Behind the Scenes at The Electrode Store
An overview of how our electrodes are manufactured.
There are several steps that go into the manufacturing of disposable needle electrodes. First, all raw materials and components (needles, plastics, wires, etc.) are carefully inspected. Most needles are coated with a proprietary coating material that eases the insertion and movement of the needles, minimizing any pain that end-patients may experience. Next, The Electrode Store’s highly-trained employees assemble the electrodes in our class 10,000 clean room. All needle electrodes go through many different phases including disinfecting, assembly, inspections, verification, testing, individual packaging, bulk packaging, labeling, and sterilization.
Every 3 to 4 weeks a large batch of our disposable needle electrodes are sent out for e-beam irradiation performed by a world-class sterilization firm. The products are irradiated thoroughly – without even being removed from their bags. The red dots you see on our labels indicate that the products went through the radiation process. The dots start out as yellow, but after being irradiated they are returned to us red, which means they are ready for final use.
We also make a wide variety of surface electrodes, which are hand-assembled, starting from scratch, by a highly-trained and skilled employee. Because the surface electrodes we make are reusable, they are typically not irradiated like the needles.
Throughout our operations we utilize approved processes, work instructions, quality assurance checks, and traceability procedures as defined in our ISO-13485 quality management system. Each operations team member at The Electrode Store is trained one-on-one for an extended period of time to ensure the employee’s quality abilities are on par with our high standards.
Written by Courtney, Production Supervisor