Preparing for Medical Electronics RoHS Compliance
Next July, certain medical electronics will fall under the scope of RoHS—the European Union’s Restriction on Hazardous Substances (RoHS). In terms of the electronics industry, that is now a tight deadline for manufacturers. Medical devices that have so far been exempt from RoHS, which requires the elimination of lead, cadmium, mercury, and other substances from electronics, fall into scope under the RoHS Recast (RoHS 2) beginning in July 2014; the rest must comply by 2019.
Since RoHS was first implemented in 2005, the electronics industry has faced its share of challenges—among them, finding a replacement for lead in common solders. In the high-reliability medical field, there is zero tolerance for issues such as “tin whiskers,” which has plagued commercial electronics. So what can medical equipment manufacturers do to prepare?
First, understand that many common components—traditionally attached to a board with lead solders—have already been declared end-of-life (EOL) by manufacturers. Products with long lifecycles, such as medical equipment, will need to replace parts during the transition to RoHS compliance. There are a number of risks associated with sourcing EOL products outside the authorized supply channel during this phase.
Once a component reaches its end-of-life, the chances of sourcing a counterfeit or mis-handled part skyrockets. Some companies buy EOL inventory and resell authentic products. Others may take substandard parts and pass them off as EOL devices. A buyer or repair-person desperate for an EOL part might not know the difference.
OEMs can plan for EOL well in advance. Manufacturers should look at new product design and ask the following question: How many of these components will go EOL before the production schedule has reached its end?
Then, OEMs should talk to a long-term authorized component specialist while the product is still active. Spell out your needs. Try to anticipate how long your production cycle may last to avoid a future hassle. Don't concentrate on what products are funded today; think about what will have to be funded tomorrow.
Few manufacturers can confidently predict how long their product will be in production. Markets and customer demands can change significantly in 10 years. Funding allocations also change. However, a proactive company will plan for EOL anyway and talk to specialists in that market. With a proper, long-term supply plan and the right authorized partner, it is possible to ensure a safe, financially-sound supply chain for years to come.
Relying on an authorized source ensures devices are compliant and fully functional. Original component manufacturers (OCMs) are very 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.
Because of the high value and high-demand for EOL components, counterfeiters target these devices. Rochester’s relationship with the OCMs guarantees the authenticity of its components. In addition to the materials used in a component, engineers and buyers must consider its source. In mission-critical applications such as medical devices, the risk of failure is too high if it results in loss of life.