Why You Need a UDI-Ready Line… or Even Better, a Sterile-Packed One (Jérôme Trividic - LinkedIn)
read also Ortho Companies challenge the FDA’s directive on Unique Device Identifications (UDIs)
UDI, the FDA Unique Device Identification System was signed into law back in 2007. Yet, eight years later, the spine industry seems to be reluctant to embrace this change, with large manufacturers requesting additional extensions or exemptions.
So is UDI Bad?
While many opinions have been voiced, UDI is ultimately great news for patient safety. UDI will improve effective implant traceability, post-market surveillance, accurate reporting of implant-related events and ensure a more efficient implementation of a product recall if necessary.
In the wake of the Affordable Care Act, UDI and associated labels will also support the processes hospitals have to implement in order to improve quality of care and reduce costs. In addition they will enable a closer link between use of implants and procedure outcomes.
What is the Link Between UDI Compliance and Sterile Packaging?
The FDA did not mandate individually sterile packed devices. However, there are many advantages for hospitals and distributors to...
