A new system to investigate “unexpected deaths” of patients at medical institutions — a product of more than 10 years of discussions involving victims of medical accidents and their families, doctors and lawyers — will be launched in October. The system is aimed at improving the safety and quality of medical services by exploring the causes of medical accidents, and the results of the probe will not be reported to the police or public prosecutors. It is important for medical workers, patients and people at large to understand the purpose of the system and make efforts to improve it through its operation.
The system is based on a revision to the Medical Service Law enacted in June last year. It will cover some 180,000 medical institutions, including hospitals, clinics, maternity homes and dental clinics. The institutions will report all unexpected deaths that happened during medical examinations and treatments to third-party organizations known as medical accidents investigation and support centers, which will be designated by the Health, Labor and Welfare Ministry. The ministry estimates that 1,300 to 2,000 such deaths are occurring every year across the country. According to the Supreme Court, the number of lawsuits related to medical accidents began to increase in the 1990s, hitting a peak of more than 1,100 cases in 2004. In recent years, 700 to 800 suits are being filed every year against doctors and medical institutions.
Under the new system, if unexpected deaths have occurred, hospitals and clinics have to explain to the patients’ families and then report them to the third-party organizations. The medical institutions will then immediately start their own probe into the deaths and report the outcome to the bereaved families and the third-party organizations. The latter will collect and analyze investigation results from various medical institutions, and use the findings to enlighten doctors and medical institutions and to make proposal to prevent similar deaths in the future. These probes will be separate from any possible criminal procedures or damage suits related to the medical accidents.
Before details of the system were adopted, differences surfaced between medical institutions and victims of medical accidents. Organizations supporting victims and their families urged hospitals to hand over their investigation results in written form to bereaved families, saying that verbal explanations would not be conducive to them fully understanding what went wrong with the medical treatment of their relatives. Representatives from the medical circles opposed this, citing fears that written reports would be used by the victims’ families to start legal action or submitted to law-enforcement authorities.
A compromise worked out by the health ministry leaves the issue vague. It says medical institutions “will make efforts” to use a method that bereaved families want — verbal explanations or written reports or a combination of both. But medical institutions should realize that the bottom line is for patients’ families to be informed of the cause of death in ways that they can scrutinize.
To ensure neutrality, transparency, fairness and expertise of the probes, outside experts will join the in-house investigation carried out by medical institutions. The principle of investigation under the new system is that its results will not be used to punish those involved and therefore will not be submitted to the police or public prosecutors. This is in accordance with the World Health Organization’s guideline. The basic idea behind the system is to highlight structural problems that have caused patients’ deaths and to respect the autonomy of doctors and medical institutions to learn from the mistakes responsible for the deaths.
While the new system is aimed at reducing deaths in medical examinations and treatments, it falls short from the viewpoint of patients and their families. Medical institutions are not required to report to the third-party bodies fatalities that do not fall into the category of unexpected deaths, including cases in which patients died after they and their families had been informed of a risk of death from medical tests and treatments in advance. But the scope of unexpected deaths may vary depending on doctors and their institutions’ judgment on how detailed the prior explanations had been. There may arise many cases in which patients’ deaths that should be reported are not, with doctors and the institutions interpreting the rule to their advantage. It will be all the more important for medical institutions and doctors to properly inform patients and their families of the risks involved in medical examinations and treatments.
Under the system, doctors and medical institutions decide whether patients’ deaths fall into the category of unexpected deaths, and bereaved families are not given the power to urge medical institutions to launch investigations. It is also uncertain whether doctors will report all of their patients’ deaths to hospital officials in charge of safety management.
A case in point is what happened at Gunma University Hospital. Between 2010 and 2014, eight patients died within two weeks to four months after they had received laparoscopic liver surgery by a surgeon there. Even though the first of these operations took place in December 2010, it was only in June 2014 that the hospital director learned of the deaths. For example, if a doctor determines that a patient died not due to the operation itself but a complication resulting from the surgery, the doctor may not report the death to the hospital’s safety management authorities — and thereby no report will be filed to the third-party organization.
The new system contains some problems and it will be necessary to improve it. But it should go hand in hand with efforts to raise the consciousness of doctors and nurses about the importance of sharing information on medical accidents with other medical workers with the aim of learning from mistakes and reducing the number of unexpected deaths.