Data Standards for Medical Devices

A New Milestone

Prasanthi Potluri

Prasanthi Potluri

Editor Asian Hospital & Healthcare Management

The US Food and Drug Administration's (FDA) Unique Device Identification (UDI) regulation is a milestone in the efforts to make medical devices more effective and safe. The regulation establishes a single device identification system that is consistent, standardised, and globally harmonised. This comes at a time when regulators the world over are taking similar measures.

The final rules on UDI Regulation and Guidance were announced on September 24, 2013.The European Commission has also published draft regulations as well as a recommendation for a common framework for a UDI system across the European Union. For enabling safe and effective use of medical devices, authorities from China, Japan, and Australia along with Canada and Brazil are considering similar regulations.

According to the final rule the label and device package of each medical device will include a UDI that is provided in a plain-text version and in a form that uses Automatic Identification and Data Capture (AIDC) technology, which will improve the recall process. When fully implemented, the rule promises benefits like reduced medical errors, secured distribution chain, robust post market surveillance system and dealing with counterfeiting issues.

As part of the UDI system, the FDA is also creating the Global Unique Device Identification Database (GUDID) which will include a standard set of basic identifying elements for each device with a UDI. The FDA has issued Global Unique Device Identification Database (GUDID) - Draft Guidance for Industry to give labelers an overview of the GUDID. With the help if this draft guidance, labelers will describe key GUDID concepts such as accounts, user roles, the device identifier record life cycle, package configurations, and the GUDID data attributes and descriptions, and will submit information to the GUDID.

In order to make this successful, the industry needs to create capabilities for managing the data required for new submissions, update submissions, UDI-compliant submissions for each and every product, including unique product versions, variants, configurations and packaging.

The cover story in this issue by Karen Conway, Executive Director, GHX, US, explains how important the standard identifiers are to achieve better visibility into the role of products in delivering better value in healthcare. It also looks at the critical role of all key stakeholders in coming together to create and accept industry-wide standards.

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