RoHS is just the beginning of environmental regulation. Future regulations are going be much more stringent than RoHS, so it's imperative medical-device manufacturers start thinking in environmental terms. While the United States has yet to issue legislation, California will begin regulation in January 2007. Other states will follow. Internationally, China's RoHS equivalent goes into effect next March. South Korea and five South American countries (Argentina, Brazil, Chile, Paraguay, and Uruguay) will also enact RoHS-style regulations next year. Medical-device manufacturers need to pay attention, because it is unlikely there will be any exemptions.

It's uncertain how long RoHS exemptions for medical-device manufacturers will stay in place. The European Commission is currently reevaluating the health impact of hazardous materials in electric equipment — including medical devices. Fortunately their findings are unlikely to have any immediate ramifications.

In the medical-device industry, where unreliable products can cost lives, and devices are expected to have life cycles measured in years, reliability concerns have kept manufacturers from going to lead-free soldering. However, lead-free manufacturing has advanced and some electronics manufacturers offer lead-free soldering that rivals their leaded counterparts in reliability.

Lead-free solder is applied at a higher temperature than leaded solder, which raises concerns about stresses put on components. However, EMS providers can tweak the process to reduce stresses on PCBs.

Here are some tips to help ensure devices meet RoHS and future environmental regulations:

• Identify non-compliant parts and find substitutes.

• With rules changing almost daily, find manufacturers that work closely with established suppliers who can locate appropriate replacement parts, and identify lead times.

• Remember, not all lead-free soldering is the same. A tin-silver-copper alloy with a 217°C melting point is the best.

• Consider dual-solder systems. While most products can be made without using lead, leaded soldering will still be needed on some products indefinitely. As a result, most manufactures will have to manage lead-free and leaded production lines. If you outsource assembly, make sure the manufacturer uses rigorous material controls and training to ensure dual solder systems work properly and prevent cross-contamination.

• While exemptions might not currently require the jump to lead-free production, other factors might force the issue. With the tremendous demand for lead-free parts, fewer leaded parts are being made and are therefore harder to obtain.

One more tip: Don't wait until the last minute. Thinking about these regulations in advance reduces the cost of compliance — not to mention stress.