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New healthcare material coding system in USA
25/08/2014
The FDA (Federal Drugs Administration) has regulated the coding of medical devices in the USA, creating a unique identifier for each article, known as the UDI (Unique Device Identification). A centralized database called GUDID (Global Unique Device Identifier Database) will record all the medical material referenced by the UID.
WHAT IS THE UDI?
THE UDI is the unique identifier for each item, and consists of two parts:
- DI (Device Identifier): Set part for each article
- PI (Production Identifier): Variable part for each item, which may contain expiration dates, batch or lot number, SSCC, etc.
WHAT IS THE GUDID?
The GUDID is the database where all medical supplies and medicines are recorded, indexed by UDI. It will include the basic information on the item, such as description, contraindications, dosage, etc.
This database is maintained by the Food and Drug Administration (FDA). Manufacturers must supply the GUDID with the information on their articles, and they will have three ways to do so:
- Through the web provided free of charge by the FDA
- Via the web-service providing integration based on HL7 files (XML defined in USA for the health sector)
- Through GDSN with a specific extension for the purpose.
START-UP TERMS
The FDA has set out different dates by which the different medical articles must be encoded with the pertinent UDI, depending on the article type.
- 1 year after publication of the final ruling (September 24, 2014)
- 2 years after publication of the final ruling (September 24, 2015)
- 3 years after publication of the final ruling (September 24, 2016)
- 5 years after publication of the final ruling (September 24, 2018)
- 7 years after publication of the final ruling (September 24, 2020)
There are three types of medical supplies, according to the level of controls to be applied by the FDA to ensure the safety and effectiveness of each medical item.
You can access the classification of medical items via the following link: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm
Find out the product classifications as indicated on the FDA website: http://www.fda.gov/%20MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/default.htm
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