PRISYM ID is a leading label lifecycle management solutions provider, with many year's experience implementing compliant solutions for our customers. Here we discuss best practices and interesting industry updates that we've come across.
An examination of UDI implementation and lessons for manufacturers of Class II devices In September 2013, the FDA set out its framework for establishing a unique device identification system to identify medical devices through their distribution and use. By 2020 most medical devices will need to include a Unique Device Identifier (UDI) in human and machine-readable form. In addition, device labellers must submit mandatory data about each device to the FDA/National Library of Medicine’s Global Unique Device Identification Database (GUDID), enabling the public and healthcare stakeholders to access and download device information.
As many of you will know, this year PRISYM ID has chosen Thames Hospice as its Charity of the Year. Throughout 2016 we will be raising funds in a variety of innovative and exciting ways all to support the Thames Hospice’s provision of expert nursing, medical and therapeutic care for adults in the local area.
Label Lifecycle Management (LLM) is mission critical for global device manufacturers – if labels cannot be printed accurately, a product cannot ship and the associated costs are huge. Get it right, however, and there are major productivity gains and real economies of scale. Despite this, labeling is often an ‘orphaned’ business function within device companies; with many organizations still relying on silo’d, local systems to manage perceived local requirements.
Managing change is a constant challenge. This is particularly true in life science industries where regulatory changes, product innovations and the drive to achieve supply chain efficiencies are ever present.
For many years, validating labeling processes has felt like an impossible mission for global medical device manufacturers, and has in some ways become a major barrier to the deployment of new systems for the fear of lengthy testing cycles and spiraling costs. Yet Label Lifecycle Management (LLM) is a mission critical ‘must have’ for life sciences organization that need to streamline processes, reduce labeling errors and mitigate risk.
In a recent survey, 43% of responders were not confident or were unsure as to whether their current labeling solution would do everything required beyond 2015. With regulations such as 21 CFR Part 11 to comply to and others coming to fruition including FDA UDI, medical device manufacturers whether large or small need to be change.
For the sake of patient safety, the ability to track and trace medical devices at a global level is paramount. However there are some key considerations to be aware of when implementing UDI.
'Labeling Trends' Blog Series #2 Playing a Tactical Game – Efficiencies through Labeling Postponement
Labeling as part of the supply chain is a costly business for medical device companies. With the bottom-line being a priority for any organization, seeking areas to deliver better efficiencies is key. Yet finding those hidden gems isn’t always easy, even when it’s under our noses.Labeling postponement may be one such gem.
The implications of product recall are well understood, and they serve as an operational driver for a change of approach. But the latest FDA announcement that its online Global Unique Device Identification Database, AccessGUDID, is now available to the public brings the labeling of medical devices under unprecedented levels of scrutiny – with ramifications not only for manufacturers but also throughout the entire supply chain.