The FDA’s mandate for Unique Device Identification (UDI) of medical devices aims to offer a practical solution which proposes a standard way of presenting standard information in a standard format or barcode. This information can include (but is not limited to) the manufacturer of the device, expiry dates, the make and model of the device, serial or lot number and any special attributes that the device may possess.
UDI aims to reduce medical errors involving medical devices by:
- Providing a single, globally-accepted source for positive identification of medical devices
- Ensuring the adequate identification of the device through its distribution and use
- Providing rapid access to key attributes relating to the device
- Simplifying integration of information on device use into medical records
- Providing a means of added depth to patient and physician educational materials without adding greater complexity
UDI also aims to provide for more rapid resolution of device problems by:
- Making it possible to more rapidly identify devices involved in adverse events
- Providing for more rapid resolution of confirmed problems
- Provide a single, globally-accepted “key” that can be used to link and integrate existing government, hospital, and corporate data bases that relate to medial devices
- Meet other Federal agencies’ needs for a single, consistent means of identifying medical devices
- Reduce the costs of moving medical devices in international commerce
Who is it Relevant to?
UDI is relevant to any organisation working in or supplying medical device products to the US. Where can I find out more about UDI? Visit www.fda.gov for more information.
Prisym Medica Labeling Software:
PRISYM Medica labelling software is a purpose designed labelling solution for Life Science organisations that need to meet the FDA’s labelling regulations. Medical device companies can easily implement UDI utilising the PRISYM Medica Solution. PRISYM Medica is supplied as a validated labelling solution including auditable security protocols and lifecycle documentation based on the GAMP V Model.
Available both as a thin or thick client, PRISYM Medica allows you to design, review, approve, print, reprint and reconcile your labels with the peace of mind that it has purpose built user security, group security and secure audit logging. It can also simply link to ERP and MRP systems to ensure that information from production can be delivered to the label at time of print.
Tags: FDA, Labeling Regulations, UDI
