## Overview

## Medical Safety Measures

[Basic idea] Implement respective measures with great respect being paid to the viewpoint of medical safety and quality improvement taking into consideration report of the study group on medical safety measures (June 2005).

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## [Improved medical quality and safety]

Systematization of establishment of certain safety management system in clinics with no beds, dental clinics, maternity clinics, and pharmacies ([1]preparation of safety management guideline manual, [2]implementation of training on medical safety, and [3] internal report of accidents, etc.)

Improved measures against hospital infection in medical institutions ([1] preparation of guidelines/manuals for preventing hospital infection, [2] implementation of training on hospital infection, [3] internal report on situation of infection, and [4] establishment of committee on hospital infection (only in hospitals and clinics with beds))

Security of drug/medical device safety ([1] clarification of responsibilities regarding safety use, [2] establishment of work processes regarding safety use, and [3] regular maintenance check on medical devices)

○ Improved quality of medical professionals

○ Obligation for administratively punished medical professionals to take re-education training

### [Thorough implementation of preventive measures against recurrence through investigation/analysis of causes of medical accident cases, etc.]

O Thorough implementation of preventive measures against recurrence through investigation/analysis of causes of accident cases

○ Discussion on reporting system of medical related deaths, investigation system of cause of medical related deaths, and out-of-court dispute resolution system in medical areas

## [Promotion of information sharing with patients and the public and independent participation from patients and the public]

Promotion of information sharing with patients and the public and independent participation from patients and the public

Systematization of medical safety support centers

## [Roles of the government and local governments on medical safety]

Clarification of responsibilities of the government, prefectures, and medical institutions and roles of patients and the public, etc.

☐ Establishment of laws and regulations, promotion of research, and provision of financial support, etc.

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Enhancement of medical safety management system (revision of law in 2006, etc.)

Obligation of establishment of hospital infection control system (revision of Ministry Ordinance in 2006)

Obligation of placement of responsible persons regarding safety use of drugs/medical devices, etc. (revision of Ministry Ordinance in 2006)

Work guidelines for medical safety managers and guidelines for formulating training programs (March 2007)

Obligation for punished medical professionals to take re-education training (revision of law in 2006, etc.)

Promotion of projects to collect information on medical accidents, etc. (from FY2004)

☐ Provision of “medical safety information” (from FY2006)

O Model projects for investigation/analysis of deaths related to medical practices (from FY2005)

Training projects for developing human resources to engage in coordination/mediation of medical disputes (FY2006)

○ Discussion on investigation of causes and prevention of recurrences of deaths caused by medical accidents, etc. (from April 2007)

Japan Obstetric Compensation System for Cerebral Palsy (from January 2009)

O Liaison Conference of Alternative Medical Dispute Resolution Organizations (from March 2010)

○ Discussion on utilization of autopsy imaging for determination of cause of death (September 2010 to July 2011)

○ Discussion on ideal no-fault compensation system that will contribute to the improvement of medical care quality (from August 2011)

Promotion of Patient Safety Action (PSA) (from FY2001)

Obligation for medical institutions, etc. to make efforts in providing appropriate consultations to patients (revision of law in 2006)

Systematization of medical safety support centers (revision of law in 2006, etc.)

Clarification of responsibilities of the government, local governments, and medical institutions (revision of law in 2006)

Promotion of comprehensive support projects of medical safety support centers (from FY2003)

Research for promoting medical safety management system (scientific research of health and welfare)

Guidelines for safety management in Intensive Care Unit (ICU) (March 2007)

○ Model projects for making perinatal medical institutions open hospitals (from FY2005 to FY2007)