A wide and varied array of conditions and operative scenarios are presented to a general surgeon in daily practice. In addition, a wide variety of light sources, wavelengths, and laser delivery systems are used in general surgery to cut, coagulate, vaporize or remove tissue.
With over 20 years of experience designing and manufacturing specialty optical fibers, OFS has the production history, process control, and insight to design and manufacture optical fiber, cable and assemblies to exact performance and product specifications.
Biocompatibility
Many of our medical products meet ISO 10993 and USP Class VI standards for nontoxicity and biocompatibility. Many are also already certified as biocompatible by NAMSA, and we work with our customers to qualify other fibers to these standards where needed. For the assembly stage, we maintain, test, monitor, and control a low-bioburden room for medical assembly and packaging.
Traceability
Upon customer request, OFS is equipped to provide Device Master Records, maintain Device History Records, and adhere to other components of FDA Current Good Manufacturing Practices.
Sterilization
Most OFS medical fibers are biocompatible and sterilizable. These can also be cabled, tubed, terminated, and assembled into higher-end components. ETO (Ethylene Trioxide) method is preferred. Autoclave is also recommended. We do not recommend gamma radiation sterilization, as this method can damage the fiber. We also offer sterilizable fibers for disposable use. OFS is equipped to follow managed sterilization protocols for prepackaged devices.
NOTE: Although OFS provides sterilization service as an option and many of our fibers are certified as biocompatible, it is the customer’s responsibility to test all finished medical assemblies for biocompatibility and to recommend the sterilization procedure for their devices.
