Laser marking tech "essential" to track reusable medical devices
NHS Tayside says Datalogic laser marking technology has been an ‘essential asset’ to track and trace reusable medical devices and ensure the prevention of high-risk instrument migration at its Central Decontamination Unit (CDU).
The CDU provides decontamination services to 52 surgical theatres and Dundee Dental Hospital, processing eight million instruments in compliance with ISO standards and medical device directives. Keen to ensure full traceability of devices and in readiness for the new unique device identification (UDI) regulatory requirements being introduced in 2020, NHS Tayside CDU began investigating solutions to mark surgical instruments so that each item could be accurately tracked through the decontamination process including washing, disinfection, packing and sterilisation.
Following an initial meeting with NHS Tayside to understand the trusts specific requirements, a solution was needed to allow for a unique GS1 GTIN barcode to be marked onto each instrument. It was important that the barcode would not affect or be affected by the decontamination process and the same process needed to be used on a range of instruments of different sizes made from a variety of different materials.
To meet NHS Tayside’s requirements, Datalogic partner Sciamed recommended the Ulyxe laser marking system which it delivered in partnership with specialist laser marking provider Laser Lines. Together Sciamed and Laser Lines carried out an onsite demonstration of the product, enabling NHS Tayside to see first-hand the quality and accuracy of the marks on various materials including stainless steel, anodised aluminium, titanium and plastic.
Following the successful implementation of the Datalogic laser marking system, Alan Simpson, quality and technical manager at NHS Tayside said: “The use of the laser marking equipment integrated seamlessly with our tracking and traceability system and has been an essential asset in ensuring the prevention of high-risk instrument migration. We are grateful to Sciamed who have supported us throughout this project and ensured that the laser marking equipment was incorporated into our demanding throughput requirements without incident.”
A label-based identification system would require labels to be replaced every two years. In contrast, the Ulyxe laser marking system had no on-going requirement for consumables and the equipment itself requires minimal housekeeping. Laser Lines and Sciamed recommends Datalogic’s DPSS (diode-pumped solid state) Ulyxe product as it delivers short bursts of energy which result in a neat mark, tested and approved by independent laboratories. The system can also be used to mark alphanumeric characters and even logos if required. And unlike other methods that change the surface of the kit, the laser also does not affect the protective passive layer.
In addition to supplying the laser marker itself, Laser Lines also provided a workstation to NHS Tayside that would enable them to mark different sized instruments while providing the required levels of safety for operators when the machine is in use. Training was also delivered to allow NHS Tayside’s decontamination technicians to get up and running as soon as possible.
Patrick Robinson, UK & Ireland sales manager, healthcare at Datalogic said: “Reusable surgical instruments and medical devices present a unique challenge to hospitals when it comes to ensuring complete traceability across the supply chain. Unlike medication and disposable packaged items, it is very difficult to use traditional label-based systems on these items to reduce risk and improve patient safety. Laser marking is perfectly suited to the variety of reusable devices that will need to be marked under the EU unique device identification regulation and we are delighted that NHS Tayside is leading the way with a Datalogic solution.”