» Unique Device Identification (UDI)

Unique Device Identification (UDI)

2013-09-24
  • 美国食品药品管理局(FDA)
Medical device identification system with UDI barcode in hospital setting.

The Unique Device Identification (UDI) system is a global standard for marking and identifying medical devices throughout their lifecycle. Mandated by regulators like the US FDA, a UDI consists of a device identifier (DI) for the specific model and a production identifier (PI) for batch, serial number, or expiration date. It enhances traceability, post-market surveillance, and patient safety.

The Unique Device Identification (UDI) system was established to create a single, standardized 方法 for identifying medical devices. Before UDI, tracking devices was difficult due to proprietary and non-standard numbering systems, which complicated recalls and adverse event analysis. The UDI code, which must appear in both human-readable and machine-readable (e.g., barcode, RFID) formats on the device label and packaging, is composed of two parts.

The first is the Device Identifier (DI), a mandatory, fixed portion that identifies the specific version or model of a device and the labeler (manufacturer). The second is the Production Identifier (PI), a conditional, variable portion that contains information like the lot or batch number, serial number, expiration date, and manufacturing date. This two-part structure allows for precise tracking not just of a device model, but of a specific production run or even an individual unit.

Manufacturers are required to submit their UDI information to a publicly accessible database, such as the FDA’s Global Unique Device Identification Database (GUDID). This database serves as a reference catalog for every device, linking the UDI to key product attributes. The implementation of UDI is a significant step towards a more transparent and secure global healthcare supply chain, enabling stakeholders—from manufacturers and distributors to hospitals and patients—to reliably identify a device and access its critical information.

UNESCO Nomenclature: 3308
– Industrial engineering

类型

Abstract System

Disruption

Incremental

使用方法

Widespread Use

Precursors

  • development of barcode and rfid technology
  • universal product code (upc) system in retail
  • need for improved post-market surveillance following major device recalls
  • globalization of the 医疗器械 supply chain
  • creation of public health databases

应用

  • rapid and precise medical device recalls
  • improved adverse event reporting
  • anti-counterfeiting measures in the medical supply chain
  • better management of hospital inventory
  • integration into electronic health records for device tracking per patient

专利:

Potential Innovations Ideas

级别需要会员

您必须是!!等级!!会员才能访问此内容。

立即加入

已经是会员? 在此登录
Related to: UDI, unique device identification, medical device tracking, FDA, gudid, supply chain management, patient safety, traceability, device identifier, production identifier.

发表回复

您的邮箱地址不会被公开。 必填项已用 * 标注

迎接新挑战
Mechanical Engineer, Project, Process Engineering or R&D Manager
有效的产品开发

可在短时间内接受新的挑战。
通过 LinkedIn 联系我
Plastic metal electronics integration, Design-to-cost, GMP, Ergonomics, Medium to high-volume devices & consumables, Lean Manufacturing, Regulated industries, CE & FDA, CAD, Solidworks, Lean Sigma Black Belt, medical ISO 13485

我们正在寻找新的赞助商

 

您的公司或机构从事技术、科学或研究吗?
> 给我们发送消息 <

接收所有新文章
免费,无垃圾邮件,电子邮件不分发也不转售

或者您可以免费获得完整会员资格以访问所有受限制的内容>这里<

Historical Context

(if date is unknown or not relevant, e.g. "fluid mechanics", a rounded estimation of its notable emergence is provided)

Related Invention, Innovation & Technical Principles

滚动至顶部

你可能还喜欢