Just imagine: You have to undergo an operation, that would be quite unpleasant, wouldn’t it? Fortunately, you have survived the operation without any complications and are now on the road to recovery. And then suddenly the bitter reality: a staple has been forgotten in your body. Then you think to yourself, why does something like this have to happen to me of all people? – That is certainly what the surgeon asks himself! If he and his team had scanned all the medical equipment used before and after the operation, this would probably not have happened. In conclusion, it is better for your health, your well-being and the efficiency of the treatment!
UDI – What does it mean?
UDI stands for “Unique Device Identification” and means: Unique Product Identification. This UID is a unique identification and is used for monitoring throughout the EU. In addition, the UDI supports the fight against product counterfeiting and process optimisation, e.g. product-related recall actions can be made easier.
Regulation of the FDA, USA (Food and Drug Administration) and the MDR, EU (Medical Device Regulation)
On 30 June 2020, the FDA published immediate guidance on its policy regarding compliance dates for Class I and unclassified devices that are not implantable, life-sustaining or life-sustaining. For more information, click here
The objectives of the UDI system are the following:
- making devices easier to identify (down to the individual device, batch or software version),
- the location of devices can be traced and thus users can be found more quickly and specifically,
- illegally marketed medical devices can be found more easily.
Accordingly, identification numbers are to be assigned by organisations. These will be affixed to the product or packaging to guarantee recognition. You can find the entire procedure here
What does this UDI contain?
Within this “ID” which contains your product, the following data is integrated:
- Serial number
- Expiry date
- Special data which can be defined customer-specific
UDI and monitoring result in great advantages
MySolutions has been offering a comparable solution for years with its 2D.ID and can therefore be used directly with the UDI through the database-based monitoring product. In networked systems that optimise and simplify processes in the background, all data of a medical product are digitally recorded. They contain all the important data you need for your daily work and its use:
- Seamless data acquisition
- Preventive and maintenance measures
- Best possible use of your products
- Can be used for all medical articles
In a planned process cycle, in addition to the actual product manufacture/use (workpiece), residual materials such as chips, cooling waste water, etc. are also produced. Among other things, these substances decisively define the consumption behaviour and their dependencies on the respective machine operating states. Keep an eye on these thanks to our solution and save time and costs!
Sustainability with monitoring? HELL YES!
The MyXPert monitoring solution thus enables:
optimise energy consumption through planned and preventive maintenance, because in an emergency it is important to be able to call on the complete information from a monitoring / UDI system.