Keep Your Eyes On The Prize

Abstract

Medical technology is evolving at a remarkable rate, prompted by its major role in health care services. The Health Care Inspectorate monitors this technological advance and should take action whenever the quality of care and/or patient safety is at risk. Regulation is therefore inevitable. However, as far as the use of medical technology in care institutions is concerned, there are still some gaps. This research explores how a regulatory arrangement specifically aimed at the use of medical technology in hospitals could complement the Inspectorate?s current regulatory arrangement and how it should take form. The 2006 Twenteborg accident, claiming the life of a patient, served as the motive for this research, as it is a typical example of the complexity entailed in regulating the use of medical technology in hospitals. The main research question was therefore: ‘What amendments can be made in the Health Care Inspectorate’s regulatory arrangement to enhance patient safety when using medical technology in hospitals?’ In order to find the answer, the research included an analysis of the current regulatory arrangement of the Inspectorate, an analysis of several theories on regulation, a field analysis, and an analysis on the specific complexities entailed in regulating the use of medical technology. The research also included a design & evaluation phase, to make an assessment framework for a regulatory arrangement specifically aimed at the use of medical technology in hospitals and assess the Inspectorate?s current regulatory arrangement. The Inspectorate?s current regulatory arrangement includes a cycle of enforcement and three inspection instruments, namely phased, thematic and incident-based supervision. Medical technology is regulated by means of the Medical Devices Act and the Care Institutions Quality Act. The first act regulates the production and trade of medical devices and is thus essentially meant for manufacturers, whereas the latter regulates the use of medical technology, thus essentially regulating care institutions. In this way a clear distinction is made between supervision on the production and trade of medical devices and supervision on the use of these medical devices. However, actual practice has shown that it is hardly feasible to keep these two apart. The cycle of enforcement and the inspection instruments are based on three regulation theories namely system-based, risk-based and responsive regulation. Fundamental to the system-based regulatory approach is that the regulatee should have a self-regulatory capacity and thus aims for regulation on the system-level. The risk-based approach aims for selective regulation and requires the regulator to „pick important problems and fix them?. The responsive regulation approach focuses on interventionist response and tries to establish a synergy between punishment and persuasion. Each theory has a number of opportunities and risks that need to be considered when applying them. Many of the risks or complexities that were identified in the theory were confirmed by the field analysis. The field analysis also provided some additional insights into other (practical) complexities. An analysis of the complexities has revealed that they are mostly created by the multi-actor environment, by organizational and technical issues, or by the formal obligations the Inspectorate has to comply with. An adequate regulatory arrangement and thus the standards of the assessment framework should be designed in such a way that the opportunities and the risks identified in the analyses of the theories and the field analysis should be reckoned with, in that one should try to gain advantages from the opportunities and try to reduce or prevent the risks. Furthermore, as the Inspectorate?s current regulatory arrangement consists of a combination of different regulatory theories, the assessment framework should also provide standards which enable a practicable combination of theories. Keeping the above in mind, I have designed an assessment framework. It is intended to serve as an assessment tool for the Inspectorate and can be interpreted as a normative checklist or guideline to verify if and the extent to which the standards are imbedded in the regulatory arrangement. Upon assessing the Inspectorate?s current regulatory arrangement by means of the assessment framework, a number of shortcomings were identified including communication issues, accountability issues and issues regarding the content and focus of the actual inspections. The recommendations to the Inspectorate therefore also include suggestions as to how to improve on these aspects. The general conclusion of this research is that the Inspectorate?s current regulatory arrangement still has a number of gaps, especially with regard to the use of medical technology in hospitals. These gaps can be narrowed by a more meticulous design of the regulatory arrangement. The general complexity of regulating the use of medical technology is mainly due to the multiplicity of aspects, each of which should be given careful consideration. The title of this report was inspired in the light of this complexity. Keep Your Eyes on the Prize is a warning that one should not lose sight of the main objective, which is the quality of care, with the focus on patient safety. The main recommendation is therefore to use the designed assessment framework as a guideline to gain perspective on regulating the use of medical technology in hospitals. It should be noted, however, that the designed assessment framework still needs some finishing touches, as it was not feasible to include them in the limited time frame of this research. The finishing touches include the aspects of a measurable assessment, which should enable the user to obtain a valuable rating of the situation, and the terms of reference, which should specify the usage. As medical technology is now also increasingly used in nursing homes, it may be worthwhile finding out if the assessment framework can also be applied in a wider setting than just hospitals.