Maintenance

of

Medical Equipment
Dr A Prakash
Sr Professor, Health Management
National Academy of Indian Railways
Lalbaug
Vadodara

OBJECTIVES

Highest level of availability of medical

equipment to the clinical users

Quality improvement & cost reduction

Applicable regulations & standards

Reduce the need of premature replacement of

the equipment

DEFINITIONS

FUNCTION

what the equipment is designed to do

PERFORMANCE STANDARDS

limits within which a function is considered acceptable to the user

but established by OEM when designing the equipment

FUNCTIONAL FAILURE

inability to fulfill a function to a performance standard acceptable to

the user
or to perform according to the original technical specification

FAILURE TYPES

EVIDENT FAILURE
that on its own eventually & inevitably becomes evident to the user
under normal circumstances

HIDDEN FAILURE
that will NOT become evident to the user under normal
circumstances if it occurs on its own

SEQUENTIAL FAILURE
when a protected function fails after the failure of a 'not fail-safe'
protective device goes undetected

FAILURE PATTERNS

Wear-out Failure Pattern

Normal distribution of failure frequency after MTBF. Age related
failure traditionally addressed by preventive maintenance &
scheduled replacement of parts.

Steady Increasing Failure Pattern

The probability of failure increases steadily with age. Common for
mechanical devices that wear out with time.

FAILURE PATTERNS

Random Failure Pattern

The probability of failure does not change with age but is constant
through out the life of the equipment. Typical of electronic
equipment.

Low Initial Failures Pattern

The probability of failures increase rapidly initially but becomes
constant after a short period of time. Bad quality machines.

FAILURE PATTERNS

Infant Mortality Failure Pattern

High probability of failure initially but becomes constant afterward.
Bad QC.

'Bathtub' Failure Pattern

Combination of Infant Mortality Failure Pattern & Wear-out Failure
Pattern

MAINTENANCE CATEGORIES

Proactive
Maintenance

Reactive
Maintenance

MAINTENANCE CATEGORIES

PROACTIVE

REACTIVE

Preventive Maintenance

Failure-finding Task

Scheduled replacement of
parts for age/usage related
deterioration
Predictive Maintenance
To check for potential
failure & action taken to
prevent functional failure

Periodic inspection to detect

Hidden Failures & Failure of
non-fail-safe protective
devices

ALL MAINTENANCE
MUST BE
TECHNICALLY
FEASIBLE & WORTH
DOING !

MAINTENANCE SERVICE TYPES

Equipment Acceptance

Operational Check

OC frequency High Risk-Each Use/Medium-Daily/Low-Weekly

Safety & Performance Inspection

To detect potential/hidden failures & includes Electrical Safety Test

Preventive Maintenance

Corrective Maintenance

Replacement

MAINTENANCE STRATEGIES

Replacement only

Repair or Replace

Scheduled Inspections

Non-sampled Inspections

Sampled Inspections

Full Service ( Scheduled PM)

MAINTENANCE STRATEGIES vs
SERVICE TYPES

Equipment Maintenance
Management Plan

WHAT TO INCLUDE ?

ECRI Method (1984)

RISK LEVEL

Function - therapy/diagnosis/monitoring

Application Risk injury/dangerous energy

Experience & General

SPECIAL REQUIREMENTS

Life Cycle Cost

Operational Difficulties

Standards & Regulations

ECRI Risk Levels

Life Support, Resuscitation, Critical Monitoring &

other devices whose failure or misuse is likely to
seriously injure the patient or staff

HIGH RISK

Devices including many diagnostic equipment whose

failure, misuse or absence would have significant
impact on patient care but is not likely to cause
serious direct injury

MEDIUM RISK

ECRI Method Implementation

Use Risk Levels & Special Requirements

Include all High & Medium and some Low Risk
devices in Maintenance Plan

Inspection Frequency

High Risk Twice a year

Medium Risk Annually

Low Risk Eliminate unnecessary inspections based on

experience

Fennigkoh & Smith Method

Also known as Risk Based Criteria

Equipment given a value Equipment
Management Number (EM)
EM = Function + Physical Risk + Maintenance
Requirements

Function

Therapeutic

Life Support ---------------------------------------------------- 10

Surgical & Intensive Care ----------------------------------- 9

Physical Therapy & Treatment

Diagnostic

Surgical & Intensive Care Monitoring --------------------- 7

Additional Physiological Monitoring & Diagnostic ------ 6

Analytical

Analytical Laboratory ------------------------------------------ 5

Laboratory Accessories --------------------------------------- 4

Computer & Related ------------------------------------------- 3

Miscellaneous Patient related & Others

---------------------------- 8

---------- 2

Physical Risk

Patient Death

Patient or Operator Injury

Inappropriate Therapy or Misdiagnosis

No significant injury

Maintenance Requirements

Extensive

Average

Minimal

Fennigkoh & Smith Method

Implementation

EM min = 4 & max = 20

If EM 12, the equipment is included in the
Maintenance Management Plan

Otherwise EXCLUDED

Excluded equipment is repaired as needed

Included equipment goes for preventive

maintenance monthly/quarterly/half
yearly/yearly as per EM value

Subsets of Equipments

Repair
PMPM

Use & Throw

ANOTHER WAY CLASSIFICATION

Mission

Critical

Patient

Risk

High

Medium

Low

Tier 1

Tier 1

Tier 1

EXAMPLES OF TIER SYSTEM

MISSION

CRITICAL

CRITICALITY IMPORTANT

PATIENT

RISK

HIGH

MEDIUM

LOW

Anaesth.
Machine,
Ventilator

Auto Chem
Analyser, CT,
MRI, Cath Lab

Electron
Microscope

PCA Pump,
Defibrillator,
Incubator

Infusion Pump,
ESU, ABG,
Monitors

Special
Procedure
Table

IMPLEMENTATION

Tier 1 Definitely SPI, Some for PM

PSI for need & frequency, PM for need

Tier 2 May require SPI or PM for operational

efficiency or quality of care

SPI for need & frequency analysis, PM cost effectiveness?

Tier 3 Record maintained for asset control or

replacement planning

Replace only for low cost, Repair or Replace the rest

MAINTENANCE SCHEDULING

THEORATICAL APPROACH

PM Period MTBF

SPI Period = 2 X (1 availability) X MTBF

PRACTICAL APPROACH

OEM Recommendation

Past Experience

Expert Openion

MAINTENANCE MONITORING

Total Maintenance Expense as % of Total

Inventory Acquisition Cost

Total Maintenance Expense / Pt. discharge or

Pt. Day

Total Maintenance Expense / Bed or Total

Operating Expenses

Total Uptime available

SUMMERY

OBSELENCE & REPLACEMENT

Replacement is not needed for a well working old
machine.
Changed safety standards
Changed work needs
Other machines of different designs
Lack of service from vender (explore OEM)
Lack of accessories
Post servicing certification/calibration not possible

Thank you
Questio

ns ?

email: prakash.nrch@gmail.com