2013
Business & Management: International Perspectives
on Healthcare Technology Management (Part 1)

The Maintenance of Medical Equipmentby Clinical Engineers-The Importance of Clinical Engineers in Hospitals-Jun yoshioka
Kiyoshi Matsusaka, Shuichi Nasuno, Tadayuki Kawasaki

Japan Association for Clinical Engineers (JACE)

Background
Past presentations at AAMI’s conference
2010“The Challenge of the Next Generation ofMedical Equipment from the CE’s Perspective”
Kiyoshi Matsusaka, AAMI 2010 Conference & Expo (Tampa FL)

2011“Clinical Engineers System in Japan and New
Basic Job Guidelines 2010”
Kiyoshi Matsusaka, AAMI 2011 Conference & Expo (San Antonio, TX)

2012“Defining the Role of the Medical Equipment
Safety Manager"
Kiyoshi Matsusaka, AAMI 2012 Conference & Expo (Charlotte, NC)

OutlineHealthcare Technology Management‣YAMAGATA UNIV. HOSPITAL
Department of Clinical Engineering‣Safety Management In Japan
Common method of maintenance of medical equipment‣The benefits of having Clinical Engineers
Example of a mechanical ventilator, ME rack

‣The Unique Device Identification System
We hope to build the UDI system

YAMAGATA UNIV. HOSPITAL Department of Clinical Engineering
Business Operations• Extracorporeal circulation• Blood purification• Hyperbaric oxygenation• Maintenance• Education

Safety management
Technological Developments
Technological developments have led to significant improvementsin the performance of more advanced models.

➾ More complicated circuitry among numerous CPUboards and sensors.
➾ More possible weaknesses leading to breakdowns.

Increased special maintenance of
medical equipment is necessary.

Incubator Analyzer

Defibrillator Analyzer

Mechanical Ventilator Analyzer

VariousAnalyzers

The inspection of medical equipment is evaluated using
various analyzers.
Replacing faulty parts in house at our department
contributed to more prompt responses and less repaircosts.
YAMAGATA UNIV. HOSPITAL

Infusion Device Analyzer

External Pacemaker Analyzer

Electrical Safety Analyzer

Electrosurgery Analyzer

Focus point
Clinical engineers maintainmedical equipment- Specifically by those who can use
a specialized analyzer.
Clinical engineering has decreased medicalequipment failure which exposes patients topotentially harmful risks.

The benefits of having Clinical engineers
Example of a mechanical ventilator[Purpose] The usefulness of maintaining ventilators by
Clinical Engineers was studied. [Methods] We evaluated 30ventilators, with accuracy measured 2500 times using thePTS-2000 ( Mechanical Ventilator Analyzer) during after-use
inspections. Faulty mechanical ventilators were repaired bycalibration and by replacing sensors, circuit boards, and so on.
timeyear
Jun Yoshioka, The 17th Congress of APACCM and The 12th Joint Scientific Congress of JSICM and KSCCM (Chiba, 2012).

The Number of Ventilators,
Minor Problems, and Failures
NUMBER

Ventilators
Minor Problems
FailuresYEAR
YAMAGATA UNIV. HOSPITAL

The involvement of CEs in maintaining ventilators
has ensured safe management.
Jun Yoshioka, The 17th Congress of APACCM and The 12th Joint Scientific Congress of JSICM and KSCCM (Chiba, 2012).

Development
Development of ME rackAn efficient battery charging management system for battery equipped medicalequipment.

Jun Yoshioka et al. Journal of Japan Association for Clinical Engineering Technologists (2012)

CHARGE Plug

ON/OFF CHARGCOMPLEPRIORITYPRIORITY Lamp（White）
ON/OFF Button

YAMAGATA UNIV.HOSPITAL

Details of ME rack

COMPLETION Lamp（Green）
CHARGING Lamp（Orange）

ME rack

First InFirst OutFFIO SystemAn original management ledger of individualmedical equipment
User
Restitution

Bar-CodeRental

OK

Inspection
completed

Bar-Code reader
currently on loanNO

Not yetinspection

FailureDepartment ofclinical engineering

YAMAGATA UNIV. HOSPITAL

The management ledger
tool scans the barcode andprovides us with complete
medical equipment
management

The Unique Device Identification system

UDI

Simplify the Integration of Device Information Into Data Systems.

PRESENT

FUTURE
EASY

HARD
modelversion
serial number
manufacture

We manually input device
information (model, serial number,etc) into an original management
ledger. It takes time and effort.

The hospital database

UDI label marks on the medical device itself

The UDI system eliminates
the need for such manual
date entry.

We believe that the utilization of UDI in the clinical field is effective.

Reduce Medical Errors
Patient Identification
Medical Device
Wristband

MaterialMedicine

Medical Staff ID

OK✗

If all is OK,
a medical device isusable for patients
If only one is not used correct,
a medical device is unusablefor patients

The UDI system will remove possible confusion and inappropriate usage of medical devices.
(e.g., a device failure, wrong patient, different material, different medicine, or user ID)

We hope to build the UDI system for a safer and more
effective therapy treatment.

‣ Clinical Engineers are anessential profession for the safe
operation of medical equipment.

Conclusion‣ Clinical engineering has
decreased medical equipment
failure which exposes patientsto potentially harmful risks.

YAMAGATA UNIV.HOSPITAL

END

Yamagata Prefecture