SATO has built an end-to-end supply chain solution for Italy-based orthopedic implant manufacturer LimaCorporate.
The solution, comprising hardware, software, and tags, centres around SATO’s next-generation PJM RFID technology for source tagging of implantable products prior to gas and radiation sterilisation. This technology enables a new streamlined workflow that is not possible using barcodes or conventional RFID products.
Touchpoints requiring scans
Orthopedic implants — artificial replacements for joints, bones, or cartilage to address damage or deformity are made in many sizes to suit the wide range of human body types. Since the correct size often remains unknown until surgery, manufacturers may supply several hundreds of implant parts in advance, based on patient data. Yet only a few of these are actually used, and the rest are returned, resulting in a labour-intensive process. Each supply chain touchpoint — picking products, shipping, receiving, returning after surgery, and restocking for unused products — involves a scan of every item to accurately understand what is in stock. Multiply this task into the thousands for just a single shipment.
As the healthcare sector adopts Industry 4.0 practices, source tagging with RFID is essential for streamlining logistics and warehousing to improve supply chain visibility and productivity. However, conventional RFID products face a significant drawback—they cannot withstand the radiation sterilization process, which erases or corrupts their memory. LimaCorporate selected PJM RFID from among the range of RFID products SATO handles because of its next-generation chip, which can withstand electron beam and gamma ray sterilization.
Source tagging of implants with PJM RFID removes the need for retagging at various touchpoints, enabling faster inspections, reconciliation of kits and stock rotations, with end-to-end visibility from the factory to the operating room. Furthermore, source tagging with RFID can help meet medical device labelling reporting1 and identification2 compliance requirements and bring quality control benefits of smart traceability and real-time post-market surveillance.
Application of SATO PJM RFID tags
SATO conducted a successful pilot for LimaCorporate in late 2018, demonstrating the potential for a 50% increase in productivity with a PJM RFID tunnel reader-based system3. LimaCorporate has since begun applying radiation-hardened tags inside the packaging of its products during the production process before sterilization to streamline its production logistics and distribution.
We built a sterilisation hardened tag, which was key for LimaCorporate. We provided a total qualified solution with PJM hardware, bespoke software and PJM RFID tags, aiming for a seamless integration into the customer’s ERP system. We aimed for something deeper than just a supplier to end user relationship, and I am excited that this gave birth to a cutting-edge technical partnership.
Kevin Allart
SATO Global Head of Healthcare
The technology adopted by LimaCorporate is also designed to bring numerous benefits to hospitals. The SATO PJM RFID tags are NFC-enabled for on-the-fly verification of implants with a smart device on the front lines of care. By managing owned or consigned medical device inventory with fixed-in-place or mobile shelves or cabinets, hospitals can further improve inventory management processes from expiration control of products in the warehouse and verification of received materials.
For more about LimaCorporate, visit its official website or LinkedIn.
FDA Medical Device Reporting (MDR) regulations (21 CFR Part 803) and European Medical Devices Regulation (MDR 2017/745), which govern the safe production and use of medical devices
UDI (Unique Device Identification): A system to assign a unique identifier to medical devices for traceability and safety; currently utilized in the US, EU, China, South Korea and Saudi Arabia.
Based on the combination of bulk scanning items, assisting the rebuilding of kits and the integration to the ERP system made possible with PJM tags, tunnel readers and PJM ORBIT™ management solution.
ISO 18000-3 Mode 2 Phase Jitter Modulation (PJM) RFID is the answer for situations where large volumes of tagged items need to be quickly and accurately identified with 100% accuracy. In addition to providing 100% accuracy, PJM RFID was specifically designed to allow tagged items to be stacked or stored in any random orientation in static or dynamic conditions where bulk-tagged items are moving at high speed.