Whitford’s extensive experience within the coatings industry and commitment to responding to our customers’ needs is not only true within the markets in which we have traditionally operated but also extends to Whitford’s Medical coatings. Hosting a purpose-built Medical Coatings division on-site at our American Headquarters, Whitford has become the first fluoropolymer coating manufacturer to receive ISO 13485:2003 certification.
A strict quality system, ISO 13485 specifically focuses on the medical-device field, providing assurances in the production of a high quality, reproducible product. Having set a validated manufacturing process, the use of dual operator manufacturing controls reduces the potential for human error to a minimum. Conducting regular internal risk assessments, FMEA (Failure Mode and Effects Analysis), Whitford’s medical coating process is regularly reviewed to identify the potential for manufacturing failures. Minimal risk, continuous awareness and a robust system, means that Whitford’s medical-device coatings offer a high-quality consistent performance.
A coating range specifically formulated for medical-device use, XylaMed® coatings are biocompatible, low friction coatings proven safe to use within invasive medical devices. Due to the sensitive nature of all medical devices, the primary applications identified for coating compatibility are cardiac, neurovascular & peripheral catheter guidewires, hypotubes, electrosurgical blades, ultrasonic surgical tools and neurology needles.
XylaMed coatings offer a range of features and benefits within the medical-device sector:
- Biocompatibility tested and proven by OEM’s
- One-coat products
- Can be spray or dip applied
- Multiple color options to meet marketing requirements
- Compatible with most sterilization techniques
- Adhesion to most substrates: Stainless, Nitinol
- Good flexibility and elongation properties
- Corrosion and chemical resistance
- Low CoF
- Operating temperatures ranging from -330°F to 480°F (-200°C to 250°C)
- Pass saline soak per ISO 11070
- Toxicological risk assessments performed on new products in support of ISO 10933-17
With specific teams dedicated to the medical-device market, Whitford has a customer-focused approach from initial ordering and customer service through to complaint management and resolution. Having an advisory notice system in place, Whitford recognizes the sensitivity of the Medical arena. A customer notification system is in place to advise of any changes well ahead of implementation.