The Unique Device Identifier system was first implemented in the US back in 2007 and was signed into law when it became a part of the Food and Drug Administration Amendments Act. The UDI Final Rule was finally brought in on 24th September 2013. Though it was difficult for firms to start implementing initially, the system has brought about a whole host of benefits to the medical industry, as well as assisting in patient care. Its implementation has made it extremely simple for healthcare professionals to carry out their task with high efficiency.
What industry are they used in?
The UDI system is now used fully across the medical industry. Of course, there are many medical devices which still do not contain a UDI, but all newly issued medical devices do. There is a Global Unique Device Database (GUDID) which houses all of these identifiers, ready for immediate access around the world to those who need access to it.
What exactly are UDI?
Essentially, the UDI system is a means to create a complete and ordered language for all medical practices to identify medical equipment. Every piece of newly issued equipment within the medical industry will have a UDI, which allows healthcare representatives to search them on the database and get fast access to exactly what piece of medical equipment it is. They can then offer far better customer care than they could before UDI’s were in place.
The breakdown of a UDI
A UDI comes in the form of a machine-readable bar code, underlined by a long series of numbers. It is much like the typical barcode system you would see on packaged food. It is broken down into two key parts:
DI – The Device Identifier is the mandatory part of a UDI and identifies who the device manufacturer is and the exact model of the device. This is then submitted to the GUDID.
PI – The Production Identifier is the part of the UDI that is non-compulsory. They are not submitted to the GUDID, and are instead held by the manufacturers themselves to track their own range of products internally.
As you would imagine, a UDI format is the same across the board, and all must come in the same format and be machine readable. To ensure continuity, UDIs are issued by an FDA accredited Issuing Agency (IA).
What are the uses of UDI?
UDI allows you to fully track all newly issued electrical medical devices and see where they are being used. This allows a lot of useful functions, such as:
- Being able to issue recalls on faulty devices: If a device manufacturer was to come across a fault in one of its products, they UDI system is much easier in helping to enable this recall. You know exactly which patients have that particular model and can contact them much faster and more efficiently.
- Offer faster repairs: If a patient is experiencing issues with their device, they can contact their doctor or the device manufacturer. They can then quickly identify exactly which model is and provide more tailored help towards fixing typical issues that device may have. Once the problem with the device is fixed it can be easily used by medical professionals.
- Improve patient safety: Within the medical industry, there are a number of counterfeit products which are a danger to customers. Such counterfeit devices can be spotted and destroyed if brought to a medical professional as they can see that the UDI is invalid. In the absence of UDI, such counterfeit products were often used by the customers, which had severe consequences for them.
- Offer greater care: If the device is taken to a medical professional, then rather than that doctor being unaware of what the product is and failing to offer care, they can scan the UDI. They can then get access to full information about the device and how they can assist the patient themselves now they have that knowledge.
Considering the fact that, nothing remains more important than the safety of the patients, the UDI system will surely bring a sea change across the globe in ensuring that much-needed safety to them in future.
Contributed by Krysta Jackson: