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.


“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.

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