Rapra Publishing

Polymers in Disposable Medical Devices: A European Perspective

By C.R. Blass, Polytec Innovations Ltd.

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The application of polymers in medical devices has grown rapidly within the last 50 years and today provides major business opportunities for both bulk and specialist raw material companies. Polymers were initially regarded as a substitute for metal, glass and natural rubber, but the polymer industry now provides a host of new materials and solutions to many of the advances seen in all branches of medical technology.

The European medical device industry is a major consumer of polymeric materials and maintains a position of an innovative arena for polymer development. This report analyses the European disposable medical devices industry with reference to the different application sectors and the materials being employed.

The report begins with a description of the major disposable medical device categories by patient application and the importance of polymer attributes for the intended application are highlighted:

  • Anaesthesia and respiratory care,
  • Blood collection, storage and delivery,
  • Cardiovascular and cardiopulmonary,
  • Diagnostics; Dialysis; Drug delivery,
  • Fluid drainage systems: ostomy and colostomy bags,
  • Intravenous fluid injection sets and enteral devices,
  • Wound dressings,
  • Catheters, and
  • Miscellaneous devices.

    In the main part of the report, the contribution of various polymers to the disposable medical devices industry are considered, with particular developments highlighted:

  • Acrylics,
  • Aromatic polymer ketones,
  • Hydrogels,
  • Liquid crystal polymers,
  • Polycarbonate,
  • Polyolefins,
  • Polyvinyl chloride,
  • Silicone,
  • Styrene polymers,
  • Thermoplastic polyesters,
  • Polyurethane, and
  • Other miscellaneous polymers.

    Sterilisation methods are considered and new procedures for the processing of disposable medical devices are examined. The critical importance and the means of polymer validation, testing and regulatory issues are discussed with special reference to the European Medical Device Directive, United States Pharmacopoeia Regulations and the moves towards global harmonisation.

    The report concludes with allusion to the challenges and future opportunities for the polymer and the medical device industries. A series of Appendices provides contact details for polymer suppliers, device manufacturers and service providers.

    The author, Colin R. Blass, is an independent consultant with a career in polymeric materials spanning 38 years. He worked in the field of vinyl polymers and compounds with positions in research, development and marketing. He developed a particular interest in polymeric biomaterials through an association with the Bioengineering Unit at the University of Strathclyde where he is an Honorary Lecturer. He is a member of the editorial board of Medical Device Technology and author and presenter of numerous papers concerned with the application of polymers in medicine and surgery.



    • ISBN:
    978-1-85957-182-8
    Pages:
    104
    Publisher:
    Rapra Market Report, 1999
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