Ensuring medical device competence with device passports
Image: Wellbeing services county of Kanta-Häme
The regulation on medical devices also applies to software products, such as the Medanets app. From the point of view of patient safety and smooth practical work, it is important to ensure that healthcare professionals know how to use the medical devices safely and as intended. In the wellbeing services county of Kanta-Häme, south-west Finland, competence to use the Medanets app and other medical devices is ensured with the help of ‘device passports’.
Ensuring the safe use of devices and systems and sufficient competence is part of the Finnish national client and patient safety programme for 2022–20261, which is targeted at service providers. Competence management is also part of the management of medical devices, which is regulated by legislation2. The wellbeing services county of Kanta-Häme uses the digital device passport provided by a company called Qreform. The same model is also used by a few other Finnish wellbeing services counties.
Harmonious induction across all units
“We wanted a tool that allows us to harmonise the competence requirements, receiving demonstrations and ensuring competence across the entire organisation,” says Tiina Koskinen, Device Management Coordinator for the wellbeing services county. “The digital device passport harmonises the competence requirements and the reception of demonstrations. When the same device passport is used for all induction training, the content of the induction or the competence requirements are the same for everyone, regardless of their unit or the induction provider.”
The digital device passport has other benefits, too: the passports are run in Qreform’s Quality Gate portal, which makes the device passport completion rate accessible to both supervisors and employees. Furthermore, Quality Gate makes the induction materials available whenever needed. “Thanks to digital device passports, we can easily demonstrate to the authorities how our wellbeing services county manages medical device competencies,” Koskinen says.
The device passports are used in the wellbeing services county for a number of medical devices, such as the haemodialysis device, devices used in neonatal intensive care, clinical physiology examination devices, pain relief devices, blood glucose measuring devices, the patient monitor and the Medanets app. Several new device passports are also currently under preparation.
Device passports are prepared in cooperation
In the wellbeing services county of Kanta-Häme, the collection of information needed for the device passport is always started by an employee of the device safety workgroup who works in the client and patient safety unit. The preparation of the passport can be triggered by unit needs or , for example, by a reported event of compromised patient/client safety. The Qreform device passport catalogue contains a lot of options, often suitable for use as such or after minor modification. If a device passport has not been prepared for the device in question before, the device safety working group of the client and patient safety unit starts preparing it together with the unit that will first implement the new passport.
The supervisor and the device manager usually give their comments on the content of the passport. They also approve the passport for use. “To ensure accuracy, the aim is to verify the content of the device passports with the supplier of the medical device,” Koskinen says. For example, the device passport for the Medanets app was verified by several Medanets representatives, such as the quality and development manager and a member of the Service & Delivery team that was responsible for the implementation, training and customer support related to the app. Medanets also provided device instructions for the passport.
Completing device passports digitally is convenient
The supervisor or the device manager specifies which device passport each employee needs to complete. “The employee receives an e-mail notification that invites them to log into the Quality Gate portal. In the portal, they can start completing the device passports. Each induction stage is recorded electronically in the device passport, including the review of the induction training and the demonstration. When everything has been reviewed and accepted, the device passport enters into force,” Koskinen explains.
Although device passports are already used quite a lot in the wellbeing services county, the aim is to use them even more extensively. “The implementation at the start of 2023 coincided with the early stages of the reform of social and healthcare services in Finland, which slowed down the extension of the digital device passports,” Koskinen says. “However, the units are showing increased interest towards the device passports, both in the central hospital and elsewhere in the wellbeing services county. The number of contacts related to launching the process has clearly increased,” Koskinen says. Most of the feedback received during the pilot phase was positive. “The digital device passport feels easy to use, and the performance is easier to monitor than with the old system that was based on unit-specific methods.”
Sources:
1. Finnish Centre for Client and Patient Safety: Action plan for client and patient safety strategy for service providers, 2022–2026. Referred to on 30 November 2023.
2. The Medical Devices Act 719/2021, Section 32.
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