From the October 2012 issue of HealthCare Business News magazine


Worldwide legislation
There is a strong movement against the use of lead coming out of Europe with the Restriction of Hazardous Substances directive, which was adopted by the European Union in 2003 and took effect in 2006. The initiative restricts the utilization of six hazardous materials in manufacturing processes: lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls, and polybrominated diphenyl ether. However, in the medical equipment industry there has been an exemption, which will run through the end of 2013, notes Russ Wolff, business development manager, Thogus Products, a custom injection molder.
“From what I understand right now, primary shielding can still be a lead-based material, even beyond the end of 2013,” explains Wolff. “But secondary shielding will need to be converted over to a lead alternative.”


For example, if there is an X-ray machine that has a collimator that focuses the X-ray beam, lead-based material could continue to be utilized, as it falls directly in the line of radiation. On the other hand, if there were housing encasing the Xray tube, to shield against scatter or bounce back, an alternative material would need to be used.

Meanwhile, the U.S. continues to use lead across the nation in a multitude of products. Sery speculates, though, that the U.S. is about five years behind Europe in terms of lead exemption. Currently, the U.S. Environmental
Protection Agency and the Occupational Safety and Health Administration are eyeballing companies that perform various processes involving the fabrication, machining and casting of lead to ascertain they are managing it as carefully as possible.

“When you’ve got a toxic substance such as lead, it is very difficult to handle it in a safe manner,” says Wolff. “We’ve got a number of our customers that not only want an alternative because of the direction coming out of
Europe, but with the EPA and OSHA restrictions in this country, they want to get away from lead.” But the real wall here is the International Lead Association’s strong lobby, resulting in very few lead-replacement legislations, says Sery.

“When the U.S. government tackled the toxic substance asbestos, they did it very aggressively and that’s what they need to do with lead,” he says.

Bit by bit, however, lead’s use may be waning for some. Among other projects, Samsung in South Korea recently contacted Thogus about developing a green, RoHS-compliant collimator for their CT machine. Additionally, China is intending to echo the EU directive with its own RoHS, entitled, “Management Methods for Controlling Pollution Caused by Electronic Information Products Regulation.”

October 2012 Magazine

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