Evidence-Based Introduction of Large-Scale Medical Technology Into Healthcare Through Test of Chance and Proof of Concept

Abstract

Traditional or “off the shelf” or “out of box” method of acquisition of medical devices and technology is currently being challenged by clinical users. As hardware, connectivity, and Health information systems (HISs) are becoming the key enablers of delivery of integrated patient monitoring; there is an increasing requirement for a coproductive approach to the choice and implementation of patient monitoring systems. The complexity of the clinical environment requires a collaboration of many stakeholders with a common focus and shared goals to ensure the correct choices and outcomes are delivered to satisfy requirements of clinical users and the wider system. Implementation of change through operationalization of such technologies is, however, complicated by regulation, accreditation, and standards requirements. In response to these and other issues, clinical engineers are recommending that the safest, efficient, and most effective approach to introduction of new systems is to conduct a test of change prior to major acquisitions of medical devices and systems that carry organization-wide clinical impact. The proposed approach is consistent with the Plan-Do-Study-Act cycle improvement model. In this case study, neonatal intensive care unit was used to assess the introduction of an “integrated patient monitoring system” into NHS Tayside.