Companies Join Forces to Develop More Durable Medical Device Labels

Alpharetta, Ga.-based Solvay Specialty Polymers, a supplier of high-performance thermoplastics, recently announced that S+P Samson GmbH, a provider of specialty labels for industrial applications, selected Radel polyphenylsulfone (PPSU) film for the inlay of its new Structobond labels for medical instrument and device applications.

Sandwiched between layers of S+P Samson’s advanced epoxy materials are “thin but tough” ribbons of Radel PPSU from Ajedium Films, the film division of Solvay Specialty Polymers. Those ribbons deliver “exceptional steam and gamma sterilization compatibility, strong chemical resistance and high contrast for imprinted data used for improved product identification and traceability of surgical instruments,” according to Solvay officials.

“Our patented, adhesive Structobond® labels represent a more durable, cost effective and higher contrast instrument labeling technique than conventional solutions, such as laser marking, engraving or etching,” said Karl Tochtermann, managing director of S+P Samson GmbH in Kissing, Germany. “The technology is currently being tested in the European market, and so far the reaction has been extremely positive among instrument manufacturers and end-users alike.”

S+P Samson developed its medical device labels to address the industry’s growing need for improved identification and management of surgical instruments in the operating theater. The U.S. Food & Drug Administration, for example, is proposing new regulations—the Unique Device Identification system, or UDI—that requires hospitals to institute more stringent tracking and identification systems over the next two years. In addition to offering an economical solution, S+P Samson’s durable labels enable broader options for more detailed and higher contrast images and data, officials from the Germany company noted.

To create the labels, Solvay’s 25-nanometer-thick Radel PPSU film is first marked with a dot matrix code, color or other data through a high-contrast, digital thermal transfer printing process. S+P Samson then encapsulates the PPSU film between two layers of its Structobond epoxy resin system, which S+P Samson developed in partnership with Germany-based Lohmann GmbH & Co KG. The bottom layer forms a strong bond between any type of media, including metal, PPSU and coated surfaces. The 5-millimeter by 5-millimeter (0.2-incn by 0.2-inch) PPSU film is then laminated with a top layer of the Structobond epoxy. After the curing process the top layer protects the printed data.

On its own, Radel PPSU film can withstand repeated chemical disinfection and over 1,000 autoclave steam sterilization cycles while maintaining toughness and impact resistance. Recent tests targeting the polymer’s performance in S+P Samson’s medical application indicate that the three-layer construction withstood more than 700 autoclave cycles with no delamination. The cycles include disinfection using acid and alkaline sterilants, ultrasonic cleaning and temperatures up to 134 degrees Celsius (273 degrees Fahrenheit) at a pressure of 2 bar. Solvay’s high-performance thermoplastic film also provides critical tear propagation performance up to 130 G force (1.275 N).

“The broad selection of high-performance polymer films in Solvay’s Ajedium Films product family offered a wide range of widths and tolerance control to help S+P Samson quickly find the optimal solution for its innovative new medical labels,” said Maria Gallahue, global business development manager for Healthcare at Solvay. “This application is emblematic of how Solvay’s materials and collaborative expertise help customers develop differentiated new solutions for emerging applications and compete more effectively in their target market.”

To support its technology’s success in medical markets, S+P Samson recently established a new company named Clinic-ID GmbH, which is working closely with medical device manufacturers and full-solution providers serving central sterile service departments in medical centers and hospitals. Through Clinic-ID, S+P Samson will introduce its advanced new medical device labels to the European market, primarily in Germany. It is planning to expand availability of its technology to the United States and other key global regions over the next year.

Solvay Specialty Polymers offers a broad range of high-performance medical-grade polymers for devices, instruments, and equipment. Solvay also offers a family of Solviva Biomaterials for use in a range of implantable devices.