As a critical component in patient healthcare, medical device manufacturing is highly regulated and requires the utmost attention to sanitation, safety, and biocompatibility. Used both internally and externally, devices must be clean, defect-free, and burr-free; meet stringent demands from a variety of regulators such as the Food and Drug Administration (FDA); and successfully pass biocompatibility testing.
These stringent requirements ensure that medical devices, whether used internally or externally, are safe for patients. Common concerns in the medical community include: pathogen spread, implant rejection, corrosion, surface contamination, premature failure, and biocompatibility.
For manufacturers of medical devices or parts used for biological applications, precision and performance are vital. Addressing these challenges is necessary for optimal performance of medical devices and components as well as to meet strictly regulated standards for quality, cleanliness, and precision.
Many companies in the medical device and surgical instrument industries specify electropolishing for their metal parts. Electropolishing is an ideal finishing process to achieve the desired results required by these industries. There is no other process that can achieve the same high-quality finish along with the multiple benefits. Benefits of electropolishing include: enhanced corrosion resistance; clean, sanitary, easy-to-clean surface; improved microfinish; fatigue life improvement; burr-free surface; decorative finish; and consistent/repeatable finish.
Electropolishing, often the final step in the manufacturing process, allows medical device manufacturers to address varying finishing needs as well as meet industry regulations. From implantable devices to surgical instruments, electropolishing offers medical device manufacturers a reliable, high-quality, sanitary surface finish that improves fit and function and yields better patient outcomes.
Fabrication processes such as stamping, grinding, machining, and heat treating all are employed to transform a metal bar, casting, or sheet into a finished part. As metal is bent, ground, and heated, the metal surfaces become altered significantly. These alterations can cause burrs, contamination, scale, and tooling marks, which need to be removed before being used on a patient. In many cases, these surface imperfections can be a focal point for infection or metal contamination for the patient. As a result, manufacturers expend much energy and time trying to transform these metal surfaces to an inert, passive condition.
Metalworking processes such as machining, grinding, lapping, and mechanical polishing leave a false layer on the surface referred to as an “amorphous layer.” This occurs when metal is moved about the surface during these cold-working operations. This amorphous layer can be observed with a scanning electron microscope under high magnification. The contamination imbedded in this false layer has significant air space that is perfect for trapping bacteria, water, or other liquids. Research has proven that electropolished surfaces are highly resistant to biofilm production. The shear number of applications for electropolishing continues to grow due to the ever-present concerns regarding resistant bacteria in the surgical arena.