RoHS, REACH, WEEE & ERP Impact on the Medical Industry April 18, 2011

1. U.S. Department of Commerce & EU Directives RoHS, REACH, WEEE & ERP Impact on the Medical Industry April 18, 2011 Beth A. Hulse GE Healthcare Global Regulatory Manager - Stewardship

2. GE Business Segments Home & Business Solutions Appliances Lighting

3. Global regulatory landscape • Over 300 new env. product regulations in 2011 • 46% worldwide growth in 2 years • “Medical devices” no longer excluded Compliance is ongoing • Must know composition of our products … FSD • Shift from supplier declaration to testing & cert. • Required by regulators … requested by customers

4. Product Substance & Waste Regs … Growth Latin Am & N. Am …81% new regs

5. Visibility to New Regs … Key to Compliance Regulatory Tracking Reg. Overview Impact Assessment • Businesses • Functions • Products • Parts • Processes • eTools • Agencies • Industry • Consultants Standard Docs & Processes Communication & Training Redesign Ongoing Compliance • Leadership • Suppliers • Impacted functions BOM Internal Requirements & specifications Data Repository

6. Medical Device Technical Challenges • Device Complexity • Similar to aerospace products …> 10,000 parts, reliability critical • Operation Environment • Mechanical shock, vibration, G force, Magnetic fields, Ionizing Xray, • Chemical Stresses, Industrial settings • Regulated • Highly regulated products … e.g. SFDA, FDA, MDD

7. Considerations When Designing for Substance Restrictions • Materials are chosen for performance & reliability characteristics. They must be thoroughly evaluated before any change is incorporated. • Reliability of Medical Devices is of the highest level of importance to ensure safety of patient and clinicians. • Impact to GEHC Medical Devices…changes to >10,000 parts for each major product • Must repeat product testing to ensure compliance with Medical device regulations & product performance MRI CT Scan

8. EU RoHS, REACH, WEEE

9. EU RoHS Recast • Dec. 2010: Publish in journal ~June 2011 • Scope: • Inclusion for Medical Devices & Monitoring & Control 3 yrs after in force • Exclusions: Large scale fixed installations (e.g. Cyclotrons), R&D equip, LSIT • Open scope added in 8 years… no impact on Medical Devices • Substances: • 6 RoHS substances still in scope…HBCDD, DEHP, BBD & DBP priority for review • No add’l substance bans or inclusion of Nanomaterials • No RoHS label • Exemptions: • Rationale: Socio-economic,technically impracticable, reliability, alt. availability • Category 8 & 9 exemptions valid 7 yrs; 1 - 7 & 10 valid 5 years • 18 mo. grace period after exemption withdrawal • 24 medical device exemptions included in recast …but 11 more needed • Conformity Assessments … Overlapping RoHS2 & MD req’t • CE mark of finished product … Technical Documentation per 768/2008/EC • Register of non-conforming EEE & product recalls • Demonstration of compliance • 10 year retention

10. EU RoHS Recast … Impact on Medical Devices • 2014 MD & MC inclusion in EU RoHS … Industry preparing for compliance. • EU Agencies collaborative engagement with Industry ... Scope, exemptions, timing. • Exemptions & Exclusions … Favorable outcome • Inclusion of 24 early exemptions... add’l 11 exemptions too late for inclusion. Technical alternatives … failure modes driving more R&D. • Socio-economic allowance … very positive, e.g. Gold for patient shielding • Exclusion for LSFI, LSIT, & R&D important to MD’s • Technical review of priority substances before elim. … positive • Conformity assessment, Positive for compliance … but challenges • CE mark requirement … overlaps with other reqm’ts e.g. MDD • Notified bodies unsure how to evaluate for RoHS. • MD NC & recall processes in place … safety & reliability. How incorporate RoHS? • Shift from self-declaration will improve compliance • Challenge… data availability for compliance. • Electronics industry ~70% provide as requested, ~ 10% non-electronics. • Gap … availability of data from subtier suppliers.

11. EU WEEE Recast … Key Issue for Medical Devices Shipments of used EEE (Annex IC) – Council agreement Equipment take back… refurbish & parts harvesting Environment benefit Critical Issues for Medical Devices • Reduce electronic waste generation in EU • Refurbishment & reuse of used equipment • Re-use of parts for Installed Base • Illegal exports…proof goods are not waste • Equipment for reusefully functional in sales contract and or transfer of ownership • Functional testing & evaluate every item. • Self declaration that no material is waste.

12. European REACH … Impact on MD • Reporting: June 1, 2011 • Who:Producers & Importers of articles • Requirement: Notify ECHA if SVHC in the candidate list is present in articles • >0.1% w/w • Qty of substance in article >1tonne/year • Within 6 mo of SVHC added to list • Impact on Medical Devices: • Understand where SVHC’s used … requests to suppliers w/new lists • If > 0.1%, notify customers • Compile data to determine if must report • GAP … data availability from suppliers • Restriction: Annex XIV List – POM if authorization granted or exempted • 1st Substances in Annex XIV: • Musk Xylene, MDA, HBCDD, DEHP, BBP, DBP • Applications ~2013, sunset dates ~2014 • Impact on Medical Devices • Authorization not required if used in medical devices under: • Directives 90/385/EEC, 93/42/EEC (Medical Device directive, 98/79/EC

13. EU ErP Energy Related Products

14. EU Energy Related Products (ErP)– 2009/125/EC • FocusToreduce the environmental impact of energy using products • Scope • Significant EU sales volume • Env. impact & potential for improvement • Dependent on energy input • Medical devices were on high priority list…but not in scope • All Environmental aspects …entire life cycle: • Consumption of raw materials, energy, other resources • Air, water, and soil emissions • Waste materials generated • Reuse, recycling, recovery of materials & energy • Wt & volume of product • Use of hazardous substances

15. Self Regulation…Proactive focus on env.responsibility Benefits of Self Regulation: • Industry recommends: • Products in scope • Proposes timing for inclusion • Aggressive targets…but achievable • Partnership with the government • Effective for ~3+ yrs…without implementing measures • Earlier inclusion in ErP Benefits to Customers: • Greener products…across the lifecycle • Focus on areas of greatest impact • Validated with reporting & 3rd party review. MD Self Regulation U/S, MRI, CT, X-ray, NM LCA MD Industry initiated self regulation

16. U.S. Nat’l Framework For Electronics Stewardship EPA, GSA (General Series Admin), & CEQ (Council on Environmental Quality) Objective: Develop a system approach to design, manage, dispose electronics. • Stewardship goals • Tracking • Reporting • Reduce exports to country if can’t properly manage. Commenting: March 11, 2011 … Framework avail May ‘11 In scope: “Manufacture, distribute, sell, label, certify, verify, refurbish, recycle, purchase or use consumer, commercial, or industrial electronics” Impact on MD: • MD Design controls under 21CFR820 … overlap • Consistent approach vs. state by state approach • Tracking, reporting • Funding for take back • Re-use business Support U.S. Nat’l Approach & Global Harmonization

17. Summary

18. Overall Summary • Regulations growing exponentially … EU, China, Korea, India, Canada, U.S etc. • Variation in country regs … duplication of efforts: testing, certification, labeling, reporting, tracking, design for specific markets • “Most of all, we request an international standard… It is so challenging to keep up that we are simply in ‘reaction mode.” (Medium N. American OEM) • Test to International Stds to ensure consistent results. • Inconsistent regulations and standards can result in trade barriers. • Ensure transparency and non-discriminatory. MD committed to compliance …harmonization needed.

19. Beth A. Hulse Global Regulatory Manager - Stewardship GE Healthcare RoHS, WEEE, REACH, Battery Beth Hulse is the GE Healthcare Global Regulatory Manager for Environmental Product Regulations & Stewardship As the Global Regulatory Manager, she is responsible for keeping the business abreast of new and developing environmental regulations that impact the products. She drives shaping policy while partnering with government officials and industry to ensure global consistency. She is the GEHC Global Program Manager for RoHS, WEEE, REACH, and Battery across all businesses and functions, ensuring program execution and compliance with the regulations. Most recently she was the Global Manager for ERP and Trade Control Automation. She started her career with Whirlpool Corporation, advancing to Manager of Process Engineering, joined GE Appliances as an Advanced Manufacturing Engineering Leader, followed by GE Healthcare, progressing to X-ray Tubes IB Engineering Manager, and GEHC Global Supply Chain Manager of Quality Assurance and Environmental Health & Safety. Education: B.A. Chemistry, Hanover College M.S. Manufacturing Management, GMI M.S. Operations, Kettering University Six sigma Master black belt and Black belt Certified beth.hulse@med.ge.com (414) 416 3396