ADVANCED STERILIZATION PRODUCTS...STERRAD® NX System 1983 J&J Medical Pioneers Hydrogen Peroxide for Use in Gas Plasma Sterilizer H 2 O 2 1993 Introduced STERRAD® 100 System (later

Event Samen sta je sterkDima Mousa

ASP sales Consultant

ADVANCED STERILIZATION PRODUCTS

AD-180023-01-CT_A

THE NEW RHYTHM OF REPROCESSING

ASP: elevating infection prevention solutions

• Advanced technologies designed to support the battle against HAIs

• Sterilization solutions help deliver contaminant-free instruments in the OR

• Millions of devices processed every day, helping you keep your patients safe

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Advanced Sterilization Products, a Fortive Company: a global leader in solutions for healthcare-associated infection (HAI)


1 in every 20 hospital patients will get a hospital acquired infection (HAI).

Every year in the EU, 37,000+ patients will die from an HAI + they are thought to contribute to an additional 110.000

HAI > Car Accidents + Breast Cancer + Prostate Cancer

The risk of developing an HAI in developing countries is ~8 times greater than developed countries.

The facts…


Burden of HAIs

HAIs are major economic burden for healthcare systems

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FINANCIAL BURDEN

1. Pelag AY, Hooper DC. Hospital-Acquired Infections Due to Gram-Negative Bacteria. N Engl J Med. 2010; 362(19): 1804-1813; 2. Europa: The Official Website of the European Union. Questions and Answers on Patient Safety, Including the Prevention and Control of Healthcare AssociatedInfections. Available at: http://europa.eu/rapid/pressReleasesAction.do?reference=MEMO/08/788&format=HTML&aged=0&language=EN. Accessed February 2, 2010; 3. GLOSAIR™ Global Value Dossier Nov 2010 ; 4. Medtech Insight, Oct 2010; vol 12, no.9 and US Centers for Disease Control and Prevention, 2010; 5. GLOSAIR™ Global Value Dossier Nov 2010.

•US $5-10 Bil/Year1

•EU €5.48 Bil/Year2

•HAIs increases the patient’s hospital stay - most studies report between 10 and 30 days3.•Extra staff time to manage infected patients and containing outbreaks.•Treatment costs approximated at $10,000 per patient4 (can range $1,000 to $20,0005).

Approximately 20–30% of healthcare-associated infections are considered to be preventable by intensive hygiene and control programs.


Healthcare-Associated Infections (HAIs)

• HAIs of most concern:

• Surgical Site Infections (SSIs)

• Central Line-Associated Bloodstream Infections (CLABSIs)

• Ventilator-Associated Pneumonia (VAP)

• Catheter-Associated Urinary Tract Infections (CAUTIs)

• Biggest concern at the moment is the growing number of infections caused by drug-resistant organisms (DROs)

• Linked to overuse and misuse of antibiotics.

• Patients at risk

• Elderly; Immune-compromised; On large spectrum antimicrobials

• Hospital areas of concern:

• Burn units; Neonatal; Intensive Care; Infectious diseases; Hematology; Oncology

page 5

1. Winning ways: working together to reduce healthcare associated infection in England', Department of Health, December 2003


SSI: the most common HAI

Surgical site infections (SSIs) potentially caused by contaminated instruments represent a prevalent and deadly threat to hospitals

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22% of HAIs

• SSIs are the most common HAIs—22%

– 28% of SSIs are related to equipment cleaning and sterilization

• The US Department of Health has identified SSI reduction as a top national priority due to the impact of SSIs on morbidity, mortality, and cost of care

Sources: http://www.sciencedirect.com/science/article/pii/S1473309915002704; http://www.ahrq.gov/professionals/quality-patient-safety/pfp/interimhacrate2013.html; http://www.ncbi.nlm.nih.gov/pubmed/22704634;

http://www.ncbi.nlm.nih.gov/pubmed/22080656; Kirkland KB, et al. The impact of surgical site infections in the 1990s. Infection Control and Hospital Epidemiology.


Main sources of infection

There are Three Sources of Infection

Surgical Instruments

Human Contact The Environment


Spaulding Classification System for Processing

Medical Devices

•Critical – must be sterile •Items that penetrate skin and mucous membrane, contact the blood stream, enter normally sterile areas of the body (ex. Laparoscopes, Arthroscopes, Cardiac Catheters, dissecting devices)

•Process modality: sterilization, kills all microorganisms including bacterial spores

•Semi-Critical – high-level disinfection•Instrumentation comes into contact with mucous membranes or non-intact skin•Process modality: high-level disinfection, destroys all vegetative organisms including high numbers of bacterial spores BUT not necessarily all spores

- Mycobacteria (TB) - Gold standard for HLD

•Non-Critical – disinfection according to local regulations•Instrumentation comes into contact with intact skin- but not with mucous membranes


Sterility Assurance Level (SAL) & Overkill Method

Sterility Assurance Level (SAL)

is defined as: The probability of

a viable microorganism being

present on a product unit after

sterilization.

SAL is normally expressed as

10-x. SAL of 10-6 or less is

most often used for sterile

devices and drugs.

6

5

4

3

2

0

1Log 1

0Sp

ore

Red

uct

ion

6

5

4

3

2

0

1

Log 1

0Sp

ore

Red

uct

ion

Cycle Phase I

Cycle Phase II

Chandrapati. (2009). Sterility Assurance: It is Less About Time, More about the Kill. Central Sterile Management, May 2009, 40-44.


Sterilization methods

• Steam

• Oldest and most cost-effective method

• Advantages: readily available, considered to be inexpensive, nontoxic

• Disadvantages: heat-resistant instruments only, stationary, instruments are hot

• Ethylene Oxide/ Formaldehyde sterilizers

• The low-temperature sterilization alternatives to steam

• Advantages: good materials compatibility, often endorsed by MDMs

• Disadvantages: toxic, carcinogenic, long cycle duration (up to 12 hours including aeration)

• Hydrogen peroxide (H2O2) Sterilizers

• Liquid biocides*, Steris System 1


2007Launched

STERRAD® 100NX™ System

1983J&J Medical

Pioneers Hydrogen

Peroxide for Use in Gas Plasma

Sterilizer

H2O2

1993Introduced

STERRAD® 100 System (later to become the

STERRAD ®100S System)

More than 30 Years of Innovation

1999STERRAD®

CYCLESURE® Biological Indicator

2017STERRAD ALLClearSoftware Upgrade

2017ASP ACCESSTM

Data Station

2017STERRAD® 100NX / NX With

INTEGRATED LOW TEMPERATURE STERILIZATION ECOSYSTEM

HISTORY OF INNOVATION IN TERMINAL STERILIZATION

2002Launched

STERRAD® 200 System

2005Launched

STERRAD® NX™ System

2017VELOCITYReader &

30’Biological Indicator


Market Presence

INSTALLED BASE

> 20.000 installed systems worldwide> 4.000 installed systems in Europe

IFU ENDORSEMENTS

> 23.000 Medical Device Manufacturer Endorsements

COMPLIANCE

• ISO Standards and EN Norms

INNOVATION

• Pre-conditioning cycle eliminating cycle cancellations

• Fully integrated sterilization ecosystem with seamless information sharing

• Fastest in the world BI readout, result in 30 minutes

ASP IS THE WORLD LEADER IN LOW TEMPERATURE STERILIZATION


page 13

The STERRAD® System

The STERRAD® Sterilization System involves the combined

use of hydrogen peroxide and low-temperature gas plasma

to rapidly and safely sterilize most medical devices and

materials without leaving toxic residues.


page 14

Hydrogen Peroxide (H2O2)

STERRAD® System Killing Mechanism

Hydrogen Peroxide: a strong oxidizing agent is used to kill microorganisms via the hydroxyl free radical. The hydroxyl free radical, being highly reactive, attacks membrane lipids, DNA, and other essential cell components, resulting in microbial death.

Geobacillus stearothermophilusspores are highly resistant to

the STERRAD® Sterilization Process and are used for cycle

development and validation

TEM image of cross section of G. stearothermophilus spore

Photograph by Comm Tech Lab and the Center for Microbial Ecology at Michigan State University.

Shintani et al. (2010). Gas Plasma Sterilization of Microorganisms and Mechanisms of Action (Review). Experimental and Therapeutic Medicine, 1, 731-738.


What is Plasma?

–It is the 4th state of matter

–99% of all matter in the universe exists in the plasma state

–Plasma is created when energy is applied to a gas with enough force to

strip electrons from atoms


STERRAD® Sterilization Cycles - 4 Key Stages

Chamber P

ressure (To

rr)

0

500

600

700

800

First Phase Second Phase

Injection

Diffusion

Plasma

Injection

Diffusion

Plasma

Two Phase Double-Kill Cycle

1

14

2

3

4

2

3

Complete inactivation of

>1 million spores achieved

Apply vacuum to chamber

Inject liquid peroxide, which

vaporizes into the vacuum

Allow time for diffusion of

peroxide vapor into devices

Apply plasma to break down

residual peroxide

Repeat

Stages

1→4

1

2

3

4


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Plasma Phase

STERRAD® System’s unique plasma phase breaks

down H2O2 and reduces any residual peroxide


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, healthcare workers

• 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




Cassettes

• STERRAD® System cassettes are validated specifically for your STERRAD® System to keep you and your patients safe.

• Cassettes are individually packaged with a visible internal leak monitor to visually indicate to the healthcare worker if there has been a chemical leak within the package, keeping you and your staff safe.

• The individually sealed ampules of sterilant are precisely measured to deliver the accurate amount of sterilant for each cycle.


ASP Tyvek Pouches & Rolls

• Designed exclusively for use with STERRAD® Sterilization Systems, ASPs Tyvek® Pouches and Rolls come with the convenience of a built in STERRAD® Chemical Indicator (CI).

• Variety of Tyvek® Pouches and Rolls with STERRAD® Chemical Indicator (CI), including heat-seal and self-seal styles.

• When using ASP Tyvek® Pouches and Rolls with STERRAD® Chemical Indicator customer is guaranteed with:

• Superb Sterilant Penetration - sterilization efficacy for single anddouble-wrapped instruments

• Maintenance of Sterility - efficient barriers to microorganisms during storage over 6 month after sterilization*

• Colour change of chemical indicator

• Seal Strength

* Proper storage conditions must be maintained


APTIMAX Trays & Holders

• Protecting your valuable, delicate surgical instruments and devices during sterilization, storage, and transport is vital.

• Offers a full line of trays, silicone mats and instrument holders to secure and protect your instruments sets.

• APTIMAX® Instrument Trays feature a rugged, patented material that is compatible with STERRAD and most commonly used sterilization systems.

• Lightweight design.

• Snug-fitting lid.

• Stackable design

APTIMAX® Instrument Trays and Accessories offer the ultimate in protection for your valuable instruments.


Chemical Indicator Strips and Tape

STERRAD® SEALSURE® Chemical Indicator Tape and STERRAD® Chemical Indicator Strips are used to verify that the load has been exposed to hydrogen peroxide.


ASP TESTING SERVICES

Sterility and Functionality testing services for medical device manufacturers (MDMs).

The Sterility Assurance process


The STERRAD® Sterility Guide

More than 23.000 device

listings in the SSGwww.sterradsterilitiyguide.com

Listings endorsed by 100+ MDMs worldwide

More than 10 years trusted source

The Sterility Assurance process

THANK YOU

Documents

ADVANCED STERILIZATION PRODUCTS...STERRAD® NX System 1983 J&J Medical Pioneers Hydrogen Peroxide for Use in Gas Plasma Sterilizer H 2 O 2 1993 Introduced STERRAD® 100 System (later