Medical polymers under the microscope

Dublin was the setting for Rapra Technology's most recent and successful international conference, Medical Polymers 2003.

Dublin was the setting for Rapra Technology's most recent and successful international conference, Medical Polymers 2003.

The meeting took place over 2nd and 3rd April and was well attended by healthcare and polymer-based companies and professionals throughout Europe.

Rapra Technology, Europe's leading independent polymer consultancy, chose to site the event in Ireland, based on the extensive Irish healthcare manufacturing market that has developed there in recent times.

Rapra itself opened an office in Galway in September 2002 and has subsequently increased its sales of testing and analytic services to the healthcare manufacturers in Ireland.

The Medical Polymers 2003 event updated delegates with an important number of technical and legislative pointers for the sector.

For example, Steve Owen, Head of European and Regulatory Affairs at the UK's Medical Devices Agency opened the conference with an overview of legislation developments in the area of medical devices - "everything from a bandage to an implant", as he explained.

Owen commented on the Medical Devices Directive report published in June 2002 which identified several areas in need of improvement if standardisation and audit procedures are to be uniformly applied across the EU states.

Notified bodies, which are currently set up to monitor the standards in individual countries are to be overseen and poor or inadequate data provided by manufacturers would not be acceptable in the future.

Owen also quoted the example of surgeons and medical practitioners who are expecting data to back up the CE mark on the products that they use.

Such data are currently largely unavailable in the EU, a situation that would be unacceptable in the USA where the FDA website openly publishes such information.

The Medical Devices Agency encompasses many materials in use in the healthcare sector but Owen did alert the polymer sector audience to the ongoing concerns relating to DEHP plasticisers, which are subject to further work being undertaken by the DEHP Task Group, which will report on acceptable levels.

Owen issued a warning to the industry over the continued use of this plasticiser.

New materials were a focus in the second session with papers from industry and academia ranging from Peek as an engineering polymer for medical devices to polymers as dental restorative materials and new biomaterials for tissue engineered products Rapra Technology itself fielded a number of important contributions: Andrew Hulme opened the second day of the meeting with an overview on medical device failure modes.

Approximately 70% of plastics products fail before their expected lifetime and these failures have causes.

Hulme went on to delineate these further and he stressed the need to closely examine the data given by materials suppliers.

Is it the right data for the real environment that the device is set to experience.

John Sidwell of Rapra looked at how extractables (monomers, antioxidants, stabilisers, lubricants, curatives etc) from plastic and rubber components used in medical devices are examined using chemical characterisation techniques (GC-MS and LC-MS).

Examination of extractables is an important part of the registration process for medical products and devices (ISO10993 - part 18) and in most cases very little information is available from the materials supplier on the nature of extractables or any contaminants from the manufacturing process, thus a detailed analytical investigation is needed to conform to the requirements of this standard.

Demand from the industry has led Rapra to organise special training for the ISO standards.

The first such courses will be held at Rapra's site in Shawbury, Shropshire on Thursday 5th June and on Thursday 23rd October.

The subject will be "Getting ready for ISO10993 Pt 18".

The course content will provide: a guide to the methodology for the chemical characterisation of the commonly used materials; an overview of the analytical techniques used and their strengths and limitations; an introduction to the practicalities of sample preparation and solvent extraction; an introduction to the toxicological interpretation of the data generated; case studies detailing the characterisation of different materials; and an opportunity for Q and A with some of Rapra's senior analytical staff.

Copies of the full conference proceedings, Medical Polymers 2003, are available from Rapra Technology.

The 200-page A4 book is priced at GBP 150.

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