In the U.S., the FDA (US. Food and Drug Administration) demands that manufacturers trace medical device throughout all stages of distribution, from manufacturing to the patient. These requirements are reflected accurately in the 21CFR Part821 (1).
On September 27, 2007, The US President signed into law establishment of a Unique Device Identification (UDI) system. Requiring the label of the device to bear a unique identifier. The unique identifier should adequately identify the device through distribution and use.
A UDI system may provide for early detection of the warning signs of defective device and facilitate device recalls.
In Europe, regulation related to CE marking of medical devices (2) requires that the manufacturer ensures the traceability of medical devices from manufacturing up to the hospital.
The hospital is then obligated to guarantee the traceability of the device to the patient according to specific modalities of the current regulations.
Furthermore, manufacturers must be able to ensure the medical devices tracking and when necessary, implement effective corrective actions on the field such as the recall of implants.
The configuration of this technology may be adjusted to comply to different European and American legislation and specificity in vigor for each type of device.
Source (1) 21CFR821 : Medical Device Requirements.
Source (2) Directive 93/42/CEE amended by directive 2007/47/CE and harmonized standards.
is a unique technology that guarantees automatic and secure medical device traceability from manufacturing to the patient and vice-versa.
BNT offers Unique Device Identification system according to FDA recommendations.
- UDI ready.
- Medical Device Recall.
- Adverse Event reporting and market surveillance.
- Unique serial number (GS1/HIBC) Device lot number, expiration date, reference. Human and machine readable.
- Automatic and secure traceability of Medical Devices.
- Information accessible in real time for all stakeholders in healthcare chain.
- Forms accessible via internet.
- Secured data base.
- Supply chain management and inventory savings.
- Supply chain security and anti-counterfeiting.
- System to reduce medical error.
- Spectrum of tools offering real time information and analysis throughout the supply chain.
- RFID technology and serial number (according to GS1 and HIBC standards) allow automatic authentification of medical Device.
- Automated traceability and supply chain system eliminates human errors.
- Assist user service in identifying appropriate device.
- Documenting medical device use in patients’medical records.
- Strengthen regulatory authorities’ ability to query necessary data.
- Guaranteed product compatibility before and during the operation.
- Real time information on medical device availability.
- Numeric and secure registration of relevant information regarding medical device and associated patient.
- Storage of the information in a secure data bank for 20 years.
- Information available on demand via a secured web space for all authorized actors throughout the healthcare chain.
- Capacity to communicate efficiently and quickly relevant information to the competent authorities.