Information and/or medical technology staff experience with regulations for medical information systems and medical devices

Objectives: Regulations heavily control medical technology (MT), which often includes information technology (IT), but staff experiences related to these regulations are unknown. The study aim was to assess Swedish IT/MT staff experiences regarding regulations for medical devices and medical information systems. Methods: An anonymous, ten-item, self-report questionnaire was administered to IT and MT staff (N=228) who attended a 3-h training course on IT and information security and MT regulations in 2014. Results: Most of the 228 (86%) IT and MT staff who completed the survey strongly agreed that IT security and MT security are relevant to patient safety. One third of the IT staff reported feeling that their knowledge about regulations within MT was sufficient. Less than half of the respondents experienced that healthcare professionals generally had sufficient knowledge of IT or MT regulations (41% versus 46%, IT and MT regulations, respectively). Conclusions: Although IT/MT staff felt that they had knowledge of regulations for medical devices and medical information systems, they reported that maintaining and increasing this knowledge is important and that there is a need for recurring training programs in IT and MT regulations. Improved knowledge in IT and MT regulation, and a better understanding of clinical healthcare, could lead to an increased quality in the daily operations and support to the healthcare professionals. Healthcare professionals may need education to develop their knowledge of IT or MT regulations, which in turn will ensure higher patient safety. (C) 2016 Fellowship of Postgraduate Medicine. Published by Elsevier Ltd. All rights reserved.