Unique Device Identification (UDI) is an identification mechanism utilized to identify medical devices throughout their lifecycle. The mechanism is anticipated to enhance patient safety and improve healthcare processes.
UDI with a Global Perspective
The American Food and Drug Administration (FDA) reinforced patient safety a strategic concern by adopting particular regulation for UDI. Also, UDI can have a much extensive application zone, if the world agrees on a single harmonized standard for the effective implementation of UDI all across the globe.
Similarly in UK; The National Health Service (NHS) brought its own version of UDI with the help of the Department of Health e-procurement methodology, which was issued in 2014. The notion behind the NHS leading UDI had been to adopt variety of different control measures to allow transparency and effectiveness in NHS procurement to assist and enhance patient safety.
With the momentous issuance of the Medical Device Regulations (MDR) in Europe, UDI is anticipated to become a prequalification criterion for all medical device manufacturers, traders selling in the Union. The manufacturers and producers who are previously in the employing UDI for the U.S. or with the UK NHS have, on the other hand, come through important challenge.
UDI in Europe; Starting Point
Although manufacturers have the long term benefit despite of the efforts and labor needed to apply UDI. If companies are applying these requirements beforehand of the enforcement, then they can also experience the benefits of it. Some business returns are enhanced inventory control, expected improved sales, less time to recognize important issues, better billing accuracy and minimized fraudulent levels. When there is discussion on the inception of UDI in Europe, there are substantial outcomes, which companies selling in Europe can acquire from the learning of the U.S. and the UK.
Learning from FDA’s enforcement of UDI in the sector
Benefit to Cost Analysis for UDI Implementation
The benefits are far worthy considering the implementation constraints such as money, time, and resources.
Cost Saving with Inventory Control
When UDI is comprehensively implemented; manufacturers will be well situated to have long-term advantages. If UDI is built into manufacturing systems with the perspective to restructure production process for improvement and to implement more comprehensive tracking and inventory control systems, medical device manufacturers may acquire important cost savings from improved inventory control and from other business processes.
Beat the Counterfeit Products
Incorporating an efficient system for tracking, ordering, and submitting information for UDI compliance can yield important benefits, which go way beyond just complying EU MDR compliance regulations. Companies might examine an important fall in forged products and they will have enhanced management of old inventory and batch product with an enhanced tracking process.
Products Evaluation & Patient Safety
UDI permits producers to thoroughly assess their product portfolios and inventory levels. It will help providing a database of all manufactured medical devices. It signifies a business can identify expired medical devices or specified products to be taken away from its inventory or finished goods catalogue. Enhanced medical device traceability ensures patient safety in different means. For instances, that comprises of contaminated medical devices, hospitals could identify which specific devices hospital staff utilized on patients. The information is sought primarily with the help of UDI system.
Mergers & Acquisitions
UDI is also moving to offer incredible assistance when it comes to acquisitions and mergers. As soon as an anticipated acquisition or merger is declared, both companies agreed must have due carefulness before going to the merger. Utilizing all the data from the UDI can empower both companies to confirm a smooth transition. Having an accurate and precise list of all manufactured devices at the table permits the acquiring company to assess the transaction and implement a very comprehensive risk assessment.
The Time of EU UDI to come in the EU
Companies can face dangerous legal consequences, if a device will fail to comply with the new regulations (after the timeline of enforcement). Delayed compliance presents serious business continuity implications. The member country authority can take UDI non-compliance very seriously and can outlaw the non-compliant manufacturers from selling their products across the Union. For manufacturers outside the EU, this can lead to the ban of importing devices into the Union. In very extreme situations, customers might not admit a medical device in their use without a UDI and in that case manufacturer might have to disown the medical devices.
Implementation Steps for EU UDI and EUDAMED
Obviously manufacturers will be going to invest so as to prepare the company for complying EU UDI compliance. It is mostly advised by consultants that manufacturers now need to have a comprehensive readiness assessment to identify whether all devices are conforming or will be conforming by the deadline.
Companies should work towards a problem less implementation solution; internally they should have a strong team with a Project Manager appointed for the purpose of implementation. There are such as external solutions as well such as consultants and third party software solution like Alysidia which offers complete traceability and asset enrichment solutions. The companies should adopt a company-wide strategy for implementation of both UDI and EUAMED; they need to adapt the labelers with the EUDAMED as well.
Alysidia can help for both EUDAMED & UDI
Regardless of the early investment of time, money and resources for employing UDI, there are many important short-term and long-term advantages that will come along with the way. Manufacturers will be in a potential position to acquire substantial cost savings from enhanced inventory tracking and effective recall management. Both the healthcare sector and public in general will gain benefits from billing accuracy along with minimization in serious occurrences and removal of counterfeit devices from the market.
With a European perspective, manufacturers should completely exploit UDI system as early as they can. The early entrants of UDI compliance will have the competitive advantage in the market and will earn the bounties exclusively. Alysidia is offering integrated solution not only for EU UDI but also for EUDAMED, e-IFU etc. with a block-chain embedded platform.