The purpose of this paper is to describe a study which aimed to develop and validate an assessment method for the International Electrotechnical Commission (IEC) 80001-1 (IEC, 2010) standard (the Standard); raise awareness; improve medical IT-network project risk management processes; and improve intensive care unit patient safety.
An assessment method was developed and piloted. A healthcare IT-network project assessment was undertaken using a semi-structured group interview with risk management stakeholders. Participants provided feedback via a questionnaire. Descriptive statistics and thematic analysis was undertaken.
The assessment method was validated as fit for purpose. Participants agreed (63 per cent, n=7) that assessment questions were clear and easy to understand, and participants agreed (82 per cent, n=9) that the assessment method was appropriate. Participant’s knowledge of the Standard increased and non-compliance was identified. Medical IT-network project strengths, weaknesses, opportunities and threats in the risk management processes were identified.
The study raised awareness of the Standard and enhanced risk management processes that led to improved patient safety. Study participants confirmed they would use the assessment method in future projects.
Findings add to knowledge relating to IEC 80001-1 implementation.
This research was undertaken in part fulfilment for an MSc in Health Informatics at Trinity College Dublin (the University of Dublin). This study contributed to developing an assessment method for IEC 80001-1 (International Electrotechnical Commission, 2010) by S.T. MacMahon from the Regulated Software Research Group, Dundalk Institute of Technology, Dundalk, Co. Louth, Ireland.
Kielty, L.A. (2017), "Improving ICU risk management and patient safety", International Journal of Health Care Quality Assurance, Vol. 30 No. 5, pp. 445-457. https://doi.org/10.1108/IJHCQA-05-2016-0074
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