{
  "abstract": "Background and Importance The increasing digitalisation of hospitals exposes healthcare institutions to cyberattacks, particularly ransomware, which can paralyse operations and compromise patient safety. The management of implantable medical devices (IMDs) is critical, as their traceability is mandatory for materiovigilance and regulatory compliance. In the event of an information system (IS) outage it is essential to ensure the continuity and security of the IMD circuit.Aim and Objectives This work, part of the COPIL DMI action plan, aims to establish a degraded procedure enabling the tracking, traceability, and provision of IMDs when IS systems are inaccessible, due to either a major outage or a cyberattack.Material and Methods A working group from COPIL DMI was created, bringing together the hospital pharmacy (PUI) team (pharmacists, technicians, RSMQ), operating room managers, the Digital Services Department (DSN), and the hospital quality department. The IMD circuit was analysed, and its critical steps were identified using the FMEA (Failure Mode, Effects, and Criticality Analysis) method. Based on the control points identified, a degraded procedure was developed and tested in a simulated IS outage scenario.Results The FMEA highlighted the most critical steps, particularly implant traceability in the electronic patient record (EPR) and order transmission to suppliers. The degraded procedure, based on paper documentation, offline Excel files, and extracted product and supplier references, allowed for minimal continuity of activity. The simulation confirmed that the procedure was functional but also revealed increased risks of errors due to manual data entry and a heavier workload for staff.Conclusion and Relevance This work emphasises the strong reliance of the IMD circuit on hospital IS and its vulnerabilities during outages or cyberattacks. The degraded procedure and its testing are essential to ensure continuity of care and minimum device traceability. These efforts must be part of an institutional approach involving the PUI and clinical departments. Once validated by COPIL DMI and COVIRIS, the next steps will include the development of a business recovery plan and formalisation of the associated proceduresConflict of Interest No conflict of interest",
  "authors": [
    {
      "affiliations": [
        "Chu Amiens, Pharmacie, Amiens, France"
      ],
      "name": "L Gaudefroy"
    },
    {
      "affiliations": [
        "Chu Amiens, Pharmacie, Amiens, France"
      ],
      "name": "M Babin"
    },
    {
      "affiliations": [
        "Chu Amiens, Pharmacie, Amiens, France"
      ],
      "name": "A Petit"
    }
  ],
  "title": "2SPD-023 Implementation of a degraded procedure for the implantable medical devices circuit at Amiens-Picardie University Hospital in the event of an information system outage or cyberattack",
  "uid": "8ec1e0b0-f63e-5831-9796-d47880325db6"
}