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EU restrictions challenge U.S equipment manufacturers

May 22, 2014

 

 

 

by Loren Bonner , DOTmed News Online Editor

A new European Union directive for medical devices has kept manufacturers on their toes as they work to get new imaging equipment up to standard for the July 22 deadline. 

The European Union’s Restriction on Hazardous Substances directive, or RoHS Recast (RoHS2), will require medical devices entering the EU to comply with stringent limitations on certain metals that can become toxic and leach into groundwater when disposed in landfills, or become hazardous ash when incinerated. The banned materials include lead, cadmium, mercury and polybrominated flame retardants, which are commonly found in the electrical components of medical equipment. 

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“The Recast RoHS directive is a CE-marking directive, which means your medical devices and imaging equipment cannot CE-mark the way you used to with the medical device, EMC and low voltage directive,” said Kirstin Rasmussen, a quality engineer at Northwire, a contract engineering company and cable manufacturer. “Requirements to assess all EEE manufacturers to demonstrate compliance with RoHS2 are legally enforceable. Some of the responses to non-compliant products include physical and laboratory checks on samples, documentation checks, handling complaints, ruling on penalties, withdrawing, prohibiting and even restricting your products from the EU.” 

According to Northwire, it is not enough to simply modify products to comply by removing the hazardous and restricted substances. Manufacturers, importers, distributors, and authorized representatives, recognized as “economic operators”, are required to provide proof of RoHS2 verification on various forms of technical documentation — not limited to the Declaration of Conformity. 

When RoHS was introduced back in 2003, the first compliance deadline applied just to information technology equipment, such as computers and printers. Medical equipment was exempt at that time, although manufacturers were aware that their products were next in line. 

Carestream Health, for example, allotted a two-year window, starting back in 2012, to get 100 percent of parts in products ready for 2014. This affected 50,000 individual components in Carestream equipment and included all of its medical imaging equipment. 

“Anything you declare in the EU as a medical device must be compliant by July 22nd,” Dale Parks, director of worldwide equipment compliance & commercialization regulatory affairs & quality systems for Carestream, told DOTmed News. 

 

In order to accomplish this task, Carestream became a member of a material information data collection tool called BOMcheck, which helped them manage supply chain compliance. They went through their entire portfolio of parts and identified the risk and then the suppliers, who they also had to ask to join BOMcheck. Today, more than 3,500 suppliers worldwide are a part of the database. 

While it’s certainly been a lot of work for equipment manufacturers, Parks said engineers on the supply chain side have been even more challenged in redesigning the components.

 

 

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“Tin lead solders have been the baseline for electronics for 80 years. So now you’re taking lead out and you’re replacing it with copper or silver and what happens is the melting point of solder rises so all those components on these complicated circuit boards [the heart of most electronic products] will see a higher temperature when they are processed, which can have negative effect on them,” he said. 

Besides Carestream, roughly 580 manufacturers including Philips, Siemens, GE, Toshiba, Agfa and Texas Instruments, are part of the BOMcheck web database. 

Carestream also decided to develop its own capability to test the parts, using an X-ray fluorescence material analyzer test. But for companies that have not invested in X-ray fluorescence test analyzers, resources such as Northwire have the capability to do the testing for them. 

“The device detects restricted substances instantly and provides both an electronic and hard copy record. Northwire’s in-house, non-destructive test capability is the same technology utilized by regulatory agencies. If test results are positive for the presence of hazardous substances, NWI can help you source alternatives in our validated supply base,” said Rasmussen. 

Refurbished medical equipment will also be impacted by RoHS2. According to Joe Langton, business service line leader at the product inspection company Intertek, after July, equipment imported for the first time into the EU market as secondhand or refurbished will need to be RoHS compliant. However, medical devices placed on the EU market before RoHS restrictions, once repaired, upgraded or refurbished, do not need to be RoHS compliant, as long as the device is made available as "used", "pre-owned", or "refurbished". 

Although the process to comply has been long and costly, Parks said Carestream was on board from the get-go because of the green impact they believed in. 

“It’s a lot of money to be compliant in the medical world — there are regulations everywhere, it’s the cost of doing business in the medical device industry,” said Parks.