27 Jul 1.26 As stated in R1.1.19 Treatment – Triage Status Change: change status/colour based on vital signs, the solution should be able to change the triage colour of the victim based on the measured vital signs. However, according to the relevant literature, there is only a limited number of triage algorithms that can support automatic change of status based only on automatically measured vital signs(R 3.1.1-R3.1.8). Other frequently used triage algorithms include the evaluation of mental status which according to the Call for Tenders is to be evaluated manually. Could you please clarify if the change of status/colour should be made automatically (in case the algorithm used allows that), or semi-automatically (after manual evaluation of other, non-automatically measured, parameters)? Moreover, given the intended use of the device (having in mind also MDR), could you please clarify if there should be always a manual verification of the change in colour/status (especially if it has been fully automatically changed) or if the solution should be able to autonomously change it?
Following the overall scopes of the Pre-Commercial Procurements, the iProcureSecurity PCP keeps the description of the requirements open, so that innovation and creativity from the suppliers’ side can be promoted. It is therefore up to the supplier(s) to decide how this specific requirement should fit the proposed solution, taking into account the prioritization level of each requirement and the current regulatory framework (MDR-Regulation (EU) 2017/745 & GDPR – Regulation (EU) 2016/679).