June 1, 2008

Hideo Takayanagi, Senior Managing DirectorJapan Association of Clinical Engineering Technologists

Enhancing the Role of the CE in JapanEnhancing the Role of the CE in JapanEnhancing the Role of the CE in JapanEnhancing the Role of the CE in Japan

（（ BRIEF EXPLANATION OF JAPANESE CEBRIEF EXPLANATION OF JAPANESE CE ））（（ BRIEF EXPLANATION OF JAPANESE CEBRIEF EXPLANATION OF JAPANESE CE ））

Agenda

1. History & Current Status of CE in Japan

2. Definition & Duties of CE in Japan

3. Situation of CE in Japan

4. Issues & Challenges of CE’s Activities in Japan (in 2005)

5. Current Situation of CE (in 2008)

6. Future of CE in Japan

1.1. History & Current Status of CEHistory & Current Status of CE in Japan in Japan

1.1. History & Current Status of CEHistory & Current Status of CE in Japan in Japan

・ Improvement of Medical & Engineering Technologies(Technology)　　　　　　 (ex. Rapid growing of medical support by artificial organs )

・ Substantial increase of ESRD patients in hemodialysis (HD) field　 Safe and appropriate operation/application of HD machine　 Need of more HD specialists and CEs operating artificial heart &

lung ・ Strict requirements for safe & appropriate operation of all medical　 equipments

　 Need of more specialists ・ Requests for specialists from medical field 　

Growing need & number of CE

Establishment of CE

Administrative Milestone of CE

1987 “Clinical Engineers Law”“Clinical Engineers Law” was promulgated by MHLW　　　　 ( Ministry of Health, Labour and Welfare)

1990 Professional organization JACET JACET was founded　　　　 ( Japan Association of Clinical Engineering Technologists )

2002 JACET was certified by MHLW ascertified by MHLW as a public utilities corporation

2008 20th. Anniversary of “ Clinical Engineers Law ”

2. Definition & Duties of CE in Japan2. Definition & Duties of CE in Japan 2. Definition & Duties of CE in Japan2. Definition & Duties of CE in Japan

1) Qualification of Clinical Engineer 　 :・ Licensed by the Government (MHLW)Licensed by the Government (MHLW)・ Under “ the Clinical Engineering Law”Under “ the Clinical Engineering Law”

2) Main Duties : ・ Operation of life-support medical equipmentslife-support medical equipments

Check & maintenance workCheck & maintenance work

Direct medical actions to patientsDirect medical actions to patients

Blood & drug injection to patients

Blood sampling of patientsElectronic care to patientsOthers

Care to patientsCare to patients 　　　　　　

・ Training of Other medical stuff・ Cooperation with doctors, nurses and other

medical stuff to take team approachteam approach

3) Applicable Medical Equipment Life-Support Equipments:Life-Support Equipments:

Biogenic functional support of respiratory, circulation and metabolism with life-support equipments and others

3.3. Situation of CE in JapanSituation of CE in Japan 3.3. Situation of CE in JapanSituation of CE in Japan

No. of Licensed CE:24,61124,611 (as of March 2008)(1,510 were newly licensed in March 2008)

Actually working CE:approximately 15,00015,000

Member of JACET:approximately 9,8009,800 (as of March 2008)

CE at Work

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CE Breakdown by J ob

4. Issues & Challenges of CE 4. Issues & Challenges of CE Activities in Japan (in 2005)Activities in Japan (in 2005)

4. Issues & Challenges of CE 4. Issues & Challenges of CE Activities in Japan (in 2005)Activities in Japan (in 2005)

1) Issues of CE in 2005

・ Jobs not clearly defined by LawJobs not clearly defined by Law

・ No public remuneration guaranteedNo public remuneration guaranteed

・ DutiesDuties including sanction of phlegm and blood drawing are not legally are not legally

admitted admitted

・ Insufficient education periodInsufficient education period

・ Lack of understanding of CE’ jobs in medical institutionsLack of understanding of CE’ jobs in medical institutions

2) Challenges of CE in Japan in 2005

－ For Safer Medical Equipments Operation －

・・ Longer & continuous education/trainingLonger & continuous education/training

・・ Clear legal definitionsClear legal definitions

・・ Enhance CE’s position in LSS at medical institutionsEnhance CE’s position in LSS at medical institutions

・・ Improve skillImprove skill by Certification Systemby Certification System

・・ More central ME control centers at medical institutionsMore central ME control centers at medical institutions

・・ Cooperation with industries in the development of safer & advanced LSCooperation with industries in the development of safer & advanced LS

SS

・・ OthersOthers

5.5. Current situation of CE (in 2008)Current situation of CE (in 2008) 5.5. Current situation of CE (in 2008)Current situation of CE (in 2008)

Some examples are as follows:Some examples are as follows:

1.The revision of Medical Law was enforced in April 2007, and staffing 1.The revision of Medical Law was enforced in April 2007, and staffing of a person in charge of medical equipment management became of a person in charge of medical equipment management became mandatory for the safety purpose.mandatory for the safety purpose.

2.MHLW issued a notification in December 2007 which urged positive 2.MHLW issued a notification in December 2007 which urged positive utilization of CE.utilization of CE.

3.A law enforced in April 2008 restricts the attendance of medical 3.A law enforced in April 2008 restricts the attendance of medical equipment manufacturer representatives to clinical site, and original equipment manufacturer representatives to clinical site, and original role of CE is highly recognized again.role of CE is highly recognized again.

4.Public remuneration for one of CE’s jobs became payable in April 4.Public remuneration for one of CE’s jobs became payable in April 2008.2008.

6. Future of CE in Japan6. Future of CE in Japan 6. Future of CE in Japan6. Future of CE in Japan

・・ Continuous efforts towards safe operation of LSSContinuous efforts towards safe operation of LSS

・・ Legal enhancement of CE’s dutiesLegal enhancement of CE’s duties

・・ Authoritative specialists to LSS at medical institutionsAuthoritative specialists to LSS at medical institutions

・・ Improvement of Education system & Certification Improvement of Education system & Certification systemsystem

・“・“ JACET Academy” & “JACET Seminar center”JACET Academy” & “JACET Seminar center”

・・ OthersOthers

Objectives of Conceptual Scheme of Objectives of Conceptual Scheme of “JACET Academy” & “JACET Seminar center”“JACET Academy” & “JACET Seminar center”Objectives of Conceptual Scheme of Objectives of Conceptual Scheme of “JACET Academy” & “JACET Seminar center”“JACET Academy” & “JACET Seminar center”

““JACET Academy”JACET Academy”

・・ Sharing of know-how and technologiesSharing of know-how and technologies・・ Contribution to future developmentContribution to future development・・ Award system Award system

““JSC”JSC”

Planning and running of educational programsPlanning and running of educational programs