The Specialty Photonics Division of OFS today begins its 25th year in business in its Avon, CT headquarters, which is home to the company's medical manufacturing operations. With its research arm, OFS Laboratories, the firm invests substantially in the design and production of medical-grade fibers and components. Its many product lines--such as medical lasers, imaging and sensing, data transmission and illumination—serve applications in urology, ophthalmology, orthopedics, dermatology, cardiology, angioplasty, dentistry, oncology, general surgery, and medical sensing.
According to OFS, many of its medical products meet ISO 10993 and USP Class VI standards for nontoxicity and biocompatibility. Many are also already certified as biocompatible by NAMSA, and the company works with customers to qualify other fibers to these standards as needed. The company is proud to maintain its quality and commitment to continuous improvement with certification to International Standard ISO 13485.
"We…are both happy and humbled to be in the fortunate position of celebrating a Silver Anniversary. We continue to stay on the cutting edge of innovation, production methods, and customer-centered market and product development," said Willy Cote, General Manager of the Specialty Photonics Division.
Upon request, OFS can provide Device Master Records, maintain Device History Records, and adhere to other components of FDA Current Good Manufacturing Practices. The company also provides consultation on product types needed. For instance, intra-body applications must use fibers that are USP Class VI nontoxic and biocompatible—and the ability to withstand sterilization in an Autoclave/ETO is useful to minimize the cost of disposables. Because many medical applications use high laser powers to deliver light, cut, or coagulate tissue, fibers in these applications must be tolerant of and resistant to loss under these high powers.
The company's manufacturing facility offers 100,000 square feet of manufacturing and office space and includes extensive facilities for the design, fabrication, customization, and packaging, with on-site testing labs (to ensure fibers are made to specification), cable extrusion lines, and monitored and controlled low-bioburden assembly rooms.
For more information on OFS's medical solutions, see the company's Fiber Optic Solutions for Medical Devices brochure.
