Implementation of Implant Traceability at Landspitali Hospital

Abstract

Iceland is obliged to adopt the regulations of the European Union in cooperation with the European Free Trade Association (EFTA). In 2019, Regulation (EU) 2017/745 (2017) concerning medical devices was approved by the Icelandic Parliament. The regulation was established to prevent the mishandling of equipment used in medical procedures and thereby enhance patient safety. One requirement is complete traceability of an implant – an object used in a procedure and left in the body for longer or shorter periods – from the manufacturer until it is used in a patient. To ensure traceability, it is necessary to review and simplify the entire process and to prevent errors as much as possible. The Lean methodology, which focuses on simplifying processes, eliminating waste, and getting things right the first time, is used for project management at Landspitali, the National University Hospital of Iceland. Landspitali’s working environment is complex, and mistakes can be costly. There is a high demand for data collection and record keeping, which contribute to ensuring patient safety. The process of implementing changes to workflows needs to be carefully managed, and it is crucial to inform and establish trust with those involved in workflows and technical solutions. Involving staff in process improvement using Lean principles enhances insight and fosters greater acceptance of changes, making it easier to respond to problems and external circumstances affecting the transition.