RoHS exemption for medical devices is under review

In short, the RoHS exemption for medical equipment is under review and is widely expected to be included in the scope of RoHS. The Commission promised to prepare a statement at the end of July, but has not yet done so. "Everyone is waiting to see how the EC interprets [the ERA report] and how its interpretation is brought into legislation," said Jean-Marc Abbing, manager of worldwide environmental affairs at Johnson & Johnson, in Leiden, The Netherlands.

Candido Garcia Molyneux, an environmental lawyer at Covington & Burling LLP in Brussels, believes the Commission will release a proposal by year's end or early 2007. He expects Categories 8 and 9 to be subject to RoHS requirements in 2010.

Parts obsolescence, rising prices drive compliance

Still the medical device industry has found that freedom from RoHS restrictions is no advantage. In fact, the non-converts have discovered a big downside to living in a RoHS world including parts obsolescence and rising prices. The wholesale migration to RoHS parts, particularly to lead-free devices, is beginning to drive up component prices for the leaded parts that medical manufacturers critically require. Moreover, RoHS will most likely make some leaded components uneconomical to produce and therefore obsolete.

"These are not just concerns, they're reality," said John Lowell, vice president of operations for SonoSite, Inc., a supplier of portable ultrasound systems in Bothell, Washington. Since the company uses a lot of proprietary technology when designing its units, the industry-wide move from tin/lead solder to lead free has had a significant impact on research and development, and has pushed the company toward compliance despite the exemption.

SonoSite has already begun efforts with the goal of being RoHS compliant before 2010. "Our custom components are not compatible with lead-free processing of circuit boards," Lowell said. "Proprietary devices will have to be re-engineered. Essentially, we have to re-design all our circuit boards."

Mike Tendick, engineering services manager for EMS provider Plexus Corp., Neenah, Wisc., which designs and produces medical equipment, said many medical devices are highly-complex, low-quantity products using FPGAs and microprocessors that are changing over to lead-free versions. "Leaded versions are becoming obsolete and forcing the bill of materials for medical customers to shift over to RoHS," he said.

In some cases, medical equipment manufacturers have purchased several years supply of a component to ensure availability. "Last time buys are very critical," Tendrick said.

Page 2: On the path to compliance
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