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BIOMEDICAL

COMPETENCY
ACCORDING TO CODE OF
PRACTICE (COP) MS
2058: 2009

Ir. Dr. Syed Mustafa Kamal b. Syed Aman


smkamal@moh.gov.my

Senior Biomedical Engineer,


Ministry of Health Malaysia.

Chairman TC 10,
The Medical Devices and Facilities for
Healthcare Industry Standards Committee
(ISC R)
MS 2058:2009

Code Of Practice For


Good Engineering
Maintenance Management
Of Active Medical
Devices
Scope

This Malaysian Standard applies to all active


medical equipment placed for use in any
healthcare facility or any other facility which
requires maintenance.

This standard is not applicable for medical


equipment placed and used in any facility not
intended to be used on human.
From Wikipedia

Competence (or competency) is the ability of


an individual to perform a job properly.
Competence (or competency)

Some scholars see "competence" as a combination


of attitudes , skills and knowledge used to improve
performance;
or as the state or quality of being adequately or well
qualified, having the ability to perform a specific
role.
Competency

ASK
Attitude

Attitude (psychology), a person's perspective


toward a specified target and way of saying
and doing things
ATTITUDE RELATED TO COP
This Malaysian standard provides guidance to all
Biomedical Engineering Maintenance services on:

Scheduled Maintenance
Unscheduled Maintenance
Acceptance Testing
Mechanisms to avoid failure or breakdown during use
Uptime
Quality Assurance Program
Maintenance Management Information System
Management of Warranties

IFHE TOKYO-2010
This Malaysian standard provides guidance to all
Biomedical Engineering Maintenance services on:

Decommissioned Equipment
Disposal of equipment
Processes for handling hazardous/contaminated
equipment
Incidents and hazards
User training
Stock of genuine spares
On-site library
Workshop Setup
Advisory service
Procurement of equipment
IFHE TOKYO-2010
SKILL

1. ability to do something well: the ability


to do something well, usually gained
through training or experience

2. something requiring training to do


well: something that requires training and
experience to do well, e.g. an art or trade
skill
SKILL
Knowledge

The state or fact of knowing.


Familiarity, awareness, or understanding
gained through experience or study.
Knowledge
Biomedical Engineering Competency
Assessment Of Competence
Professional Competency Examination,
conducted by the recognised
Competency Certifying Body (CCB),
MOH authorised by the Engineering Services
Division of the Ministry of Health
Malaysia (MOH).

The examination will be against the


CCB competence and commitment
standards developed as per this
Malaysian Standard and relevant
national regulation.
Professional Competency
Examination The decision whether or not to accept
an applicant for competency
examination registration shall be made
by the CCB authorised by MOH, which
is responsible for governing the
competency registration.
Pelan Kursus Pengenalan Kejuruteraan Biomedikal Tempoh 3 Tahun

Basic anatomy, Basic Engineering and Clinical


Maintenance and Servicing of
Topics physiology and Applications of all Biomedical
Biomedical Equipment
pathology Equipments

Year 1 Module 1 3 days i. Introduction to the i. Coagulation Analyzer i. Coagulation Analyzer


Human Body ii. Bilirubinometer ii. Bilirubinometer
ii. Introduction to iii. Blood gas/pH Analyzer iii. Blood gas/pH Analyzer
Cells, Tissues, iv. Non Invasive Blood iv. Non Invasive Blood
and Membranes Pressure Pressure
v. High Performance Liquid v. High Performance Liquid
Chromatography Chromatography
vi. Microscope vi. Microscope
vii. UV/VIS Spectrophometer vii. UV/VIS Spectrophometer
viii. General X-ray Systems viii. General X-ray Systems

Module 2 3 days i. Introduction to i. Infusion & Syringe i. Infusion & Syringe


Skeletal System ii. Phototherapy Unit ii. Phototherapy Unit
ii. Introduction to iii. Patient Monitor iii. Patient Monitor
Muscular System iv. Electrocardiograph iv. Electrocardiograph (ECG)
(ECG) v. Bone Densitometer
v. Bone Densitometer vi. Centrifuges
vi. Centrifuges vii. Endoscopy Systems
vii. Endoscopy Systems viii. Ultrasound Systems
viii. Ultrasound Systems
Pelan Kursus Pengenalan Kejuruteraan Biomedikal Tempoh 3 Tahun

Basic anatomy, Basic Engineering and Clinical


Maintenance and Servicing of
Topics physiology and Applications of all Biomedical
Biomedical Equipment
pathology Equipments

Year 2 Module 3 3 days i. Introduction to i. Radiographic Units, i. Radiographic Units, Mobile


Nervous System Mobile ii. Anesthesia Unit (GA)
ii. Introduction to ii. Anesthesia Unit (GA) iii. Pulse Oximeter
Endocrine System iii. Pulse Oximeter iv. Ventilator
iv. Ventilator v. Mammography Unit
v. Mammography Unit

Module 4 3 days i. Introduction to i. Cardiotocograph i. Cardiotocograph


Cardiovascular ii. Defibrillator ii. Defibrillator
System iii. Hemodialysis Unit iii. Hemodialysis Unit
ii. Introduction to iv. Computed Tomography iv. Computed Tomography
Urinary System Scanner System Scanner System
Pelan Kursus Pengenalan Kejuruteraan Biomedikal Tempoh 3 Tahun

Basic anatomy, Basic Engineering and Clinical


Maintenance and Servicing of
Topics physiology and Applications of all Biomedical
Biomedical Equipment
pathology Equipments

Year 3 Module 5 3 days i. Introduction to i. Reverse Osmosis i. Reverse Osmosis System


Respiratory System (RO) (RO)
System ii. Angiogram System ii. Angiogram System
ii. Introduction to iii. Fluoroscopy System iii. Fluoroscopy System
Digestive System iv. Electrosurgical Unit iv. Electrosurgical Unit (ESU)
(ESU) v. Infant Incubator
v. Infant Incubator

Module 6 3 days i. Introduction to i. OT Table & OT Light i. OT Table & OT Light


Lymphatic System ii. Magnetic Resonance ii. Magnetic Resonance
ii. Introduction to Imaging (MRI) Systems Imaging (MRI) Systems
Reproductive iii. Linear Accelerator iii. Linear Accelerator Systems
System Systems
END
Medical Device Maintenance Spcialisation
Classification
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Radiology And Imaging Equipment


Specialisation Classification (sample)
Basic High
Densitometres, Bone, X-Ray, Dual-Energy Calibrators, Radiosotope
Absorptiometry Cameras, Gamma
Densitometres, X-Ray Fi lm Computers, Radiotherapy Planning System
Dosimetres, Radiation Counters, Gamma
Sensitometres, Radiographic Injectors, Contrast Media, Magnetic Resonance Imaging
X-Ray Film Duplicators Linear Accelerators
X-Ray QA Test Cassette
Radiographic Systems, Digital
X-Ray Film Processors
Radiographic Units, Mammographic
Intermediate
Radiographic/Fluoroscopic Systems, Angiographic/Interventional
Laser Imagers
Radiographic/Fluoroscopic Systems, Cardiovascular
Radiation Survey Metres, Geiger-Muller
Radiographic/Fluoroscopic Systems, General-Purpose
Radiation Survey Metres, Ionization Chamber
Radiographic/Fluoroscopic Units, Mobile
Radiographic Units, Chest
Radiographic/Tomographic Systems, Linear
Radiographic Units, Dental
Radiotherapy Simulation Systems
Radiographic Units, Dental Intraoral
Radiotherapy Units, Cobalt
Radiographic Units, Mobile
Radiotherapy Units, Orthovoltage
X-Ray Film Handling Equipment, Automatic,
Scanning Systems, Computed Tomography
Daylight
Scanning Systems, Magnetic Resonance Imaging, Full-Body
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Laboratory Equipment Specialisation


Classification (sample)
Basic High
Baths, Freezing Analyzers, Laboratory, Microbiology
Baths, Water Analyzers, Laboratory, Radioimmunoassay
Bilirubinometres Chromatography Systems
Blood Cell Processors
Cytometer
Carbon Di Oxide Monitors, Laboratory Incubator
Dna Sequencing Systems
Centrifuges
Concentrators, Specimen Iontophoresis Units, Sweat Test
Distilling Unit Microscopes, Electron
Evaporators Synthesizers, DNA/RNA
Extractors, Plasma Tissue Processors
Fluorometres
Spectrometres, Mass, Laboratory
Hot Plates
Spectrofluorometres
Intermediate
Analyzers, Laboratory, Blood Gas/PH Separators, Plasma
Analyzers, Laboratory, Blood, Urea Nitrogen Viscosimetres, Plasma
Analyzers, Laboratory, Body Fluids Nephelometres
Analyzers, Laboratory, Haematology Electrophoresis Systems
Analyzers, Laboratory, Clinical Chemistry
Analyzers, Laboratory, Immunoassay Spectrophotometres
Tissue Embedding Equipment
Microscopes, Light, Laboratory
Urodynamic Measurement Systems
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Diagnostic Equipment Specialisation


Classification (sample)

Basic Intermediate
Audiometres Blood Gas Monitors, Carbon Dioxide
Balances, Electronic Blood Gas Monitors, Oxygen
Balances, Mechanical Brachytherapy Systems, Remote After Loading
Calibrators, Mass Spectrometer Carbon Dioxide Monitors, Exhaled Gas
Cardiotocographs Nerve Function Monitors
Dialysate Conductivity Metres Oxygen Monitors
Disinfectors Physiologic Monitoring Systems
Dispensers, Fluid Respiration Monitors
ECG Monitors Stimulators, Electrical, Neuromuscular, Diagnostic
EEG Monitors Uterine Activity Monitors
Electrocautery Units Urodynamic Measurement Systems
Electroencephalographs Spirometres
Electromyographs
EMG Monitors, Telemetric
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Therapeutic Equipment Specialisation


Classification (sample)
Basic High
Baths, Dialysate Warming Angioplasty Systems, Atherectomy
Baths, Paraffin, Physical Therapy Cataract Extraction Units, Phacoemulsification
Cast Cutter Vacuums Circulatory Assist Units, Intra Aortic Balloon

Cast Cutters, Electric Circulatory Assist Units, Venous Return

Casting Furnaces, Dental Lasers, Argon


Lasers, Carbon Dioxide
Casting Units, Dental
Lasers, Diode
Chairs, Examination/Treatment
Lasers, Dye, Photodynamic Therapy
Compression Unit, Sequential
Lasers, ER:YAG, Surgical
Counters, Intravenous Drop
Lasers, Excimer, Ophthalmic
Intermediate
Lasers, HO:YAG, Surgical
Anaesthesia Unit Vaporizers
Lasers, ND:YAG
Anaesthesia Units
Lithotripters
Bronchoscopes
Microscopes, Scanning Laser, Optical
Chairs, Examination/Treatment, Dentistry
Microwave Therapy System, Tissue Ablation,
Colonoscopes Endometrial
Cryosurgical Units Stimulators, Electrical, Brain, Convulsive Therapy
Defibrillator Thyroid Uptake Systems
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Competency vs. Skill


Skills

Theory
Understanding of the anatomy, physiologic and biomedical equipment classification for
specific medical device (refer to table A2-A5).

Operations
Understanding of specific medical devices operations and its applications.
Identify and verify operation of all safety features for specific medical devices.

Safety
Be able to perform an effective electrical safety procedure on the specific medical device.
Understanding of test fixtures and test equipment specific to the medical device.

Servicing
Understanding of manufacturer Planned Preventive Maintenance procedures and follows
appropriate steps to complete the task for specific medical devices.
Be able to perform an effective performance testing and calibration on the specific medical
device.
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Competency vs. Skill


Cont.

Repair
First line repair: Be able to identify and perform breakdown and corrective maintenance of
the medical devices at the point of care.
Second line repair: Be able to identify intermediate corrective actions required for the
corrective maintenance of the specific medical device up to module/board levels at
maintenance workshop either internal or external.
Third line repair: Be able to identify advance corrective actions required for the breakdown
maintenance of the specific medical device up to component levels and complete overhaul at
specialised or manufacturer facilities.

Managing
Be able to complete accurately the necessary Biomedical Engineering related documentation.
Understanding of Biomedical Engineering Maintenance Services management level 1. Refer
to Management Level Matrix.
Understanding of Biomedical Engineering Maintenance Services management level 2. Refer
to management level matrix (Table A8).
Understanding of Biomedical Engineering Maintenance Services management level 3. Refer
to management level matrix (Table A8).
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Skills
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Biomedical Engineering Breakdown


Maintenance Scopes
Breakdown maintenance scope of repair

Breakdown Response

Equipment resetting and general checking

Common repair such as replacement of light bulbs, batteries, probes, electrode,

tubing, and equipment consumables.

Troubleshoot and repair minor defect related to power supply.

Spare parts identifications

Repair and replacement of equipment modules, assemblies or boards (PCB)

Ensure equipment requiring calibration is calibrated before use on a patient.


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Biomedical Engineering Breakdown


Maintenance Scopes (continued)
Breakdown maintenance scope of repair

Repair and replacement of component or subcomponent of the equipment PCB

Performing complex maintenance tasks that call for special skills, tools, or

equipment

Software re-programming of medical device

Performing specialized calibration on medical device

Modification and upgrading of medical device system & software.

Total overhaul or refurbishment of medical device


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Biomedical Engineering Breakdown Maintenance


Levels
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Management Skills
1. General technical support and facilities
2. Schedule maintenance management
3. Unscheduled maintenance management
4. Communication skills
5. Biomedical Engineering Services documentations
6. Hospital Biomedical Engineering Services administrative functions
7. Education and training for Biomedical Engineering
8. Staff supervision and monitoring
9. Relevant contractual management and implementation
10. Standard, quality and risk management
11 . An advisory service on available Biomedical Engineering technology
12 . Planning, evaluation, procurement and asset management of medical
devices
13 . Service management: To provide organisation with vision, leadership and
resources to achieve planned service goals and objectives.
14 . Biomedical Engineering research and development.
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Management Skills
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Career Development
Entry levels

1. Degree in Biomedical Engineering


2. Degree in Electronic Engineering
3. Degree in Other relevant Engineering
4. Diploma in Biomedical Engineering
5. Diploma in Electronic Engineering
6. Diploma in other relevant engineering field
7. Certificate in Biomedical Engineering
8. Certificate in Electronic Engineering
9. Certificate in other relevant engineering field
10. Lower qualifications
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Career Development
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Career Development
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Certification
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Competency Certification
Certification category

Certificate A
Basic Biomedical Equipment Maintenance Certification.
(Certificate of Competency Biomedical Engineering Maintenance Level 1)

Certificate B
Intermediate Biomedical Equipment Maintenance Certification.
(Certificate of Competency Biomedical Engineering Maintenance Level 2)

Certificate C1
Biomedical Equipment Specialisation Maintenance Certification in Radiology
(Ionizing & Non-Ionizing) & Imaging medical devices.
(Certificate of Competency Biomedical Engineering Maintenance Level 3 -
Radiology and Imaging)
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Competency Certification
Cont

Certificate C2
Biomedical Equipment Specialisation Maintenance Certification in
Laboratory equipment and devices.
(Certificate of Competency Biomedical Engineering Maintenance Level 3
- Laboratory)

Certificate C3
Biomedical Equipment Specialisation Maintenance Certification in
Diagnostic medical devices.
(Certificate of Competency Biomedical Engineering Maintenance Level 3
-Diagnostics)
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Competency Certification
Certificate C4
Biomedical Equipment Specialisation Maintenance Certification in Therapeutic
medical devices.
(Certificate of Competency Biomedical Engineering Maintenance Level 3 -
Therapeutic)

Certificate D
Advanced Biomedical Equipment Specialisation Maintenance Certification in
any specialisation of medical devices.
(Certificate of Competency Biomedical Engineering Maintenance Level 4 )