Clinical Engineers and Biomedical Engineers in Japan and the U.S
Environment of medical device development, role of biomedical
department toward to develop new medical equipment

June 5 | 10:00 AM
Tamotsu Tsunekage
Sr. Biomedical Engineer
Westchester Medical Center© 2016 Association for the Advancement of Medical Instrumentation www.aami.org

MAJOR DIFFERENCES• Direct involvement of patient care (Japan)• Must have government certification (Japan)• Background education, job requirement• Daily task, duty & activities• Salary, pay
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June 3-6

Tampa, FLADVANTAGE/DISADVANTAGE(JAPAN)• KNOWS EQUIPMENT AS A USER – EASY TO IDENTIFY THE PROBLEM• CAN FOLLOW PATIENT ONE UNIT TO OTHER UNIT – KNOW PATIENTCONDITION• RESPECT FOR MEDICAL EQUIPMENT• LESS TIME FOR MEDICAL EQUIPMENT MANAGEMENT• NOT ENOUGH BACKGROUND FOR TECHNOLOGY ASSESSMENTAAMI 2016 Conference & Expo

June 3-6

Tampa, FL

JAPANThe qualification of CE, incorporating
both engineering and medicine, was firstestablished in 1987. The CE is a healthcare professional who ensures the safetyand effectiveness of medical equipment.

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June 3-6Tampa, FL

A basic duties guideline for CEs devised in 2010

The main duties of the CE are classified as
respiratory therapy, cardiopulmonary bypass,
dialysis units, intensive care units, cardiac
catheterization, hyperbaric oxygen therapy,
pacemakers and medical equipment management.
To enhance the ability of CEs to engage in more
extensive duties and develop specialties, there is acertification system in each field. The CE plays a rolethat is socially important by ensuring the safety ofmedical equipment and its effective maintenance.
AAMI 2016 Conference & ExpoJune 3-6Tampa, FLUSA• Respiratory Therapist（RT）• Perfusionist• Dialysis Technician• Asset Managers• Hospital IT Specialists• Other Healthcare Technology
Management Professionals• Etc. Task is separated by Certificate
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Tampa, FL

Vision Statement
Biomedical Engineering makes aneffort so that the patient care is
economical and more effective byoffering services of the highest level
to users so that equipment may betechnically and safely operated.
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June 3-6Tampa, FLTASK OF CLINICAL ENGINEERINGDEPARTMENT IN USAMEDICAL EQUIPMENT
MANAGEMENTEDUCATIONRISK ANAGEMENT

CLINICALENGINEER

FACILITY PLANNING &PROJECT MANAGEMENTTECHNOLOGY ASSESSMENT

INSPECTION, SURVEY
AAMI 2016 Conference & Expo

PM, REPAIR

June 3-6

Tampa, FLPOINT OF CAREGAS MONITOR
INFUSION
DEVICEPHYSICIAN ORDER
OTHER MONITORPATIENT ADMISSIONDATA (SMS)

LIFE SUPPORTEQUIPMENTCARDIAC MONITORPATIENT(EKG, SpO2, NIBP, BP, CO2,C.O., TEMP)

CLINICAL LAB
RESULT
RADIOLOGYPAC SYSTEMOTHERSCENTRAL MONITOR

AAMI 2016 Conference & Expo

June 3-6

Tampa, FLWMC Biomed Involvement• Developed interface program between
monitor & Ventilator, blood gas analyzer,
infusion pump (1993) – Exhibited at PGA• Infusion pump drug simulation forAnesthesiologist (1994)• Interface between hospital informationsystem, clinical lab system & physiologicalmonitoring system (1995)• Display PAC image at bedside monitor(1998)• Design transport incubator for helicopter
AAMI 2016 Conference & Expo

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POINT OF CAREGAS MONITOR
INFUSION
DEVICEPHYSICIAN ORDER
OTHER MONITORPATIENT ADMISSIONDATA (SMS)

LIFE SUPPORTEQUIPMENT

CARDIAC MONITORPATIENT(EKG, SpO2, NIBP, BP, CO2,C.O., TEMP)

CLINICAL LAB
RESULT
RADIOLOGYPAC SYSTEMOTHERSCENTRAL MONITOR

Medical Chart

CLINICAL INFORMATION /CHARTING SYSTEM

Interface Engine

Physician’s office/home, Management Office

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June 3-6

Tampa, FLWMC Biomed Involvement inmedical device development• Concept – Point of care
• Safety oriented idea
• Provide best tool to care givers• Reduce human error• Increase readiness of equipment• Monitor environment to ensure theproduct, performance
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POINT OF CAREGAS MONITOR

OTHER MONITOR

INFUSION
DEVICE

LIFE SUPPORTEQUIPMENTPHYSICIAN ORDERPATIENT ADMISSIONDATA (SMS)
CLINICAL LAB
RESULT

CARDIAC MONITOR(EKG, SpO2, NBP, BP, CO2, CO, TEMP)CENTRAL MONITORPATIENT
Medical Chart

RADIOLOGYPAC SYSTEMOTHERS(ECG, EEG)

CLINICAL INFORMATION / CHARTING SYSTEM
Interface Engine

PagereICU, Physician’s office/home, Management Office
Wi-Fi - TEMPRATURE MONITORING,DEFIBRILLATOR DAILY STATUS MONITORING,INFUSION PUMP DRUG LIBRARYAAMI 2016 Conference & Expo

June 3-6

Tampa, FLWeb AccessTECHNOLOGY ASSESSMENTu Defibrillator Auto test monitoring – Wi-Fi
u Refrigerator Temp/Room Temp/CO2/Humidity/etc. real time monitoring – Wi-Fiu eICU – LAN/Webu Infusion Pump Drug Library – Wi-Fi/Web

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June 3-6

Tampa, FLBiomedical Technician I
Job Description
Provide technical knowledge and the ability
to test, repair and maintain medical devices.
Equipment includes electronic test
equipment and various types of medicalequipment. Testing will be done in our facilityand will involve staff interaction.

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June 3-6

Tampa, FLBiomedical Technician II
Job Description
The Biomedical Tech II works independently on
preventive maintenance, safety inspections andwill make repairs on moderately sophisticatedclinical medical equipment with little or nosupervision and will make repairs on highlysophisticated clinical medical equipment
under the supervision of a BMET Supervisor.
Maintains records, makes reports, andcoordinates outside repairs.

AAMI 2016 Conference & Expo

June 3-6

Tampa, FLBiomedical Technician II
Position Requirement
Associates degree in biomedical instrumentation technology,
biomedical equipment technology, biomedical engineering
technology, electronics
orrelated field, plus 5 years' experience in a healthcare
environment repairing patient related equipment, and eligible
for certification as a CBET, CLES, or CRES by AAMI
(Association for the Advancement of Medical Instrumentation)ora High School Diploma, plus seven 7 years‘ experience in ahealthcare environment repairing patient related equipment
and eligible for certification as a CBET, CLES, or CRES byAAMI.
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June 3-6

Tampa, FLBiomedical Technician III
Job Description
The Biomedical Equipment Technician III will
perform highly skilled work and preventive
maintenance of considerable difficulty on very
sophisticated clinical equipment with minimal
supervision. The Technician III will perform
repairs on all facets of medical, diagnostic andtherapeutic equipment and perform scheduled
preventive maintenance and electrical safety
inspections on medical, diagnostic andtherapeutic equipment used in the treatment ofpatients at --------.
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June 3-6

Tampa, FLBiomedical Technician III
Position Requirement
Associate's degree in Biomedical Instrumentation
Technology, Biomedical Equipment Technology,
Biomedical Engineering Technology Electronics orrelated field plus 4 years preventive maintenanceexperience, plus certification as a CBET, CLES, or
CRES by AAMI (Association for the Advancementof Medical Instrumentation)
or

AAMI 2016 Conference & Expo

June 3-6

Tampa, FLBiomedical Technician III
Position Requirement
Equivalent Military Training, plus 4 years
experience working in a hospital or other
healthcare environment performing preventive
maintenance, plus certification as a CBET, CLES,
or CRES by AAMI (Association for theAdvancement of Medical Instrumentation)
or

AAMI 2016 Conference & ExpoJune 3-6

Tampa, FLBiomedical Technician III
Position Requirement
High school diploma/GED plus 6 years experience
working in a hospital or other healthcare
environment performing preventive maintenance,plus certification as a CBET, CLES, or CRES by
AAMI (Association for the Advancement of Medical
Instrumentation)

AAMI 2016 Conference & Expo

June 3-6

Tampa, FLEducation Requirements
to BMET in US
Although prospective candidates with a high school
diploma may be able to secure an entry-level job,
those who have completed an associate's degree
program in biomedical technology or biomedicalengineering may have an easier time finding
employment and may begin with a higher pay level.
Coursework in an associate's degree program for thismajor consists of classroom lectures that focus onelectronics and equipment troubleshooting. Students
also complete hands-on laboratory work on equipment
repair and preventative maintenance.
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June 3-6

Tampa, FL

NY State CSEA
(35 Hours per week)• Biomedical Technician (C09)$47,163 - $66,641• Sr. Biomedical Technician (C10)$52,102 - $73,439• Biomedical Engineer (C12)$61,878 - $93,483• Sr. Engineer (Biomedical) (C13)$68,574 - $102,634
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June 3-6

Tampa, FLUS• Clinical Engineer（CE）：Salary＄80,000〜120,000• Biomedical Engineer（BME）：Salary＄54,000〜98,000• Biomedical Equipment
Technician（BMET）：Salary ＄45,000〜58,000

AAMI 2016 Conference & Expo

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Tampa, FLUS
Clinical Engineer average salary is $70,193,
median salary is $69,784 with a salary range from
$48,415 to $109,637.
Clinical Engineer salaries are collected fromgovernment agencies and companies.
Low48,415
Average 70,193
Median 69,784
High109,637AAMI 2016 Conference & Expo

June 3-6Tampa, FLJapan$37,130 – $55,556
20th 25.7％、30th 40.5％、40th 19.7％、50th 12.3％(日本臨床工学技士会会誌2015No.55P28より引用）$ = 108 Yen
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June 3-6Tampa, FL© 2016 Association for the Advancement ofJune 3-6 Tampa, FL
Medical Instrumentation www.aami.org

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Transforming Healthcare

NEW 11 BED MICUAAMI 2016 Conference & Expo

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Phase II
Labor and Delivery Expansion and renovation
Phase 1

Phase IIIPhase IV
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Special ProcedureLabs

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MFCH OR /Procedure Room
#1To

Concept

Reality32
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Infrastructure Wiring & Networking

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Patient Monitoring

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Technology- Continuation of Transformation
Operating Room-Audio / Visual Integration

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Technology- Continuation of Transformation
Infant Transport System / Internal / external

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© 2016 Association for the Advancement ofJune 3-6 Tampa, FL
Medical Instrumentation www.aami.org

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