yoshihide oishi managing director japan association for clinical engineering technologists jacet1
TRANSCRIPT
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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
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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
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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
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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
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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
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Notification of MHLW :promotion of the division of rules among doctors, co-medicals and office staff
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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
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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
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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
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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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