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.
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.
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.
Source: http://www.qmed.com/mpmn/medtechpulse/top-5-ways-ensure-your-fiber-source-meets-fda-standards
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