The voyage data recorder (VDR) is a data recording system that aims to provide all navigational, positional, communicational, sensor, control and command information for data-driven investigation of accidents onboard ships. Due to the increasing dependence on interconnected networks, cybersecurity threats are one of the most severe issues and critical problems when it comes to safeguarding sensitive information and assets. Cybersecurity issues are extremely important for the VDR, considering that modern VDRs may have internet connections for data transfer, network links to the ship's critical systems and the capacity to record potentially sensitive data. Thus, this research adopted failure modes and effects analysis (FMEA) to perform a cybersecurity risk assessment of a VDR in order to identify cyber vulnerabilities and specific cyberattacks that might be launched against the VDR. The findings of the study indicate certain cyberattacks (false information, command injection, viruses) as well as specific VDR components (data acquisition unit (DAU), remote access, playback software) that required special attention. Accordingly, preventative and control measures to improve VDR cybersecurity have been discussed in detail. This research makes a contribution significantly to the improvement of ship safety management systems, particularly in terms of cybersecurity.

In industry, Failure Mode and Effects Analysis is an established quality tool for minimizing development risks in systems, products and processes. Nevertheless, the presented use case shows that the application of the FMEA method in the development of Product-Service Systems in a SME requires modifications to ensure that the special character of PSS is appropriately included and that risks can be adequately assessed and prioritized.

Objectives: The aim of this study was to identify risk points in the different stages of the smart infusion pump implementation process to prioritize improvement measures.

Methods: Failure modes and effects analysis (FMEA) in the pediatric intensive care unit (PICU) of a General and Teaching Hospital. A multidisciplinary team was comprised of two intensive care pediatricians, two clinical pharmacists and the PICU nurse manager. FMEA was carried out before implementing CareFusion infusion smart pumps and eighteen months after to identify risk points during three different stages of the implementation process: creating a drug library; using the technology during clinical practice and analyzing the data stored using Guardrails® CQI v4.1 Event Reporter software.

Results: Several actions for improvement were taken. These included carrying out periodical reviews of the drug library, developing support documents, and including a training profile in the system so that alarms set off by real programming errors could be distinguished from those caused by incorrect use of the system. Eighteen months after the implementation, these measures had helped to reduce the likelihood of each risk point occurring and increase the likelihood of their detection.

Conclusions: Carrying out an FMEA made it possible to detect risk points in the use of smart pumps, take action to improve the tool, and adapt it to the PICU. Providing user training and support tools and continuously monitoring results helped to improve the usefulness of the drug library, increased users’ compliance with the drug library, and decreased the number of unnecessary alarms.