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Integration of Environmental Aspects into Product Standards

Gerd SchmidtSiemens Medical SolutionsVice President Quality & Technology

December 2005

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Too many and too detailed laws & regulations - OEMs in Germany have to comply with more than 3000 different

laws!

Pressure 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

Current 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 Not-harmonized environmental laws mean more costs for customers and reduced opportunities for innovative products.customers and reduced opportunities for innovative products.

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Future 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 Reduction of adverse environmental impacts can’t be achieved only by laws and regulations. achieved only by laws and regulations.

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European directives should contain only general requirements (like EuP)

Product specific regulations will be determined by process and product standards

Standards contain product related environmental protection requirements including testing requirements and criteria how to measure the achievement of objectives

European 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 Standards say what to do (not how). That’s the reason why they provide more flexibility for innovations.they provide more flexibility for innovations.

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Continuous technological innovation

1 Knowledge Management: data mining/brokering, data integration in clinical workflow, etc.

II IIIIIIIIIIIIIIIIII

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

1885 1900 1910 1950 1960 1970 1980 1990 20001877 2010

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Legislators will set protection targets defining general requirements (e.g. EuP)

Implementation of these general requirements will be carried out by process and product standards (e. g., IEC 60601-1-9 for medical devices)

Standards will be developed jointly by producers, operators, testing laboratories and legislators

Use 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 – Laws set targets – standards provide implementation specifications.standards provide implementation specifications.

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Standards have greatly improved patients‘ and users‘ safety

IEC TC 62 „Electrical Equipment in Medical Practice“

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Product standards are well known tools in the medical industry.Product standards are well known tools in the medical industry.

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Needed push for the creation of environmental standards is still missing - Laws should call for and encourage standards where there are none

to refer to

The developing process of standards still takes to long- Standards committees should be involved timely into the creation

process of European directives

Unilateral manipulation of standardization activities- Balanced filling of standard committees (stakeholder principle)

Different qualities of standards - Increased use of harmonised standards

Risks and need for action

Laws have local impact - standards have worldwide impact!Laws have local impact - standards have worldwide impact!

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Deregulation and reduction of bureaucracy (red tape)

Flexibility for product innovations

Emphasis on corporate responsibility

Worldwide harmonized requirements

Product related requirements will enhance resource and energy efficiency

Standards are well accepted due to the consensus principle

Efficient implementation and control by the market

Benefits of product standards

Worldwide accepted standards - worldwide market access.Worldwide accepted standards - worldwide market access.

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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

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Weight of magnet – 44 % Weight of electronics – 33 % Gradient coils

Polymer – 50 %Copper – 50 %Time of assembly – 70 %Stock – 55 %Area for production – 33 %

Weight of magnet – 44 % Weight of electronics – 33 % Gradient coils

Polymer – 50 %Copper – 50 %Time of assembly – 70 %Stock – 55 %Area for production – 33 %

Proven Outcomes: Magnetic Resonance Imaging Systems

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Proven Outcomes: MAGNETOM AvantoProven Outcomes: MAGNETOM AvantoProven Outcomes: MAGNETOM AvantoProven Outcomes: MAGNETOM Avanto

ResultsResults

Audio ComfortAudio ComfortNoise-Reduction up to 30 dB Noise-Reduction up to 30 dB

Zero-Helium-Boil-Off-TechnologyZero-Helium-Boil-Off-TechnologyRefill interval > 10 yearsRefill interval > 10 years

Reduction of adverse Reduction of adverse environmental aspectsenvironmental aspects

Recycling quota > 90 %Recycling quota > 90 %

ResultsResults

Audio ComfortAudio ComfortNoise-Reduction up to 30 dB Noise-Reduction up to 30 dB

Zero-Helium-Boil-Off-TechnologyZero-Helium-Boil-Off-TechnologyRefill interval > 10 yearsRefill interval > 10 years

Reduction of adverse Reduction of adverse environmental aspectsenvironmental aspects

Recycling quota > 90 %Recycling quota > 90 %

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System reuse

+ +

Components reuse Reuse for spare parts

Recycling

Spare parts

Recycling

Re

us

e r

ate

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

Cooperation between…Cooperation between…

… is critical for increasing healthcare efficiency!… is critical for increasing healthcare efficiency!

UsersUsers

AcademiaAcademia

LegislatorsLegislators

IndustryIndustry