non-Critical (Contact intact
skin) ex: blood pressure cuff
2
Sterilization Processes
(Healthcare, Present Day)
Product
Process
Application
Location
Remarks
STERIS Small
& Medium
Sterilizers
Steam
Sterilization
Heat Stable
Items
Point of Care
and
Centralized
Reliable, safe,
inexpensive
g 3017
Eagle
EtO
Sterilization
Heat Sensitive
Items
Centralized
Productivityy
and safety
considerations
STERIS
System 1
Peracetic Acid
Immersible
Heat Sensitive
Items
Point of Care
Sterilization
Just in Time,
no shelf life
STERIS
Hydrogen
Peroxide
Heat Sensitive
Items
Centralized
Efficacious and
Productive
V-PRO
Sterilization
Medical device manufacturers must state what method of sterilization is appropriate for their device.
STEAM STERILIZATION
Saturated steam under
pressure is the oldest and
most common agent used
in healthcare facilities for
sterilizing heat and
moisture stable medical &
surgical instruments, devices,
and supplies.
20
BASIC STEAM STERILIZATION
THEORY
Completely destroys all
microbial life
z moist heat coagulates
protein/protoplasm
3
STERIS® STEAM STERILIZATION
SYSTEMS
Small, Medium, Large Chamber Size
Fully Jacketed Chamber
Single Door or Double Door
Two Year Warranty Door Gasket
Floor Mounted or Cabinet Mounted
M
Manual
lL
Load/Unload,
d/U l d A
Automated
t
t dL
Load/Unload
d/U l d
Chamber Loading, Floor Loading
Internal Generator, External Generator, House Steam
STERIS PORTFOLIO
High Temperature
Solutions
Low Temperature
Solutions
Ethylene Oxide (EO) Sterilization
20
4
How Does EO Sterilize?
z Chemical reaction between
EO and microbial cell
z Cell is unable to normally
metabolize and reproduce
z Effects are irreversible and
cause cell death
EO Historic Overview
z Discovered in 1859
z 1950’s - health care applications
z 1980’s - safety issues surface
– Aeration is now part of the process
z 1990’s - environmental concerns
– EO is not banned
– EO is not destroying the ozone layer
– Chamber exhaust within local codes
z Today – almost exclusively 100% EO
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Eagle 3017 100% EO Sterilizer/Aerator
z Sterilizes and aerates heat
and moisture sensitive
medical instruments
z Used in Central Service
Departments of hospitals
& off site reprocessing
facilities
z Introduced in 1994
z Built in worker and
environmental protection
z Single door or double door
Proven better penetration than competition.
5
EO Sterilization is in Use
Worldwide – Daily – in Hundreds of
Hospitals
z
Effective
z
Proven
z
Safe
z
Versatile
z
Economical
Vaporized Hydrogen Peroxide Sterilizer
44
What is VHP?
z VHP = Vaporized Hydrogen Peroxide
z Dry, low temperature sterilization of heat and
moisture sensitive instruments
z Oxidizing agent with a broad range of microbial
kill
z No toxic residuals at the end of the cycle
– By-products are water vapor and oxygen
z Originally developed by STERIS in the late 1980’s
for use in pharmaceutical production
6
How is VHP different from Gas
Plasma?
z Hydrogen Peroxide “gas” sterilizes
z Followed by electrically charged “plasma” which
breaks down toxic residuals
z Cycle
C l may actually
t ll abort
b t due
d to
t plasma
l
interference with metal instruments or contact
with sterilizer walls
z Pure STERIS VHP does not require plasma
Why No Plasma?
Unlike the STERRAD gas plasma systems, the
V-PRO Sterilization Systems do not use plasma as
part of their validated sterilization cycles.
g the Reasons Why:
y
Among
The V-PRO Sterilizers do not require plasma because
VHP, on its own, is a powerful sterilant.
The role of plasma in a VHP sterilization
process is unclear.
Why No Plasma?
ƒ The FDA has questioned the role of plasma in the
sterilization efficacy of the STERRAD Systems.
Specifically, the FDA stated in a letter to ASP:1
“you have now suggested that the plasma step contributes
very little,
littl if att all,
ll to
t the
th sterilization
t ili ti process.””
1Freedom Of Information (FOI) copy of STERRAD CycleSure submission K994055,
FOI page 191, item #5. Letter to Advanced Sterilization Products from FDA, Office of
Device Evaluation, Center for Devices and Radiological Health.
7
Latest Technology:
V-PRO MaX Features
z Addition of 35 min.
Flexible Cycle
z
Updated Design
z Easy Open Door
– Just pull and push closed (no
handle)
z Large screen for easy
viewing
z Updated software
z Cycle Phase color coded
Processing Alternatives
The V-PRO Flexible Cycle can sterilize single or dual lumen
surgical flexible endoscopes and bronchoscopes in either of
two load configurations:
Load #1
Load #2
p
Scopes
2 Scopes
p
1 Scope
p
Additional Load
Yes
Size
No
A single Lumen with ID ≥ 1mm Length ≤ 1050mm
(or) 2 Lumens with 1 Lumen with ID ≥ 1mm Length ≤ 998mm
and the other lumen having an ID ≥ 1mm Length ≤ 850mm
Weight
Total 24 Pounds
A single Lumen with ID ≥ 1mm Length ≤ 1050mm
Total 24 Pounds
8
Comparison of V-PRO Sterilization Cycles
Sterilant/
Injection
(g)
Pre-Injection
Pressure (Torr)
# Injections
Sterilant
Exposure
Time (min)
~55 minute
V-PRO 1 Cycle,
V-PRO 1 Plus Lumen Cycle
V-PRO maX Lumen Cycle
2.1
0.4
4
32
~28 minute
V-PRO 1 Plus Non Lumen Cycle
V-PRO maX Non Lumen Cycle
2.1
1.0
4
12
~35 minute
V-PRO maX Flexible Cycle
2.1
0.4
4
12
Sterilization Cycle
-VAPROX HC Sterilant (59% H2O2) used by all cycles.
-V-PRO technology does not concentrate sterilant (as does NX
technology). All cycles use 2.1 g sterilant injection of VAPROX HC Sterilant
(~59% H2O2 solution) each sterilization pulse, with 4 sterilization pulses per
cycle, and a 50 °C chamber temperature.
Devices Commonly Processed
Endoscope
Batteries
Endoscopes
Defibrillator
Paddles
Camera
Light Cable
… and much more!
Flexible Devices
Routinely Processed with VHP
Bronchoscope
Ureteroscope
Examples of
Flexible Devices
9
Lumen Devices Routinely Processed with VHP
Non-Lumen Devices Routinely
Processed with VHP
V-PRO Sterilizer Accessories
Available with the Max Cycle
Process
Indicator
Sterilant
15
cycles/cup
Adhesive PI
labels
24 hr SCBI
Instrument
Organizers
Tyvek
pouches
Sterilization
Trays
Challenge
Pack
10
VAPROX HC Sterilant
ƒ
VAPROX® HC Sterilant – 59% liquid hydrogen peroxide
ƒ
Specially designed cartridge to eliminate user error
ƒ
Contains sterilant for 15 cycles (SKU PB007)
ƒ
Air shippable version has sterilant for 4 cycles (SKU PB028)
ƒ
Same sterilant for all V-PRO Sterilizers & all cycles
ƒ
B C
Bar
Code
d eliminates
li i t risk
i k off using
i expired
i d sterilant.
t il t
Trays
Instrument
Organizers
Mats
V-Pro mats are lightweight,
durable and allow for sterilant
penetration when processing
instruments. They feature
flexible prongs which loosely grip
instruments.
instruments
11
Peracetic Acid Sterilization
34
Peracetic Acid Sterilization
z Identified in the early 1900’s
z is a biocidal oxidizer that sterilizes even in the
presence of organic soil
z the extra oxygen atom in PA chemistry reacts
with cell components to cause cell death
z devices must be prepared prior to processing to
insure that sterilant contacts all surfaces
Peracetic Acid Historical Overview
z 1902 – Germicidal properties
reported
z 1984 – Food
F d processing/
i /
beverage industry
z 1985 – Healthcare Applications
z 1988 – Sterilizer
35
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SYSTEM 1 EXPRESS
•
Automated, validated system for liquid chemical sterilization
•
Cycle
Cyc
e Parameters
a a ete s
o 6 minute exposure time
o temperature 43-60ºC
o 0.2% concentration of diluted sterilant
•
Offers great productivity with 18-minute cycle time
o Fastest cycle time for sterile processing of critical devices
o Minimizes downtime between patients
z
S1 EXPRESS Provides a high standard of patient care, whether it’s
in your OR or GI department.
System Components
Quick Connects
A&B
Prefilters
Trays/Containers
S40 Sterilant Concentrate
Copyright 2011 STERIS Corporation – Alteration or Unauthorized Duplication of this Material is Prohibited
SYSTEM 1EXPRESS Overview
Feature
SYSTEM 1 EXPRESS
Sterilant Used
S40
Shelf Life of Sterilant
8 Months
# of Rinse Cycles
2
CI and BI available
Yes
Average Cycle Time
~18 Minutes
Exposure Time
6 Minutes
Incoming Water Temp
Requirement
43◦C
Water Quality Requirement
< 140 ppm
13
S40 Sterilant Concentrate
• S40 - 35% Peracetic Acid –
an oxidative chemistry
o Does not affix bioburden*
o Removes biofilm*
• Gentle on Devices
• S
Safe
f for
f Staff
St ff
o Cup design minimizes chance
for contact with sterilant
o Use Dilution (0.2% PAA) is
discharged safely down the
drain
o No special ventilation required
• 8 month shelf life
* ESGE Technical Note on Cleaning and Disinfecting 2003; WGO-OMGE and OMED Practice Guideline:
Endoscope Disinfection 2005
A Validated System: Quick Connects
zQuick Connects facilitate
the proper flow of use
dilution to contact internal
channels for sterile
processing efficacy
zSTERIS has devices
identified in SYSTEM
1EXPRESS labeling
zSTERIS Device Testing
Program qualifies new
devices for reprocessing in
SYSTEM 1EXPRESS for both
efficacy and material
compatibility
Copyright 2011 STERIS Corporation – Alteration or Unauthorized Duplication of this Material is Prohibited
Transport to Point of Use
z Cleaned, critical
devices are reprocessed
in trays with covered
containers
z Containers are easily
removed
d and
d transported
t
t d
to sterile field
z Containers are
designed to reduce the
risk for environmental
contamination of critical
devices
Copyright 2011 STERIS Corporation – Alteration or Unauthorized Duplication of this Material is Prohibited
14
Process Monitoring
• SYSTEM 1EXPRESS control monitors process
parameters of liquid chemical sterilization
• Processor aborts and alarm sounds if there is a
failure associated with one of the process
parameters
• Diagnostic cycle run every 24 hours
• Chemical and Biological Indicators are available for
extra assurance
Copyright 2011 STERIS Corporation – Alteration or Unauthorized Duplication of this Material is Prohibited
Device Validation for SYSTEM 1 EXPRESS
z A comprehensive listing of devices that may be
processed in the S1 EXPRESS is available from
STERIS
Copyright 2011 STERIS Corporation – Alteration or Unauthorized Duplication of this Material is Prohibited
Hot Issues in Hospital Sterilization
z Immediate Use (Flash) Sterilization – caution!
z Glutaraldehyde soak for Critical Surgical
Instruments – see Spaulding’s Classification
z Reprocessing single use devices – ask device
manufacturer
z EO “banned” – no!
15
Questions?
Technologies to Control Infection and
Contamination
16
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