The use of industrial-grade yarn in medical device applications has a long history. It has been customary to use the same fiber found in t-shirts and seatbelts in medical devices. This occurred because, until now, industrial fiber was the only source available. This trend continues as some medical device manufacturers and converters use industrial-grade fibers to keep cost down or they aren't aware that medical grade fiber suppliers, like RxFiber LLC, exist.
With current FDA and other regulatory bodies stepping up their oversight of materials used for medical device applications, the use of industrial-grade fibers for this purpose is becoming obsolete. Therefore, it makes sense from a risk mitigation and quality compliance standpoint for engineers to source suppliers that can replace industrial-grade fiber with medical-grade fiber.
With that in mind, we present the top five issues engineers should be most concerned about related to using industrial-grade fibers in their devices, including questions to keep in mind when working with fiber suppliers:
Risk 1. Insufficient Quality Controls: Engineers should consider if they always get the same fiber for repeat orders. Do their industrial-grade fiber suppliers ensure the raw materials are always the same? Do they ensure the process to manufacture the fibers are always the same? Do they test spool-to-spool, batch-to-batch to qualify the quality of the fiber?
|Underneath the image of the seatbelt is a close-up of a 100% polyester t-shirt. The fiber for both of these applications has historically also been used in medical devices.|
Risk 2. Lack of Traceability: Does your industrial-grade fiber supplier ensure the materials going into the fibers are in fact the same materials each time a fiber order is placed?
Risk 3. Lack of Process Controls: Do your suppliers qualify the process to repeatedly reproduce the fiber? Do they monitor and document changes to the process, calibrate the equipment to ensure repeatability?
Risk 4. Difficulty in Obtaining Custom Fibers: Can you secure custom yarns to create your medical device with the proper fibers to manufacturer the medical device with proper properties for the function of that device?
Risk 5. Risk to Patients: The patient is the number one priority. Are industrial-grade fibers adequate for patient safety?
By using medical-grade fiber produced for the medical device industry under ISO 13485 standards, the concerns above can be addressed.
So how can engineers ensure their fiber source meets the standards of FDA and other regulatory agencies? In our next post, we present strategies to help accomplish that objective...
Contributing author Robert Torgerson is the president and founder of RxFiber LLC. The company opened a new facility in 2012 focused on production of medical-grade fibers produced under ISO 13485 standards dedicated solely to the medical device industry.
Robert Torgerson, Founder/President of RxFiber, LLC