Medical device manufacturer replaces lead in collimator blades

PolyOne announces that a medical device manufacturer has chosen special nylon compounds as lead-free alternatives for radiation shielding in computed tomography scanners.

To help medical device manufacturers stay ahead of tightening environmental restrictions on the use of toxic lead, PolyOne Corporation, a leading global provider of specialized polymer materials, services, and solutions, developed Trilliant* HC PbF compounds as lead-free alternatives for radiation shielding. The success of these new materials was highlighted at MD&M East with PolyOne’s announcement that a leading global manufacturer of computed tomography (CT) scanners chose Trilliant HC PbF tungsten-filled nylon 12 compound to replace lead in the collimator blades of its equipment. The manufacturer not only achieved shielding performance equal to or better than that of lead, but also gained a market advantage through the use of this environmentally progressive PolyOne material. Other benefits from the upgrade to Trilliant HC technology included greater design freedom, more robust finished parts, and lower overall systems costs.

CT scanners – the use of which is growing by 10 to 15 percent annually – must be shielded to minimize radiation exposure for patients and clinicians. Although the European Union’s (EU) Restriction of Hazardous Substances (RoHS) and Waste Electrical and Electronics Equipment (WEEE) directives currently exempt healthcare devices, tighter restrictions on the use of lead are expected in the future. In 2003, California also passed SB 20: Electronic Waste Recycling Act (EWRA). This law prohibits the sale of electronic devices after January 1, 2007 that are already prohibited from being sold under the EU RoHS directive and includes liquid crystal displays (LCDs), cathode ray tube (CRTs), and similar devices. EWRA also has a restricted material disclosure requirement and other U.S. states and cities are reviewing whether to adopt similar laws.

“We developed the Trilliant HC PbF portfolio to give medical device manufacturers new alternatives to problematic lead shielding,” said Jeff Pollis, market manager, healthcare, for PolyOne’s Specialty Engineered Materials (SEM) business. “But lead avoidance is only one of its many benefits. Changing to our new materials technology can also give healthcare device manufactures greater design flexibility to create better, safer, and more cost-effective products. The Trilliant HC PbF materials do more than cure a potential environmental headache – they provide a strong competitive advantage for our healthcare customers.”

The CT scanner manufacturer had previously tried replacing the lead/steel collimator blades with molybdenum but found the costs prohibitive. Using Trilliant HC PbF compound greatly minimized the material cost and also reduced system costs by eliminating machining and regulatory costs.

Compared to lead, Trilliant HC PbF compound provides designers with enhanced freedom, including part consolidation. Using the PolyOne material, the device maker was able to shield portions of the X-ray tube that were impractical to shield with lead or molybdenum. Molding instead of machining allowed an opening for signal and power cables to be completely shielded against radiation leaks.

Molded Trilliant parts are also less prone to damage than softer lead versions, and there are fewer service and field replacements. They are also less brittle than pure tungsten.

Testing done by the CT scanner manufacturer showed that parts made with Trilliant HC PbF compound perform to the specification of lead without the lifetime costs of preventative health tests for employees, worker safety issues, and lead disposal costs.” The Trilliant HC PbF technologies combine a base polymer – polyamide, polypropylene, polyurethane, or polybutylene terephthlalate – with copper, tungsten, or stainless steel filler/reinforcement to achieve a high specific gravity of 2.0 to 11.0 g/cc.

The new Trilliant HC portfolio is offered by PolyOne’s Specialty Engineered Materials business and is supported by the company’s product stewardship program. This program provides facilities certification for Food, Drug & Medical Product - Good Manufacturing Practices (FDM – GMP) compliance via yearly audits, screening of raw materials for adherence to United States Pharmacopeia (USP) Class VI standards, random testing for heavy metals, and review of all new product formulations to determine compliance status.

* Trademark of PolyOne Corporation.

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