Compliance Driven: UDI and Drug Traceability Unique Identification of Medical Devices (UDI) regulations require a full link traceability of medical devices from production to use.Drug traceability requirements are similar - each carton is traceable from the factory to the patient.Traditional barcode schemes cannot be read in batches and are prone to staining, so they are overwhelmed in the sterilization environment of surgical instruments and high-frequency circulation scenarios.RFID's bulk-reading and sterilization-resistant properties make it an ideal technology for medical traceability.
Mapping of UDI encoding to RFID EPC UDI consists of DI (Device Identification) + PI (Production Identification).We map the DI to the company prefix + item reference in the EPC area, and the PI (lot + serial number + production date + expiration date) to the EPC area serial number and User area.In this way, the reader and writer can get the full UDI in one read, without the need for database queries.Key: Drugs and devices have different UDI coding rules, and EPC coding schemes must be designed separately.
Third-Art Hospital Equipment Tracking Actual BattleA surgical instrument room in a third-class hospital manages 3,000 + devices and 200 + surgeries per day.In the traditional mode, the assembly, sterilization, distribution, recycling and inventory of device packages are all based on manual records, with an error rate of 3.5%, and it is impossible to trace the use history of each device.After RFID deployment: Each device bag is affixed with a high-temperature-resistant and metal-resistant label (which can withstand 134 ℃ steam sterilization), and the flow link is automatically recorded through the channel door.At the end of the procedure, the 3-second inventory of the entire device was completed, and the error rate was reduced to 0.02%.More importantly, the number of uses and sterilization of each device can be traced back, and automatic early warning replacement will be given when it expires.
Cold chain extension of drug traceability Pharmaceuticals (especially vaccines and biologics) require cold chain tracing.The RFID temperature sensing label records the temperature of the entire transportation, and automatically marks it when it exceeds the range of 2-8 ℃.After the deployment of a vaccine distribution center, the number of temperature exceeding events dropped from 12 to 1 per month (a decrease of 92%), and the exceeding drugs can be accurately positioned and recalled, no longer need to be destroyed in batches.Compliance value: RFID data can be directly connected to the FDA's traceability system to meet GSP/GDPs requirements.
