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?
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.
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-risks-using-industrial-grade-yarn-medical-devices
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