gms | German Medical Science

48th Meeting of the Particle Therapy Co-Operative Group

Particle Therapy Co-Operative Group (PTCOG)

28.09. - 03.10.2009, Heidelberg

Treatment, development and conformity: a specific equation for Particle Therapy?

Meeting Abstract

Search Medline for

  • author S. Meyroneinc - Centre de Protontherapie, Institut Curie, Orsay, France
  • S. Delacroix - Centre de Protontherapie, Institut Curie, Orsay, France

PTCOG 48. Meeting of the Particle Therapy Co-Operative Group. Heidelberg, 28.09.-03.10.2009. Düsseldorf: German Medical Science GMS Publishing House; 2009. Doc09ptcog137

DOI: 10.3205/09ptcog137, URN: urn:nbn:de:0183-09ptcog1376

Published: September 24, 2009

© 2009 Meyroneinc et al.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by-nc-nd/3.0/deed.en). You are free: to Share – to copy, distribute and transmit the work, provided the original author and source are credited.


Outline

Text

General background: From its early stages, Radiation Therapy (RT) has combined treatments with development of the treatment devices, thus managing the conformity of the setup. The field of Particle Therapy (PT) seems to be a special "cocktail" for this equation. From three examples of our facility (Institut Curie – Centre de Protonthérapie – Orsay (CPO)), we will discuss the reasons of this particularities.

Local background: The Institut Curie – CPO has been built from a research facility. The in-process project of extension (new accelerator, gantry and medical wing provided by IBA-BESIX) will lead the centre in 2010 to a full hospital environment and, as other Particle Therapy centres, many potential upgrades are and will be to consider.

In France, the A.S.N. (Autorité de Sureté Nucléaire) is the regulatory authority in charge of the control of the radiation therapy centres. Due to many accidents happened in the country several years ago, A.S.N. has reinforced the control of the RT, in particular for the organisational aspects.

Material: The three cases presented will be:

  • process of integration of new part of the I.T. system before the use in routine
  • project management and referring to regulatory authorities, for the interfacing of the safety signals between the existing treatments rooms and the IBA systems (CE marked).
  • mode of planning and use of the facility towards the different activities (tuning, QA, treatment, maintenance, development,... ), mode (clinical/service) and users.

Methods and Discussion: For the three entities concerned (the medical users, the equipment suppliers and the conformity authorities (notified body or regulatory authorities)), the equation treatment-development-conformity is specific in PT for several reasons:

  • specificities of the field and of the risks: new kind of particle and associated technologies, accuracy of positioning, number of innovations in process, ...
  • specificities of the users: know-how on the device, partially involved in the development, ...
  • specificities of the market: small market (only few facilities), size and duration of the projects, ...
  • specificities of the facilities: size and configuration (ex: only one accelerator), configuration of IT systems, ...

References

1.
EN 93/42 Directive on medical devices
2.
IEC 60601, The international product safety standard for electrical medical equipment
3.
ISO EN 13485 Medical devices – Quality management systems – Requirements for regulatory purposes
4.
Autorité de Sûreté Nucléaire. Décision n° 2008-DC-0103 de l'Autorité de Sûreté Nucléaire du 1er juillet 2008 fixant les obligations d'assurance de la qualité en radiothérapie. 2008.
5.
Recommandations relatives à la recette des dispositifs médicaux de radiothérapie externe (AFSSAPS, mars 08)