Nov 2012 Webinar - When Steam is Too Extreme - Todays...

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3M™ Sterile U Network3M™ Sterile U Web Meeting – November 15, 2012

© 3M 2012. All Rights Reserved.1

When Steam is Too Extreme –Today’s Options for Low Temperature Sterilization

Today’s meeting times: 9:00 a.m., 11:00 a.m. and 1:00 p.m. CST

To hear audio, call 800-937-0042 and enter access code 7333633Phone lines are muted. Audio will commence when the webinar begins.

Introducing the 3M Learning Connection:New Name, Same Great Courses•It’s an educational resource bringing you 3M™ Sterile U and other Infection Prevention courses. You’ll soon see some exciting new benefits as our program evolves!

•Improved features:• “Add to my Calendar” feature


Add to my Calendar feature added this month!•Other 3M courses will be more accessible as we expand our offerings.

•What do you need to do? •Nothing. Your current registrations remain and our Sterile U offerings have not changed.

Welcome!• Topic: When Steam is Too Extreme – Today’s Options for Low

Temperature Sterilization

Facilitators: Diane Koch 3M Sandra Velte 3M


Speaker: Larry Talapa, Technical Specialist, 3M Infection Prevention

Housekeeping• Questions

• Mute feature (*7 = unmute; *6 = mute)

• “Chat” feature

• Technical difficulties

• Post session follow-up

For more information: www.3M.com/3MSterileU

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Next week, all of today’s meeting participants will be sent an email containing instructions for obtaining a CE Certificate for today’s meeting.

How do I get a CE Certificate?


The email will be sent to the email address you provided when you logged-in to today’s meeting. If there are others listening with you today who did not log-on, you may forward the CE certificate email to them.

Disclosure Statement

Larry TalapaTechnical Specialist3M Infection Prevention Division


3M Center, St. Paul, MN

Learning Objectives

List the low temperature sterilization technologies that are available in the industry

Describe how each of the low temperature sterilization technologies work


Recognize the benefits and limitations of each low temperature sterilization technology

Understand the factors to be considered for choosing a low temperature sterilization technology

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Outline

• Quick review– The basics of steam sterilization

• Low temperature sterilization technologies

• Examples, strengths, and limitations• Ethylene Oxide


• Ethylene Oxide• Hydrogen peroxide• Ozone• Low Temperature Steam and

Formaldehyde (LTSF)• New technologies?

• How to choose?

Egyptians (B.C.E.)

TarResinsSulfur fumes

Sterilization . . . the beginning


Hippocrates (B.C.E.)

Boiling water

Sulfur fumesDrying

L iPioneer in heat

Disproved theory of spontaneous generation



LouisPasteur

(1822 - 1895)

Charles Chamberland

Developed one of the first pressure steam sterilizers (1880)

disinfection/sterilization

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Defined effectiveness of steam under pressure as sterilization method

Research paper listing over 70 h i l f ‘di i f ti ’



RobertKoch

(1843 - 1910)

chemicals for ‘disinfection’

Wilmot Castle company began operations 1883

Hall Bros. founded the American Sterilizer Company (AMSCO) in the early 1900’s


Today, an estimated 75-85% of terminal sterilization in health care facilities is conducted with steam under pressure


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Steam sterilization - advantages

• Fast

• Effective

• Inexpensive

• Easy to use


y

• Readily available

• Technology well understood

• No toxicity or hazardous residues

• Compatible with many devices

• Gravity displacement

• Dynamic air

Types of steam sterilization processes


yremoval• Prevaccum• Steam-flush

pressure-pulse (SFPP)

Item Exposure time at 132°C Exposure time at 135°C

Wrapped Instruments 4 minutes 3 minutes

Textile Packs 4 minutes 3 minutes

Typical steam sterilization process conditions . . .

Minimum cycle times for dynamic air removal steam sterilization


Textile Packs 4 minutes 3 minutes

Wrapped Utensils 4 minutes 3 minutes

Unwrapped nonporous items 3 minutes 3 minutes

Unwrapped porous and nonpororus (mixed load)

4 minutes 3 minutes

Reference: ANSI/AAMI ST79: 2012 & A1 & A2 & A3

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When steam is too extreme . . .


Low Temperature Low Temperature SterilizationSterilization


Sterilization processes using chemical gases or vapors at lower temperatures to process heat and moisture sensitive instruments.

• High efficacy• Penetrability• Materials compatibility • Rapid activity

N t i

Attributes of the Ideal Sterilant


• Non-toxic• Organic material resistance• Adaptability• Monitoring capability• Cost effectiveness

Source: “Guideline for Disinfection and Sterilization in Healthcare Facilities” 2008, CDC

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Low temperature sterilization technologies available* today. . .

• Ethylene oxide

• Vaporized hydrogen peroxide• With and without plasma phase


p p

• Ozone

• Low temperature steam/formaldehyde (LTSF)

*Not all technologies/products available in the United States

Great references . . .


ANSI/AAMI ST 58: 2005ANSI/AAMI ST 41: 2008

Ethylene oxide (EO, EtO)

Ethylene oxide sterilization – fun facts

• Gas at ambient temperature and pressure

• EO kills by alkylation of macromolecules (nucleic acids, proteins)

T i l t t 37ºC t 55ºC


• Typical process temperatures 37ºC to 55ºC

• Typical exposure times 60 to 120 minutes

• Highly penetrating; minimal material interaction

• Aeration times vary by materials and process

• Health care and industrial applications

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Total Volume of Sterilized Medical Products in US

2004 EO Sterilized Product

Contractors 70%

OEMs 18%

© 3M 2012. All Rights Reserved.22 Source: Balchem Specialty Products, 2005

100% Hospitals 9%

Blenders 3%

Ethylene Oxide Sterilization Process

Critical Variables

• Time

• Temperature


• Relative humidity

• Ethylene oxide concentration

Ethylene Oxide Sterilization Processes

• 100% EO• Small, single dose cartridges• Eliminate cost of diluent • Smaller chamber size

G Mi t


• Gas Mixtures• Tanks• EO mixed with HCFC or CO2

• Reduces risk of flammability• Tank change is a possible source of worker

exposure

• Larger chamber size

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100% Ethylene Oxide Cycle

ConditionExposure Exhaust Aerate

Pre

ssu

reP

ress

ure


Time (Hours)

Ch

amb

er

Ch

amb

er

Negative Pressure

Condition

Exposure

Exhaust Aerate

ress

ure

ress

ure

EO Gas Mixture Cycle

Positive Pressure


Time (Hours)

Ch

amb

er P

rC

ham

ber

Pr

Ethylene Oxide - Aeration

• Ethylene oxide – readily penetrates polymeric materials

• Aeration process required to remove ethylene oxide from the polymers


p y– Heat, with air flow

• Consult the medical device manufacturer for recommended aeration times

Composition of deviceIntended application

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Ethylene Oxide - Aeration

• Aeration Time Guidelines*

Temperature Aeration Time

50°C 12 ho rs


50°C 12 hours

60°C 8 hours

* Based on polyvinylchloride (PVC) tubing

Source: ANSI/AAMI ST41:2008

EPA recognizes the necessary use of EO – EO is not being banned!


“Rumors of my death have beengreatly exaggerated”

Mark Twain

“Rumors of my death have beengreatly exaggerated”

Mark Twain

Ethylene Oxide Sterilization -Advantages and Limitations

• Advantages– Penetrability (lumens,

packaging)– Materials compatibility


– Materials compatibility

• Limitations– Cycle time (aeration

required)– EPA compliance

requirements

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Vapor Phase Hydrogen Peroxide (with plasma)


Vaporized Hydrogen Peroxide (without plasma)

Hydrogen Peroxide (H2O2)

Hydrogen peroxide sterilization – fun facts

• Vapor vs. gas

• Dissociation into chemical radicals (e.g. OH-)

• Kills by oxidizing macromolecules


Critical Variables

– Time

– Temperature

– Concentration of hydrogen peroxide

– Plasma, if applicable

Vaporized Hydrogen Peroxide with Gas Plasma

• Examples

• Sterrad™ Systems• NX 100NX 100S


• NX, 100NX, 100S

• HUMANMEDITEK HTMS™ Sterilizers• HTMS 30, 80, 142

HTMS brand manufactured by HUMANMEDITEK Corporation

Sterrad™ is a registered trademark of Advanced Sterilization Products, a Johnson and Johnson Company.

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Hydrogen Peroxide Sterilizers with Plasmsa


HTMS -80 HTMS -142

Plasma – 4th State of Matter


Primary role – destruction of residual hydrogen peroxide

Source: HUMANMEDITEK, www.hmmdt.com

Hydrogen Peroxide Systems – With Plasma

• Sterilant Containers


Sterrad™

HTMS

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Hydrogen Peroxide/Plasma Systems

• Typical Process Temperatures: ≤ 55°C

• Typical Process Times:


yp• Vary by device to be sterilized

• Range 24 minutes to 55 minutes

• Chamber size:• 30 liters to 142 liters

Vaporized Hydrogen Peroxide Systems (without plasma)

• Example: Amsco® V-PRO™ Systems• V-PRO™ 1

• V PRO™ 1 Plus


• V-PRO™ 1 Plus

• V-PRO™ maX

Amsco® and V-PRO™ are registered trademark of Steris Corporation

Amsco VPRO 1 / VPRO 1 Plus Lumen Cycle


Source: Steris Technical Data Monograph

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V-PRO™ Processes

• Sterilant Containers


Hydrogen Peroxide Systems – No Plasma

• Typical Process Temperatures: Approx. 50°C

• Typical Process Times:

Vary by device to be sterilized


• Vary by device to be sterilized

• Range 28 minutes to 55 minutes

• Chamber size:

• 136 liters

Amsco V-PRO Series

Hydrogen Peroxide Based Sterilization Systems - Advantages and Limitations

• Advantages– Cycle time

Li it ti


• Limitations– Penetrability

– Material compatibility

– Packaging limitations (cellulosic materials)

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Ozone

Ozone sterilization – fun facts

03 molecule• Christian Friedrich Schönbein coined the term

“ozone” from the Greek word “ozein”, meaning “to smell”, due to its characteristic odorP t ti l i E th’ t h


• Protective layer in Earth’s atmosphereOzone sterilization

• Dissociates into chemical radicals• Kills by oxidation

Critical variables – ozone sterilization• Ozone concentration• Time• %RH

Ozone

• Sterilant• Oxygen source required

• Self-contained ozone generator


O2 ‘electrified’ to ozone (O3)

Ozone Sterilization

• Example: SteriZone™ 125L

• Cycle Time: 4.5 hours


• Temperature: 31°C - 35°C

• Chamber Size: 125 liter

SteriZone™ is a registered trademark of TSO3 Inc.

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Ozone Sterilization –Advantages and Limitations

• Advantages• Low temperatures

• Lumen penetration


Lumen penetration

• Limitations• Materials compatibility

• Relatively longer cycle time

Steam and Formaldehyde Combination Process Low temperature steam and formaldehyde (LTSF) fun facts . . .

• Comprised of gaseous formaldehyde (2-5%) and low temperature steam (50°C to 80°C)

• Formaldehyde: Colorless gas, biocide


• Examples: Getinge HS66 Turbo Combi

Matachana 130LF

Source: www.matachana.com; www.getinge.com

Not available in the United States

Example – Formaldehyde solution (formalin)


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Low Temperature Steam and Formaldehyde –Advantages and Limitations

• Advantages• Equipment with both steam and low

temperature capability


• Limitations• Concerns - formaldehyde toxicity and

residuals• Paraformaldehyde formation –white powder

• Penetrability

Chemical sterilants can be classified into two basic categories:

• a) LCSs/HLDs in which the items to be processed are immersed manually or processed in an automated system under defined conditions; or

• b) Gaseous chemical sterilants that are used in a sterilizer under defined cycle conditions

What about liquid chemical sterilants?


defined cycle conditions.

“Processes that use LCSs/HLDs and gaseous chemical sterilization processes are validated by different methods. Therefore, they do not provide the same level of sterility assurance. Medical devices undergoing gaseous chemical sterilization can be packaged to maintain product sterility indefinitely. However, devices processed with LCSs/HLDs are not packaged.”

Source: ANSI/AAMI ST58, “Chemical sterilization and high level disinfection in health care facilities”, 2005.

Liquid Chemical Sterilants - Examples:

Product Manufacturer Chemical Agent Contact Time

Acecide™ MinntechCorporation

8.3 % Hydrogen peroxide & 7.0 % Peracetic acid

5 hours at 25°C


Rapicide™ Medivators Inc. 2.5% Glutaraldehyde 7 hours 40 minutes at 35°C

SYSTEM 1E™/S40™Sterilant

Steris Corporation 35.5% Peracetic acid 6 minutes at 46-55°C

Source: www.hhs.gov; www.FDA.gov

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Low Temperature Technologies – What could be next?

• Nitrogen Dioxide Gas (NO2)

• Chlorine dioxide


• UV Light

• Pulsed light

Or maybe we won’t need sterile instruments . . .


Considerations for selecting a low temperature sterilization process

Devices to be sterilized

Packaging

Acquisition cost


q

Installation costs and complexity

Operating costs (sterilant, monitoring products, wraps/containers)

Availability of local service personnelSee also ANSI/AAMI ST58, Section 5

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Considerations for selecting a low temperature sterilization process (cont.)

Operator safety

Equipment warranty

Medical device compatibility


Chamber size (i.e. how many/which model needed to handle volume of goods to be processed)

Cycle time

Operator training

Device turn-around time needed

All low temperature sterilization technologies have advantages and limitations

Penetrability and materials compatibility are

Summary


Penetrability and materials compatibility are the major limitations of the oxidative low temperature sterilization technologies

Follow manufacturer’s recommendations regarding choice of sterilization process

Next 3M™ Sterile U Web Meeting:

Thursday, December 13th

Y ’ N t Al ! 3M’ St ili ti T h

Thank you!


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Nov 2012 Webinar - When Steam is Too Extreme - Todays...

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