最新一期
- 發布單位：科技法律研究所
Japan’s 2015 Medical Accident Investigation Scheme and Its Failures
作者：Futoshi Iwata, Ryoko Hatanaka
出版年月：202409
關鍵詞：Medical Accident Investigation；Professional Autonomy；Medical Safety；Unexpected Death；Root Cause Analysis；Legal Liability
英文摘要
This paper argues that Japan’s 2015 Medical Accident Investigation Scheme, which places great emphasis on professional autonomy, has fatal flaws.
After nearly two decades of discussions on how to establish a transparent and thorough medical accident investigation scheme and improve medical safety. Japan implemented the Medical Accident Investigation Scheme in 2015 (the 2015 Scheme). Under its scheme, (1) each hospital and clinic is required to report to the third-party organization approved by the Ministry of Health, Labour and Welfare (MHLW) when any“unexpected death”of a patient occurs in the course of medical treatment, regardless of any negligence. (2) Then, each hospital and clinic must conduct a transparent and thorough root cause analysis of how and why such death occurred and submit the final investigation report with a new safety measure to the third-party organization and the patients’families. (The investigation committee may include at least one member from outside the institution, but that is not required.) (3) The third-party organization analyses the final reports of reported cases and provides feedback on safety issues to hospitals and clinics.
MHLW predicted about 3,000 reports each year based on the medical records review for accidental deaths in hospitals several years ago. However, the number of reported cases has been much lower than previously predicted, around 350-400 cases per year (only about one report per day). And so, by not reporting, professional autonomy–the very foundation of the current scheme–is being shaken.
To explore what barriers prevent the reporting of unexpected deaths and what benefits of such reporting there are in reality after the implementation of the 2015 Scheme, we conducted online interviews with 20 medical safety experts (doctors, nurses, and families of medical accident victims). Each interview lasted a minimum of 60 minutes for each interviewee.
There are some positive results of the 2015 scheme, such as that (1) some hospitals have significantly increased their efforts to report accidents and analyse the causes of accidents scientifically and objectively; (2) bereaved families are often satisfied with the results; (3) the medical community’s initial concerns about the 2015 Scheme’s possible effect of promoting conflicts with victims’families and litigation were largely unfounded; and (4) external review committee members have often proven effective.
But our conclusion is that many challenges remain. The single undeniable problem is that many medical institutions neither report medical accidents nor conduct in-hospital accident investigations. Ironically, the 2015 Scheme’s structure is based on trust of professional independence, yet that trust has been undermined by the professionals themselves. In order to regain the societal expectations of medical professionals, the 2015 Scheme should be thoroughly reexamined.
出版年月：202409
關鍵詞：Medical Accident Investigation；Professional Autonomy；Medical Safety；Unexpected Death；Root Cause Analysis；Legal Liability
英文摘要
This paper argues that Japan’s 2015 Medical Accident Investigation Scheme, which places great emphasis on professional autonomy, has fatal flaws.
After nearly two decades of discussions on how to establish a transparent and thorough medical accident investigation scheme and improve medical safety. Japan implemented the Medical Accident Investigation Scheme in 2015 (the 2015 Scheme). Under its scheme, (1) each hospital and clinic is required to report to the third-party organization approved by the Ministry of Health, Labour and Welfare (MHLW) when any“unexpected death”of a patient occurs in the course of medical treatment, regardless of any negligence. (2) Then, each hospital and clinic must conduct a transparent and thorough root cause analysis of how and why such death occurred and submit the final investigation report with a new safety measure to the third-party organization and the patients’families. (The investigation committee may include at least one member from outside the institution, but that is not required.) (3) The third-party organization analyses the final reports of reported cases and provides feedback on safety issues to hospitals and clinics.
MHLW predicted about 3,000 reports each year based on the medical records review for accidental deaths in hospitals several years ago. However, the number of reported cases has been much lower than previously predicted, around 350-400 cases per year (only about one report per day). And so, by not reporting, professional autonomy–the very foundation of the current scheme–is being shaken.
To explore what barriers prevent the reporting of unexpected deaths and what benefits of such reporting there are in reality after the implementation of the 2015 Scheme, we conducted online interviews with 20 medical safety experts (doctors, nurses, and families of medical accident victims). Each interview lasted a minimum of 60 minutes for each interviewee.
There are some positive results of the 2015 scheme, such as that (1) some hospitals have significantly increased their efforts to report accidents and analyse the causes of accidents scientifically and objectively; (2) bereaved families are often satisfied with the results; (3) the medical community’s initial concerns about the 2015 Scheme’s possible effect of promoting conflicts with victims’families and litigation were largely unfounded; and (4) external review committee members have often proven effective.
But our conclusion is that many challenges remain. The single undeniable problem is that many medical institutions neither report medical accidents nor conduct in-hospital accident investigations. Ironically, the 2015 Scheme’s structure is based on trust of professional independence, yet that trust has been undermined by the professionals themselves. In order to regain the societal expectations of medical professionals, the 2015 Scheme should be thoroughly reexamined.
