3M Health Care Business Tapes & Dressings – Role of Standards & Regulations Nov 30th, 2011 © 3M 2007. All Rights Reserved. Kulveen Singh Bali Head – Regulatory Affairs & Quality Assurance 3M India Ltd Contents Development of Tapes & Dressings over the ages Applications Regulatory Status Standards supporting Tapes & Dressings Support required 2 © 3M 2007. All Rights Reserved. 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. 3 © 3M 2007. All Rights Reserved. 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! 4 © 3M 2007. All Rights Reserved. Cloth Tape 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. 5 © 3M 2007. All Rights Reserved. Cotton Bandages Cotton Bandages, with / without cotton wadding developed and still is, in certain sections, used in course of wound management 6 © 3M 2007. All Rights Reserved. First cloth Tape with Rubber and Zinc Adhesive 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. 7 © 3M 2007. All Rights Reserved. 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. 8 © 3M 2007. All Rights Reserved. With time, the adhesive will flow into the contours of the skin resulting in increased adhesion Tapes & Dressings - Applications 9 © 3M 2007. All Rights Reserved. One Tape does not meet all requirements Level of Adhesion Importance of secural Activity level/ strain Part of the body Contoured vs flat Subject to stress: friction, shear, pulling, picking Potential for skin to stretch, edema, distention, movement Durapore Skin condition Dry vs Moist or Oily Intact vs ‘at-risk’ vs damaged Length of wear Short time 1-2 or more days 10 © 3M 2007. All Rights Reserved. Micropore Medipore H 11 © 3M 2007. All Rights Reserved. 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 12 © 3M 2007. All Rights Reserved. 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. 13 © 3M 2007. All Rights Reserved. Product Design Requirements Customer Requirements Holding Power Technical Parameters Adhesion Backing Strength No Skin irritation Comfort Design / Customization Sterility Should meet ISO 11135 requirements Brand Quality assurance 14 © 3M 2007. All Rights Reserved. Cytotoxicity and primary skin irritation test Hypoallergenic ISO 10993, ISO 14791 Conformability / High MVTR Backing material Specific designs to suit standard surgical procedures, no change in practice ISO 13485 Validations & Testing Design Installation Operation Performance a a a a 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 15 © 3M 2007. All Rights Reserved. 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 16 © 3M 2007. All Rights Reserved. Thank You 17 © 3M 2007. All Rights Reserved.