wfhss workshop20090325 lecture02 02 en

8/10/2019 Wfhss Workshop20090325 Lecture02 02 En

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Advances in

hydrogen peroxidegas plasmasterilization

Tatiana Yermakova

International Product Manager LTS

Europe, Middle East and Africa


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Topics of Discussion

Development of sterilization technologies Hydrogen Peroxide Gas Plasma Technology

STERRAD 100NX System Overview

Independent studies on prions inactivation


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Trends Affecting Sterilization Methods

Minimally Invasive Surgery

Multi-Resistant Organisms

Regulatory Climate changes

Need for Safety and Speed


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Sterilization Trends - Temperatures

Ethylene Oxide

1900

40

50

60

80

120130 Steam

1940 1950 1980

Formaldehyde

Peracetic Acid LiquidH202 gas plasmaChlorine Dioxide

T e m

p e r a

t u r e

0 C

Time Period


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Sterilization trends - Time

Ethylene Oxide

1

1950 1980

3

5

8

10

24

Hydrogen Peroxide

H202 gas plasmaPeracetic Acid Liquid

T i m e

i n H o u r s

Time Period

Ozone


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Ideal Sterilization system attributes

Terminal sterilization: packaged instruments

Fast cycle time: Instruments/device turn-around

Safety: No toxic dangers to humans and environment

Safety for the instruments: Low temperature process, compatibilityendorsed by Medical Device Manufacturers

Availability to built in CSSD (double door option)

Versatile to allow use in variety of locations

Cost effective

Simple to use by operators

Broad spectrum of antimicrobial efficacy


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HydrogenPeroxide Gas

PlasmaTechnology


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1880First

AntisepticSurgicalDressingby J&J

1890J&J

pioneersDry-Heat

and SteamPressure

Sterilization

1963J&J pioneers

CIDEX

ActivatedDialdehydeSolution for

HLD

1980Discovery of

HydrogenPeroxide as

a GasPlasma

Percursor

1993STERRAD

100 System

1997STERRAD

50 System

2000CIDEX

OPA

1999STERRAD

200 System

2004Next

Generation:STERRAD NXSystem

Infection Control InnovationInfection Control InnovationHistory of CommitmentHistory of Commitment

2008Next

Generation:STERRAD

100NX

System


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STERRAD Systems worldwide

Over12,000 STERRAD

Systemsinstalled and over 32 million cycles run worldwide

15 yearsof experience in health

care market!


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STERRAD Systems Features

Low temperature and dry process

Safe for heat- and moisture-sensitive items Short cycle time: Rapid instruments turnaround

Non-toxic: safe for instruments, environment, healthcareworkers

No need for aeration of the instruments

Easy to install: no plumbing or ventilation system needed

Instruments are wrapped for use or storage

Easy to use: simple push-button or touch screen operation


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What is Plasma?

It is the 4th state of matter

99% of all matter in the universe exists in theplasma state

Solid Liquid Gas Plasma


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How is Plasma Created?

Plasma is created when energy is applied to a gaswith enough force to strip electrons from atoms

The resulting mixture of free radicals, ultravioletlight, positive and negatively charged particles isknown as plasma

Aurora Borealis Plasma TV Neon Lights


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What is Gas Plasma?

Gas plasmas are highly ionized gases, composed

of ions, electrons and neutral particles thatproduce a visible glow

The benefit of low-temperature gas plasma is that

it has the ability to efficiently eliminate traces ofresidual hydrogen peroxide from materials anddevices

- No toxic residue on instruments

- Increased patient safety


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STERRAD Systems Sterilization Process

A vacuum is created inside the chamber

Hydrogen peroxide sterilant is injected into the chamber andallowed to surround and interact with devices to be sterilized

- This is the phase of the process in which microorganisms arekilled

Applying a strong electrical field creates plasma

Plasma breaks down the peroxide into a cloud of highlyenergized species (this produces the visible glow)

- The primary purpose of plasma is to efficiently eliminate tracesof residual hydrogen peroxide


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STERRAD Systems Sterilization Process

When the electrical field is turned off, these species recombine,turning the hydrogen peroxide into water vapor and oxygen

The divided hydrogenperoxide (H 2O2).

Recombine to simple water(H2O) and oxygen (O 2)

The result = No toxic residuesThe result = No toxic residues


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STERRAD 100S SystemOver 15 Years of Proven

Performance

Established industry standard in lowtemperature sterilization

- The original with reliable, proven

technology 55-minute Standard Cycle

- Most general surgical instruments

72 minute cycle for Flexible scopeswith use of boosters


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STERRAD 200 System

It Speaks Volumes

75-minute standard cycle- Most general surgical instruments

105 minute cycle for Flexible scopes

with use of boosters Large chamber helps process more

devices and allows for flexible loadconfigurations

1 or 2 doors configuration

Ideal for high volume Centralsterilization Departments


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STERRAD Systems ConsumablesAchieving and Maintaining Excellence

in Sterilization

STERRAD Systems Cassettes- Sterilant in safe, easy-to-use cassettes

CYCLESURE 24 Biological Indicator- Provides evidence of proper sterilization in

24 hours

Instrument Trays, Mats, and Holders- APTIMAX Instrument Trays come in a

variety of sizes and offer optimal protectionfor your instruments


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Next Generation

in hydrogenperoxide gas

plasmasterilization


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NX Technology

Vaporization system concentrates hydrogen peroxide byremoving most of the water

Increased ability to penetrate lumens, including single-channel flexible endoscopes and other difficult to sterilizelocations

Overall sterilization cycle times are reduced

H2O

2

H2

O2 H

2O

2

H2

O2

H2O

2

H2

O2

H2

O2

H2

O2

H2

O2

H2O

2

H2O

2

H2O

2

H2O

H2O

H2O

H2O

H2O

H2O

H2O

H2O

H2

O2

H2

O2

H2

O2

H2

O2

H2O

2

H2

O2

H2

O2

H2O

2

H2

O2

H2

O2

H2

O2 H

2O

2

H2O

H2O

Typical STERRAD SystemVapor Mixture

NX SystemVapor Mixture


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STERRAD NX SystemSterilizer for all your

departments needs

28-minute Standard Cycle

- Most general surgical instruments

38-minute Advanced Cycle

- Single-channel flexible scopes

- Longer-lumened devices

Fast = Increased productivity

Highest level of sterility at points ofuse assured


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STERRAD 100NX System overview


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STERRAD 100NX System Overview

The most advanced development from inventors of STERRAD

Designed to enhance the features and capabilities of the STERRAD 100S System

Incorporates NX technology in a larger system

Expanded capabilities

Enhanced lumen claims (to 0.7 mm)

Standard cycle time of 47 minutes

Flex Cycle time of 42 minutes

Larger, rectangular chamber size

Network connectivity capabilities

1 or 2 doors options


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STERRAD 100NX Sterilization Chamber

Rectangular Chamber

Chamber shape is designed toaccommodate multiple instrumentsets in one cycle

Useable chamber with double shelves

maximizes productivity by enablingmore instruments to be processed atonce

27% greater usable volume than theSTERRAD 100S System


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STERRAD 100NX Fast Cycle Times

STANDARD Cycle: 47 minutes

FLEX Cycle: 42 minutes

Provides exceptional instrument turnaround time

Eliminates need for duplicate inventories

Approximately 15% faster than the STERRAD 100SSystem


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STERRAD 100NX RFID Cassette

Built-in RFID (Radio FrequencyIdentification) Tag

RFID tag contains information thecassette expiration date,manufacturer, cell status and cyclecompletion

A partially used cassette that hasbeen ejected can be reinserted toavoid wasted sterilant, resulting incost savings

Five cycles per cassette


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STERRAD 100NX Network Connectivity

Users have the option to connect theirSTERRAD 100NX System to a remote PC or

network via an Ethernet connection on thesterilizer.

Users may also utilize the USB port.

Ability to electronically maintain cyclerecords and download & view one-secondcycle data.

Allows for easy upload of instrument

inventory to create menu for load entry datalist. Eliminates need to hand-write load list.


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Hydrogen Peroxide Monitoring

Directly measures vaporized hydrogen peroxide concentrationin the chamber every second

Ensures that sufficient peroxide is available for sterilization tooccur

STERRAD NX SterilizerAdvanced Full Nominal Cycle with 1.8 ml of 59% hydrogen peroxide with validation load

0

2

4

6

8

10

12

14

16

18

20

1 7 8

1 5 5

2 3 2

3 0 9

3 8 6

4 6 3

5 4 0

6 1 7

6 9 4

7 7 1

8 4 8

9 2 5

1 0 0 2

1 0 7 9

1 1 5 6

1 2 3 3

1 3 1 0

1 3 8 7

1 4 6 4

1 5 4 1

1 6 1 8

1 6 9 5

1 7 7 2

1 8 4 9

1 9 2 6

2 0 0 3

2 0 8 0

2 1 5 7

2 2 3 4

Time, Seconds

P r e s s u r e ,

T o r r

a n

d H y

d r o g e n

P e r o x i

d e

C o n c e n

t r a

t i o n ,

M g /

L

Hydrogen peroxide

Decay rate constant

Area under the peroxide-timecurve


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SterilizationClaims


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Sterilization Claims

Metal and non-metal medical devices at low temperatures

Instruments that have diffusion-restricted spaces

Hinged portion of forceps and scissors

Single-channel Polyethylene and Teflon flexible endoscopes

Rigid and semi-rigid endoscopes

Polyethylene & Teflon tubing

All Claims validated for 10 -6 SAL per ISO 14937 at half-cycle conditions.

Please refer to User guide for more detailed processing information


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Sterilization Claims STANDARD CycleSTANDARD Cycle 47 minutes

Single channel stainless steel lumens with

Inside diameter of 0.7 mm or larger

Length of 500 mm or shorter

Maximum 10 lumens per load; 5 lumens per tray

Polyethylene and Teflon tubing with

Inside diameter of 1 mm or larger

Length of 1000 mm or shorter

Up to 20 pieces of tubing at one time

Flexible endoscopes are excluded

Please refer to User Guide for more detailed processing information


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Clinical &Service Support


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Clinical Education & Service Support

Clinical Education Consultants

Provide on site in-service training (OR, GI, CSSD, Surgery Centers)to help standardize in all areas of the hospital

Provide Consultative Services to Customers in all proceduredepartments to offer best practice solutions in sterilization and HLD

Service Engineers

Assure validation & configuration kits are ordered

Installation and validation process

FSE will discuss the validation process with customer and follow upto assure success


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Independentstudies on

prionsinactivation

AD-XXXXX-001 (04/08)


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Prion: Unconventional Transmissible AgentUnlike conventional diseases

No virus or microorganism

No immune reaction

No inflammation

Degeneration of the Central Nervous System (CNS) with lesions identified in the CNS only(spongiosis)

Transmissible (e.g. food, blood transfusion, surgery), but not contagious

Always fatal Suspected agent is a protein (Prion protein)

Long asymptomatic period (several years before signs of disease appear)

Extreme resistance to conventional sterilization/disinfection processes. With dryheat infectivity is still detectable after:

180C during 24 hours

320C during 1 hour

600C during 15 minutes


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Prions diseases

ANIMALS

1732: Natural Scrapie / Sheep Europa

1985: Bovine Spongiform Encephalopathy (180,000

cases more than 900,000 contaminated bovine infood) UK

1990: Cat SE (Switzerland)

Transmissible Mink Encephalopathy (TME)

Chronic Wasting Disease (CWD)HUMANS

1951: Kuru New Guinea

1920: Creutzfeld-Jakob Disease (CJD) Europa

Gerstmann-Strussler-Scheinker Syndrome (GSS)

Fatal Familial Insomnia (FFI)

1995: Variant of CJD (vCJD)


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INACTIVATION COMPARISON

Efficacy comparison of high-temperature steam versus differentgenerations of low-temperature sterilizer systems

Three STERRAD systems tested against steam

STERRAD

100S STERRAD NX STERRAD 100NX

Inactivation Studies Supported by ASP


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Laboratories Conducting the Studies

IN VIVO STUDY

Directed by Klaus Roth, SMP GmbH (Tbingen, Germany) incollaboration with: University of Tbingen, Federal Reference Centerfor Virus Diseases of AnimalsPublication : Low-Temperature Inactivation of Prion Protein onSurgical Steel Surfaces with Hydrogen Gas Plasma Sterilization. Z.X.Yan, L. Stitz, P. Heeg, K. Roth, P.-S. Mauz. Zentral Sterilisation , Volume 16, 2008.

IN VITRO STUDYDirected by Pascal Clayette, PhD, SPI-BIO, NeurovirologyLaboratory (Fontenay aux-Roses, France)

SPI BIO is a spin-off of CEA, one of the reference research centers for

Prion diseases in France.Pascal Clayette was a close collaborator of the late Dr. DominiqueDormont, a scientist involved in Prions research and expert for Afssaps.


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Results 1: Alkaline Detergent Combined with


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Results 1: Alkaline Detergent Combined withSTERRAD 100S

Alkaline detergents plus STERRAD 100S, 1 or 2 long cycles:significant effects with no detected infectivity.

TRANSMISSION

RATE (%)

INCUBATIONPERIOD (DAYS)

INCUBATION

DELAY (DAYS)

REDUCTION

FACTOR

1% alkaline detergent A (55 C, 10 min) 11% 446 153 363 5-6

1% alkaline detergent A (55 C, 10 min)plus STERRAD 100S 1 long cycle 0% 540 14 457

5-6

1% alkaline detergent A (55 C, 10 min)plus STERRAD 100S 2 cons. longcycles

0% 540 30 457 5-6

1% alkaline detergent B (55 C, 10 min) 0% 524 42 441 5-6

1% alkaline detergent B (55 C, 10 min)plus STERRAD 100S 1 long cycle 0% 540 13 457

5-6

1% alkaline detergent B (55 C, 10 min)plus STERRAD 100S 2 cons. longcycles

0% 552 0 469 5-6

Transmission Rate: Number ofsick animals / total number ofanimals in group (usually 10animals/group).

Incubation period: Number ofdays between contamination.

Incubation delay: Additional survival period obtainedby processing of wire (= incubation time - # of days ofsurvival for hamster contaminated with a non-processed wire) .

Reduction Factor: Estimated reduction of initialcontamination load expressed on a logarithmic scale.Twelve additional days of survival correspond approx.to 1 log reduction of infection load. Experimentalmethod does not allow to make statement above 5-6log.

Results 2: STERRAD NX with and


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Results 2: STERRAD NX with andwithout pre-treatment

STERRAD NX: Infectivity not detectedSTERRAD NX: 1 Advanced cycle = 2 consecutive Advanced cyclesAlkaline detergents plus STERRAD NX: no antagonism

TRANSMISSION

RATE (%)

INCUBATION

PERIOD (DAYS)

INCUBATION

DELAY (DAYS)

REDUCTION

FACTORSTERRAD NX 1 Advanced cycle 0% 570 18 487 5-6

STERRAD NX 2 cons. Advanced cycle 0% 574 0 491 5-6

1% alkaline detergent A (55 C, 10 min)plus STERRAD NX 1 Advanced cycle 0% 559 22 476

5-6

1% alkaline detergent B (55 C, 10 min)plus STERRAD NX 1 Advanced cycle 0% 562 16 479 5-6

Steam 134 C 18 min 50% 428 103 345 5-6

NaOH 1N 1h RT + Steam 134 C 18min 28% 574 197 471 5-6

Transmission Rate: Number of sickanimals / total number of animals ingroup (usually 10 animals/group).

Incubation period: Number ofdays between contamination .

Incubation delay: Additional survival period obtained byprocessing of wire (= incubation time - # of days of survivalfor hamster contaminated with a non-processed wire) .

Reduction Factor: Estimated reduction of initialcontamination load expressed on a logarithmic scale.Twelve additional days of survival correspond approx.to 1 log reduction of infection load. Experimentalmethod does not allow to make statement above 5-6log.


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Results 3: in vitro study

263 K strain

Humanstrains

TYPE OF STRAINS AND PLATES STEAM134C, 18

100SLONG CYCLE

NXADVANCED

CYCLE

100NX

STANDARDCYCLE

FLEX CYCLE

263 KStrain

Stainless steel plates 5 log2.5 log

IL: 5 log

(*)

5 log 5.5 log 5.5 log

Polyethylene plates - - 6.5 log - -

Polypropylene plates - - 6.5 log - -

6PB1 strain 4.5 log 4.5 log 4.5 log - -

vCJD strain

2.5 log

2.5 log

2.5 log - -

Coherent with in vivo results - STERRAD NX > STERRAD 100S

Identical efficiency of STERRAD NX on the different surfaces STERRAD 100NX = STERRAD NX

Steam: no PrPres detected ( 4.5 log) STERRAD 100S and NX: no PrPres detected

(*) IL = Initial Load (i.e. level of PrPres on plates before processing). Initial load depends on availability of contaminated brain homogenates. vCJD strain ismore difficult to obtain than 263K . Except for 100 S Long cycle, reduction factor equals Initial Load (i.e. no PrPres was detected after processing).


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Conclusions

In vivo German laboratory study showed STERRAD

NX sterilization system is effective in inactivatingPrions and just as effective as high temperature steamsterilization.

In vitro study in French laboratory showed theSTERRAD 100 NX sterilization system is effectiveagainst Prions and just as effective as high temperaturesteam sterilization.

Efficacy comparison of high-temperature steam versus different generationsof low-temperature sterilizer systems: three STERRAD systems testedagainst steam

STERRAD 100S

STERRAD NX

STERRAD 100NX


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Prion Inactivation studies

STERRAD NX (alone or combined with alkaline detergent)

No infectivity detected ( in-vivo ): 5-6 log

Efficiency ( in vitro ) against 263K strain & human strains

STERRAD

100NX

Identical efficiency ( in vitro ) against the263K strain as compared to STERRAD NX


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SummaryThe STERRAD 100NX

The most advanced development from Inventors of STERRAD technology

Utilizes the time proven hydrogen peroxide gas plasma technology

Incorporated NX technology

Incorporates up to date features:

Double door option

Hydrogen peroxide monitoring IMS capability

Network connectivity

User friendly (foot pad, touch screen)

Two cycles option for flexibility Validated per ISO 14937

Independent studies on Prions inactivation & Performance verifiedby independent sterilization experts


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Advanced Sterilization ProductsInnovative Infection Prevention

Solutions

Proven track record

Pioneering technology

Leader in the market withthousands of customers worldwide

Allows customers to focus on whatthey do best - preventing infection

and saving lives


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ThankYou!

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