What is Medical-Grade Silicone?

Medical grade silicone is produced with special non-toxic techniques in a clean-room environment to allow it to be used for medical silicone purposes. To understand the difference it is helpful to compare other silicone production to medial silicone.

Silicone is used in a wide variety of applications from sealants to lubricants and adhesives including caulking. The production of silicone involves PDMS or dimethyldichlorosilane with a polymerization process that creates hazardous hydrogen chloride gas. When silicone is used for medical purposes, a special process replaces the chlorine atoms with acetic acid, which is less dangerous. Acetic acid is the acid found in vinegar and as such it is non- toxic.

Medical grade silicone is also tested for biocompatibility, which means that it is compatible with the human body and not reactive with body fluids and tissue. The FDA regulates medical silicone that is implantable in the body. There are three categories of medical silicone, non-implantable, short-term implantable and long term implantable. When you consider the wide range of medical silicone products it provides better insight into the quality of production for medical silicone when it is implanted into the body. Medical silicone is used for medical tubing, which is part of air, fluid and medicine delivery into the body. It is also used for fluid transfer out of the body, including dialysis and catheters. Medical silicone devices are also used for pain pumps, blood pumps, insulin pumps, anesthesia breathing materials and devices, oxygen supply systems, IV systems, blood separation systems, ultrasound equipment and more. Implantable medical devices include pacemakers, artificial joints and urological implants for vascular repair in the urinary tract. Silicone is also used for surgical sutures and scar reducing bandages and creams. Recent advances in neurostimulation and neuromodulation are being developed to treat Parkinson’s, epilepsy, migraine and spinal cord injury.

More medical silicone devices can be easily developed because silicone medical products can be prototyped and developed with minimal effort, little cost and quick turn-around time. This allows testing, product improvement and approval of medical devices with a quick and cost effective process.