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Regulatory and Standardization

issues- Global Perspective

Nov 18 2010

Sudisha Bhola

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Ahlstrom in brief

• Leading supplier of high performance nonwovens and specialty papers

• 5,800 employees in over 20 countries on six continents

• Listed on the NASDAQ OMX Helsinki since 2006

• Net sales EUR 1.6 billion in 2009

• Founded in 1851

New picture

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• Other roll goods producers

Raw materialsupplier

• Pulp producers• Synthetic fiber producers (PET, PP, glass)• Chemical suppliers

Converter

• Healthcare and consumer goods suppliers • Transportation industry suppliers• Air and liquid filter manufacturers • Packaging industry• Printers and siliconizers: label, decor, poster, wallcover

Marketer/seller

•World class consumer or industrial brands Consumers

& Industrial customers

Primary production

• Natural fibers:wood, cotton, hemp•Oil and petrochemicals

Ahlstrom in the value chain

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Global manufacturing presence & global markets

Sales offices

Plants

Net sales 2009

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2010: new Medical Fabrics plant in India

• After an investment of 38 Million Euro (47 Million USD) Ahlstrom has started a new spunmelt nonwoven plant in Mundra, in the western Indian state of Gujarat.

• Mainly targeting the medical market, it will manufacture a full range of SMS (multi-layer spunmelt fabrics) for applications in gowns, drapes, face-masks.

• Strategically located close to suppliers and customers.

• Consolidates Ahlstrom position as one of the top-three global nonwoven suppliers.

• Commercial production started in early 2010.

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Tackling hospital acquired infections is one of the key challenges for hospitals around the world.

• A 2009 edition study in JAMA found that 51% of patients in ~ 1,300 ICUs in 75 countries were suffering from some kind of HAI

• In Europe – WHO estimates more than 4 million patients are affected every year by HAIs, resulting in 16 million extra-days of hospital stay and 37,000 deaths.

• In USA - Centers for Disease Control and Prevention (CDC) estimates that HAIs affect nearly 2 million Americans annually, resulting in 90,000 deaths and up to $6.5 billion in extra costs

• Further these infections are becoming increasingly difficult to treat because increased resistance of bacteria to antibiotics along with advent of new viruses like AIDS,MRSA,SARS etc

• Number of factors can help reduce infection like use of sterile devices, microbiological cleanliness of OT, use of single use medical fabrics like drapes, gowns, wraps, face masks etc

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Situation in India

• There is no specific study that quantifies the hospital-acquired infections in India

• Estimates of HAI vary widely, from 5-12 per cent of patients to up to 30 per cent

• Concept of reusable linen is slowly getting eliminated and shift to single use disposable products is the norm of the day in many of the Hospitals

• The biggest challenge is non existence of Medical Standards for gowns & drapes.

• We believe if standards get implemented on lines of PB 70,there will be tremendous potential in the medical nonwoven segment.

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Industry Guidelines

• CDC: “Regardless of the material used to manufacture gowns &

drapes, these items should be impermeable to liquid & viruses”1

• AORN: “Materials used for surgical drapes & gowns should be…

resistant to penetration to blood & other body fluids ………

resistant to tears, punctures, & abrasions ………………... low-linting …. & as lint-free as possible. Lint particles are disseminated

into the environment where bacteria attach to them…[which] may settle in surgical sites and wounds with a resultant increase in postoperative patient complications.”2

• AAMI, FDA, & Industry: Established a system of classification & associated minimum requirements for protective apparel & drapes used in healthcare facilities based on their liquid barrier performance.3

1 CDC Guideline For Prevention of Surgical Site Infections – 1999.2 AORN Standards, Recommended Practices, and Guidelines – 2004 Edition3 AAMI PB 70 - 2003

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• AAMI is the Association for the Advancement of Medical Instrumentation. This organization consists of healthcare professionals, professional organizations, medical device manufacturers and trade organizations.

• AAMI is dedicated to increasing the safety and efficacy of medical instrumentation through education and the creation of uniform standards.

• Within AAMI there are technical committees (representing users, manufacturers, academia and regulators) that create the different standards and recommended practices.

AAMI

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• The main objectives of the standard are:– To help end-users select the types of drapes and gowns most

appropriate for a particular task

– Assist manufacturers in qualifying, classifying and labeling the barrier performance of their products

• These objectives are accomplished through a system of classification based on the products’ liquid barrier performance (in the critical zones)

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

AAMI Standard PB70:2003Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities

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Critical Zones

•AAMI defines the critical zones as those areas where direct contact is likely to occur with

–Blood

–Body Fluids

–OPIM (other potentially infectious material)

•Critical areas include the material as well as areas of construction, such as seams.

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Surgical Gown Critical Zones

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Surgical Drape Critical Zones

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AAMI Levels - Test Methods

The AAMI guideline classifies the barrier performance of surgical gowns and drapes through the use of four industry standard tests:

1. AATCC 42: Water impact – measures the resistance of fabrics to penetration of water by spray impact.

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AAMI Levels - Test Methods

2. AATCC 127: Hydrostatic Pressure – measures the resistance of fabrics to the penetration of water under constantly increasing pressure.

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AAMI Levels - Test Methods

3. ASTM F1670 - measures the resistance of fabrics to the penetration of synthetic blood under continuous contact.

4. ASTM F1671- measures the resistance of fabrics to the penetration of bloodborne pathogens under continuous contact.

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AAMI Level Classifications

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

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• 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

Microporous; SMS

Ahlstrom BVB; Film re-inforced

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Thank You!

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Other Considerations

• Sterility – Meet requirement for medical devices(Use appropriate sterilization method – Gamma, ETO, Steam …)

• Bio-compatibility – Skin sensitivity and cyto-toxicity

• Cleanliness

• Quality

• Packaging