Human-machine interphase plays an increasingly important role in implementing client andpatient safety

The Safety In­ves­ti­ga­tion Au­thor­ity has com­pleted its in­ves­ti­ga­tion into the mal­func­tion of a teleme­try de­vice, which led to a de­lay in de­tect­ing a pa­tien­t’s life­less­ness in South Os­tro­both­nia on 23 Oc­to­ber 2024. The pa­tient was con­nected to a teleme­try de­vice in the hos­pi­tal ward. They were found life­less, and a mal­func­tion in the teleme­try de­vice was de­tected at the same time. The pa­tient died de­spite re­sus­ci­ta­tion at­tempts.

Telemetry monitoring is a system used in hospitals that allows wireless and real-time monitoring of the electrical activity of a patient’s heart. Monitoring takes place using a device that transmits information about heart function to a central monitoring unit. The use of telemetry is particularly common with cardiac patients in situations where continuous monitoring of heart function is important, but the patient does not need intensive care-level treatment. The purpose of the telemetry system is to detect significant changes in the electrical function of the heart that are life threatening, and to issue alarms about them.

“Healthcare and social services have strong trust in the functioning of medical devices, such as a telemetry device, and the assumption is that they will work as expected. A safety investigation examines the sequence of events and the factors that led to the accident. In this investigation, the root cause of the accident was a battery at the end of its service life, but the investigation also revealed other contributing factors. These included the instructions for professional users working in a hospital, which should be clear, understandable and easy to use – and naturally also sufficient in terms of their scope,” states Investigator in Charge Hanna Tiirinki.

“We have also encountered the phenomenon of human-machine interphase (HMI) in other fields. Technology and the number of devices will increase even more rapidly in the future. This will put pressure not only on the manufacturer but also on end users of the device. Legislation, standards and instructions must be clear, usable and compatible. This is why our recommendations to the Ministry of Social Affairs and Health and the Finnish Medicines Agency Fimea are so wide-ranging. The relationship between medical devices, their safe use and usability has to be appropriate. A patient must feel confident that they will remain safe during treatment,” adds Tiirinki.

“In terms of research, this investigation also revealed that the authority will need to consider how to deal with the data produced by people’s smart watches or other wearable self-measurement devices in the future. This includes information about cardiac rhythm. The heart rate data produced by the patient’s smart watch during hospitalisation proved unreliable in some respects, and ultimately we could not fully utilise that data. Technology will continue to develop, and in the future this data will certainly become even more important,” says Tiirinki.

As a result of the investigation, the Safety Investigation Authority issued three recommendations to the Ministry of Social Affairs and Health and the Finnish Medicines Agency, Fimea.

Markku Mård, Head of Division, The Finnish Medicines Agency, Fimea: “ The Safety Investigation Authority’s (SIAF) comprehensive report contributes to the safe professional use of medical devices and related supervision. Fimea takes SIAF’s recommendations into account in its supervisory activities, while ensuring that all of Fimea’s actions continue to be based on legislation. “