GE Healthcare

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• GE Healthcare
• China RoHS
• Compliance

_______________________________________Beth A.
Hulse GEHC Global  Regulatory Manager
Environmental Products
4/17/07
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GE is a family of businesses aligned with our
customers needs.
A global company
Operations in over 100 countries
Manufacturing facilities in 40 countries
300,000 employees worldwide
Infrastructure
Industrial
Commercial Finance
Infrastructure
Consumer Finance
Healthcare
NBC Universal
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GE Healthcare

• GE 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 Surgery Interventional
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 Systems
• Advancing 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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• Services
• Enabling 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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Awareness of regulation
GE Corporate, GE Healthcare, and subscription
tracking of new environmental regulationsall
countries Participation in Industry groups, i.e.
electronics industry and medical device
industry
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Understand the requirements
Industry group participation Industry group
meetings with MII with GEHC participation GEHC
meetings with government agencies Participation
in MII working groups Legal interpretation
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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 FAQs
Electronic Information Products
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Communication Operating Mechanisms
Communication of regulation to stakeholders Traini
ng 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 requirements
Items clarified during MII meetings

• Requirements
• Label the product
• Provide Xs Os Haz substance table
• Update User manual for China Label description
• Compliant w/Packaging std GB 18455-2001

• 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.

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Translation of requirements across engineering
GEHC Engineering Documents
GEHC RoHS Requirements Summary of RoHS
Directives Applicable to GEHC Products
GEHC Engineering RoHS Reqts Translates RoHS
requirements into Required GEHC Engineering
Actions
GEHC RoHS Position Paper Defines RoHS compliance
expected from GEHC suppliers
GEHC Position Statement on China RoHS
Labeling Defines GEHC actions for compliance
with China RoHS labeling requirements
SustainabilityEngineering design tool in place
for China RoHS compliance for existing and
future products
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Product compliance Example of GEHC tracker
Track by business, by PL, 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 Healthcare Beth 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 Bachelors 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.