Engineers and buyers in the medical device manufacturing industry should note the following date: July 22, 2014. That is the day medical electronics must comply with the EU’s Restriction on Hazardous Substances (RoHS) regulation.
Medical devices have so far been exempt from RoHS, which requires the elimination of lead, cadmium, mercury, and other substances from electronics, but they will now fall under the scope of RoHS Recast (RoHS 2). July 2014 is the earliest date medical devices are affected, but additional compliance requirements will continue to be phased in through 2019.
Although there are exemptions to the regulation under specific circumstances, regardless of inclusion or exemption, manufacturers must demonstrate that their equipment has been designed and manufactured in accordance with the requirements set out in RoHS, prepare the required technical documentation, and implement the internal production control procedures in line with the directive.
Designers and manufacturers of medical equipment are facing a lot of decisions—as well as a lot of paperwork—to prove either compliance or exemption. More importantly, medical OEMs must consider the impact on their supply chain. As demand for non-compliant devices declines, more components will be declared end-of-life (EOL) by suppliers. Medical equipment already has a long shelf life of 10 years or more. RoHS 2 will be phased in through 2019. Thus, the ability to source replacement and repair devices will increasingly become a differentiating factor for many medical electronics suppliers.
Looking down the road at the phase-in calendar: In vitro medical devices fall into scope in 2016, as does monitoring and control equipment. Industrial monitoring and control instruments fall into scope a few years later; as will all other electrical and electronic equipment not covered by any of the other categories by 2019. Component makers may be planning their obsolescence strategies right now.
Like military electronics, medical components are a highly-regulated industry, so ensuring components meet the original design specs is crucial. Relying on an authorized source ensures devices are compliant and fully functional. Original component manufacturers (OCMs) are required to be diligent about authorizing their resellers—an authorized distributor carries, stores, handles, and packages components per OCM specifications. Authorized distributors, such as Rochester Electronics, specialize in EOL components, and their relationship with the OCMs guarantees the authenticity of its components.
Because of the high value and high demand for EOL components, counterfeiters often target these devices. A recent high-profile case in the defense industry involving counterfeit components highlights the danger of counterfeits in the supply chain; in fact, the case was a major factor in creating the National Defense Authorization Act. Thus, it is not enough for a manufacturer to verify the materials used in a component, but their engineers and buyers must consider the ultimate source of the component. In mission-critical (i.e., life-sustaining) applications such as medical devices, the risk of failure due to a counterfeit component is too high if it can result in loss of life.