On July 1, 2006, a quiet but dramatically disruptive law went into effect that has wide-reaching business and environmental implications. While it formally impacts only products sold in Europe, its effects are global. It isn’t a plague but some might call it a pandemic.It’s called the Restrictions of Hazardous Substances directive, or RoHS. It is one of many similar “green” initiatives being adopted and/or expanded in countries around the world. While medical devices are exempt from the European Union’s RoHS, there is far less certainty that medical devices will be so fortunate in other, similar directives. But even if medical devices remain exempt, we see an undercurrent of change in the supply base that could turn RoHS from a mere ripple for medical devices into a tsunami. Why? Many of the materials and components found in medical devices are going green. As the supply base shifts, medical manufacturers must take the proper precautions and steps to ensure product protection and enhance competitive position.
RoHS ... And Beyond
Government bodies are adopting environmental regulation with rapid speed while cracking down on OEMs. In 2001, Sony spent more than $80 million to replace peripheral cables in over one million PlayStation game consoles because they contained more cadmium than permitted under the Netherlands environmental law, which closely mirrors the EU’s RoHS initiative.
What Does This Mean?
RoHS is driving the “greening” of the supply base, and it has huge implications for medical devices, not the least of which could require complete product redesigns.
to fully understand the long term reliability impact.
Cost Of RoHS
At the risk of stating the obvious, there are substantial resources requirements medical OEMs need to consider as they migrate to environmentally safe materials.
Where To Start
It would be nice to have a magic wand we could wave to instantly comply with all current and pending RoHS regulations. But there is no such quick fix, no Merlin the Wizard who can help. However, in working with major medical device firms grappling with environmental issues, the biggest and most costly challenge is the revalidation process for medical devices where RoHS approved components have been integrated.
• Removal of lead in printed circuit boards: While this involves data collection and parts management, the substitution itself is reasonably straightforward. However, revalidation issues can become significant (e.g., reliability), making the whole process highly complex, time consuming, and costly.
• Removal of “5 of 6” substances: Here data collection is tricky because most OEMs and their suppliers do not really know if or where, for example, polybrominated biphenyls are used. However, revalidation tends to be a much easier task, because these components rarely have a significant functional role. The level of government oversight of medical devices can equate to months in the revalidation process, not weeks since you’re not likely to be re-validating electrical functionality. In most cases, you will be revalidating reliability issues, which can take six months to a year per product. A practical approach to address these issues would be as follows:
• Instead of a full product BOM scrub, start with a pilot of a couple of typical and common products, which are representative of things like board density.
• Run all studies with controls (i.e., side-by-side tests—original product vs. “green” product.)
• Use the same number of products (and controls) used in original reliability studies for the non-compliant product.
• Start, in parallel, a HALT (Highly Accelerated Life Testing)/HASS (Highly Accelerated Stress Screening) study, and a field life test study.
• Based on the early HALT/HASS test results on the pilot units, decide whether to:
• Grandfather all products beyond the pilot group (only if all results are positive)
• Expand the tests to products beyond the pilot group
• Conduct additional reliability studies/analysis
• Continue the field