Clinical Engineering

SWB 4043

Lecture 2:
Medical Device
Management
Dr. Maheza Irna Mohamad Salim
 Think Pair Share 15 minutes

Suture Pacemaker Lung ventilator

contact lens condom

X-ray films
disinfecting
 Patient simulator
Dental chair

Prosthesis

Reagent
MRI Image processing
Dental implant
software
 Medical Device - Definition

Any instrument, apparatus, implement, machine,

appliance, implant, in vitro reagent or calibrator,
software, material or other similar or related article,
intended by manufacturer to be used, alone or in
combination, for human beings, with some kinds of
purpose (diagnosis, prevention, monitoring, treatment,
etc)
IMDRF is a voluntary group of representatives from national medical device regulatory authorities (such as the U.S.
Food and Drug Administration (FDA)) and the members of the medical device industry
 Instruments - alat
Apparatus/ implement/ appliances- perkakas
Machine - mesin
Implant - implan
In vitro reagent reagen
Calibrator - penentuukur
Software -perisian
Materials - bahan
Articles barang/perabot/artikel
 Types of medical device

Diagnostic Acquire data for presentation

to human in clinical investigation
Therapeutic Device use to control or
arrest physiological process that has
affected due to disease or trauma
Assistive and rehabilitative Used to make
up diminished function or to provide for a
lost function.
MEDICAL DEVICES REGULATORY ACTIVITIES

Pre-market

Placement On Market

Post - Market
 The different phases of
medical device

From Conception to disposal

 Life Cycle of a Medical Device

Conception Manufacture Packaging Advertising Sale Use Disposal

and Design Labelling

Pre-market On-market Post-market

 Life Cycle of a Medical Device

Biomedical Engineering Clinical Engineering

Conception Manufacture Packaging Advertising Sale Use Disposal

and Design Labelling

MANUFACTURER VENDOR USER

 Management practice of a Medical
Device

Planning Acquisition Installation, Commissioning

And acceptance

Inventory and User training Monitoring of use and

Documentation performance

Maintenance Replacement and disposal

 1 Planning of equipment

Covers equipment and financial planning

Equipment planning must consider 5 factors
Needs and benefit
Available qualified user
Confirmed maintenance service
Adequate environmental support
Regulatory compliance
 Financial planning should consider
Approved and allocated budget
Device cost
Training cost
Maintenance cost
Procurement Financial alternative
Cash purchase requires high funding to cover device cost,
maintenance cost and upgrade cost
Rental less money, equipment is not owned by the
hospital, pay periodic rental
Lease purchase cross between rent and cash, term of
leasing, transfer of ownership at the end of certain leasing
period
 2 Acquisition
Covers evaluation stage and procurement
stage
Evaluation stage
Stage for hospital to investigate and compares
safety, performance and ease of maintenance
between available products
Come out with certain conditions to be included
during procurement. Eg: supply of operating and
service manual, user training, disposables
Evaluation of vendor capability: service, training,
disposable supplies
 Procurement
Request for Info technical spec
Option of Procurement financial alternative
Request for quotation
Product comparison
Decision making
Payment after Acceptance and training
3T MRI vs 7T MRI
 3T MRI vs 7T MRI
Equipment
Adv and disadv of both equipment (resolution,
contrast, scanning time, image manipulation features,
storage)
Do we really need?
Limitation ? (heat effect to patient), comfortability
Space size? Fit with floor plan?
Space requirement ? (shielding)
Financial
Procurement cost
Maintenance cost
 3 Installation, Commissioning and
Acceptance test
Qualitative and Quantitative tests carried out on
the medical device upon completion of
installation and prior to use for clinical service to
ensure its safety and performance is in
accordance with manufacturers specification ,
purchase agreement and statutory
requirements.
Compulsory for new equipments
Done either by in house staff of supplier with
monitoring
 Objective
Ensure equipment is in proper working condition
before being used to patient
Conduct safety and performance test
Avoid shipment damage
Ensure compliance with specification in the PO
Complete delivery of device, accessories, spare
parts, operating and service manuals
 Installation Requirements of an
MRI
Shielded Room design
 Transportation from manufacturers plant
 Modification to hospital building, lifting
method, lifting procedure
 Commissioning and acceptance
test of MRI
Thorough inspection following manufacturers
specification upon arrival of a device
 4 Inventory and Documentation
Equipments registration as hospital assets
Help the hospital schedule routine maintenance for the
device
To easily retrieve the device when it is recall
Minimum inventory parameters:
Unique equipment ID
Manufacturer
Model
Serial No
Descriptions
Location, department
Acceptance date
 Asset Tag Number
 5 User training
To familiarize user with new equipments
Ensure the safety and effectiveness of usage by
medical personnel
Avoid operator error the leading cause to
device malfunction
Avoid unnecessary maintenance cost
Hospital can request for a repeated user
training until users are competent
Condition can be made for user training to be
compulsory before payment can be made
Practicle /Hands-On
 6 Monitored use and performance

Warranty period (1-2 years)

Schedule of warranty service liaise with
vendor
 Tag for equipment under warranty
 7 Maintenance

Objectives:
Ensure the device are kept functioning within
the limits imposed by the test criteria
To return the device to the required level of
functioning after failure
2 Major types
Corrective maintenance
Preventive maintenance
 Person performing the maintenance must be
well trained
Should receive at least 72 hours training in 3
years
New staff receives 36 hours training in first year
Have sufficient working staff to meet the
maintenance workload. This applies to both
in house and contract service provider
 Corrective Maintenance

The action performed to restore an item to a

specified condition when it fails to function as per
manufacturers specification
Includes routine corrective maintenance,
emergency maintenance and breakdown
maintenance
Breakdown maintenance Defect in the operation
is detected by user
 Emergency maintenance performed as
necessary at the quickest and most efficient
manner to ensure restoration of affected
service
Elements in preventive maintenance should be
repeated after a breakdown maintenance
 Danger Tag for Breakdown equipments
 Preventive maintenance

A planned maintenance program which

specifies frequency, task and activities to be
done in order to ensure that all equipment is
operating as per manufacturers
specification and in the safe working
condition
 Maintenance Tag
 Hospital should have Inspection and Repair
SOP for each device
Time estimation should be included in the
SOP
Real inspection time determine the
adequacy of the inspection
Be used to estimate staff working load
Must use testing tool
Patient monitor testing tool
Defibrillator testing tool
Electrosurgical unit testing tool
 8 Replacement and Disposal

Should consider
Personal safety
Environmental
 Disposal/ Exemption Tag
 Independent study

You are a biomedical engineering trainee in

Radicare Sdn Bhd, Hospital Tengku Ampuan
Rahimah, Klang. Your industrial training scope
is to learn about medical device management
in hospital. You are assigned to do
independent learning on a specific medical
device and present your findings in front of the
Radicare management on your last training
day.