1 Advancement of Medical Nonwovens Seminar on Medical Textiles Opportunities & Applications 6 th September 2008 Madurai Organized by: Ministry of Textiles

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Advancement of Medical Nonwovens

Seminar on Medical TextilesOpportunities & Applications

6th September 2008Madurai

Organized by:Ministry of TextilesGovt. of India.

Presented by:Ajay SahniSenior Business Development ManagerAhlstrom Fibercomposites India Pvt Ltd.

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Ahlstrom overview

• Headquarters in Helsinki, Finland

• Global network of fiber specialists serving niche markets worldwide

• Group net sales in 2007 of approximately EUR 1.8 billion

• 5700 employees worldwide

Home

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The biggest name in fiber-based specialty materials.

The widest range of cost-effective solutions.

The longest track record in the industry.

We are the world leader.

Home

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Our knowledge benefits many sectors

• Healthcare

• Environment

• Automotive

• Packaging

• Homes

• Offices

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Ahlstrom’s global network of operations

Ahlstrom Research Corporate Center France

Belgium Korea Brazil NetherlandsChina NorwayEstonia PolandFinland RussiaFrance SpainGermany SwedenGreat Britain USAItaly

FinlandRussia

Australia JapanBelgium KoreaBrazil Russia China Singapore Finland South AfricaGreat Britain SpainGermanyIndia TaiwanIndonesia ThailandItaly USA

Sales offices Production units Head officeFinland

International office France

Affiliated production units

USA

Joint venture production units

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OVERVIEW

• Global leader in medical nonwovens globally

• Broadest technology offering of any Nonwoven producer

• Research focus on fiber management & web formation

• Customer satisfaction survey rated #1 in quality & service

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• Drapes

• Gowns

• Sterile Barrier Systems

• Face mask cover stock

Medical applications

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Ahlstrom Invests in INDIA

• Ahlstrom, a global leader in high performance fiber-based materials will invest EUR 38 million in a new medical nonwovens plant utilizing spunmelt technology in India. The investment is in line with Ahlstrom's strategy to grow in the fast growing emerging markets.The new plant will manufacture a full range of spunmelt fabrics with a main focus on the medical fabrics & hygiene.

• The new facility, using state of the art nonwovens technology, will be located in the Mundra Special Economic Zone (SEZ) in the western state of The plant will start its production in last quarter of 2009.

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Why Nonwovens ? Need for Infection Control !!

• ± 1800 : about 60% of the patients died of hospital fever

• ± 1867 : Lister was one of the first who acknowledged cross-infections, aseptic technique. Reduced morbidity to 1.5%

• Today, we are still talking about infection control. Cost of Hospital Infection in England alone is 1 Billion pounds and 5000 deaths.

• Advent of super bugs such as Avian Flu, AIDS, Hepatitis makes infection control a high priority.

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• Use of disposable nonwoven medical fabrics plays an important role in reducing hospital infections.

• A study by Moylan indicated that single-use nonwoven products reduced infection by 2.5X compared to traditional textiles.

• A study by Werner showed that 56% of reusable textiles had significant defects that could sacrifice their performance

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High barrier/Protection

• Traditional textiles are typically absorbent.

• Nonwoven fabrics are engineered to have high barrier.

• Re-usable textiles can develop tears and holes during the washing process.


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Low Linting

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• Lint is a source of infection since bacteria can use it as a carrier

• Re-usable generate lot of lint during washing process.

• Nonwoven fabrics typically have low lint


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Proven Sterilization Performance

Nonwovens are compatible with multiple sterilization methods such as steam, ETO,gamma (depending on composition)


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Comfort/Conformability

• Comfort critical for gowns

• Nonwovens have good breathability

• Conformability imp. for drapes

• Nonwovens are flexible/soft


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Single Use and Economical

• Various studies indicate that when total costs are calculated single-use fabrics are generally lower cost than re-usables.


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Meets New Regulatory Standards

• AAMI PB 70/CEN standards for drapes and gowns

• EN 868-1 and EN 868-2 for sterilization wraps

• Additional standards for face mask and protective clothing


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AAMI Classification System

Level Test Result

1 AATCC 42

Water Impact (WI)

< 4.5 g

2 AATCC 42, WI

AATCC 127 Hydro Head (HH)

< 1.0 g

> 20 cm

3 AATCC 42, WI

AATCC 127, HH

< 1.0 g

> 50 cm

4 ASTM F1671, Gowns

ASTM F1670, Drapes

Pass

Pass

Least Protective

Most Protective

• There are four levels of barrier performance, level 4 being the highest protection available

• AAMI - Association for the Advancement of Medical Instrumentation

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General relationships between barrier performance and anticipated exposure risks

ANSI/AAMI

PB70 Barrier

Performance

Fluid Amount Fluid Spray or Splash

Pressure on Gown or Drape

Examples of Procedures with

Anticipated Exposure Risks

Level 1 Minimal Minimal Minimal Simple/excisional biopsies

Excision of “lumps and bumps”

Opthalmological procedures

Simple eye, nose, and throat (ENT) procedures

Level 2 Low Low Low Tonsillectomies and adenoidectomies

Endoscopic gastrointestinal procedures

Simple orthopedic procedures with tourniquets

Open hernia repair

Minimally invasive surgery

Interventional radiology/catheter lab procedures

L:evel 3 Moderate Moderate Moderate Mastectomies

Arthroscopic orthopedic procedures

Endoscopic urological procedures(e.g., transurethral prostate resections)

Open gastrointestinal and genito-urinary procedures

Anticipated Risk of Exposure

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General relationships between barrier performance and anticipated exposure risks (cont.)

ANSI/AAMI

PB70 Barrier

Performance

Fluid Amount Fluid Spray or Splash

Pressure on Gown or Drape

Examples of Procedures with

Anticipated Exposure Risks

Level 4 High High High Any procedure in which te surgeon’s hands and arms are in a body cavity.

Orthopedic procedures without a tourniquet

Open cardiovascular/thoracic procedures

Trauma procedures

Caesarean sections

Anticipated Risk of Exposure

2525

• Good protection level for cost

• Different fabrics for the AAMI levels 1-4 (US Regulations)

Product offering that meets Regulations

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1 & 2

FDA PB-70 Standard

Surgical Gown Market

Spunlace; Wetlaid; Spunbond

Ahlstrom SMS

Ahlstrom BVB; Film re-inforced

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What do we do till standards come in India ?Do Hospitals need to put specifications for procurement ?

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Indian Market Trends

•• Single-use disposables have started getting recognized.

• Face mask, head covers and shoe covers primarily disposable.

• Private hospitals are beginning to use disposable drapes and gowns

• Spunbond is widely used which provides little barrier for most applications

• No standards for medical disposables; Quality is poor

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Conclusions

•• Significant Marketing & Education effort needed to increase awareness

• Single-use / Disposable pricing is a key factor in decision making

• Indian Medical market provides an excellent opportunity for growth due to its large population, increasing affluence and a good healthcare system.

Documents

1 Advancement of Medical Nonwovens Seminar on Medical Textiles Opportunities & Applications 6 th September 2008 Madurai Organized by: Ministry of Textiles