Intro to Plastics & Rubber in Medical Devices - April 2017

26th - 27th April 2017

Shawbury Shropshire, UK

Price: £660

Course duration: 2 days

Overview

This course will take place over 2 days, 09.15 – 16.00 on the first day and 09.00 - 15.30 on day 2.

Depending upon the application and classification of a medical device and/or accessories , the use of a plastic or rubber material in its manufacture may require consideration of biocompatibility, traceability, sterilisation techniques and their impact, manufacturing environment, regulation and testing, in addition to the engineering requirements and capabilities of the material to be used.

This course will concentrate on providing an introduction to the material requirements and manufacturing conditions which may apply and will explore the scope and impact of the European Medical Device Directive (MDD) Regulations in relation to their use.

Course Objectives

The objective is to provide companies considering entering the medical device and/or accessories supply chain,  manufacturing or supplying plastic or rubber products, or already supplying into it but with little experience of using these materials, with an insight into the requirements of this rapidly expanding market that they need to consider and meet.

Attendees will:

  • Gain an awareness of the scope of the EU Medical Device Directive and its impact
  • Understand what is classified as a Medical Device
  • Appreciate the essential differences between quality systems ISO 9001 and ISO 13485
  • Gain detailed awareness of the additional technical criteria which apply in the selection of medical grade polymer materials
  • Understand the options for sterilisation and their impact on different plastics and rubber materials types
  • Discover the different options for testing for biocompatibility, when to use them and what they will reveal
  • Appreciate the general requirements for manufacturing medical devices, depending upon classification and type

Course Content

Setting the Scene: the regulatory impact on requirements for performance of plastics and rubber materials in medical devices

While the EU Medical Devices Directive (MDD) does not specifically mention polymer materials, it does impact on the chemical, physical and microbiological requirements for performance of polymer materials, including sterilisation and bio-burden. This section will provide an overview and guidance on the parameters and impact of the regulations with regard to plastics and rubber materials.

Overview of the EU Medical Devices Directive (MDD)                                                          

Medical Devices and accessories are subject to classification rules according to the degree and time of contact with the patient. An explanation of the classification system will be given.   The relationship between Medical Device classification and European Standards such as ISO10993 and harmonised European Standards will be discussed.

Quality Management Systems for Medical Devices

An overview of the Quality System Standards ISO13485 and ISO9001 will be presented, with a focus on the sections of ISO13485 that address essential requirements of the Medical Devices Directive.

Introduction to the Medical Device Risk Assessment Standard ISO 14971

ISO14971 is an important harmonised standard that details the requirements for the application of a risk management system for medical devices. The last revised version: ISO14971:2012 applies to manufacturers placing medical devices on the market in Europe. An overview will be given of this medical device risk management standard, which will explain the actions that should be taken to meet the requirements of this standard.

Material Selection for Medical Devices, including sterilisation methods and their impact

A review of the different types of plastics and rubber materials which can be used for medical devices and accessories. A method of material selection criteria will be explored focussing on the special considerations needed to ensure a device performs safely. An important consideration is disinfection or sterilisation.

Manufacturing environment for Medical Devices: options and requirements 

An overview of the manufacturing arrangements needed for medical devices and where these differ from other products.

An overview of biocompatibility and types of testing 

An overview will be given which will provide a general introduction to the subject and the types of tests that can be employed to assess the interaction between medical devices and patients. The contents and scope of the international biocompatibility standard, ISO 10993 will be included and a comparison provided of how the EU and USA/FDA biocompatibility testing requirements and application of this standard differ from one another.

Packaging Systems for Medical Devices 

Medical Devices are required to provide the desired function after they have passed through the distribution system from manufacturer to patient. Packaging systems are an integral part of the function of a medical device. Requirements for packaging systems will be discussed with reference to performance specified by European Standards, including integrity and testing.

Who Will Benefit?

This course will benefit:

Moulders and fabricators considering supplying medical device companies, typical roles may include:

  • Technical Managers
  • Quality Managers
  • Others needing insight into the material and manufacturing and quality systems requirements and scope of MDD regulations which may apply when making medical devices or medical grade materials.

Existing suppliers or medical device manufacturers with little or no experience of engineering with plastics or rubber materials, typical roles may include:

  • Designer/Engineers
  • Technical/Production managers
  • Others needing to understand the additional material specific considerations, the scope of the MDD regulations in relation to their use and how these may differ from traditional engineering materials.

Presenter Information

Tom Forsyth, Consultant - Smithers Rapra

Tom joined Smithers Rapra in 2008, prior to which he was Technical Director of BM Polyco, a manufacturer of medical products. Before BM Polyco, he was a Technical Manager with London International Group (Durex condoms and Marigold gloves). Tom has direct experience of setting up the regulatory and testing facilities for certification of products to the Medical Devices Directive 93/42/EEC; and has conducted audits of sub-contractors to the requirements of EN13485 Medical Devices – Quality Management Systems. As a Principal Consultant, Tom continues to provide advice on medical device compliance

Martin Forrest, Consultant - Smithers Rapra

Martin commenced his career in 1977 with James Walter & Co. Ltd, a manufacturer of rubber based products. He has a first degree and an MSc in Polymer Science and Technology and a PhD in Polymer Chemistry.   He joined Rapra Technology Ltd., later Smithers Rapra in 1988 and has worked on a range of medical device related projects involving plastics and rubber, and other polymeric materials. These have addressed a wide range of topics, such as extractable and leachable studies, material selection, and failure diagnosis. During this time, he has also had senior technical roles in research projects concerned with the medical sector, such as the EU funded project Custom IMD, which was concerned with the development of novel, customised medical devices. 

Paul Shipton, Director of Consultancy - Smithers Rapra 

Prior to joining Smithers Rapra, Paul ran Plastics Consultancy Services. He has special interest in material selection, product development and failure diagnosis of medical devices.

Paul Shipton holds doctorate in polymer technology. Previous positions include Technical Manager for Ticona UK Ltd, Visiting Lecturer to the School of Engineering and Built Environment, University of Wolverhampton and Consultant to the Technology Innovation Centre, Birmingham City University.                                                         

His publications in material science include ‘The innovative use of polymers’.