Yoshihide Oishi Managing Director Japan Association for Clinical Engineering Technologists JACET1

2 AGENDAAGENDA １． Revised Medical Law ２． Promotion of Division of Roles between Doctors and co-medicals ３． Application of Standard of Observing Medical Equipments at Medical Institutions ４． Point rating of Works Involved in Safety Measures of Medical Equipments （ CE’s additional medical fee ） JACET

① Appointment of person in charge ② Training of persons involved ③ Planning and correct implementation of medical equipments maintenance program ④ Implementation of measures for the collection of information required for the safety of medical equipments 3 Measures for the safe use of medical equipments JACET

 Allocation of a person in charge of maintenance and safe use of medical equipments 4 Doctors Pharmacists Nurses Try to maintain the systems Dentists Dental hygienists Clinical technologists Clinical engineers Radiologists Safety Manager of medical equipments:a person with any of above qualifications Provide training Planning and correct implementation of maintenance program Implementation of measures for the collection of information required for the safety JACET

 Share information on effectiveness and safety  Provide know-how for correct operation  Appropriate ways of maintenance  How to deal with troubles and faults  Compliance issues 5 JACET

 １． Collection of information on maintenance methods ２． Keep track of use of medical equipments  ３． Planning of maintenance program and archiving of records  ４． Outsourcing of maintenance inspection 6 Date of purchase Maintenance status Repairs Based on the data Provide advice on introduction of New medical equipments for safety purpose For the equipments that require better maintenance Repairs Usage Evaluation Inspection and replacement by model according to features Planning Record JACET

7 Safety Manager of medical equip- ments ① Grasp and manage medical equipments ② Establish a system For correct infor- mation sharing ③ Report to manager of medical institution Instructions and annex MR providing of medical equipment information Centralization of understanding and management of information Centralized col- lection of necessary information from manufacturers Troubles and health hazard by medical equipments JACET

 Notification of MHLW :promotion of the division of rules among doctors, co- medicals and office staff 8 JACET

 Eliminate unfair actions of soliciting purchase of equipments  Prohibit manufacturer’s rep’s involvement in team medical care at clinical site  Prohibited by Fair Trade Agreement as of April JACET

10 Source: JACET 2007 JACET

Notification and newspaper article 11 Notification of MHLW 2007 ． 9 Article in Nippon Keizai Newspaper 2008 ． 3 JACET

Services in questionConflicting law Involvement of unqualified rep in team medical care Medical Law Qualified rep’s paid or unpaid involvement in team medical care Manpower Dispatching Law Providing free of charge services by qualified or unqualified reps Fair trade Agreement 12 JACET

Point rating of safety management services  Medical Equipments Safety Management Fee:50 points (1/month) Above points are applied when patients are treated by LSS in medical institutions with good medical safety systems where more than 1 full-time CEs are staffed who engage in operation and maintenance of LSS under the direction of doctors. Applicable medical equipments （１） Cardiopulmonary pumps （２） Auxiliary circulating pumps （３） Respirators （４） Blood purification devices （ excluding artificial kidney ） （５） Defibrillator （６） Closed incubators 13 JACET

Number of Beds Medical Equipments Safety Management Fee (yen/month) 250 ～ 1,00040,000 ～ 210, ＊ About ￥ 180/bed/month Source: JACET, March 2008 JACET

 Revised Medical Law  Promotion of division of roles between doctors and co-medical  Involvement of manufacturer’s reps at clinical sites  Points rating of medical equipments safety management services 15 JACET