rohs, reach, weee & erp impact on the medical industry april 18, 2011 beth a. hulse ge...

RoHS, REACH, WEEE & ERP Impact on the Medical Industry

April 18, 2011

Beth A. HulseGE Healthcare Global Regulatory Manager - Stewardship

U.S. Department of Commerce & EU Directives

2 /Beth A. Hulse, GE Healthcare /

04/18/23

GE Business Segments

Home & Business Solutions

Appliances

Lighting


04/18/23

Over 300 new env. product regulations in 2011

46% worldwide growth in 2 years

“Medical devices” no longer excluded

Global regulatory landscape

Compliance is ongoing

Must know composition of our products … FSD

Shift from supplier declaration to testing & cert.

Required by regulators … requested by customers

0

50

100

150

200

250

300

350

400

450

2003 2004 2005 2006 2007 2008 2009 2010

Nu

mb

er R

egu

lati

on

s E

nte

red

Into

Fo

rce


04/18/23

Latin Am & N. Am …81% new regs

Product Substance & Waste Regs … Growth


04/18/23

Reg. Overview Impact Assessment

Internal Requirements & specifications

Ongoing Compliance

Standard Docs& Processes

•Businesses•Functions•Products•Parts•Processes

Communication& Training

Visibility to New Regs … Key to Compliance

• Leadership• Suppliers• Impacted

functions

Redesign

Data Repository

BOM

•eTools•Agencies•Industry•Consultants

Regulatory Tracking


04/18/23

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


04/18/23

CT Scan

MRI

• 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

Considerations When Designing for Substance Restrictions


04/18/23

EU RoHS, REACH, WEEE


04/18/23

EU RoHS RecastDec. 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


04/18/23

EU RoHS Recast … Impact on Medical Devices2014 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.


04/18/23

EU WEEE Recast … Key Issue for Medical Devices

•Reduce electronic waste generation in EU

•Refurbishment & reuse of used equipment

•Re-use of parts for Installed Base

Equipment take back… refurbish & parts harvesting

Environment benefit

Shipments of used EEE (Annex IC) – Council agreement

•Illegal exports…proof goods are not waste

•Equipment for reuse fully functional in sales contract and or transfer of ownership

•Functional testing & evaluate every item.

•Self declaration that no material is waste.

Critical Issues for Medical Devices


04/18/23

European REACH … Impact on MDReporting: 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


04/18/23

EU ErP Energy Related Products


04/18/23

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

EU Energy Related Products (ErP)– 2009/125/ECFocus To reduce 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


04/18/23

Benefits of Self Regulation: Industry recommends:

Products in scopeProposes timing for inclusionAggressive targets…but achievable

Partnership with the governmentEffective for ~3+ yrs…without implementing measuresEarlier inclusion in ErP

Benefits to Customers:Greener products…across the lifecycle Focus on areas of greatest impactValidated with reporting & 3rd party review.

Self Regulation…Proactive focus on env.responsibility

MD Self RegulationU/S, MRI, CT, X-ray, NM

LCA

MD Industry initiated self regulation


04/18/23

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”

U.S. Nat’l Framework For Electronics Stewardship

· 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

Impact on MD:


04/18/23

Summary


04/18/23

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.


04/18/23

Beth A. HulseGlobal Regulatory Manager - StewardshipGE HealthcareRoHS, 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 CollegeM.S. Manufacturing Management, GMIM.S. Operations, Kettering University

Six sigma Master black belt and Black belt Certified

[email protected] (414) 416 3396

rohs, reach, weee & erp impact on the medical industry april 18, 2011 beth a. hulse ge...

Documents

medical industry

reliability of medical

years medical devices

weee slide

medical device exemptions

medical devices substances

mdd slide

eu rohs industry