1. 1 Integration of Environmental Aspects into Product Standards Gerd Schmidt Siemens Medical Solutions Vice President Quality & Technology December 2005

2. 2 CToo many and too detailed laws & regulations -OEMs in Germany have to comply with more than 3000 different laws! CPressure from the EU (WEEE, RoHS, EuP) -WEEE: 25 different national adoptions! -Non-European countries adopt European Directives without having sufficient knowledge about exemptions and consequences of the implementation CCurrent laws and regulations -are focused on single lifecycle phases -may have counterproductive effects -continue to support an „End of Pipe“ - philosophy Current Situation Not-harmonized environmental laws mean more costs for customers and reduced opportunities for innovative products.

3. 3 CFuture environmental requirements should/will be product- based, not facility-based -Environmental problems don’t stop at national borders. -“Global Players” buy, produce and sell worldwide -Not the severity of a law is critical, but the fact that it is geographically limited  We need…  a holistic approach  to focus on the products Future development Reduction of adverse environmental impacts can’t be achieved only by laws and regulations.

4. 4 CEuropean directives should contain only general requirements (like EuP) CProduct specific regulations will be determined by process and product standards CStandards contain product related environmental protection requirements including testing requirements and criteria how to measure the achievement of objectives CEuropean directives need to encourage the creation of standards (e.g. WEEE Art. 11 Labeling) Alternative: Process and Product standards Standards say what to do (not how). That’s the reason why they provide more flexibility for innovations.

5. 5 Continuous technological innovation 1 Knowledge Management: data mining/brokering, data integration in clinical workflow, etc. IIIIIIIIII Electromedicine Audiology Nuclear Medicine Ultrasound Computed Tomography Magnetic Resonance Radiological Diagnoses Radiation Therapy Workflow Management Systems Mobile Health Knowledge Management 1 Networking/Internet Molecular Medicine 18851900191019501960197019801990200018772010

6. 6 CLegislators will set protection targets defining general requirements (e.g. EuP) CImplementation of these general requirements will be carried out by process and product standards (e. g., IEC 60601-1-9 for medical devices) CStandards will be developed jointly by producers, operators, testing laboratories and legislators CUse of market forces -Room for innovative and creative solutions -Emphasis on Corporate Responsibility -Efficient and consistent implementation Strategy to reduce adverse environmental impacts and business risks at the same time Laws set targets – standards provide implementation specifications.

7. 7 Standards have greatly improved patients‘ and users‘ safety IEC TC 62 „Electrical Equipment in Medical Practice“ Usability/Alarms Software Safety Data Safety & Privacy Hazards 200019902005Year Electric Shock Mechanical Safety Radiation Protection Electromagnetic Compatibility (EMC) Risk Analysis (as tool) Systems Integration Environmental ProtectionSafety Networked Systems Risk Management (as tool) Product standards are well known tools in the medical industry.

8. 8 CNeeded push for the creation of environmental standards is still missing -Laws should call for and encourage standards where there are none to refer to CThe developing process of standards still takes to long -Standards committees should be involved timely into the creation process of European directives CUnilateral manipulation of standardization activities -Balanced filling of standard committees (stakeholder principle) CDifferent qualities of standards -Increased use of harmonised standards Risks and need for action Laws have local impact - standards have worldwide impact!

9. 9 CDeregulation and reduction of bureaucracy (red tape) CFlexibility for product innovations CEmphasis on corporate responsibility CWorldwide harmonized requirements CProduct related requirements will enhance resource and energy efficiency CStandards are well accepted due to the consensus principle CEfficient implementation and control by the market Benefits of product standards Worldwide accepted standards - worldwide market access.

10. 10  Considered reuse during design phase  Established take- back system for all x- ray tubes  Achieved up to 80 % reuse of materials in refurbished systems Proven Outcomes: X-Ray Tube

11. 11 BWeight of magnet – 44 % BWeight of electronics– 33 % BGradient coils Polymer– 50 % Copper– 50 % Time of assembly– 70 % Stock– 55 % Area for production– 33 % BWeight of magnet – 44 % BWeight of electronics– 33 % BGradient coils Polymer– 50 % Copper– 50 % Time of assembly– 70 % Stock– 55 % Area for production– 33 % Proven Outcomes: Magnetic Resonance Imaging Systems

12. 12 Proven Outcomes: MAGNETOM Avanto Results BAudio Comfort Noise-Reduction up to 30 dB BZero-Helium-Boil-Off-Technology Refill interval > 10 years BReduction of adverse environmental aspects Recycling quota > 90 % Results BAudio Comfort Noise-Reduction up to 30 dB BZero-Helium-Boil-Off-Technology Refill interval > 10 years BReduction of adverse environmental aspects Recycling quota > 90 %

13. 13 System reuse ++ Components reuseReuse for spare parts Recycling Spare parts Recycling Reuse rate 0 % 100 % Recycling Refurbishing Reuse Supported by Bavarian State Ministry of the Environment, Public Health and Consumer Protection, Munich, Germany Proven Outcomes: End of Life Strategy

14. Cooperation between… … is critical for increasing healthcare efficiency! Users Academia Legislators Industry