Original Title: 보건의료 안전관리체계분석 연구

Authors' objectives: Human lives are always exposed to various kinds of risks and it is practically impossible to live a life without risks. The opposite concept of "risk" would be "safety" which means protection from undesirable things of physical, social, spiritual, financial, political, emotional, occupational, psychological and educational dimension. A more practical definition of "safety" is that activity or exposure is sustained at the level of acceptable risk, which indicates to minimize controllable risks not to remove all the risks. Healthcare system is a national or social system to describe every activities primarily relating to health. Healthcare safety is sustained through the approaches of setting the acceptable risk levels scientifically and controlling the risks via various systems and activities. These risk management includes activities to prevent risks might occur due to all kinds of error and mistake. In healthcare field, it has started to establish the systems to review and set the acceptable risk level and to control the risk for health technologies such as pharmaceuticals, medical devices and procedures. On the other hand, the approach to safety matters regarding error and mistake which might occur in the process of implementation of health technologies has been started relatively late, which is currently regarded as "patient safety". This study aimed to investigate and analyze comprehensive healthcare safety management systems as well as their associated institutions and activities in developed countries. The goal is to suggest a direction for policy development by extracting management systems that must be either established or improved in order to enhance safety in domestic healthcare industries. The following provides the details of the research. First, this study defined the concept and range of healthcare safety and categorizes healthcare safety management systems into more detailed levels based on state activities. Second, this study investigated overseas cases of more sub-divided healthcare activities and areas that could or could not take preventative measures using the current knowledge and technologies. Third, domestic safety management systems and their status were investigated to compare and review the analysis of the overseas cases to propose safety management activities for domestic implementation or improvement.

Authors' recommendations: Safety management systems for the risks associated with medical technology itself are relatively well-constructed for medicines or medical devices; the risk monitoring system is especially well-established compared to medical treatments. A voluntary side-effect reporting system to collect and manage the safety information regarding medicines and medical devices is not legally required, but it actively supports data collection at the national level as it is a basic system collecting safety information from the actual medical field. It was found that the amount of information collected was gradually increasing, contributing to safety information reports and establishing a culture for reporting side effects. In contrast, medical treatments do not have pre-approval systems such as item approvals. Therefore, medical technology evaluation works as a gatekeeper for medical technology management, and safety evaluation is very important when implementing new technologies. In addition, safety management must be enhanced systematically since the implemented medical technologies, such as high-risk surgeries, do not have well-constructed monitoring or reporting systems. It is necessary to monitor and understand the status using the main clinical indicators even after the new medical technologies are approved if these technologies require surgical procedures and additional education and training for professionals. In December 2014, procedures were followed to enact regulations for a safety management system regarding safety issues during medical technology implementation. This legislation is intended to construct and manage a patient safety reporting and learning system at the national level. Previous studies on patient safety insisted on enacting patient safety laws and providing a patient safety reporting system. The patient safety reporting system would be mandatory for deaths or any other serious incidents; it can be voluntary for minor incidents or errors. As shown in many state-level incidents in the United States or United Kingdom, support from the national government is required in order to clearly define mandatory reports and activate voluntary reports. It is necessary to construct a detailed system in which patients or their legal guardians who directly receive medical services and experience side effects can file reports. In addition, safety information collected through the reporting system must be analyzed consistently to understand the incidents' status (not necessarily their cause), to study incidents that occur repeatedly, and to see whether responsive actions can be taken at the national level. Constructing a response system that provides medical service providers and consumers with information about the analysis of the incidents and preventative measures is one of the most crucial missions of legislating patient safety laws.

Project Status: Completed

Year Published: 2015

URL for published report: https://www.neca.re.kr/lay1/program/S1T11C145/report/view.do?seq=167

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: South Korea

Organisation Name: National Evidence-based healthcare Collaborating Agency

Contact Address: National Evidence-based Healthcare Collaborating Agency (NECA), 3~5F Health and Welfare Social Administration B/D, 400 Neungdong-ro, Gwangjin-gu, Seoul, Korea.

Contact Name: int@neca.re.kr

Contact Email: int@neca.re.kr

Copyright: National Evidence-based Healthcare Collaborating Agency (NECA)