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As medical treatment makes rapid progress, it also becomes more complicated, carrying with it greater risk of accidents. To help improve safety and reduce mishaps in medical services, the government and medical institutions need to join hands to beef up a system introduced last year to probe unexpected deaths of patients without bringing criminal charges against the medical professionals involved.

Under the system, launched in October 2015 through a revision of the Medical Service Law after more than 10 years of discussions involving victims of medical accidents and their families, as well as doctors and lawyers, some 180,000 medical institutions across Japan are required to report unexpected deaths of patients during medical examinations and treatments to a third-party organization called the Japan Medical Safety Research Organization, carry out internal probes and submit the results to the organization.

The system is not aimed at determining possible criminal responsibility of the medical professionals involved. The investigation results are not to be reported to the police or public prosecutors. Medical institutions are required to explain the results to the families of deceased patients, but it is optional for each institution whether to provide the written reports in their entirety to the relatives. After receiving the results of the probes from hospitals and clinics, the organization is tasked with analyzing them and sharing relevant information to prevent similar incidents from happening again.

During the first year under the system, medical institutions reported 388 deaths to the organization — far fewer than the 1,300 to 2,000 unexpected deaths that the health ministry estimates are occurring every year. One possible reason is that medical institutions do not fully understand the purpose of the system — that it is not aimed at assigning blame to individual doctors or nurses. The organization needs to make further efforts to inform medical institutions of what the system aims to achieve.

Medical institutions may also be having trouble judging which cases constitute unexpected deaths. In the past year, there were 1,820 times in which hospitals and clinics consulted with the organization on whether they should report a certain death under the system. One problem is that the criteria for whether to report a death is left to each medical institution. The government and the relevant medical organizations should try to set standard criteria. The health ministry has also called for establishing a liaison council in each prefecture to help hospitals and clinics share information to narrow the disparity in their judgment on whether to report the deaths of patients.

Under the system, heads of medical institutions decide whether the deaths of patients fall in the category that must be reported to the organization by looking into their medical records as well as what their doctors had explained to them in advance about the risks inherent to specific treatment employed. Beginning in June, it became mandatory for hospital chiefs to examine all deaths that took place at their institutions in a centralized way. This represents a step forward, but without standardized criteria the decision whether to report a death and start an internal investigation will still be in the hands of each institution.

There are also differences in what the hospitals will specifically examine. Currently, the health ministry allows each institution to choose from among examples as to what to evaluate in each investigation — including the patient’s medical data, records of treatment, autopsy results and interviews of the doctors and staff involved. The ministry and medical circles should introduce some sort of standard minimum procedure.

Some families of medical accident victims are calling for ensuring transparency in the internal probes. Irrespective of whether they will probe each death, institutions need to sufficiently explain the cause of death to the relatives. The health ministry should require hospitals and clinics to provide full reports on their probes to the families upon request. In this connection, some medical professionals fear that the reports may be used to seek a criminal investigation — a concern that should be addressed in improving the system. Parties involved should also clarify the distinction between the unexpected deaths to be reported to the third-party organization under the system and the “unusual deaths” of patients that must be reported to the police under the Medical Practitioners Law.

One big problem with the new system is that people don’t know very much about it. The government and medical institutions should make more efforts to publicize the system — and specifically let people know that they can ask hospitals and clinics to launch a probe or consult with the third-party organization. The health ministry should also consider whether to make it mandatory for medical institutions to listen to the relatives of deceased patients during investigations.

The relevant parties should keep in mind that the key to the system’s success is transparency. Otherwise, the system will not serve its intended purpose.

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