COCIR Self Regulatory Initiative (SRI) under EuP Directive EuP - PowerPoint PPT Presentation

EDD-CF-2009-11-17-Doc02 COCIR Self Regulatory Initiative (SRI) under EuP Directive EuP Consultation Forum Meeting 1 7 th Novem ber 2 0 0 9 Nicole Denjoy, COCIR Constantin Herrmann, PE I nternational page 1 EuP Steering Committee – CF 17 Nov. 2009

Part 1 - Generalities page 2

Structure § I ntroduction to COCI R § COCIR leadership in environmental matters § EuP Initiative § What has been done § Concept of Self Regulative Initiative (SRI ) § Scope § Participants § Method of the concept § Compliance with Annex VIII of EuP Directive § Conclusion § Next Steps § Q&A EuP Steering Committee – CF 17 Nov. 2009 page 3

W hat is COCI R? COCIR is representing the Industry Voice in Medical Imaging, Electromedical and Healthcare IT Our Industry is leading in innovative healthcare technologies and provides solutions for the complete care cycle EuP Steering Committee – CF 17 Nov. 2009 4

COCI R Mem bers ( 1 of 2 ) COCI R Com pany m em bers: EuP Steering Committee – CF 17 Nov. 2009 5

COCI R Mem bers ( 2 of 2 ) National Trade Association m em bers: HUNGARY EuP Steering Committee – CF 17 Nov. 2009 6

COCI R Profile § 3 I ndustry Sectors: § Medical I maging § Electromedical § Healthcare I T § 5 core com petencies: § Market Statistics (Medical Imaging and Healthcare I T Intelligence Centre) § eHealth § Contribution to sustainable healthcare with Institutions and other stakeholders (Europe) § Regulatory Activities and Standardisation (EU and Global) § Environment (EU and Global) § Hosting EuP Steering Committee EuP Steering Committee – CF 17 Nov. 2009 7

Healthcare: need for sustainability and innovation § Our products are: § Saving lives and contributing to quality of life of citizens globally § Covering the complete care cycle § Capital investment goods § High technology and highly innovative § Safety conscious and highly regulated § Sustainability § Benefits for citizens and patients: § Better management of chronic diseases § More efficient data exchange & work flow § Prevention § Early diagnostic § Therapy § Quality of care EuP Steering Committee – CF 17 Nov. 2009 page 8

I ndustry Needs Dem and and necessity of: § Raw materials § Partly hazardous materials, e.g. for personal protection, patient safety (e.g. optimized radiation dose) or product reliability/ optimal performance § Energy § Freedom in innovation § Quality of information (e.g. images) Consequence is: § Necessity of risk/ benefit analysis § Transparency and structured approaches as information baseline § Existing good track record in environmental protection EuP Steering Committee – CF 17 Nov. 2009 page 9

Structure § I ntroduction to COCI R § COCI R leadership in environm ental m atters § EuP Initiative § What has been done § Concept of Self Regulative Initiative (SRI ) § Scope § Participants § Method of the concept § Compliance with Annex VIII of EuP Directive § Conclusion § Next Steps § Q&A EuP Steering Committee – CF 17 Nov. 2009 page 10

COCI R Leadership in Environm ental Matters § 2 0 0 0 : Applying Integrated Product Policy (IPP) in business and design – Thinking in life cycles § 2 0 0 0-2 0 0 7 : Development of a global benchmark – the product standard IEC 60601-1-9, Requirements for environmentally conscious design § 2 0 0 6 : Furthermore on IPP, Customer information, e.g. EPDs from Hamburg project § 2 0 0 7 : Refurbished equipm ent – GRP concept (version 1) § 2 0 0 8 : Hazardous Substances Management – amongst others REACH compliance, RoHS substances, … § Guide for manufacturers § BOMcheck I nitiative (involvement of supply chain) § 2 0 0 9 : 1 st COCIR Industry Standard on GRP together with version 2 of GRP EuP Steering Committee – CF 17 Nov. 2009 page 11

2 0 0 0 -2 0 0 7 : I EC 6 0 6 0 1 -1 -9 , a Helping Tool for SRI I EC 6 0 6 0 1-1 -9 (First edition 2007-07) “Requirements for environmentally conscious design (ECD) to become harmonized standard” § Assess all environmental aspects (EuP relevant) § Involve the supply chain (EuP relevant) § Identify significant environmental aspects (EuP relevant) § Reduce environmental impacts (EuP relevant) § Provide environmental information (EuP relevant) § Packaging (EuP relevant) § Normal use (EuP relevant) § End-of-Life (EuP relevant) § Annex with guidance and examples EuP Steering Committee – CF 17 Nov. 2009 page 12

2 0 0 8 : Hazardous Substances Managem ent EuP Steering Committee – CF 17 Nov. 2009 page 13

2 0 0 9 : Refurbished Equipm ent GRP Concept Source: http: / / www.cocir.org/ uploads/ documents/ -560-cocir_industry_standard1806.pdf EuP Steering Committee – CF 17 Nov. 2009 page 14

Structure § I ntroduction to COCI R § COCIR leadership in environmental matters § EuP I nitiative § What has been done § Concept of Self Regulative Initiative (SRI ) § Scope § Participants § Method of the concept § Compliance with Annex VIII of EuP Directive § Conclusion § Next Steps § Q&A EuP Steering Committee – CF 17 Nov. 2009 page 15

Actions on SRI done so far § December 2007: Start of development of the general SRI Concept § May 2008: First announcement about SRI at CF meeting § During 2008: Development of the detail SRI Concept § January 2009: Commitment on participation from 11 companies (equals 100% COCIR members on electrical medical equipment) § March 2009: Creation of EuP Steering Committee § May 2009: First product group (ultrasound) investigated § November 2009: Presentation on methodology and preliminary achievements to the Consultation Forum (gathering new input for improvements ) EuP Steering Committee – CF 17 Nov. 2009 page 16

Scope of the SRI Concept § Medical Imaging Products: § Ultrasound (already investigated) § X-ray § Computed Tomography § Magnetic Resonance § Nuclear Medicine EuP Steering Committee – CF 17 Nov. 2009 page 17

Current Representativity 2 0 0 8 Estim ated EU Participating Other targeted Market Market Coverage com panies com panies Value 6 3 0 M€ GEHC, Philips, None Com puter 1 0 0 % Siemens, Toshiba Tom ography ( CT) 8 3 9 M€ Aloka, GEHC, Esaote Medical, Ultrasound 8 0 % Medison, Philips, Sonosite, Mindray, Siemens, Toshiba Ultrasonix, Zonare X-ray Cardio 3 8 1 M€ 1 0 0 % GEHC, Philips, None ( 4 5 % ) Siemens, Toshiba GEHC, Philips, Approx. 50 Others 4 9 0 M€ 8 2 % ( 5 5 % ) Siemens, Toshiba, companies incl. Agfa, Shimadzu, Hologic, Konica, Canon Mindray Magnetic 7 6 9 M€ 1 0 0 % GEHC, Philips, None Siemens, Toshiba Resonance I m aging ( MRI ) 2 2 4 M€ GEHC, Philips, None Nuclear Medicine 1 0 0 % Siemens ( SPECT, PET) EuP Steering Committee – CF 17 Nov. 2009 page 18

The SRI Concept per Product EuP Steering Committee – CF 17 Nov. 2009 page 19

Overview and Tim escale on the SRI Concept EuP Steering Committee – CF 17 Nov. 2009 page 20

Exam ple Ultrasound § Coverage of largest number of COCIR member companies § Highest market value 2008 § Ultrasound equipment is less complex compared to others and supports learning curve perfectly § Efficiency improvement is already done and well understandable and communicable I mprovements: - miniaturisation - more functions - more efficiency - image accuracy EuP Steering Committee – CF 17 Nov. 2009 page 21

Use Phase Relevance § Most significant environmental aspect is energy consumption in use phase (LCA result) § Hazardous materials or End of Life is not critical § Directives apply: RoHS, WEEE, REACH, packaging directive Materials Materials procurement, 10% procurement, 14% Manufacturing, 2% Manufacturing, 3% Distribution, 2% Distribution, 2% Energy consumption in Energy use, 86% consumption in use, 81% LCA results: Ultrasound product 1 Ultrasound product 2 EuP Steering Committee – CF 17 Nov. 2009 page 22

Three Steps for Gathering Baseline Data § Agreement and standardized approach § for data collection § for comparability § for completeness § for transparency § for a meaningful and feasible reference (functional unit) § Gather data § for significant environmental aspects § old and new product sales § Identify and review technology trends EuP Steering Committee – CF 17 Nov. 2009 page 23

Data Collection from COCI R m em bers Total annual Tot al annual Total annual energy Tot al annual energy Average annual en ergy Average annual energy sales sales as a consum ption in consumpt ion for new consumpt ion for new consum ption for new percent age of kWh for new products as a products in kWh products com pared to 2005 annual product s percent age of 2005 2005 sales annual energy consumpt ion 13,6 28,343 2005 14 ,475 100% kWh/ year 100% 942 kWh / unit/ year 100% 14,8 64,054 2006 17 ,088 118% kWh/ year 109% 870 kWh / unit/ year 92% 15,1 21,116 2007 19 ,604 135% kWh/ year 111% 771 kWh / unit/ year 82% 15,8 51,000 Historical data Ø 2008 20 ,791 144% kWh/ year 116% 762 kWh / unit/ year 81% Prediction Œ 2009 20 ,800 144% 15,8 51,000 116% 762 kWh / unit/ year 81% 2010 20 ,800 144% 15,8 51,000 116% 762 kWh / unit/ year 81% EuP Steering Committee – CF 17 Nov. 2009 page 24