It’s always fascinating to learn how products are made, and endoscopes have one of the more interesting processes as they are Class II medical devices. Although a Class II device is considered low risk, it still requires approval for the design and manufacturing process before it can be sold. US manufacturers must go through the FDA’s 501K process, and manufacturers in other countries must go through the equivalent process.
What is an Endoscope?
An endoscope is a medical device that is used to provide visibility to aid in the diagnosis of multiple conditions, including celiac disease, ulcers, and stomach or other gastrointestinal bleeding. An endoscope, which is typically inserted into a person’s digestive tract during an assessment, may also allow the doctor to remove polyps or take tissue samples to aid in diagnosis.
How is an Endoscope Made?
The heart of an endoscope are the fiber optical components made by inserting glass rods into an oven and then melting the rods at 900° Celsius. The melted glass drips down onto a wheel, forming thin strands. The fibers are stretched on another wheel until they are finer than a human hair. Several spools of fibers are combined on a winding wheel to create a large bundle that may contain thousands of fibers.
The resulting bundle, containing thousands of fibers, is inserted into a silicon sheath. Each end of the sheath is threaded with a stainless-steel ferrule, coated with glue, and then heated and trimmed. Next, the ends are polished to ensure the dimensions meet specifications. The polishing also allows the light to shine unimpeded. The cables are then measured with a gauge and tested to ensure they can withstand the pressure they may undergo in use without cracking.
Since endoscopes vary in length and diameter depending on their purpose and the part of the body they are intended to be used on, cables are cut to length and hand tied into bundles of the correct diameter. The bundles are inserted between the inner and outer stainless-steel tube that makes up the body of the endoscope. The ends of the fibers are capped with a stainless-steel connector to attach them to the light source in the operating room.
At this point, the fiber assembly is manually examined under strong magnification to look for black spots from broken fibers or damage that would interrupt the flow of light and obscure visibility during use.
Using a special fixture, one or more lenses made from glass rods are assembled by hand to transmit the image through the endoscope. Endoscopes typically include five to seven lenses, and depending on the required focal length, the glass lenses may be separated by brass spacers to create specific distances between them. The distance and length of the lens assembly affects the image that will be seen during use. Once the lenses and spacers have been assembled, they are carefully slid by hand into the endoscope’s tube assembly.
The next step involves screwing a glass ocular cap into the endoscope’s tube. The cap holds everything in place and allows the device to be connected to a video camera for viewing. Alternatively, some ocular caps let the doctor look directly through the lens or view the images on a monitor. The glass cap must be carefully cleaned and assembled to ensure the transmitted images are not distorted. Before the endoscope can be shipped, it must undergo a quality control check using a known test pattern. The inspection is designed to identify any blank spots or areas of distortion.
In use, the endoscope is secured in a fixture and connected to a light source that illuminates the area the doctor is working on. The images are reflected to a screen or directly to the surgeon.
Because endoscopes are regulated devices, it is important to record quality attributes and lot and serial numbers in every step in the process. Unless a company has an enterprise application designed to support life science manufacturing, this requirement can be a burden. Also, in the event of a recall, fast, reliable tracking and tracing capabilities in an ERP system can keep the cost of a recall down while ensuring maximum patient safety.
Cloud ERP Built for Life Sciences Manufacturing
Medical device manufacturers must be ready for changes in regulatory requirements or problems that occur while their products are in use, necessitating engineering change orders or recalls. The best way to manage the changing world of medical device manufacturing is to adopt enterprise systems designed to support change. With its built-in tracking, tracing and recall capabilities, lot and serial number tracing, and rigorous quality management functionality, QAD Adaptive ERP is an ideal solution for medical device manufacturers.
QAD understands that no two companies are alike and a one-size ERP solution doesn’t fit all. We have specialized expertise in six specific industries – learn more about QAD Adaptive ERP built for your industry.
