[State of the art and problems in medical safety management]

The principle of medical safety management is to build a safe medical system that is equipped to prevent patient injuries due to medical errors occurring in it and not to attribute them only to individual responsibility. Methodologically, this means identifying and reducing the potential risk of medical errors by systematic reporting and tracking of errors and near misses. According to some major clinical studies on medical malpractice in the USA, the incidence of medical accidents is reported to be 3-5%, 30% of which were due to negligence, and 7-14% resulted in patients' deaths. It is also reported that 66% of the medical accidents occurred in surgical specialties and 45% were related to surgeries, which were shown to have the highest risk of medical accidents. On the other hand, according to a nationwide survey on reported errors and near misses in Japan, 50% were related to drugs, especially injections. Other major causes reported in the study were manipulation and management of medical instruments, downfalls of patients, and aspiration. These safety problems listed above were shown to compose 95% of all of medical errors and near misses. To establish a rational safety management system, it is necessary to develop research methods appropriate for the study of medical errors, which facilitate clinical research, and can be expected to yield sufficient scientific data. A generalized guideline for voluntary reporting of patients' deaths and injuries due to medical errors, in relation to Article 21 of the Doctors' Law should be established. However, for essential improvement of transparency and accountability in medicine, it is necessary to set up a new specialized institute to accept reports on medical errors, give hospitals advice for a safer medical system, and disclose information on medical errors. Moreover, such an institute should continue to study medical safety by analyzing nationwide reports of medical errors and near misses. For the latter purpose, legal protection of the disclosure of information must be assured.