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FDA has established a unique device identification number (UDI) so as to suitably distinguish medical equipment through their usage and distribution. Even though this system is now fully implemented in human-and-machine-readable form, the UDI compliance timelines are quickly getting shorter for companies to effectively plan their GUDID submissions to FDA.
Organizations including the International Medical Device Regulator Forum (IMDRF), the United States Food and Drug Administration (FDA) and the European Commission have already geared up for a globally reconciliated approach to strengthen patient safety apart from optimizing patient care by establishing a unified legislation for Unique Device Identification (UDI) as per the global standards.
Meanwhile, identifying critical DI/PI data sources from large volumes of unstructured data as well as disparate and non-authenticated sources pose as one of the biggest challenges for companies to meet their UDI compliance obligations.
Add to this an absence of version control measures, cumbersome manual submission, and inadequate data management process can further complicate the compliance initiatives.
Benefits of a UDI system
While we’ll discuss about the solutions at the later stage in this post, for the time being let’s just have a look at the benefits offered by the unique device identification system that are achieved through the integration of UDIs into the health care delivery system.
While UDI implementation mostly focuses on strengthening patient safety, enhancing device post market surveillance, and facilitating medical device innovation, below are some other benefits rendered by this system. Continue reading!
- Identifying error – Enables more authentic reports, evaluation and analysis of detrimental event hand-outs so that faulty devices can be identified and replaced promptly
- Reduces medical errors by helping health care professionals to identify a defective device and analyse the loopholes in a precise manner
- Analysis & monitoring – Helps in analysing devices launched in the market by following a standard format to monitor the device used in clinical information systems, electronic health records, data sources and registries.
- Post market surveillance - Leverages robust post market surveillance system so as to support pre-market confirmation or sanction of new devices
- Provides a standardized identifier – This identifier enables manufacturers, distributors and healthcare facilities to manage medical device recalls more efficiently
- Provides a foundation for secure distribution chain globally – This helps in addressing counterfeit and aberration, whilst preparing for medical emergencies
Development of a medical device identification system that is accepted across the globe
The UDI challenge
The FDA made UDI as mandatory so as to make the medical devices easily traceable throughout the supply chain. Besides, this step also aimed at elaborating the data offering solutions for product quality issues that might put patients at potential risk. Other healthcare organizations are also following the footsteps of FDA enabling the multinational companies to comply.
A strategic solution is required by the UDI compliance so as to back the two elements of the regulation for each shippable SKU:
- Registration of the UDI “static” device identifier (D.I.) attributes (11 required + 36 additional) with the FDA GUDID (timeline: 12 months after final ruling for Class III, 24 months for Class II)
- Confirming tracking down of the UDI “dynamic” production identifier (P.I) attributes through internal company practices that includes serialization, lot history, expiration data etc.
The Freyr UDI Solution
Ever since FDA made UDI as a mandate, several companies have been working towards establishing a clear understanding of the requisites. And Freyr is one of them that works closely with leading medical device manufacturing companies in a bid to meet specific business challenges and prove how existing industry product code standards could be leveraged to satisfy the UDI mandate.
Keep reading to find out how!
Freyr supports global companies with end-to-end UDI compliance to ensure conformance with current Regulatory Mandates, Supply Chain Management, as well as reduction of Product’s Lifecycle to enable faster Time-to-market with significant compliance cost savings of 40%.
Freyr IDENTITY – A reliable option to streamline your unstructured data
Freyr IDENTITY is an efficient, accurate, faster UDI compliance solution that helps identify and segregate specific functions and data sources from within a company to connect and collate critical device related PI and DI data.
Freyr IDENTITY ensures reliable regulatory compliance with GxP practice 21 CFR Part 11, including additional compliance capabilities like Version control, Validation, XML Conversion based on SPL and HL7 protocols, as well as Publishing and Printing to enable accurate, efficient and faster UDI compliance.
Fast-Track Your UDI Compliance
Freyr IDENTITY puts your UDI compliance on fast track with industry proven 3 Step compliance and implementation process.
It analyses and assesses your UDI obligations through effective Gap Analysis, Recommendations and Integrated Project Planning
It identifies segregates, collates and configures the source data in compliance with the regulated submission format.
Additionally, it captures, configures and manages all the critical 62 fields of Device Identifier (DI) attributes and 6 fields of Production Identifier (PI) attributes.
Efficient Lifecycle Management
Freyr IDENTITY efficiently manages a complete Lifecycle submission through its Version-control system and ensures that multiple rounds of data variations are captured and organized in indexed and searchable files.
Right from deployment to regular maintenance, this comprehensive solution enables you to easily manage multiple lifecycles of the updated, modified device information whenever it occurs.
Centralized Repository
Freyr IDENTITY tracks, monitors, updates, compiles and configures your unstructured data and thoroughly checks for redundancies, duplications, errors and omissions. The final compiled data is maintained in a structured centralized database for future reference.
In-built Validator
While FDA provides an online interface for GUDID submissions, the criticality of performing a thorough data validation check before the final submission can become a major hurdle in your UDI compliance initiative.
Freyr IDENTITY eliminates any potential approval delays and rejections through its in-built validator. It uses FDA Algorithms and pre-validates the configured XML data. The accurate pre-validation ensures error-free submissions with zero-iteration cycle.
Streamlined Processes
Freyr IDENTITY deploys a robust process to streamline the GUDID submission with its advanced version-control management and in-built data validation features built-on FDA Algorithms.
The validated data is submitted through an automated submission process that meets HL7 SPL protocols and can be published for accurate and error-free Label printing.
Pre-built Training
Freyr gives you choice and flexibility to deploy Freyr IDENTITY either in hosted environment or on-premise suiting your security, finance and IT requirements.
Whether in a hosted or in the on-premises deployment, Freyr IDENTITY offers a pre-built training to empower skills and enable compliance with GxP practice.
At Freyr, we not only address an UDI initiative tactfully as a regulatory imperative, but also make use of this opportunity in establishing a failsafe business strategy that efficiently achieves UDI compliance. Plus, we also influence the UDI foundation in rendering enhanced business value as well.
