tapes & dressings – role of standards & regulations 3m health care business kulveen singh...

Tapes & Dressings – Role of Standards & Regulations

3M Health Care Business

Kulveen Singh BaliHead – Regulatory Affairs & Quality Assurance3M India Ltd

Nov 30th, 2011

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Contents

Development of Tapes & Dressings over the ages

Applications

Regulatory Status

Standards supporting Tapes & Dressings

Support required

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Ants to the rescue - Apocalypto

History records use of ants in wound healing The ant were positioned with their mandibles across

the edges of the wound

When the ant ‘bit’ the mandibles would close thereby ‘stapling’ the wound edges together .

The thorax would then be pinched off leaving the head (and the mandibles) in the body.

Carpenter, Leaf – cutting and Army ants have been known to this category.

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Emergence of Tapes

Hieroglyphics describe how Egyptian healers recognised need for adhesives to help them heal wounds. They prepared pastes of olive oil, water, beeswax and lead oxide.

Adhesive strapping was made by applying gum to strips of linen. The cure might have been worse than the disease!

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In the Middle Ages pastes and cloth strips were used for tape wound closures - the precursor of Steri-Strips, of medieval wound closures.

These cloth strips were adhered to the skin to close the wound and approximate the edges.

Cloth Tape

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Cotton Bandages

Cotton Bandages, with / without cotton wadding developed and still is, in certain sections, used in course of wound management

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More than 100 years ago Paul Beiersdorf, a German chemist, invented the first pressure sensitive medical tape. It was composed of a woven cotton backing and an adhesive composed of natural rubber and included Zinc Oxide.

Zinc Oxide was included to improve the tolerance of the adhesive.

First cloth Tape with Rubber and Zinc Adhesive

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Skin – The Largest and Most Complex Human Organ

Skin is not flat. It has hills and valleys. Initially, the tape only sticks to the highest points of the skin. Conforming to the skin contour takes time.

With time, the adhesive will flow into the contours of the skin resulting in increased adhesion

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Tapes & Dressings - Applications

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One Tape does not meet all requirements

Level of AdhesionLevel of Adhesion Importance of secural Activity level/ strain

Part of the bodyPart of the body Contoured vs flat Subject to stress: friction,

shear, pulling, picking Potential for skin to stretch,

edema, distention, movement Skin conditionSkin condition

Dry vs Moist or Oily Intact vs ‘at-risk’ vs damaged

Length of wearLength of wear Short time 1-2 or more days

Medipore H

Durapore

Micropore

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Regulatory Status

India Current scenario – Bandages are regulated Schdl F (II) under the Drugs &

Cosmetics Act

World wide Tapes are regulated as Medical Devices – Class I / Class II depending upon

region, sterile / non sterile and intended use

Manufacturing Good Manufacturing Practices (GMP) – Controlled Environment Area, Gowning,

Validation and Process Controls

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Standards

Product Standards are limited to Manufacturers claims within the requirements of ISO 10993, 14791, 11135, 11136 and other relevant standards like ASTM and others.

Being engineered devices, Validation plays a key role in ensuring patient safety and efficacy of the product.

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Customer Requirements Technical Parameters Holding Power Adhesion

Backing Strength No Skin irritation Cytotoxicity and primary skin irritation

test Hypoallergenic ISO 10993, ISO 14791

Comfort Conformability / High MVTR Backing material

Design / Customization Specific designs to suit standard surgical procedures, no change in practice ISO 13485

Sterility Should meet ISO 11135 requirements

Brand Quality assurance

Product Design Requirements

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Validations & Testing

Validations as per International Standards ensures the Performance of the product as per Design

Quality Control is achieved through a Strong Regime of Tests Organisations like SITRA, with its complement of test facilities to be

encouraged to establish Design, Installation , Operation and Performance standards for development of Medical Textiles in the country

Design Installation Operation Performance

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Support Required from Government

Ensuring a Market for Medical Textiles through issuance of guidelines

Creating awareness amongst users on the important role played by engineered medical textiles in Infection Prevention & Promoting Healthcare

Establishing regulatory framework for Medical Devices

Encouraging greater collaboration between medical and technological centers

Including Medical Technology in Medical Curriculum

• Evolve medical technology clusters with common facilities for testing, quality, waste treatment etc

• Assist Indian medical technology companies to upgrade to adhere to International Standards

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Thank You

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