Professor Bob Stone's research on utilising virtual environments for patient care features in the Institute of Ergonomics & Human Factors (IEHF) publication, 'Human Factors in Healthcare'.
Installing our latest Virtual Restorative Environment (VRE) “window-on-the-world” modules within the Intensive Care Unit of the Queen Elizabeth Hospital Birmingham (QEHB), ready for trials investigating patient cognitive restoration though improvement of sleep quality and the minimisation of delirium, has not been without its challenges.
As well as the inevitable ethics approval (which was, of course, particularly rigorous for the introduction of experimental human interface technologies into an environment such as the ICU), our prototypes were, after much paperwork, deemed to be Class I Medical Devices under classifi cation rule 12 (Annex IX) of the Medical Devices Directive (MDD), requiring compliance with Annex VII of the MDD - 93/42/EEC. We’re not altogether convinced of the signifi cance or relevance of this, but a Class 1 Medical Device it is!
The full article is also available in 'Human Factors in Healthcare (pdf)' (third page).