Robert Torgerson, Founder/President of RxFiber, LLC
As we discussed in a previous article, the use of industrial-grade yarn, which is used for applications such as seatbelts and t-shirts, has a long history in the medical device space. The use of such material for medical device applications, however, is becoming obsolete owing to increasing oversight from the FDA and other regulatory bodies.
|This image shows RxFiber's RxFibron 40/27 fiber, which is used for applications ranging from sutures to endovascular and cardiovascular products.|
Here are the top five steps engineers can follow to ensure their fiber source meets regulatory standards:
Step 1. Quality Controls: Ensure the process to manufacture the fibers are always the same. Require that the manufacturer test spool-to-spool, batch-to-batch to qualify the quality of the fiber.
Step 2. Traceability: Ensure the materials going into the fibers are in fact the same materials each time a fiber order is placed.
Step 3. Process Controls: Ensure your suppliers qualify the process to repeatedly reproduce the fiber. Audit that they monitor and document changes to the process and calibrate the equipment to ensure repeatability.
Step 4. Custom Fibers: Inquire and select manufacturers that can produce custom fiber that will align with your device specifications.
Step 5. Qualify a new Source: Consider the risks associated using industrial-grade materials.
The FDA and other governing bodies that review medical device filings (IDEs, PMAs, etc.) are assessing what went into the device, including the raw materials.
The medical device manufacturer takes on the liability of the efficacy of the device and the patient safety. A medical device manufacturer must be aware of every material that comes in contact with the device. The statement, "that is what we did in the past (i.e. used industrial yarn)," is not a qualifying excuse for the FDA and others.
|A close-up of RxFiber's RxFibresorb, which is a medical-grade resorbable thermoplastic.|
The suppliers of the fibers must be aware of the use of their fiber, particularly if the medical device company plans to use it for implantable medical devices.
Medical device companies should be planning ahead to mitigate potential risks with industrial grade fiber. For supply chain planning, purchasing should start budgeting for medical grade fiber and securing contracts with medical grade fiber manufacturers that are focused on the medical device industry.
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.