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The first compliance date set is one year after the final rule was published: as
of September 24, 2014, the labels and packages of Class III medical devices and
devices licensed under the Public Health Service Act (PHS Act) must bear a UDI.
(Device classification determines the type of premarketing submission required
for FDA clearance to market.)
What is the benefit of medical device labeling?
This trend has the potential to improve the quality of information on adverse
event reports for medical devices, which will allow the FDA to more easily
identify recalls and improve patient safety.
2. Automation Must Support Lean Manufacturing
The controversial medical device tax, as well as the costs associated with
implementing new regulations like UDI, has put pressure on medical device
organizations to save money in other areas. Since they cannot pass the increased
tax and regulation costs onto their customers, organizations need to find new
ways to cut costs internally - for example, by streamlining their supply chain -
rather than outsourcing production.
With barcode label software, organizations can integrate label and
radio-frequency identification (RFID) technology into existing business
processes, increasing both efficiency and control. Whether the ultimate goal is
streamlining asset and resource management, controlling distribution channels
and stock levels, tracking documents and RFID tags, or managing data records,
barcode label software provides a cost-effective solution that supports lean
manufacturing.
Automation allows businesses to control a process by automatic means, minimizing
human intervention. Minimizing human intervention in the label printing process
decreases the chance for errors that can result in returned shipments or
regulation penalties - both avoidable costs.
What is the benefit of automation?
Organizations will become lean, minimizing costs where they can, protecting
their top lines and profit margin.
3. Renewed Focus on Medical Device Logistics and Traceability
Organizations in many markets are interested in establishing systems to track
and trace products throughout the supply chain. These systems can have major
benefits in the Medical Device Industry, as they support regulatory
requirements, product recall and withdrawals, logistics and quality management,
and to support patient safety. Two relative GS1 Standards are already in place:
the AIDC Application Standard for Small Instruments and the GS1 Global
Traceability Standard.
The Standard for Small Instruments specifically covers the marking of surgical
instruments to enable traceability throughout the instrument reprocessing cycle
and, in particular, to and from the sterilization department. The scope of the
GS1 Global Traceability Standard includes labeling all traceable items based on
the use of voluntary GS1 business standards.
The following GS1 standards enable implementation of the GS1 Global Traceability
Standard for Healthcare2:
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Global Trade Item Number (GTIN)
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Global Location Number (GLN)
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Serial Shipping Container Code (SSCC)
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Electronic Product Code (EPC)
-
Global Data Dictionary (GDD)
-
GS1 XML and EANCOM e-business messages (Align and Deliver)
-
Pedigree Ratified Standard (DPMS)
-
General Specifications (data carriers)
What is the benefit of traceability?
Traceability supports efficient recalls and increases patient safety. Adopting
and implementing GS1 standard barcode labeling enables the effective and
efficient rollout of AIDC and maintains the traceability of medical devices
throughout the healthcare supply chain.
Conclusion
All three of these trends support the goal of increased patient safety through
identification, automation and traceability. In the coming years, more trends
will emerge that reinforce this goal. As we’ve seen in the past, a trend can be
the beginning of an industry standard and should be taken seriously. If a new
trend develops promoting patient safety, look into implementing it and stay
ahead of the trends.
For more information, visit www.teklynx.com.
1.
https://www.federalregister.gov/articles/2013/09/24/2013-23059/
unique-device-identification-system
2.
http://www.gs1.org/sites/default/files/docs/gsmp/traceability/Global_
Traceability_Standard_Healthcare.pdf
(Ref:
http://www.mdtmag.com/articles/2014/01/3-major-trends-barcode-labeling-medical-devices)
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