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Medical OEMs Dial 911 for RoHS

Medical electronics are going to fall under the scope of the European Union's Restriction on Hazardous Substances (RoHS) beginning in 2014. This is not news, but many medical equipment makers seem unprepared for the directive, which prohibits sales of electronics containing lead, mercury, and four other substances in the EU.

“Medical OEMs are busy keeping up with guidelines from the [US Food and Drug Administration],” says Ken Stanvick, principal with consultancy {complink 12808|Design Chain Associates LLC (DCA)}, in an interview. “Many of the larger OEMs are cognizant of the directive, but that hasn't trickled down to lower levels of the supply chain.” In other words, supply chain partners may not be aware of just what RoHS entails.

What RoHS entailed for the overall electronics industry was replacing lead in many of the solders and components widely used in manufacturing. The industry spent years testing lead-free solders while component makers began running parallel manufacturing lines — leaded and lead-free parts — until parts, solders, and manufacturing equipment became compatible. The directive still creates issues in the industry because long lifecycle equipment requiring leaded parts are facing shortages of now-obsolete leaded devices.

The latest version of RoHS, referred to as the RoHS Recast, expands the scope of the directive to include medical electronics on a staggered schedule. This includes in-vitro medical devices, monitoring and control instruments, industrial monitoring and control instruments, and “other” electrical and electronic equipment not covered by any of the categories above. After 2019 — the latest date for medical device compliance — non-compliant equipment cannot be sold in the EU. This may present a challenge for users that want to resell old equipment, Stanvick says.

What does this mean for manufacturers? DCA recommends OEMs begin to look at compliance efforts from four standpoints:

  • Design:
  • Is the product compliant as designed?

  • Manufacturing:
  • Can I demonstrate that the device as manufactured is compliant?

  • Purchasing:
  • Do my contracts reflect due diligence? Am I procuring materials that are compliant?

  • Sales:
  • What do I need to know to be able to sell this product? Are there customer requirements above and beyond what RoHS requires?

The RoHS directive outlines what it calls manufacturer obligations, which include documentation procedures for compliance and notification of changes in design or spec. Some of the highlights of these obligations are:

  • Once compliance can be demonstrated, manufacturers can draw up an EC Declaration of Conformity and affix the CE marking on the finished product. (The CE does not apply specifically to just RoHS compliance.)
  • Manufacturers also have to ensure that procedures are in place for series production to remain in conformity. Changes in design or specs must be declared.
  • Manufacturers must keep a register of non-conforming electrical and electronic equipment (EEE) and product recalls, and keep distributors informed of these actions.
  • Manufacturers must ensure that any EEE bears a type, batch, or serial number or other element allowing its identification or, where the size or nature of the EEE does not allow it, that the required information is provided on the packaging or in a document accompanying the EEE.
  • A manufacturer that has reason to believe that an EEE it has placed on the market is not in conformity must immediately take the necessary corrective measures to bring that EEE into conformity, or withdraw it or recall it. It must provide details of the non-compliance and of any corrective measures.

Sometimes, materials or applications are exempt from RoHS. Some of these exemptions will expire, such as “lead in dielectric ceramic in capacitors for a rated voltage of less than 125 V AC or 250 V DC,” in 2013. Some have no expiration date, such as lead in the glass of CRTs.

The experiences of industrial and consumer electronics companies in regard to RoHS can certainly act as a guideline and, in some cases, best-practices, environmental experts say. However, RoHS is only part of a bigger movement called “sustainability,” which we will continue to cover in upcoming blogs.

7 comments on “Medical OEMs Dial 911 for RoHS

  1. dalexander
    August 16, 2012

    Barbara, what will this mean for X-Ray techs? Now they wear a lead apron and stand behind a lead wall to protect themselves. I know some x-ray operations require the tech to be standing next to the patient and that seems to be unavoidable, especially where squirmy small children are involved.

  2. prabhakar_deosthali
    August 17, 2012

    The third wolrd countries have to watch such legislations very carefully and pass similar laws in their countries . Otherwise all such non-compliant equipment will find its way to them like those banned drugs.

  3. stochastic excursion
    August 17, 2012

    Barbara, one bullet point I'm wondering about is disposal: where medical professionals and other customers must take extra precautions now to dispose of electronics, will these restrictions be eased once products clear RoHS?

  4. bolaji ojo
    August 20, 2012

    Stochastic, The restrictions will still be in place. There are numerous reasons for requiring these and the elimination of dangerous chemicals in medical and electronic equipment will not completely make this requirement irrelevant.

  5. bolaji ojo
    August 20, 2012

    Prabhakar, They are watching and they are (as in the case of India) passing similar legislation. The challenge they have is in the area of compliance. They can legislate but as you may be aware enforcing such laws is particularly difficult in developing nations.

  6. Ken Stanvick
    August 20, 2012

    Lead lined x-ray aprons are not in scope of the new directive, as they are not considered to be EEE.

  7. garyk
    August 22, 2012

    Lets review, the Aerospace and Military want Lead in the componets and solder joints because of longer life cycles.

    Phones on the other hand are replaced by phone providers and with service contactors or changed for newer technology every 2 years? Most likely its not worth a Failure Analysis on why the phone failed! (tin whiskers)

    On the other hand Medical use, equipment is expensive and must have a along life cycle.

    Maybe the EU won't have Medical Equipment in the future? The US can provide Medical Treatment and become the Hospital for the world!

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