Unique device identification

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Unique Device Identification ( UDI , German  product identification number ) is a worldwide system for uniform product identification for medical devices .

It was developed in the USA . UDI should be applied to the product in machine-readable identification ( e.g. barcode ) and in plain text. UDI serves as the key to a UDI database (Unique Device Identification Database; UDID) which will contain a large amount of information about the products.

description

The UDI system is based on an order from the US Food and Drug Administration (FDA) to improve patient safety and is intended to simplify product recalls and optimize market surveillance. The earlier international initiative for the harmonization of regulatory requirements for medical devices, GHTF (Global Harmonization Task Force) published guidelines for the implementation of UDI for the first time in September 2011. Since 2011, the International Medical Device Regulators Forum (IMDRF) has been active as the successor organization. The European Union's Directorate-General for Health and Consumers is a member of the IMDRF Management Committee.

A UDI system is also being introduced in Europe and is regulated in the new Medical Device Regulation (MDR). All medical devices belong to the scope of UDI if they fall under the definition of medical devices of the IMDRF (International Medical Device Regulators Forum).

On May 5, 2017, Regulation (EU) 2017/745 of April 5, 2017 on medical devices (MDR) was published in the Official Journal of the EU (see Directive 93/42 / EEC on medical devices ). The ordinance came into force on May 25, 2017. The three-year transition period ends in 2020.

UDI system

The UDI system should lead to an increase in patient safety and enable the recording of patient-related material consumption and thus also process optimization in the healthcare system ; for example, the data could flow into the electronic health record in the future . In addition, it supports the determination of product recalls and reports of undesirable events through qualified and comprehensive information.

UDI
(product data)		 UDI carrier
(data carrier)		 UDID (database)
Device Identifier (DI) (static data),
example: ISO -based code for article identification		 Automatic Identification and Data Capture (AIDC) (machine-readable)
Example: Linear barcode (1D) or 2D code according to ISO standard		 Database with static data on products
Examples: trade name , dimensions , storage class and packaging hierarchy (container types)
Production Identifier (PI) (dynamic data),
examples: lot number (batch number) , serial number , expiry date 		Human Readable Interpretation (HRI) (plain text) Access via Unique Device Identification (UDI)
Product identification must be carried out on the basis of internationally recognized ISO-based standards (e.g. GTIN ) Product labeling must be based on internationally recognized ISO-based standards (e.g. Code 128 - ISO / IEC 15417 , Data Matrix - ISO / IEC 16022 ). The international standard HL7 (Health Level Seven) is used for data exchange between organizations in the healthcare sector and their computer systems.

Data carriers and data structures

The UDI system uses codes such as Code128 or the DataMatrix code . The codes are pure data carriers that can hold proprietary data or ISO structured data. ISO structured data is based on a hierarchy of standards. This begins with the issuing agencies that are registered according to ISO / IEC 15459-2. The actual data structure is defined in ISO / IEC 15418 (reference to ANS MH10.8.2). There are two competing data structures in ISO / IEC 15418. One is identified as format 05 according to ISO / IEC 15434 and the other as format 06. Format 05 uses application identifiers and format 06 uses data identifiers.

UDI permits several issuing agencies according to the requirements of the FDA. GS1 is one of three issuing agencies and is a special case in this context. The Format 05 structure used by GS1 is identified by the special character FNC1 in the first place in the code (for practical reasons because it requires less space in the code). If this happens, the Code 128 is called a GS1-128 and a Data Matrix is ​​called a GS1 Data Matrix. A new type of data carrier appears to be emerging. In fact, of course, this is not the case. In the corresponding ISO standards ISO / IEC 15417 and ISO / IEC 16022, the terms GS1-128 and GS1 Data Matrix do not logically and meaningfully do not exist. The abbreviation GS1 Data Matrix for “Data Matrix Code with ISO-structured Format 05 data” is useful for concise, terminological simplification. It is counterproductive for understanding the underlying hierarchies.

It is critical that this name gives GS1 an advantage over the other issuing agencies, which is ultimately reflected in market shares.

GTIN stands for Global Trade Item Number. It is an article number under the control of the issuing organization GS1. It is one of many possibilities to obtain a globally unique article number under the ISO hierarchy. The ISO hierarchy also ensures that each article number of any issuing agency can be clearly distinguished from the article numbers of other issuing agencies at any time. Mixed or parallel use of the article numbers of different issuing agencies is therefore possible without any problems.

The application of the general ISO hierarchy for product labeling can be found in ISO 28219 . The packaged product is labeled according to ISO 22742 .

Just like the Pharmacy Product Number for drugs, the counterpart for medical devices is the Unique Device Identification.

See also

Web links

Individual evidence

  1. ↑ Regulation (EU) 2017/745
  2. ^ Center for Devices and Radiological Health: UDI Issuing Agencies. Retrieved September 17, 2018 .