Hannu Jarvinen’s research while affiliated with Säteilyturvakeskukseen and other places

As in any medical intervention, there is either a known or an anticipated benefit to the patient from undergoing a medical imaging procedure. This benefit is generally significant as demonstrated by the manner in which medical imaging has transformed clinical medicine. At the same time, when it comes to imaging that deploys ionizing radiation, there is a potential associated risk from radiation. Radiation risk has been recognized as a key liability in the practice of medical imaging, creating a motivation for radiation dose optimization. The level of radiation dose and risk in imaging is varied but is generally low. Thus, from epidemiological perspective, this makes the estimation of the precise level of associated risk highly uncertain. However, in spite of the low magnitude and high uncertainty of this risk, its possibility cannot be easily refuted. Therefore, given the moral obligation of healthcare providers, "first do no harm," there is an ethical obligation to mitigate this risk. How to precisely achieve this goal scientifically and practically within a coherent system has been lacking. To address this need, in 2016, the International Atomic Energy Agency (IAEA) organized a summit to clarify the role of Diagnostic Reference Levels to optimize imaging dose [1,2], summarized into an initial report [3]. Through a consensus building exercise, the summit further concluded that the imaging optimization goal goes beyond dose alone, and should include image quality as a means to include both the benefit and the safety of the exam. The present, second report details the deliberation of the summit on imaging optimization.

The ACCIRAD project, commissioned by the European Commission (EC) to develop guidelines for risk analysis of accidental and unintended exposures in external beam radiotherapy (EBRT), was completed in the year 2014. In 2015, the "General guidelines on risk management in external beam radiotherapy" were published as EC report Radiation Protection (RP)-181. The present document is the third and final report of the findings from the ACCIRAD project. The main aim of this paper is to describe the key features of the risk management process and to provide general guidelines for radiotherapy departments and national authorities on risk assessment and analysis of adverse error-events and near misses. The recommendations provided here and in EC report RP-181 are aimed at promoting the harmonisation of risk management systems across Europe, improving patient safety, and enabling more reliable inter-country comparisons.

Purpose: To describe the current status of implementation of European directives for risk management in radiotherapy and to assess variability in risk management in the following areas: 1) in-country regulatory framework; 2) proactive risk assessment; (3) reactive analysis of events; and (4) reporting and learning systems. Material and methods: The original data were collected as part of the ACCIRAD project through two online surveys. Results: Risk assessment criteria are closely associated with quality assurance programs. Only 9/32 responding countries (28%) with national regulations reported clear "requirements" for proactive risk assessment and/or reactive risk analysis, with wide variability in assessment methods. Reporting of adverse error events is mandatory in most (70%) but not all surveyed countries. Conclusions: Most European countries have taken steps to implement European directives designed to reduce the probability and magnitude of accidents in radiotherapy. Variability between countries is substantial in terms of legal frameworks, tools used to conduct proactive risk assessment and reactive analysis of events, and in the reporting and learning systems utilized. These findings underscore the need for greater harmonisation in common terminology, classification and reporting practices across Europe to improve patient safety and to enable more reliable inter-country comparisons.

In 2011 the European Commission launched a tender to develop guidelines for risk analysis of accidental and unintended exposures in external beam radiotherapy. This tender was awarded to a consortium of 6 institutions, including the ESTRO, in late 2011. The project, denominated “ACCIRAD”, recently finished the data collection phase. Data were collected by surveys administered in 38 European countries. Results indicate non-uniform implementation of event registration and classification, as well as incomplete or zero implementation of risk assessment and events analysis. Based on the survey results and analysis thereof, project leaders are currently drafting proposed guidelines entitled “Guidelines for patient safety in external beam radiotherapy – Guidelines on risk assessment and analysis of adverse-error events and near misses”. The present article describes the aims and current status of the project, including results of the surveys.