The Benefits According to the GHTF, the European Commission and other entities, implementation of

The Benefits

According to the GHTF, the European Commission and other entities, implementation of a global UDI system would greatly improve traceability of medical devices in all major markets, improve recall efforts, decrease device counterfeiting activities and boost patient safety. UDI numbers would be stored in an accessible UDI database (UDID).

The GHTF’s final guidelines issued in September are designed to address the current lack of a globally defined UDI system, and hopefully will increase the likelihood that regional efforts to implement UDI systems will effectively integrate with one another.

The guidelines list the following keyadvantages a truly global UDI system would provide:

1. Traceability of devices throughout their distribution to improve recall efforts and better manage corrective actions when necessary;

2. Identification of devices via unique codes that would be able tointegrate existing clinical, industry and regulatory databases;

3. Adverse event reporting improvements through the inclusion of UDIs in adverse event reports, providing more accurate reports as well as faster aggregation of related reports to

assist regulators;

4. Medical errors would decrease as UDI systems allow clinicians toaccess device safety data faster, and more accurately select appropriate devices for treating patients; and

5. Documentation improvements in terms of device use in electronicpatient records.

Every medical device type brought to market would be assigned a unique number created using globally accepted device identification and coding standards, according to the GHTF guidelines.

Attached to the label of a device, each unique device identifier includes two components: a Device Identifier, a code specific to a particular model of device that also serves as an access code to that device’s information in the UDID; and a Production Identifier, a code to identify units of device production (serial, lot or batch numbers can serve as Production Identifiers.)