Recent news reports of a recall on 80,000 EpiPens and warning of a contaminated heater-cooler device used during cardiac bypass surgery highlight how important unique device identification (UDI) systems are for the medical industry.
Medical devices are vast and varied – single use, reusable, implantable – each has its own unique design, production and use and workflows such as maintenance, decontamination, replacement [e.g. pacemaker batteries] and end-of-life. Additionally, every country has its own record-keeping mandates.
OEMs, distributors, hospitals, doctors, pharmacies and other stakeholders must be able to access and collaborate on device records. Most importantly, the devices themselves need to be individually identifiable so that as they pass through their lifecycle, authorised users can add to the device’s record and create a rich data-set and definitive point of truth.
A single source of data which includes:
- A globally unique device identifier
- Make, model, serial number, date of manufacture, batch number
- Purchaser, commissioning date
- Usage, handling, movement and location details
- Patient and procedure details
- Maintenance, disinfection and replacement procedures
- Sampling dates and test results
- Expiry and disposal date
…will ensure medical devices are being used safely, and that their unique history, movement and location is complete and can be easily accessed in case of a recall.
Part and serial numbers are not sufficient
While part numbers are often used to track and trace assets, typically they aren’t unique to a specific item and so it is difficult to differentiate between them. In other cases, serial numbers can be unique to a specific device from a specific manufacturer. However, because there is still no global standard, duplications can occur in supply chains because there is nothing preventing different manufacturers from inadvertently using the same serial number on their device. The only way to ensure that a device is accurately identified is with a secure globally-unique identifier. This ensures that users know, without a doubt, what device was used for each patient or procedure and where it is now.
Global unique serialisation brings visibility to each device
The use of a system that supports unique device identification [UDI] will facilitate the following:
- Item-level traceability – in order to minimise the costs and complexity of a recall by allowing manufacturers to identify where affected lots are/have been used.
- Better inventory management – provides a single global identifier for use across supply, government and clinical databases and improved procurement and accounting.
- Device lifecycle management – in order to meet through-life management mandates and requirements, and that proper workflows are followed for each item.
- Faster adverse event reporting – enables rapid identification of medical devices in the event of a recall or contamination.
- Simplified documentation management – A unique ID means all data associated with a specific device can be stored with the device record, associated with patients and accessed and shared when required.
Asset intelligence for medical device traceability
Item-level identification tracking not only improves patient care and helps to contain rapidly escalating healthcare costs, but when things go wrong, accurate and speedy tracking of those items becomes critical. By putting asset intelligence technology to work with unique item-level identification, organisations can improve data integrity, device traceability and patient safety. Relegen’s integrated serialisation software, flexible device marking [Barcode, RFID, DPM], mobile data capture solution can be employed for automating safe and secure medical device identification and asset lifecycle management. To learn more about assetDNA, or to request a free software demo, please reach out to us at +61 (0)2 9998 9000 or firstname.lastname@example.org.