The Unique Device Identification is a system utilized to mark as well as identify medical devices in the healthcare supply chain. Unique Device Identification was signed into law on 27 September, 2007, as part of the year 2007 Food and Drug Administration Amendments Act. This act includes language associated with the establishment of the System. The Unique Device Identification system needs:
The label of a particular device to have a unique identifier, unless any alternative location is been specified by the United State.
Food and Drug Administration known as FDA or unless there is an exception for a group of devices or certain device.
Unique Device Identifier
- The unique identifier to identify the device through use and distribution .
- The unique identifier to be able to include the lot or even serial number if FDA specified
A UDI and Unique Device Identification will work by creating a common reporting vocabulary and improve electronic tracking capabilities. Analysis of adverse event/issue reports is currently limited because the specific devices which is involved in an incident are not always known with the needed degree of specificity. Without any common vocabulary for our medical devices, meaningful analysis which is based on data from already existing voluntary systems is an issue. Consistent and reliable medical devices identification would enable safety surveillance in order that the FDA and producers could better identify device defects or possible problems, and improve care of patient.
Imagine a wedding approaching but is made impossible because the bride’s life was ruined due to the use of a counterfeit medicine or the employment of a wrong medical device; indeed, this scenario is tragic. Situations similar to these and many other different but related cases are the driving force of the implementation of this law. The UDI is really expected to improve the safety of patient (in part by assisting to identify fake products and by enhancing the staffs ability to differentiate between devices similar in appearance however, serve different functions or use), facilitate and also improve the recall process, produce efficiency within the medical field.
The UDI in the most basic format, is a coded number which is registered with standards organizations, and has many information, which include (however not limited to) the producer of the device, dates of expiration, the make and also model of the device, and a special features that the device might possess. The word “device” in a medical sense refers to a product that’s not really pharmaceutical in nature, and whereas the FDA have been offering approval to exempt certain devices, a person who was responsible for UDI requirements implementation in the Act, named Jay Crowely, has expressed his intention to apply the UDI to “every single thing until someone offers us a good reason not to”, excluding those devices that won’t require identification.
Following the passage of this Act, calls were made for the FDA to post a timeline for the UDI implementation; this was subsequently carried out.
The Unique Device Identifiers mandates medical device producers to submit to the FDA’s Global UDI Database. The submission will include the portion of the Primary Device Identifier of the UDI and associated data features about each version or model number of the device.
Some alternatives and exceptions are seen in the final rule, making sure that the burdens and costs are really kept to a minimum level. The UDI system will now go into effect in phases, over a period of seven years, to really ensure a great implementation and also to spread the burdens and costs of implementation over time, instead of having to all be absorbed at once.