1ª Jornada de Análisis de Riesgos en RT. 10 de Dic 2014 José Luis Roldán

Transcription

1 Risk in Dosimetry. Industry Stand point 1ª Jornada de Análisis de Riesgos en RT. 10 de Dic 2014 José Luis Roldán

2 Agenda IBA. IBA Dosimetry Risks in Dosimetry Product development Product manufacturing Product Lifetime Examples Protect, Enhance, and Save Lives - 2 -

3 4 ACTIVITIES TO IMPROVE DISEASE DIAGNOSIS AND THERAPY TODAY MEDICAL TECHNOLOGY 1. PROTON THERAPY (PT) 2. DOSIMETRY 3. RADIOPHARMA SOLUTIONS 4. INDUSTRIAL APPLICATION PHARMACEUTICALS THROUGH SHAREHOLDING IBA MOLECULAR Protect, Enhance, and Save Lives - 3 -

4 IBA DOSIMETRY Our Mission IBA Dosimetry Mission We are committed to improve cancer survival rates and quality of life of our patients by providing dosimetry solutions & services that truly increase Treatment Efficiency, Safety & Clinical Outcomes Protect, Enhance, and Save Lives - 4 -

5 IBA DOSIMETRY Product Portfolio Radiation Therapy Solutions Diagnostic Imaging Equipment Fiducial Markers Customer Service Protect, Enhance, and Save Lives - 5 -

6 CLINICAL WORKFLOW IN RADIOTHERAPY Patient admission Consultation Diagnosis Planning Treatment Post- Treatment Imaging (CT) Patient data managment Tumor contour Planning Planning validation Pre-Treatment verification Patient positioning Machine performance Treatment preparation Position verification Specific Patient plan verification Prescription Treatment plan Treatment delivery Protect, Enhance and Save Lives - 6 -

7 IBA Dosimetry Radiotherapy Dosimetry equipment is (mostly) considered as Medical Devices This has a number of consequences for the manufacturer: - a Quality Management System needs to be established (ISO13485) - manufacturer is regularly audited by a Notified body DEKRA - development, manufacturing and all servicing activities need to follow the same rules as other medical devices (including Risk Management) The Medical Devices Directive 93/42/EC is the European law that governs Medical Devices. ISO is the Quality Managment System standard for Medical Device manufacturers. It is based on ISO9001 and describes the basic rules to establish a Quality Management System e.g. Process approach, certain requirements for differen process areas Protect, Enhance, and Save Lives - 7 -

8 IBA Dosimetry Radiotherapy Pre-release Risk Management Activities during the Product Development Governed by ISO Medical Devices Application of Risk Management Analysis & evaluation of potential hazards and causes based on Intended Use by a group of experts (incl. Physics & Innovation, Product Management) V&V department Considering various sources of information (e.g. complaints, experience, competition) Implementing risk measures in Design, User documentation Important topics: Technology to be used Prototype management Extensive Internal testing (e.g. in our ICC) Extensive Beta tests (external) pre-clinical trial Documentation Traceability throughout the process and final approval ISO is a harmonized standard and describes the necessary process to do risk management Protect, Enhance, and Save Lives - 8 -

9 ICC INTERNATIONAL COMPETENCE CENTER Dedicated Training Facility State of the Art equipment IMRT/ VMAT 160 Agility MLC CBCT EPID FFF capability TPS Monaco OIS - Mosaiq Protect, Enhance, and Save Lives - 9 -

10 IBA Dosimetry Radiotherapy Production Risk Management Activities during Product Manufacturing Governed by ISO Extensive supplier management including quality control Well trained personell - staff Detailed description of assembly steps Continuous in-process quality checks (e.g. component testing) Complete End Test Line (including calibration at the SSDL) Complete documentation of Device History (test results) Appropriate packaging material and shipment Protect, Enhance, and Save Lives

11 IBA Dosimetry Radiotherapy After Sales Risk Management Activities during Product Lifetime Governed by ISO and the Medical Device Directive Installation (by IBA personnel or qualified and certified distributors) Training on site and at the ICC After sales support, telephone hotline (24/7) Tracking of all customer requests in a database Escalation of product issues to PM and R&D Change management of all product improvements Specific process for handling of potentially safety relevant issues Health Hazard Analysis Group led by the Safety officer Based on risk evaluation necessary steps are decided (e.g. Field Safety Notice to End Users) If necessary reporting to the authorities Correction and Replacement (if applicable) Protect, Enhance, and Save Lives

12 Field Safety Notice example Protect, Enhance, and Save Lives

13 Field Safety Notice example Protect, Enhance, and Save Lives

14 Dealing with complexity in your QA? Need an integrated solution? Protect, Enhance, and Save Lives

15 Protect, Enhance, and Save Lives

16 Thank you Back up