RoHS Compliancy in the Medical Equipment Supply Chain by 2014

© Copyright Rochester Electronics

Page 2

February 2013

Executive Summary

The Restriction of Hazardous Substances (RoHS) directive has been an ongoing initiative in many industries

across the electronics’ supply chain since the concept surfaced in the European Union in 2006. The EU’s 2006

RoHS directive banned the use of six substances—lead (Pb), mercury (Hg), hexavalent chromium (Cr (VI)),

cadmium (Cd), polybrominated biphenyl flame retardants (PBB), and polybrominated biphenyl ether flame

retardants (PBDE)—in eight categories of electrical/electronic equipment. The mission of the ROHS project is to

remove hazardous materials from electronic devices in order to facilitate the elimination of hazardous waste

effects on the environment. In December 2013, the RoHS exemption that was put in place for the medical

industry will expire, and companies will be forced to comply with current regulations. These regulations will

prohibit any leaded and non-RoHS materials from medical equipment, which, will cause a challenge for the

medical industry as they figure out what is available for their applications. As a result of long product life-cycles,

they may discover that the devices have since gone obsolete, or were never available in a RoHS package, which

could ultimately lead to costly redesigns. With that in mind, medical companies are finding themselves

scrambling to meet regulations with their manufacturers, and keep their businesses compliant.

The leaded-to-lead-free & RoHS Compliant conversion

Regardless of their current RoHS exemption, both medical manufacturers and companies across the industry

have seen a noticeable increase in requests for documentation relating to environmentally preferred products

(EPP). Leading companies are losing out on significant opportunities and bids due to their inability to show their

customers required EPP documentation, which discloses material usage and regulatory compliance certification.

The increase in these types of requests stemmed from the RoHS directive initiative that had been employed

across a number of industries. Unfortunately, moving from one requirement to the next is not an easy task.

Companies within the medical industry have put pressure on their suppliers to execute the required processes

needed to comply with RoHS constraints, but continue to hit obstacles along the way. Medical manufacturers

and existing companies have experienced mergers and acquisitions which have temporarily fragmented

productivity, and while the medical industry faces the expiry of their exemption, they have to simultaneously

plan for the next revision of RoHS (and most likely those of REACH) guidelines that will include additional

hazardous materials restrictions.

Imminent additional compliances known as the Dodd-Frank Wall Street Reform and Consumer Protection Act

include a section specific to the procurement of certain conflict minerals from the Republic of the Congo (DRC).

The minerals that are up for discussion are tantalum, tin, tungsten, and gold. These minerals are the source of

increased amount of violence and criminal activity within the DRC region, and continuing to procure these only

adds fuel to the fire. These minerals are used commonly within the electronics industry and because the Act is

fairly new, stipulations and consequences are still being worked out.

The last cause for concern revolves around the substance restrictions, and the overall effect it could have on the

functionality of medical system applications. For example, lead has proven to be an effective element in solder

because of its ability to restrict the growth of "tin whiskers.” RoHS devices using tin as a replacement terminal