23/06/1443

Medical Equipment Maintenance

By: Mohammed Faisal

Evaluation
 100 POINTS:
 70 point for final exam.
 15 points for a Midterm.
 15 point for homework's reports or presentation.

presentation :
Review and Discussion Any One of Medical Devices in the
maintenance field.

1
23/06/1443

References

• Myer Kutz, BIOMEDICAL ENGINEERING

AND DESIGN HANDBOOK, Second Edition

What’s a Clinical Engineer( CE)

 American College of Clinical Engineering (ACCE) defines a clinical
engineer as:
 “he is a professional who supports and advances patient care by
applying engineering and management skills to healthcare technology”.
 A biomedical engineering graduate who works in the hospital is called
a clinical engineer.

2
23/06/1443

What’s a BMET
 The Biomedical Equipment Technician (BMET): is the person responsible for
direct support, service and repair of medical equipment in the hospital.
 Q: Compare between CE and BMET
(definition, education, job)

 Clinical Engineer (CE) Employment

 In the hospital.
 In the Industry.
 Private practice and consultation.

 Clinical Environment
 That portion of the health care system in which patient care is delivered.
 Clinical Activities
• Clinical activities include:
• Direct patient care,
• Research,
• Teaching,
• And management activities that are intended to enhance
patient care

3
23/06/1443

Evolution of Clinical Engineering

 Engineers were first encouraged to enter the clinical scene during the
late 1960s.
 During the 1970s, a major expansion of clinical engineering occurred.
 Today, clinical engineers are an integral part of the health care delivery
team. In fact, their role is multifaceted.
 Figure 1-1 illustrates the multifaceted role played by clinical engineers.

4
23/06/1443

Medical Equipment Management

 Medical Equipment Management Programme (MEMP) is established in
hospitals to provide safe and reliable operation of medical equipment and
promote its effective utilization.
 This program defines procedures and policies to manage activities related to
medical equipment, from their selection and acquisition to decommission.
 MEMP ensures that devices can provide reliable and accurate information
to clinicians, operate safely for patients, and are used to their fullest capacity.

Clinical Engineering Responsibilities—Traditional:

 Equipment Acquisition
 Capital Budgets
 Strategic Planning (5-Year Plan)
 Equipment Maintenance
 PMs and Corrective Maintenance
 Incoming Equipment Testing
Computer-Safety Testing
Other Nonmedical Device Safety Testing
 Service Contracts and In-House
 Fiscal Accountability
 Personnel

5
23/06/1443

Clinical Engineering Responsibilities—Traditional(cont.)

 Operating Budget
 Building and Renovation Projects
 Risk Management
 Safe Medical Devices Act
 Management—Vision and Growth

Clinical Engineering Responsibilities—Traditional(cont)

 Academic affiliation/teaching
 Applications research and design
 Consulting
 Information Systems Support
 In-service training
 Technical/clinical investigation—Clinical Trials Support
 Technology Management
 Technology Assessment

6
23/06/1443

Definition of Medical Devices

 In Pharmaceutical Affairs Law , medical devices refer to equipment or
instruments intended for use in the:
 diagnosis, Cure or prevention of disease in humans or animals, or
intended to affect the structure or functions of the body of
humans or animals (e.g., medical materials, dental materials,
sanitary materials .

Medical Device Classification

International standard (GHTF: Global Harmonization Task Force)
Classification of medical equipment:-
 Class I
If a malfunction occurs, risk to patient is extremely low.
 Class II
If a malfunction occurs, risk to patient is relatively low.
 Class III
If a malfunction occurs, risk to patient is relatively high.
 Class IV
Invasive devices; a malfunction could threaten life

7
23/06/1443

Medical Device Classification..

Example: CLESTA.DENTAL UNIT

8
23/06/1443

Essential Medical Equipment

 World Health Organization (WHO) classifies
essential medical equipment in four main
categories:
1. Diagnostic Imaging Equipment
• Diagnostic Imaging equipment is
used to take pictures, which help
physicians to diagnose a patient’s
medical condition, e.g.:
• Diagnostic X-ray equipment
• Ultra-sound equipment: Ultra-sound
equipment may be less frequently
used, and is usually added if the
budget is available in a hospital.

Essential Medical Equipment..

2. Laboratory equipment
A variety of laboratory equipment is used for analysis or measurement purposes.
 Microscope
 Blood counter
 Analytical balance (lab balance )
 spectrophotometer
 Centrifuge
 Incubator/oven
 Refrigerator
 Distillation and purification apparatus(device)

9
23/06/1443

Essential Medical Equipment…

3. General electro-medical equipment:
 Portable electrocardiograph.
 External defibrillator.
 Portable anesthesia unit.
 Respirator
 Dental chair unit
 Suction pump
 Operating theatre lamp
 Diathermy unit

Essential Medical Equipment…

4. Other support equipment
1. Operating theatre table
2. Delivery table
3. Autoclave- for general sterilization.
4. Small sterilizer-for specific services (e.g., dentistry)
5. Electrical generator
6. Electrical power regulator
7. Air conditioner
8. Refrigerator
9. Ambulance-four-cylinder diesel, equipped with medical equipment for emergencies; complete
accessories, spare tires and tools
10. Gynecological examination table
11. Small, inexpensive equipment and instruments

10
23/06/1443

Healthcare Technology Management

 What Do We Mean by Healthcare Technology?
The World Health Organization (WHO) uses the term ‘health technology’,
which it defines as including:
 devices
 drugs
 medical and surgical procedures – the knowledge associated with these –
used in the prevention, diagnosis and treatment of disease as well as in
rehabilitation, and the organizational and supportive systems within which
care is provided.’

Healthcare Technology Management, cont..

 The Place of Healthcare Technology Management in the Health System see figure:

11
23/06/1443

What is Healthcare Technology Management?

 Collection reliable information about your equipment.
 Planning your technology needs and allocating sufficient funds for them.
 Purchasing suitable models and installing them effectively.
 Providing sufficient resources for their use.
 Operating them effectively and safely.
 Maintaining and repairing the equipment.
 Decommissioning, disposing of, and replacing unsafe and obsolete items.
 Ensuring staff have the right skills to get the best use out of your equipment.

Benefits of Healthcare Technology Management (HTM)

Health facilities can deliver a full service, unimpeded by non-
functioning healthcare technology.

Equipment is properly utilized, maintained, and safeguarded.

Staff make maximum use of equipment, by following written

procedures and good practice.

12
23/06/1443

Benefits of Healthcare Technology Management (cont..)

Health service providers are given comprehensive, timely, and reliable
information on:
- the functional status of the equipment
- the performance of the maintenance services
- the operational skills and practice of equipment-user departments
- the skills and practice of staff responsible for various equipment-
related activities in a range of departments including finance,
purchasing, stores, and human resources.

Staff control the huge financial investment in equipment, and this can lead to
a more effective and efficient healthcare service.

Life Cycle of Medical Equipment

 Life Cycle of Medical Equipment A typical life
cycle of medical equipment has the stages shown
in Figure 2.1

26

13
23/06/1443

Planning
 In the planning stage,
 Distinct policies on
 acquisition,
 Utilization
 And maintenance of medical equipment are clearly outlined.
 This can significantly minimize the problems arising from the contracts,
spare parts and maintenance of the equipment .

27

Acquisition
 Evaluation and procurement are two main aspects of the acquisition phase.
 Evaluation process includes:
 Safety
 Performance
 and maintainability assessment of devices.
 In the procurement process, it is emphasized that the supplier must:
 Supply operating and service manuals
 Provide operation and service training
 Provide essential spare parts.

28

14
23/06/1443

 Delivery and Incoming Inspection

 Incoming devices should be checked carefully for possible
damages in the shipment process, conformity with the purchase
order, and all required accessories, spares, and documents.
 Inventory and Documentation
 Inventory and documentation are important aspects of equipment
management and standardization
 Inventory entries should include:
 all accessories,

 spares,

 and manuals of each device.

29

 Installation, Commissioning and Acceptance

 In-house technical staff or the suppliers can perform
installation and commissioning stage.
 In the latter, in-house staff should monitor the process and
record it in the equipment service history.
 Training of Users and Operators
 Proper training of users and operators assures effectiveness
and safety of medical devices, and decreases maintenance
errors.

30

15
23/06/1443

 Monitoring of Use and Performance

 In-house technical staff should act as alink between user and supplier
and monitor the supplier’s technical services.
 Maintenance
 Medical equipment must always be maintained in working condition,
and calibrated periodically for safety and accuracy.
 Replacement and Disposal
 When a medical device is old and its spares run out of supplies, it
should be replaced and disposed according to the safety procedures

31

Why Equipment Maintenance

1. Demand for improved diagnostic facilities.
2. Sophisticated equipment with modern technology.
3. Spectacular progress in development in surgical procedures.
4. Patients expecting high quality care.
5. Introduction of computer technology and Roberts in medical field
6. Medical equipment is used for the specific purposes of diagnosis and treatment of
disease or rehabilitation.
7. Medical devices are assets that directly affect human lives.
8. They are considerable costly investments.
9. Equipment maintenance programme keep the medical equipment in a reliable,
safe and available for use when it is needed , Such a programme prolongs the useful
life of the equipment and cost effective

32

16
23/06/1443

Objective of Maintenance
 Objective of Maintenance
1. To optimize utilization to obtain maximum return for capital invested.
2. Cost efficiency/cost effectiveness.
3. Better utilization results in quick ‘Break-even point’ .
4. Optimal patient handling and rapid turn over minimises cost.
5. Quality patient care and satisfaction.
6. Patient as well as user Safety

33

Scope of Maintenance
 Planning and implementation of a programme of planned preventive
maintenance in r/o all the facilities / services under their responsibility.
 Ensuring that all the facilities, systems and services under the scope of
engineering services are well maintained and kept in a state of optimum
operational efficiency.
 Maintaining an up-to-date inventory of all the equipment available and their
distribution on the hospital.
 Maintaining an up-to-date history sheet for each and every / equipment unit in
the hospital.
 Anticipating the requirement of commonly.

34

17
23/06/1443

Scope of Maintenance
 required spares and arranging for their adequate stocking.
 6. Ensuring that break down maintenance is prompt enough to ensure
uninterrupted services. This, however, does not include sophisticated /
electronic equipment that should be better handled under the arrangement by
suppliers.
 7. Ensuring that the facilities / services coming under their scope are safe and
hazard free.

35

EQUIPMENT MAINTENANCE PROGRAM

 Equipment maintenance program starts from Procurement and ends at

Condemnation and disposal

Procurement EQUIPMENT Condemnation

MAINTENANCE

36

18
23/06/1443

EQUIPMENT MANAGEMENT SYSTEM

1. Organization
2. Inventory
3. Selection and acquisition
4. Installation
5. Calibration/validation( initial and on going)
6. Maintenance
7. Trouble suiting
8. Service and repair
9. Computer soft ware
10.Condemnation and disposal
37

EQUIPMENT SELECTION CRITERIA

 Need assessment .
 Use co-efficient.
 Specifications not brand.
 CIF(cost,ensurance and freight) destination.
 Installation on turn key basis .
 Warranty with spares.
 Continuous supply of consumables.
 Service contracts/ after sales services.
 Training of staff .
 Preparation/selection of site.
 Power supply back up .
 Good economics.
 Supplies selection and purchase procedures 38

19
23/06/1443

EQUIPMENT SELECTION CRITERIA

1. Utilization index
 Parameter to asses the productivity of service of an equipment
 2.Use co-efficient index
 Use co-efficient= N/M x 100
N=average no. of hours the equipment is used per day
M= Max no. of hours the equipment can be used per day
>50% considered to be under utilized

39

COMPONENTS OF A MAINTENANCE PROGRAMME

Component of Maintenance programme:
 Corrective Maintenance .
 IPM maintenance: Inspection and Preventive maintenance

Maintenance

Corrective
IPM
maintenance

Inspection

Preventive
maintenance 40

20
23/06/1443

COMPONENTS OF A MAINTENANCE PROGRAMME…

 maintenance strategy includes procedures for inspection, as well as preventive
and corrective maintenance.
 Inspections ensure that equipment is operating correctly, Safety inspections
ensure the equipment is safe for both patients and operators,
 Preventive maintenance (PM) aims to extend the life of the equipment and
reduce failure rates.
 Corrective maintenance (CM) restores the function of a failed device and
allows it to be put back into service.

41

Preventive and Corrective maintenance

 Preventive maintenance
 Work which is carried out regularly to ensure continued functioning.
This includes cleaning and exchange of consumables or replacing
parts when necessary in order to prevent a breakdown.

 Corrective maintenance:
Work which is carried out in order to repair an item of equipment which
has malfunctioned.

21
23/06/1443

COMPONENTS OF A MAINTENANCE PROGRAMME …

 An effective medical equipment maintenance programme

consists of :
 Planning
 Management
 Implementation

43

COMPONENTS OF A MAINTENANCE
PROGRAMME
 Planning
 It considers the financial, physical and human resources required to adequately
implement the maintenance activities.
 Management
 Once the programme has been defined, financial, personnel and operational
aspects are continually examined and managed to ensure the programme continues
uninterrupted and improves as necessary.
 Implementation
 Ultimately, proper implementation of the programme is key to ensuring optimal
equipment functionality.

44

22
23/06/1443

PLANNING

PLANNING

INVENTORY RESOURCES METHODS

• Contracts with device • Financial resources
• Equipments to be include
manufacturers • Manpower resources
in the maintenance
• Independent service • Physical resources,
programme
organizations(ISOs)
• A combination of both 45

FINANCIAL RESOURCES
INITIAL COSTS OPERATING COSTS
• Physical resources • Space, tools , test • Operation, utilities,
equipment,, computer maintenance,
resources,. vehicles calibration.
• Human Recruiting • Recruiting , initial • Salaries, benefits,
training resources. turnover,
continuing education
• Direct maintenance • NA • Service contracts,
parts and materials,
travel, shipping.

46

23
23/06/1443

PHYSICAL RESOURCES
 1)Setting Up Workshop
 Equipment cannot be effectively maintained in the health structure(s).
This would get in the way of the medical activities and the technician
is unlikely to be able to work effectively.
 A workshop is therefore needed. Due to the sensitive nature of
biomedical equipment the workshop facilities should be free of dust, as
cool and dry as possible, and must be easy to keep clean.
Similar conditions to those in the health structure where it is used
would be ideal.

47

PHYSICAL RESOURCES
 1) Setting Up Workshop
 The workshop should preferably be located close to the health structure,
ideally in the same building. This is for a number of reasons:
 The biomedical technician can respond more quickly to any problems
reported.
 The equipment does not have to be transported far, or be exposed
to rain or dust. Biomedical equipment is sensitive to heat, dust, and
moisture, it can also sometimes be large or heavy.
 The biomedical technician is better able to monitor the care and
cleaning follow‐-up and coach the medical staff where needed.
48

24
23/06/1443

PHYSICAL RESOURCES
 1) Setting Up Workshop
 The biomed technician will be able to spend more time in the health
structure and be able to see and hear the equipment working well.
This makes it easier to recognize potential problems or trace faults.
 The proximity will strengthen communication between the medical
services and the biomedical service, helping it become better
integrated as part of the team.

49

PHYSICAL RESOURCES
 1) Setting Up Workshop
 The size of the workshop depends on the quantity and type of
equipment on the project.
 The maintenance schedule will give you an idea of the quantity of
equipment you will need to service, and how often. Allow additional
space for administration files

 The workshop must have a stabilised and protected source

of electricity, and preferably a water supply.

50

25
23/06/1443

PHYSICAL RESOURCES
 2) TOOLS AND TEST EQUIPMENT
 Tools and test equipment commonly needed are listed below.
 Basic tools :
 Set of metric spanners (open‐-ended and ring) sizes 5mm ‐to 17mm
 Socket set (1/4" set) with sockets sizes 5mm ‐to 17mm
 Set of bits with wrench, full set of Torx and Hex head (Allen) bits
 Set of electricians screwdrivers (insulated), flat blade, Phillips and Posidriv
 Set of various electricians pliers and cutters (insulated)
 Stanley knife
 Soldering iron (with stand)
 Solder pump or desoldering braid (to remove old solder)
 Set of soft paint brushes for dislodging dust
 Source of compressed air for blowing dust (aerosol cans for low use, compressor for
more frequent use) 51

2) TOOLS AND TEST EQUIPMENT

 Basic test equipment:

 Oxygen flow and concentration meter( Oxygen
Analyzer)
 Digital multi‐meter
 Stopwatch (for testing syringe pump)
 5 liter plastic bucket and silicon tubing (for testing suction pumps)
 Other tools or test equipment may be needed for certain items of equipment.
Check the manuals of the equipment for details of these

52

26
23/06/1443

TOOLS AND TEST EQUIPMENT

 Set of metric spanners (open‐-ended and ring) sizes 5mm ‐to
17mm.

53

TOOLS AND TEST EQUIPMENT

 Socket set (1/4" set) with sockets sizes 5mm ‐to 17mm

54

27
23/06/1443

TOOLS AND TEST EQUIPMENT

 Set of bits with wrench, full
set of Torx and Hex head
(Allen) bits

55

TOOLS AND TEST EQUIPMENT

 Set of electricians
screwdrivers (insulated),
flat blade, Phillips and
Posidriv

56

28
23/06/1443

TOOLS AND TEST EQUIPMENT

 Set of various electricians pliers and cutters (insulated)
 Stanley knife

57

TOOLS AND TEST EQUIPMENT

Soldering iron (with stand)

 Solder pump or desoldering braid (to

remove old solder)
58

29
23/06/1443

TOOLS AND TEST EQUIPMENT

Set of soft paint brushes for dislodging dust

59

2) TOOLS AND TEST EQUIPMENT

Oxygen flow and concentration

meter. ( Oxygen Analyzer)
Digital multi‐meter

60

30
23/06/1443

2) TOOLS AND TEST EQUIPMENT

Stopwatch (for testing syringe pump)

5 liter plastic bucket and silicon tubing (for testing suction
pumps)

61

PHYSICAL RESOURCES
1. I)WORKSPACE
 It includes work benches and storage space for tools and test
equipment, repair parts and supplies, and equipment awaiting repair.
 It also includes space for records and documentation, service and
operator manuals, and access to whatever computer resources are
required.
 Inclusion of computer resources in the workspace is also important to
consider.
 Basic documentation may be maintained with paper records
 The use of a computer spreadsheet, database programme, or
computerized maintenance management system (CMMS)
62

31
23/06/1443

PHYSICAL RESOURCES
 2) TOOLS AND TEST EQUIPMENT
 Investment in tools and test equipment results in reduced
maintenance costs. Increase the reliability of the readings, the
accuracy of the calibrations, and the margin of safety for the
patients and staff, Basic test equipment includes a
physiological simulator, safety analyser and some basic tools.

63

PHYSICAL RESOURCES
 3) SUPPLIES
 Cleaning and lubricating supplies, need to be acquired in
sufficient quantities.
 The manufacturers’ service manuals give cautions about using
the wrong cleaning agents, which can damage labeling and
the plastic surfaces of some equipment.

64

32
23/06/1443

PHYSICAL RESOURCES
 4) SPARE PARTS
 Some times, it may be possible to forecast in advance what
parts need to be replaced and how often.
 By referring to the manufacturer’s guidelines. the problem of
obtaining replacement parts at a reasonable cost and in a
timely manner can be possible .

65

PHYSICAL RESOURCES
 5) OPERATION AND SERVICE MANUALS
 Ideally, the maintenance programm will have an operation
(user) manual and a service manual for each model of medical
equipment. For donated equipment, when manuals have not
been provided and due to the age or type of equipment are
impossible to access, the experience of the staff will be the
primary resource

66

33
23/06/1443

HUMAN RESOURCES
PERSONNEL SPECIALITY FUNCTION
• Engineer • Biomedical engineer, or clinical engineer • Management, specialized
,Other related fields (e.g. electrical engineer, maintenance, supervision of
mechanical engineer . external service provider, needs
assessment,, planning, and user
training.
• Technician • Biomedical equipment technicians. Other • Primary focus on specialized
related fields (e.g electrical or medical. medical equipment repair and
technologist, polyvalent technician) maintenance. and repair of less
complex equipment.
• It is important that they receive
specialized training for high-
risk medical devices.
• Service Provider • Engineer or technician • Provide maintenance that
cannot be performed house.
They are product-oriented and
specialized in a certain field.
• Engineering • MBA/PGDMA • Provide leadership for the
programme staff maintenance management 67

MANAGEMENT
FINANCIAL
MANAGEMENT

PERSONNEL Operational
MANAGEMENT MANAGEMENT

Performance Performance
Improvement Monitoring

68

34
23/06/1443

FINANCIAL MANAGEMENT
1) Financial management for a maintenance programme focuses primarily on
two tasks:
 Monitoring costs
 Managing the budget.
 Costs are monitored by accurately documenting all of the time and expenses
associated with maintenance activities.
2. 2.PERSONNEL MANAGEMENT
 The purpose of personnel management is to provide support to the maintenance
programme's human resources so that programm objectives are achieved.
 Work assignments should be made to match the skills of the technical personnel
and to promote efficiency.

69

A. SERVICE VENDORS
 It is often not possible to provide all maintenance services in
house. In such circumstances, it may be necessary to make use
of external service providers for a significant portion of the
maintenance activities. There are generally two categories of
external service providers:
 Equipment manufacturers
 Independent service organizations

70

35
23/06/1443

B.SERVICE CONTRACT
• TYPE OF • FREQUENCY
SERVICE
• AMC • Internal staff provides initial response. • Fixed charge Only service
External staff follows up as and when provided . Renewed every
required. At least four visits a year year

• CMC • Varying response time available as • CMC charges Service,

needed minor spares and
consumables free
• Full service with • Quick response available at times for • Fixed Charge Parts to be
parts maintenance repair provided on payment
(WARRANTY) 5
to 10 years
• Engineering • MBA/PGDMA • Provide leadership for the
programm staff maintenance management
71

C. TRAINING
 For the safety of the patient and the user, proper training is critical for both
the user and the technical staff.
 Self-study:
 reading the equipment service and training manuals;
 using additional self-study materials provided by the manufacturer;
 using materials provided by a third party.
 One-to-one training provided by a more experienced person from inside the
organization
 Manufacturer’s training programs
 specifically designed for equipment technicians and provided by the Indian agent.

72

36
23/06/1443

3)OPERATIONAL MANAGEMENT
IPM
FREQUENCY

SOPs PRIORITIZATION

USE
OPERATIONAL AND
MANAGEMENT USER
COMMUNICATION ERROR

LOG
BOOK
CMMS.
73

3)OPERATIONAL MANAGEMENT
 1) SOPs
 Procedures are either selected or written
 Be well designed and easy to understand.
 Clearly explain every step in the procedure.
 Explain what test equipment is required.
 Explain what the upper and lower limits for measurements the biomedical
equipment technician will take.
 Show how to replace parts.
 Explain the required frequency of specific steps.
 Provide recommended forms to be used for the IPM procedure.
 Be provided in the predominant major language of the region/country.
74

37
23/06/1443

3)OPERATIONAL MANAGEMENT

 2) Setting IPM frequency

 The frequency of IPM is specified by the manufacturer of the
equipment
 Period should be specified like Daily, Weekly, Monthly, Quarterly or
Annually.
 3)Prioritization of work
 It is better to carefully identify the equipment in the health-care facility
that is the most important to inspect and maintain, and schedule this
work as a priority.
75

3)OPERATIONAL MANAGEMENT

 4.Keeping records( Log book)

 Identification number for the equipment The record for each device
should include identifying data such as a brief description,
manufacturer, model, serial number, Installation site, date of
procurement and cost Data regarding the time and expense of
providing scheduled and unscheduled maintenance services for the
device and cost incurred.
 Cumulative expenditure on maintenance and repair.

76

38
23/06/1443

3)OPERATIONAL MANAGEMENT

 5) CMMS.
 Thus, a computerized maintenance management system (CMMS) helps by:-
 •Keep track of past service events (e.g. IPM, CM, recalls, software updates etc.)
and retrieve or print them if needed.
 • Store IPM procedures and related information.
 • Schedule IPM procedures, change the schedule of IPM procedures and print a
summary list of what has been scheduled.

77

CMMS

 Print individual IPM forms with the appropriate procedure, the past few service
events (for reference), and the expected IPM completion date/ time
 • Record and store the results of the IPM inspection procedures including tasks that
passed or failed, the measurements taken and the acceptable range of measured
values.
 • Record the CM activity including the problem with the device, time spent in the
repair process, a description of the work done and the list of parts used.

78

39
23/06/1443

 Produce summary reports of:

1. IPM completion rates;
2. IPM that failed and required repair work;
3. IPM actual versus expected completion times;
4. Inventory lists of equipment by 30 Medical equipment maintenance
programm overview location, owner or device type;
5. Repairs completed in a certain time period;
6. List of parts used to repair equipment over a certain time period.

79

6.Communication
 The ultimate objective of a maintenance programming is to improve patient
care, there fore,
 It is essential to develop strong working relationships with clinicians and to
understand their needs
 Take maintenance work according to their convenience.
 Send schedule of maintenance well in advance to departments.

80

40
23/06/1443

7.Managing use and user error

 7.Managing use and user error
 A user may be unable to meet this objective due to ‘use error’, a problem
related to the use of a medical device which may be
 -fault in the machine
 -users incompetence. .
 The root cause of user error to be identified and corrected.

81

4.PERFORMANCE MONITORING
 1.Performance measures
 Mean time between failures. The average time elapsed between
failures.
 Repeated failures. The number of failures within a specified period of
time. Response time. The time between a request for service and the
start of repair.
 Repair time. The time between the start and finish of repair.
 Downtime. The percentage of time that a device is out of service.
 Delinquent work orders. Work orders not completed within 30 days

82

41
23/06/1443

 Performance improvement
1) Always identify opportunities for improvement by careful and
thorough performance monitoring
2) Identify best practices. These are actions that have been recognized
within the profession as leading to improved performance.
3) Improve performance. Performance improvement projects should
be based on best practices.
4) The aspect of performance selected for improvement should be
closely monitored until the desired level of performance is achieved.

83

5. IMPLEMENTATION
 A. Inspection and preventive maintenance
 Most IPM procedures are completed by technical personnel from the
clinical engineering department.
 In some cases, however, routine and easy to perform tasks are
completed by the user.
 The type of inspection the user might perform would be pre-use or
daily checks, where required.
 Examples of this might be daily calibration of portable blood glucose
monitors, daily testing of defibrillators or checking the standard
calibration of laboratory equipment.
84

42
23/06/1443

5. IMPLEMENTATION
 A. Inspection and preventive maintenance
 If the IPM activities or related repairs are not accomplished in
a certain pre-defined period, by the authorised agent the
work order should be left open and the staff should inspect or
repair the device as soon as reasonably possible.

85

5. IMPLEMENTATION
 B) Corrective maintenance
1. Component level. Component-level troubleshooting and repair isolates the
failure to a single, replaceable component. In electrical devices, mechanical
devices, and for discreet Board level.
2. For electronic devices, it is common to isolate failures to a particular circuit
board and to replace the entire circuit board rather than a given electronic
component.
3. Device or system level. In some cases even board-level troubleshooting and
repair is too difficult or time consuming.
4. In such cases it can be more cost-effective to replace the entire device or
subsystem.
86

43
23/06/1443

5. IMPLEMENTATION
 C). Environmental factors
1) Electricity failure, short circuit, high voltage
2) AC failure
3) Inadequate water supply.
 D. Reporting
1) For IPM activities, the technician typically has a detailed checklist to follow in
order to record the results.
2) Having such a checklist also serves as a reminder of each step in the IPM
process and thus helps avoid skipping or overlooking specific steps.

87

5. IMPLEMENTATION
 E. Safety
 There are various safety aspects to consider when implementing a
successful and effective maintenance programing
 The safety of technical personnel while performing maintenance
 Safety of the user following maintenance
 Safety of the Patient
 Infection spread.
 It is preferable to have PPE readily available within the clinical
engineering department for hazardous maintenance.
 Lastly, when working in the clinical environment, technical personnel
should be aware of infection control risks that they might encounter.
88

44
23/06/1443

CONSTRAINTS IN MANAGEMENT
 Inadequate training of staff
 Equipment installed on turn key basis so that staff can not do
preventive maintenance
 After sales services by supplier is not satisfactory
 Facility for back up power supply some times inadequate
 Time scheduling of the hospital prevent 24x7 utilization of
equipment
 Poor Use co-efficient
 Awareness of the facility to patients sometimes lacking
 Utilization of the special facility or skill requires staff motivation
and cost to the patient
89

CONDEMNATION
 Completed Life time( 7 to 10 years) Electronic equipments.
 Beyond economic repair (BER)
 Non functional and obsolete
 Functional and obsolete
 Functional but hazardous
 Procedure/ documents required for condemnation
 1. History sheet
 2. Recommendation of Maintenance Committee.
 3. Condemnation committee recommendation to HOD.
 4. Approval of competent authority for disposal and right off.

90

45
23/06/1443

Planned maintenance work

91

Planned maintenance work

 All equipment is made up of various parts – moving and non-
moving, active and passive.
 At any time during the life of the equipment,
these parts can fail due to wear and tear.

 Thus, it is very important to give regular attention to the

equipment through planned preventive maintenance (PPM)
and corrective maintenance (repair).

46
23/06/1443

Planned maintenance work

 Planned preventive maintenance
 Work which is carried out regularly to ensure continued functioning.
This includes cleaning and exchange of consumables or replacing
parts when necessary in order to prevent a breakdown.

 Corrective maintenance:
Work which is carried out in order to repair an item of equipment which
has malfunctioned.

PLAN MAINTENANCE WORK

 Why is This Important?
 You need to prioritize how best to respond to the wide range of maintenance
and repair requests, with the resources available to you.
 You also need to decide how best to use the skills
available within your health service provider
organizationh.

47
23/06/1443

PLAN MAINTENANCE WORK

 Planned work
is arranged by the HTM Manager at facility or workshop level,
and includes regular servicing, rehabilitation, and planned
preventive maintenance (PPM) tasks.
 Unplanned work
Occurs in response to equipment user demands and includes
breakdown and emergency repairs.

PLAN MAINTENANCE WORK

 Some maintenance and repair tasks can be undertaken quickly and don’t affect
the work of the user department.
 More complicated tasks require the complete shutdown
of the equipment and therefore cause a temporary halt
to the services provided by the user department.

 With such a range of tasks, it is useful to prioritize your work. During the
initial setting up of maintenance services and for periods of heavy commitment
 the way you plan your maintenance and repair work can be organized
according to how important the equipment is for clinical operations.

48
23/06/1443

Prioritize your work

 For example, one suggestion is to concentrate on:

plant covering medical equipment covering

Sterilization operating theatres (suction pumps, etc)
electricity supply (including the generator) syringes

water supply Anaesthetics

laundry basic laboratory (microscope, etc)
Refrigeration ultrasound (maternal/obstetric)
kitchen X-ray departments
steam for heating labour/delivery
sewage and sanitation installations basic diagnostics (BP machines, etc)

cooling/air-conditioning (if climate is very hot)

Prioritize your work…

 Contrary to popular belief , sophisticated and electronic medical
equipment is not always the most important to maintain.
 In terms of patient care and comfort, items such as sufficient
water, power generation for operating theatres, effective
sterilizers, and good beds are of greater importance than ECG or
X-ray machines.

49
23/06/1443

Quiz
 Q1 ……..is undertaken when equipment has broken down,
and is required to return the equipment to a working condition.
 preventive maintenance
 Unplanned work

 corrective maintenance

 Planned work

 Q2 ……..is work undertaken to try and retain equipment in a working and safe
condition and prevent it from breaking down or becoming a hazard.
 preventive maintenance
 Unplanned work

 corrective maintenance

 Planned work

Planned Preventive Maintenance(PPM)

 PPM is important because it enables the maintenance department to:
 ◆ catch any problems before they become critical.
 ◆ Prevent breakdowns
 ◆ Save money, as PPM is cheaper than repairs following breakdowns
 ◆ Make sure that equipment is fully operational
 ◆ Guarantee accuracy and reliability (the autoclave sterilizes, the
laboratory results are correct, etc)
 ◆ Increase the availability of equipment and reduce down-time
 ◆ Extend the life-span of equipment
 ◆ Reduce equipment running costs.
 ◆ Ensure the equipment is safe, for patients, users, and maintenance staff.

50
23/06/1443

Planned Preventive Maintenance(PPM)

 There may be three levels of tasks that can be undertaken by different
types of staff:
 ◆ The simpler duties – performed by the users of the equipment, if they
are adequately trained.
 ◆ The bulk of the work–performed by in-house maintainers with a
basic training.
 ◆ More complex work – has to be done:
 by specialized maintenance personnel. This may be in-house maintainers
 OR, in the case of some sophisticated equipment, may involve staff from
the manufacturer
 OR service agent under contract.

Planned Preventive Maintenance(PPM)

 PPM schedules (protocols, or lists of activities) need to be developed
separately for both users and maintainers.
 They should provide simple guidelines for all types of equipment,
covering the tasks to be undertaken in the following areas:
 ◆ Care and cleaning.
 ◆ Safety procedures.
 ◆ Functional and performance checks.
 ◆ Maintenance tasks.

51
23/06/1443

Example of Maintainer PPM Instructions for Infant

Incubators
 Note: these instructions assume that the equipment
users are undertaking
the necessary daily PPM tasks.
 Every six months
 ◆ Check the physical condition of the power cord,
connectors, and plugs.
 ◆ Check the integrity of the electrical grounding of the
unit.
 ◆ Check the mechanical integrity of controls and
switches.
 ◆ Inspect the condition of the oxygen and air inputs.
103

Example of Maintainer PPM Instructions for Infant

Incubators
 Every six months
 ◆ ◆ Check the water level gauge and inspect the
distilled-water compartment.
 ◆ Clean or replace the water and air filters.
 ◆ Check the temperature indicator and thermometers,
according to the
 manufacturer’s specifications.
 ◆ Check the over-temperature cut-off alarm.
 ◆ Check the power failure alarm.
 ◆ Check the fan failure alarm.
104

52
23/06/1443

Example Timetable of PPM for Maintainers in Wall

Calendar Format

105

Example of Maintainer PPM Instructions for Infant

Incubators
 Every six months
 ◆ Check the operation of the unit. Warm up the unit to a
temperature setting on the temperature control,
 and check the temperature reached with an external
thermometer.
 ◆ Check the canopy for any breakages.
 ◆ Clean the inside and outside of the unit, according to the
manufacturer’s instructions.

106

53
23/06/1443

REPAIRS/CORRECTIVE MAINTENANCE
 Types of Problem
 Equipment users must be required to report faults and breakdowns promptly.
 Many of these will be emergencies, which must be attended to as quickly as
possible in order to avoid serious consequences to the equipment or its
environment (for example, a boiler explosion, a disintegrating engine piston,
the collapse of a wall).

107

REPAIRS/CORRECTIVE MAINTENANCE
 Types of Problem
 If there is no back-up equipment, a breakdown will mean that the service the
equipment was providing will come to a halt.
 For example, it may mean that the health facility:
 ◆ has no water, due to a broken pump
 ◆ cannot fill teeth, due to a broken dental drill or compressor
 ◆ cannot confirm a diagnosis, due to broken laboratory equipment.


108

54
23/06/1443

REPAIRS/CORRECTIVE MAINTENANCE
 Types of Problem
 For reported faults, it may be possible to correct the problem while the
equipment is still in use. This is known as running maintenance.
 On the other hand, the equipment might have to be taken out of service.
 This is known as shutdown maintenance, and again requires the work of the
user department to be suspended.

109

REPAIRS/CORRECTIVE MAINTENANCE
 Types of Problem
 Some equipment can be Repaird in situ while the maintainer is present at the
 health facility. Examples include:
 ◆ large installed items which cannot be moved (such as a laundry roller-ironer)
 ◆ items with a simple problem that can easily be fixed
 ◆ items for which the maintainer has tools and spare parts with him
 ◆ items that don’t need a special environment (such as an anti-static,
electronically
 clean room)
 ◆ jobs that won’t be too messy (don’t produce large quantities of oil or
material debris, for example). 110

55
23/06/1443

Keep a Record of
Maintenance Work
 Why is This Important?
 In order to manage your equipment effectively, you need
information about it
– it is very difficult to manage an unknown.
 Keeping records of your equipment, and all maintenance work
can give a complete history of each device.
 File your records according to equipment family,
and subdivide (tab‐sheet or separate folder) for each machine.
 This way you can quickly find the complete record for each
machine.

Record Keeping
 For each machine you should have a collection of the following
forms:
1. Equipment ID sheet.
2. Maintenance checklist for each preventive maintenance done.
3. Repair sheets recording any repair work done.
4. Cleaning follow‐-up sheets
5. Any other relevant documents for that specific machine
(photo's, receipt copies, etc).

56
23/06/1443

Information gathered on the equipment

inventory record sheet
 date inventory taken
 ◆ facility, department, section,
 and location/room
 ◆ type of equipment
 ◆ inventory code number (your own number)
 ◆ name of manufacturer
 ◆ model name and/or number
 ◆ manufacturer’s serial number
 (factory number)
 year made or bought
 ◆ supplier bought from
 ◆ status/condition
 ◆ your property or leased

113

Information gathered on the equipment

inventory record sheet
 date inventory taken
 ◆ facility, department, section,
 and location/room
 ◆ type of equipment
 ◆ inventory code number (your own number)
 ◆ name of manufacturer
 ◆ model name and/or number
 ◆ manufacturer’s serial number
 (factory number)
 year made or bought
 ◆ supplier bought from
 ◆ status/condition
 ◆ your property or leased

114

57
23/06/1443

Additional information to keep – usually in the

service history file
 address of the manufacturer and local agents
 ◆ address of the supplier and local representative
 ◆ technical ratings
 ◆ date when the warranty expires
 ◆ price paid
 ◆ any external funding agency involved
 ◆ stocks of consumables, accessories, and spare
 parts received
 ◆ results of inspection tests undertaken on
 commissioning
 ◆ frequency of planned preventive maintenance
 required
 ◆ details of any maintenance contract and
 maintenance contractor
 ◆ maintenance history 115

Order Calculation And Ordering

 Aside from equipment orders you will have to make regular orders
for consumable and spare parts. There are a number of sources of
information to help you define which parts you need for each item
of equipment, and how many.
 Manufacturer's documentation often provides lists of parts with a
manufacturer's part number

58
23/06/1443

Order Calculation And Ordering

 For example:
You have 10 oxygen concentrators. Each is serviced every 3
months and requires a new air filter at this time. Every year the
anti‐bacterial filter must be changed: ‐

The order for 1 year will be :

10*4*1=40 air filters, and 10*1*1=10 antibacterial filters.

Organizing Stocks And Storage Requirements

 The stocks you will have to consider for biomedical equipment fall into
three main categories and their storage is best arranged to have the best
accessibility for those who need it.

The categories are:
1. Consumables
2. Spare parts
3. Back up equipment

59
23/06/1443

Organizing Stocks And Storage Requirements

 1. Consumables
 are the various parts which need changing between each
patient, or periodically .
 The medical staff is in charge of some of these tasks.
 Examples of medical consumables are humidifiers and foam pre‐filters for
oxygen concentrators, sensors for the pulse Oxymeters, mouth‐pieces for
anesthesia ventilators etc.
 Other consumables are used by the (logistic staff) biomedical technician during
routine maintenance work. This includes chassis filters for oxygen concentrators,
anti‐bacterial filter for the mucositis suction pump, etc.

Organizing Stocks And Storage Requirements

 2. Spare parts:
 are replacement parts which are needed by the biomedical technician to
repair equipment,
either after discovering a problem during routine maintenance, or as a
result of equipment failure.
 This includes everything from valves, gaskets and seals, to electronic
and power supply components.

60
23/06/1443

Organizing Stocks And Storage Requirements

 3. Back up equipment
 Back up equipment is all items of equipment which are kept in stock to
replace damaged or failed in the health structure.
 Storage requirements for all items are basically the same.
 As they are often made from (or contain parts which are made from a
variety of plastics and rubber, contain precision mechanical parts, or
they have electronic components the conditions in any storage area must
prevent the components degrading before they can be used.
 Degradation is caused by heat, humidity and dust.

Organizing Stocks And Storage Requirements

 The manufacturer’s documentation will give specific
requirements for each device but as a general rule the
suggested storage conditions for the majority of items are :
 Temperature <30ºC
 Humidity <85% non‐-condensing
 Dust‐-free

61
23/06/1443

Organizing Stocks And Storage Requirements

 Be aware that if you move equipment from an
air‐conditioned storage area to a hot or humid working
environment you should leave it for 10 minutes or so
to avoid condensation forming on electronics. This
could damage the equipment.

REPAIRING & RETURNING

124

62
23/06/1443

Assessing The Fault and Option for Repair

125

Assessing The Fault and Option for Repair

 The biomedical technician will do an assessment using the fault finding help in the
manufacturer's documentation and give try to identify the fault.
 Essential points for maintenance are:
1. A physical check of the condition of the equipment.
check power cords, tubes and attachment points, cables etc.
2. Functional check of the equipment.
 Check if the equipment switches on correctly,
 that any controls (buttons, dials, switches etc) are functioning according
to the description in the user manual,
 and that any audible (beeps) or visual
(lights) alarms can be triggered.

63
23/06/1443

Assessing The Fault and Option for Repair

3. Clean the equipment thoroughly.
Remove accessories or covers to carefully remove any dust or debris
that may have collected.
it is preferable to do this with compressed air as this reduces the risk of
damage by direct contact with sensitive parts.

4. Condition rechargeable batteries if fitted.

Over a period of time these batteries will loose their capacity to hold
a charge and so the autonomy of the equipment will be reduced.

Signaling and Equipment Failure

 Medical ward staff (nurses) will usually be the ones who discover a device
failure as they are the ones using it and responsible for care and cleaning.
Before reporting it they must confirm that the device has actually failed by
cleaning the device and changing batteries (if applicable) or cables.
if the problem is not solved then the nurse will inform the Supervisor and
together they must fill ‐in the intervention request form provided. Two
copies should be made, one to be kept in the ward and the other should
be given to the biomedical technician. The description of the fault must
be as complete as possible to help the biomedical technician identify the
probable cause.

128

64
23/06/1443

Signaling and Equipment Failure

 Equipment which is not functioning correctly must be removed from
active use until it has been successfully Repaird and the correct
functioning has been confirmed. This avoids the risk of accidental
use by other staff who are not aware of the fault.

129

Signaling and Equipment Failure

 The medical supervisor and the biomedical technician should discuss
whether a temporary replacement is needed. This will depend on the impact the
failure has on the medical services. if there are sufficient devices,
 alternative equipment available, or alternative medical procedures which
can be used then there is probably no need for temporary replacement. if
there is a back‐up device available (and needed) the biomedical technician
should install that for the duration of the repair. The biomedical technician will
then conduct a full assessment to decide the course of action for repair

130

65
23/06/1443

Signaling and Equipment Failure

 The biomedical technician must first take a repair form and fill ‐in the
information on the location and equipment type. This document ensures
that there will be a record of the repair work.
The biomedical technician will do an assessment using the fault finding help in
the manufacturer's documentation and give try to identify the fault.

131

Fault Finding Steps:

 if you remove any parts be sure to make notes and take pictures of the
disassembly method. Keep fasteners (screws bolts etc) in bags (medication
bags from the dispensary are great for this!) and label them so they do not
get lost. it can be useful to have a box to keep all the removed parts in so
they stay together.

• Make notes (and maybe pictures too) of your observations as you

go through these points.
• These notes will be a useful reference later if you are not able to
complete the repair immediately.
132

66
23/06/1443

Fault Finding Steps:

 Ask questions of the medical staff member who reported the fault.
 Probably the fault description in the intervention request form is not
complete, or still raises questions. it could be useful to know if the
machine made any unusual noises before it failed, or if there were any
other indications or alarms shown in lights or on displays.
 Check the easiest things first.
 Without taking anything apart you can first check power cords, tubes
and attachment points, cables etc. for damage. Try exchanging the
cables and sensors with cables and sensors from other devices of
the same type which you know work.
Check the casing for cracks or signs of damage, from knocks or falls.
This could indicate that there could also be internal physical damage;
parts which have become disconnected or fragile components which
have cracked. 133

Fault Finding Steps:

 Before disassembling try starting the device.
 if nothing happens at all possibly the power supply is damaged.
This could be simply a blown fuse or it could be other components.
Any damaged components are likely to look burned and show black traces. if
the equipment starts then check for any alarms, or fault
messages if it has a screen or display. These can be checked with
the manufacturer's documentation.
 if the equipment starts but there are no alarms then listen for any
unusual noises or vibrations. Try using the different functions, a fault
may triggered by one of these. it is useful to know what equipment
normally sounds like so familiarise yourself with all the different items
of equipment when they are working normally.
134

67
23/06/1443

Fault Finding Steps:

 Open the device.
 Do not do this if it invalidates the warranty or if the equipment has
a service contract. Read the manufacturer's documentation before
removing covers. Pay attention to warnings and the disassembly
method. Do not force parts while disassembling, they can easily be
damaged.
Check for blocked vents, or dust or debris choking cooling fans, filters
etc and clean if needed. Check for damage to any internal tubes,
pipes or valves.
With the cover removed you can again start the machine and try the
different functions. Any unusual noises will be easier to localise and
you can also check for leaks or other indications of a fault. Be sure
to observe good safety practice and avoid contact with live electrical
parts. 135

Fault Finding Steps:

 Remember:
 To ensure the reliability of biomedical equipment it is
important that repairs are only attempted if the technician has
the skills and training to do the repair well. Badly Repaird
equipment can be more dangerous than broken equipment!

136

68
23/06/1443

Fault Finding Steps:

 if the fault can be identified then a decision needs to be taken on how the
repair can be done. The options could include:
 Repair on the project by the biomed technician.
 Repair externally by another contractor, either in the project location,
or the coordination.
 Return to the supply centre for repair by the manufacturer.
The document "Biomedical Référenciel" gives general advice on this.

137

Assessing The Fault and Option for REPAIR

Medical Device Repair
 In-hospital repair:
Repair by clinical engineers
 Out-of-hospital repair (outsourcing):
Repair outsourced to manufacturers and relevant
repair businesses.

69