The ever increasing apprehension for patient safety as well as supply chain management, is now calling for a robust, internationally harmonized identification system for medical devices. With a large number of medical devices available in the market, tracing each one of them is becoming a very serious issue. Which finally results in product recalls, difficult event reporting as well as some counterfeit products. This has led to the development of a global identification process that will recognize every medical device in the healthcare supply chain. The food and Drug Administration in India has executed the Unique Device identification process that will assign a unique identifier to the medical devices. This remarkable update to the Medical Device Regulation India is quickly gaining appreciation and popularity.
Let us know more in detail about this system.
The unique device identifier is offered for labelling the medical device with a unique numeric or alphanumeric code. This information in turn is displayed on the device as human-readable as well as machine-readable data. The code is further divided into two parts where one is the device identifier that is based on the medical device model and the other is the production identifier that is based on device production information. It can be in two forms namely, linear barcode and data matrix code.
How does the system help?
The system has a few notable advantages like:
- Safe global supply and distribution that helps in the prevention of medical device counterfeiting.
- Efficient management of safety based activities like adverse event reporting or recalls etc
- Growing information about medical devices that helps in decreasing medical errors by some healthcare professionals.
- Standardized documentation for sturdy pre-market assessment of medical devices.
Enforcement of the system
UDI is an internationally recognized identification system for medical devices. These are issued by various accredited agencies in India. They provide advisory services for complying with the guidelines that are offered by the regulatory authorities. But one of the major challenges faced while enforcement is effective data management.
Even a minor modification in a medical device leads to changes in the UDI data. This requires changes in every unit where the data is stored. Because of this, there is a high need for some advanced techniques and tools for managing the regulatory data with precision.
The actions required for the implementation of these processes
The UDI should be effectively furnished on the packaging of a medical device. In some cases, UDI should be printed on devices that are intended for exclusive use when it is unpacked. This direct marking assists in the identification of devices when there is no packaging, or it has been removed. Moreover, the UDI is generated separately for every accessory that is coupled with the medical device.