GE Healthcare China RoHS Compliance

GE Healthcare

China RoHSCompliance

_______________________________________Beth A. Hulse GEHC Global Regulatory Manager Environmental Products

4/17/07

2 / AeA Seminar /Hulse

04/13/23

GE is a family of businesses aligned with our customers’ needs.

Healthcare

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A global company

Operations in over 100+ countries

300,000+ employees worldwide

Manufacturing facilities in 40+ countries

Commercial Finance

Infrastructure


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GE HealthcareGE Healthcare brings the world medical science and technologies that are helping to transform healthcare. We are working with our partners in healthcare to help them predict, diagnose, inform, and treat disease earlier than ever.

Diagnostic Imaging • Interventional Cardiology & Surgery • Clinical Systems Healthcare Information Technologies • Services • Bio-Sciences


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Diagnostic Imaging Providing healthcare professionals with highly detailed images of anatomy and function, through the latest technologies.Our LightSpeed VCT

scanner can capture a detailed image of the heart in just five heartbeats.

Interventional Cardiology & SurgeryInterventional imaging, surgery guidance, and orthopedic imaging products to help guide minimally invasive surgical and therapeutic procedures.

Our vision for the future is to enable a new "early health" model of care focused on earlier diagnosis, pre-symptomatic disease detection and disease prevention.


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Clinical SystemsAdvancing every phase of patient care, from routine screening exams to life critical surgeries.

AirStrip OB allows physicians to remotely access current and historical fetal heart tracings, maternal contraction patterns, and other critical data from labor & delivery units with just a PDA or SmartPhone.

Healthcare Information Technologies Helping to digitize healthcare through radiology image archive and clinical information systems.

GE Healthcare Information Technologies provides a comprehensive array of innovative technologies that provide complete, connected and immediate information solutions.


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ServicesEnabling customers around the world to get the most out of their GE products through advanced support.

Our support analysts have access to a global customer support database, which allows them to share the most up-to-date technical information and helps them provide fast and consistent responses to you.

Bio-Sciences

Providing leading edge diagnostic imaging agents across all modalities through our Medical Diagnostic business.GE Healthcare has established

expertise in protein purification with gold standard chromatography systems. Our products are used in the manufacture of over 90 percent of all biopharmaceuticals on the market.


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GE Healthcare Strategy for China RoHS Compliance

Awareness of regulation

Understand the requirements

Determine products impacted

Communication across GE Healthcare

Upper management engagement & support

Develop operating mechanisms

Develop a sustainable solution

Track product compliance

Evidence of compliance


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Jurisdiction Status of the legislation

Covered EE Susbstances

Argentina proposed components used for repair or reuse and in new products. same scope as WEEE directive, medical devices, monitoring and control instruments

lead, mercury, cadmium, hexavalent chromium, PBB and PBDE

Australia proposed "RoHS type" "RoHS type"

Australia no but listed as priority chemicals

octa- pentaBDE.

Austria (EU) yes RoHS scope Lead; Mercury; Cadmium; Hexavalent chromium; and Polybrominated biphenyls (PBB) and polybrominated diphenyl ethers (PBDE) [with the exception of deca-BDE], which are used as flame retardants in plastics.

Belgium (EU) yes RoHS scope Lead; Mercury; Cadmium; Hexavalent chromium; and Polybrominated biphenyls (PBB) and polybrominated diphenyl ethers (PBDE) [with the exception of deca-BDE], which are used as flame retardants in plastics. homogenous material of 0.01% by weight for cadmium,Canada yes several products used by

childrencadmium, lead, mercury - prohibition.

China yes (not into force yet)

scope under prepraration Lead Mercury Cadmium Hexavalent Chromium PBB PBDE and other toxic and haz. substances or elements specified by the State.

Awareness of regulation

GE Corporate, GE Healthcare, and subscription tracking of new environmental regulations…all countries

Participation in Industry groups, i.e. electronics industry and medical device industry


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Industry group participation

Industry group meetings with MII with GEHC participation

GEHC meetings with government agencies

Participation in MII working groups

Legal interpretation

Understand the requirements


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China RoHS – Industry input

Joint Industry Position paper on Chinese substance restrictions

Many products of the electrical and electronic industry already fall under extensive regulations which include restrictions of hazardous substances. The ban of lead, mercury, cadmium, hexavalent chromium and the flame retardants PBB and PBDE according to Art. 4 of the Directive 2002/95/EC (RoHS) is part of many already existing European and national regulations on substances. Recently additional substance restrictions are coming forth from different regions of the world e. g. China, USA (California), Korea, and other countries. The substance restrictions of the new legislation are generally similar to European RoHS but differ in many details or have yet to be finalised.


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Determine Products Impacted

Review EIP list (Electronics Information Products)

Consultation with Industry groups for scope interpretation

Consultation with legal counsel for clarity

Questions from Industry groups or directly from GEHC to MII to understand product scope

FAQ’sElectronic Information Products


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Communication & Operating Mechanisms

Communication of regulation to stakeholders

Training on the regulation

Weekly operating mechanisms for affected functions

Development of GEHC position statements on how to comply

Consistency of engineering documentation

Product design reviews

Business and executive reviews


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China RoHS – Understanding the requirementsRequirements:• Label the product

• Provide X’s & O’s Haz substance table

• Update User manual for China Label & description

• Compliant w/Packaging std GB 18455-2001

logo 2 logo 1

• Spare parts do not require labeling

• Finished products in warehouse with Mfg date before March 1, 07 out of scope.

• Labeling for new products sold March 1 07, not refurbished or remanufactured

• Labeling not required for consigned products.

Items clarified during MII meetings:


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GEHC China RoHS Position Paper

…Common focus across GEHC

GEHC RoHS Requirements

Summary of RoHS DirectivesApplicable to GEHC Products

GEHC RoHS Position Paper

Defines RoHS compliance expected from GEHC suppliers

GEHC Engineering RoHS Req’ts

Translates RoHS requirements intoRequired GEHC Engineering Actions

GEHC Position Statement on China RoHS Labeling

Defines GEHC actions for compliance

with China RoHS labeling requirements

GEHC Engineering Documents

Translation of requirements across engineering

Sustainability…Engineering design tool in place for China RoHS compliance for existing and future products


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Product compliance – Example of GEHC tracker

Bus

ines

s

P&

L

RoH

S L

eade

r

100% 215 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100%

100% 161 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100%

100% 61 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100%

100% 144 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100%

100% 425 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100%

Engineering Operations QA

Track by business, by P&L, by product


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On site audits to insure compliance


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Summary and Key Takeaways

Understanding the regulation

Stakeholder engagement

Communication

Common focus across the business

Operating mechanisms & metrics

Sustainability


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Thank you


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Beth A. Hulse, GE HealthcareBeth Hulse is a Global Regulatory Manager for GE Healthcare. She is responsible for keeping the business abreast of new environmental regulations that impact the products and the environment. She is the global program manager for EU WEEE and RoHS, China RoHS, and upcoming regulations, leading global engineering, sourcing, operations, and service teams to deliver compliant products. Another area of responsibility is in leading the business in the digitization of International Trade Controls.

Beth has a Bachelor’s degree in Chemistry from Hanover College, two Masters of Science degrees in Manufacturing Management and Operations from GMI and Kettering University. She started her career at Whirlpool Corporation, advancing to Manager of Process Engineering, joined GE Appliances as an Advanced Manufacturing Engineering Leader leading multimillion dollar engineering programs, and came to GE Healthcare in 1996 progressing to GEHC Manager of Quality System Compliance and Environmental Health & Safety for Operations until her current role which she accepted in May 2005.

GE Healthcare China RoHS Compliance

Health & Medicine

Transcript of GE Healthcare China RoHS Compliance