Restriction of Hazardous Substances in Medical Devices WHITE … · 2015-09-30 · Overview of RoHS...

Big Data Analytics In M2M

WHITE PAPER

Restriction of Hazardous Substances in

Medical Devices

Big Data Analytics In M2M

WHITE PAPER

2|© 2015, HCL Technologies. Reproduction Prohibited. This document is protected under Copyright by the Author, all rights reserved.

Table of Contents

Abstract ............................................................................................. 3

Abbreviations .................................................................................... 4

Overview of RoHS ............................................................................. 5

Uses of RoHS Substances .................................................................. 6

Environmental Effects of RoHS Substances ...................................... 6

Implications from RoHS .................................................................... 8

Benefits of RoHS Implementation .................................................... 9

HCL’s Business Model Support to Industries .................................. 80

References ...................................................................................... 11

Author Info ...................................................................................... 11


Abstract

Medical devices, medical equipment, and many electronic products are a complex mix of various

components made up of heavy metals and dangerous chemicals. These chemicals and heavy metals

have adverse effects on human health, like cancer, kidney damage, increase in blood toxic levels, and

more. They also affect the environment with air pollution, water pollution, food contamination, etc. In

order to prevent this, the European Commission implemented the RoHS Directive.

EU RoHS Directives

RoHS I - 2002/95/EC (Came into force 1st July 2006)

RoHS II- 2011/65/EU (Came into force 2nd Jan 2013)

The RoHS Directive restricts the use of certain hazardous substances in medical, electrical, and

electronic products. RoHS has environmental benefits but may result in high compliance costs which

could affect the healthcare industry. Products that do not comply could be removed from the market

within the EU.

Deadline according to RoHS II

Figure 1: Deadline according to RoHS II

Source: http://ec.europa.eu/environment/waste/rohs_eee/pdf/faq.pdf

This paper provides an overview of RoHS, the usage of RoHS substances in healthcare and the various

environmental effects of RoHS substances. It also covers the implications and the benefits of RoHS,

particularly for healthcare, and provides a brief solution through HCL’s business model for industries.

http://ec.europa.eu/environment/waste/rohs_eee/pdf/faq.pdf


Abbreviations Sl. no. Acronyms Full forms

1 RoHS Restriction of the use of certain Hazardous Substances

2 EEE Electrical and Electronic Equipment

3 EU European Union

4 IVD In Vitro Diagnostic medical devices

5 EC European Commissions

6 EEC European Economic Community

7 Ppm Parts per million

8 R&D Research and Development

9 REACH Registration, Evaluation, Authorization and Restriction of chemicals

Overview of RoHS RoHS mandates that medical devices, medical equipment, and EEE products must not contain more than

0.1% (except for cadmium which is limited to 0.01%) by weight of homogenous material of any of the

listed substances. Homogenous material denotes a material that cannot be mechanically disjointed into

different materials.

RoHS substances Threshold Limit

Lead (Pb) 0.1% by weight (1000 ppm) of homogeneous materials

Mercury (Hg) 0.1% by weight (1000 ppm) of homogeneous materials

Cadmium(Cd) 0.01% by weight (100 ppm) of homogeneous materials

Hexavalent chromium (Cr(VI)) 0.1% by weight (1000 ppm) of homogeneous materials

Polybrominated biphenyls (PBB) 0.1% by weight (1000 ppm) of homogeneous materials

Polybrominated diphenyl ethers (PBDE) 0.1% by weight (1000 ppm) of homogeneous materials

New proposed substances that are not in scope - as of now

• Hexabromocyclododecane (HBCDD)

• Bis (2- ethylhexyl) phthalate (DEHP)

• Butyl benzyl phthalate (BBP)

• Dibutyl phthalate (DBP)

When substances are present in quantities more than the threshold limit, the product will be marked as

non-compliant, unless there is an exemption available for the particular application. For some

applications, there are no suitable alternatives available, so exemptions were given under RoHS

directives. But exemptions have an expiry date. Active implantable medical devices are currently

excluded from the scope of RoHS, and may be included in the future.


Uses of RoHS Substances

Substance Main Use in the Healthcare Industry

Lead

Lead in plating finishes and solder- X-ray, Ultrasound, MRI;

PVC stabilizer in medical tubing, ECG leadsets, cables and patient monitoring cables;

Anesthesia equipment

Cadmium

Cadmium pigments in ECG patient cables;

Flexible copper cadmium wire in Ultrasound equipment;

All diagnostic X-ray systems.

Mercury

Very high capacitance and loss measurement bridges

High frequency RF switches and relays in monitoring and control instruments;

reference electrodes

Hexavalent

Chromium

Alkali dispensers for in-situ production of photocathodes;

image intensifier tubes and assemblies;

All X-ray systems

PBB Flame retardant

PBDE Flame retardant

Environmental Effects of RoHS Substances The annual usage of RoHS substances in medical devices and in monitoring and control instruments is

listed.

Figure 2: Usage of RoHS Substances

Source: http://ec.europa.eu/environment/waste/weee/pdf/ia_report.pdf

http://ec.europa.eu/environment/waste/weee/pdf/ia_report.pdf


So, according to World Health Organization (WHO) and other surveys:

Source: http://www.who.int/en/

http://www.who.int/en/


Implications ofRoHS

Benefits of RoHS Implementation When the RoHS process is fully implemented, we can expect the following changes to happen.


One of the surveys show that the usage of lead, cadmium and mercury has considerably reduced in the

EU, because of RoHS.

Figure 3: Percentage reduction in usage

Source: http://www.rsjtechnical.com/NewsRoHScost&benefit.htm

HCL’s Business Model Support to Industries This is mainly divided into 3 groups:

http://www.rsjtechnical.com/NewsRoHScost&benefit.htm


1. Product Compliance Team

This team performs all RoHS compliance activities by themselves.

HCL’s Approach

Product code lifecycle analysis

Bill of materials analysis

Drawing analysis

Material weight calculation - substance level

Supplier material declaration

Compliance check

RoHS coding

Issuing compliance certificates

2. Compliance Support

This team supports the client’s compliance team in working with the supplier for material declaration.

HCL’s Approach

GAP analysis

Vendor / Manufacturer / Supplier interaction and follow-up

Compliance certificates collection

Verifying reports against regulatory standards / requirements

3. R&D Team

This team performs Design Review.

HCL’s Approach

Detailed analysis of product design and materials to reduce hazardous substance content

Identifying alternate materials

Performing change request activities

The flowchart below contains HCL’s detailed approach to RoHS.


Figure 4: Approach to RoHS

Conclusion

RoHS regulations play an important role in encouraging the elimination of six hazardous substances.

Medical devices, medical equipment and EEE products need to comply with RoHS regulations

(2002/95/EC –RoHS I and RoHS II- 2011/65/EU –ROHS II). Hence, many organizations and institutions are

taking up RoHS initiatives and assisting OEMs in getting compliance certification for their products.

HCL believes in innovation and customer satisfaction, and has the ability to define more effective RoHS

regulation processes through its vast experience in supporting global organizations through

international standards, directives, and regulations. HCL can provide product, compliance, and R&D

support that helps in RoHS compliance, for healthcare product manufacturers.

Understanding that the intentions of RoHS are mainly to protect the environment and human health

from toxic, hazardous and dangerous substances, we can make this planet greener.


References Official Journal of the European Union - Directive 2011/65/EU (recast) document-RoHS II

Directive 98/79/EC- In vitro diagnostic medical devices

Directive 93/42/EEC- Medical devices

www.ec.europa.eu

www.rsjtechnical.com

www.biois.com

www.export.gov

www.who.int

www.eucomed.org

Authors Info Glen Clifford Pereira

Glen has a Bachelor’s Degree in Mechanical Engineering from Don Bosco Institute of Technology

Bangalore, India (under VTU Belgaum). He has over 2 years of experience in Product Compliance and

Product Design in the Medical Devices domain.

Mathiyazhagan Muthusamy

Mathiyazhagan has a Master’s Degree in Applied Chemistry and Chemical Engineering. He has over 27

years of experience, of which he spent 18 years in the Medical Devices domain as the Quality Head, R&D,

the Quality Management Representative for US FDA-QSR, ISO 13485, MDD (CE Mark) and the Certified

Lead Auditor for the Quality Management System. He currently works in an engagement for a large

Medical Devices OEM across quality, design control, manufacturing, and sustaining services.

http://www.eucomed.org/

Hello, I'm from HCL's Engineering and R&D Services. We enable technology led organizations to go to market with innovative products and solutions. We partner with our customers in building world class products and creating associated solution delivery ecosystems to help bring market leadership. We develop engineering products, solutions and platforms across Aerospace and Defense, Automotive, Consumer Electronics, Software, Online, Industrial Manufacturing, Medical Devices, Networking & Telecom, Office Automation, Semiconductor and Servers & Storage for our customers. For more details contact: [email protected] Follow us on Twitter: http://twitter.com/hclers& LinkedIn:http://lnkd.in/bt8hDXM View our blog-site: http://www.hcltech.com/blogs/engineering-and-rd-services Visit our website: http://www.hcltech.com/engineering-rd-services

http://twitter.com/hclers

https://www.linkedin.com/company/3638581/redirect?url=http%3A%2F%2Flnkd%2Ein%2Fbt8hDXM&urlhash=qunp&actionToken=isSponsored%3Dfalse%26distanceFromViewer%3D-1%26model%3Dnull%26aggregationType%3Dnone%26isPublic%3Dtrue%26verbType%3Dlinkedin%3Ashare%26activityId%3Dactivity%3A5903023947821113344%26contextId%3DBdacOkcOiBNwKhzIIisAAA%3D%3D%26isDigested%3Dfalse%26isFolloweeOfPoster%3Dfalse%26actorType%3Dlinkedin%3Acompany%26pageKey%3Dbiz_share_uscp_activity%26feedPosition%3D1%26actorId%3Dcompany%3A3638581%26objectId%3Darticle%3A8930724516703538922%26rowPosition%3D1%26objectType%3Dlinkedin%3Aarticle%26moduleKey%3Dcompany_feed&goback=%2Ebzo_*1_*1_*1_*1_*1_*1_*1_hcl*5technologies*5*5*5engineering*5and*5r%26d*5services

http://www.hcltech.com/blogs/engineering-and-rd-services

http://www.hcltech.com/engineering-rd-services

Restriction of Hazardous Substances in Medical Devices WHITE … · 2015-09-30 · Overview of RoHS...

Documents

Transcript of Restriction of Hazardous Substances in Medical Devices WHITE … · 2015-09-30 · Overview of RoHS...