Yoshihide OishiYoshihide OishiManaging DirectorManaging Director

Japan Japan Association for Clinical Engineering TechnologistsAssociation for Clinical Engineering Technologists

JACET 1

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AGENDAAGENDAAGENDAAGENDA１． Revised Medical Law２． Promotion of Division of Roles between Doctors and co-medicals３． Application of Standard of Observing Medical Equipments at Medical Institutions４． Point rating of Works Involved in Safety Measures of Medical Equipments （ CE’s additional medical fee ）

JACET

①Appointment of person in charge

②Training of persons involved

③Planning and correct implementation of medical equipments maintenance program

④ Implementation of measures for the collection of information required for the safety of medical equipments

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Measures for the safe use of medical equipments

JACET

Allocation of a person in charge of maintenance and safe use of medical equipments

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Doctors PharmacistsNurses

Try to maintain the systems

Dentists Dental hygienists

Clinical technologistsClinical engineers

Radiologists

Safety Manager of medical equipments:a person with any of above qualifications

Provide training

Planning and correct implementation ofmaintenance program

Implementation of measuresfor the collection of informationrequired 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

5JACET

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

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Date of purchaseMaintenance statusRepairs

Based on the dataProvide advice on introduction of

New medical equipments for safety purpose

For the equipments that require bettermaintenance

Repairs

Usage

Evaluation Inspection and replacement by modelaccording to features Planning

Record

JACET

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Safety Manager ofmedical equip-

ments

①Grasp and managemedical equipments

②Establish a systemFor correct infor-mation sharing

③Report to managerof medical institution

Instructions and annex

MR providing

of medical

equipment information

Centralizationof understanding and managementof information

Centralized col-lection of necessary information from manufacturers

Troubles andhealth hazard by medical equipments

JACET

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

8JACET

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 2008

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10Source: JACET 2007JACET

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Notification of MHLW 2007 ． 9 Article in Nippon Keizai Newspaper 2008 ． 3JACET

Services in question Conflicting 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

12JACET

Point rating of safety management Point rating of safety management servicesservices

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

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Number of Beds

Medical Equipments Safety Management Fee (yen/month)

250 ～ 1,000 40,000 ～ 210,000

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＊ About ￥ 180/bed/monthSource: 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

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