RoHS Compliance Trends in the
Medical Device Industry
James P. Vetro, P.E.
GE Healthcare
Global RoHS Engineering Leader
23 July 2008
Agenda
• Who is GE Healthcare?
• What challenges do we face with RoHS?
• Existing Medical Device Regulations
• Safety and Reliability still highest priority
• Medical Devices have unique requirements
• Inconsistency in RoHS regulations
• Managing the Supply Chain
• How will GE Healthcare be RoHS compliant?
• GE Healthcare Strategy
• Tools and Processes
• Operating Mechanisms
• Supply chain expectations
• Supply chain control
J. P. Vetro 2008
slide#1
A global company
GE is a family of businesses aligned with our customers’ needs.
Operations in
over
100+ countries
300,000+
employees
worldwide
Manufacturing
facilities
in 40+ countries
Infrastructure
Commercial Finance
Industrial
Infrastructure
Consumer Finance
Healthcare
NBC Universal
J. P. Vetro 2008
slide#2
GE Healthcare
ƒ 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.
ƒ $15B business, 42,000 employees
Diagnostic Imaging • Interventional Cardiology & Surgery • Clinical Systems
Healthcare Information Technologies • Services • Bio-Sciences
J. P. Vetro 2008
slide#3
Challenges for Medical Device Industry
Medical Devices are already highly regulated
• MDD, FDA, SFDA, HSA, etc.
• RoHS regulations must not affect ability to meet pre-existing
regulations
MDD
J. P. Vetro 2008
slide#4
Challenges for Medical Device Industry
Safety and Reliability are still highest priority
Rotating Parts
High G-Forces
New Technology
Innovation
Complexity
More time required for safety and reliability analysis
J. P. Vetro 2008
slide#5
Challenges for Medical Device Industry
Accurate medical diagnosis is critical
Critical Information for
Doctors
Accurate diagnosis for
the patients
RoHS Compliant designs
must not compromise
system reliability
J. P. Vetro 2008
slide#6
Challenges for Medical Device Industry
Medical Devices have unique requirements
• Lead for shielding X-Ray radiation
• Lead in solders in portable emergency
defibrillators
• Lead in solders for bonding to ultrasonic
transducers
J. P. Vetro 2008
slide#7
Challenges for Medical Device Industry
Inconsistent Regulations Internationally
• Testing standards
Testing Methods for Hazardous Substances
in
Electronic Information Products
IEC 62321, Ed.1
SJ/T 11365-2006
• Self declaration vs. Certification by individual countries
• Reporting thresholds
• Hazardous substance list
Added Costs must be minimized
• Products, hospitals, patients, governments
• May be trade barrier, new technology not affordable
J. P. Vetro 2008
slide#8
Challenges for Medical Device Industry
Non Compliance for existing products is a big problem
• Industry needs better control of their Supply Chain
Circa 2005
Europe's Push for Less-Toxic Tech
… Sony was stunned to learn that nearly 1.3 million of its best-selling PlayStation
game machines had been stopped at the border by Dutch customs agents.
…Cables contained levels of cadmium considered unsafe under changes to Dutch
law
… Sony went into high gear. It had to squelch rumors of a broader recall while
sparring with its Taiwanese cable supplier over who was to blame…. the seizure
delayed the sale of $160 million worth of consoles, and Sony had to bear big costs
for replacements parts, storage, and repacking…
J. P. Vetro 2008
slide#9
RoHS Materials in Medical Devices
PWAs/HLAs
Component
s
Present in all
products, at all
levels of
assembly!!!
Plastic
s
Finished
Product
F&M
OEM
Parts
J. P. Vetro 2008
slide#10
How will GE Healthcare be RoHS Compliant?
GEHC RoHS
Design for
Ecomaginatio
n
GE Healthcare RoHS Strategy
•
•
•
•
•
One GE Healthcare RoHS Program
Consistent timing for all markets
Develop Global Tools & Processes
Ensure Compliance in all markets
Ensure Sustainability
J. P. Vetro 2008
slide#11
How will GE Healthcare be RoHS Compliant?
Tools & Processes
Quality Management System
•
•
•
Design Control
Production & Process Control
Purchasing Control
Global Documentation Tree
GEHC RoHS Req’ts
Level 2: Directives turned into Strategies
GEHC Eng. RoHS Req’ts
RoHS Req’ts for Suppliers
Inorganic Finish Spec
Level 1: Defines Directives to Follow
GEHC RoHS Assembly Spec
Fab Spec
Level 3: Tactical Approach
Electr. component Spec
Level 4: Standards
J. P. Vetro 2008
slide#12
How will GE Healthcare be RoHS Compliant?
Operating Mechanisms
Strategy
Awareness
Impact on
GEHC
Interpret
Program
Sustain/
Operationalize
Global
GlobalProgram
ProgramMgr
Mgr GEHC Global Mgr
Engagement
DI
CS
P&L’s
Leaders
LS
Surgery
IITS
Ops
Eng
Sourcing Service
EHS
Functional Leaders
Op Mechanisms
-
Weekly Core , functional & global meetings
Monthly Program Reviews
Quarterly Group staff reviews
Trackers
- By Business
- By P&L
- By product
- By part
J. P. Vetro 2008
slide#13
How will GE Healthcare be RoHS Compliant?
Supply Chain Expectations
Finished
product
1) Certificate of conformance
(Supplier declaration of conformance)
Assemblies
2) IPC1752 Material Declaration
(Concentration data for RoHS substances
Component
s
3) Test data available
Need to demonstrate compliance for all countries.
How will GE Healthcare be RoHS Compliant?
Supply Chain Control
1. Clearly define GEHC RoHS requirements for supply
chain
2. Train Suppliers (Awareness)
3. Assess suppliers’ capabilities (QMS)
• Supply chain control (2nd and 3rd tier)
• Inventory control
• Process control
4. Reduce / eliminate supplier risk through:
• Training
• On-site audits
• Incoming inspection
5. Sustain compliance
J. P. Vetro 2008
slide#15
How will GE Healthcare be RoHS Compliant?
Supply Chain Control
Testing for Compliance
diphenyl carbazide test for Cr+6
XRF Screening
J. P. Vetro 2008
slide#16
Conclusion
• Medical Devices are highly regulated
• RoHS Regs can’t contradict MDD
• Safety and Reliability are critical to generate
accurate results
• Need international consistency
• Substances
• Concentrations
• Standards
• Supply Chain control is essential
• Time to convert for viable options
• Cost… trade barrier
J. P. Vetro 2008
slide#17
Thank You!
J. P. Vetro 2008
slide#18