RoHS Compliancy in the Medical Equipment Supply Chain by 2014

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.