assessment of medical equipment maintenance management

Assessment of medical equipment maintenance management: proposed checklist using Iranian experienceMorteza Arab‑Zozani1, Ali Imani2, Leila Doshmangir3, Koustuv Dalal4,5 and Rona Bahreini6*

Abstract

Background: Effective maintenance management of medical equipment is one of the major issues for quality of care, for providing cost‑effective health services and for saving scarce resources. This study aimed to develop a comprehensive checklist for assessing the medical equipment maintenance management (MEMM) in the Iranian hospitals.

Methods: This is a multi‑methods study. First, data related to factors which affect the assessment of MEMM were collected through a systematic review in PubMed, Pro‑Quest, Scopus, Embase, and web of science without any time limitation until October 2015, updated in June 2017. Then, we investigated these factors affecting using docu‑ment review and interviews with experts in the Iranian hospitals. In the end, the results of the first and second stages were combined using content analysis and the final checklist was developed in a two‑round Delphi.

Results: Using a combination of factors extracted from the systematic and qualita‑tive studies, the primary checklist was developed in the form of assessment checklists in seven dimensions. The final checklist includes 7 dimensions and 19 sub‑categories: “resources = 3,” “quality control = 3,” “information bank = 4,” “education = 1,” “service = 3,” “inspection and preventive maintenance = 2” and “design and implementation = 3.”

Conclusions: Developing an assessment checklist for MEMM provide a comprehen‑sive framework for the proper implementation of accurate assessment of medical equipment maintenance. This checklist can be used to improve the profitability of health facilities and the reliability of medical equipment. In addition, it is implicated in the decision‑making in support of selection, purchase, repair and maintenance of medical equipment, especially for capital equipment managers and medical engineers in hospitals and also for the assessment of this process.

Keywords: Hospital, Medical equipment, Medical devices, Maintenance management, Assessment

Open Access

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RESEARCH

Arab‑Zozani et al. BioMed Eng OnLine (2021) 20:49 https://doi.org/10.1186/s12938‑021‑00885‑5 BioMedical Engineering

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*Correspondence: [email protected] 6 Tabriz Health Services Management Research Center, Iranian Center of Excellence in Health Management, Student Research Committee, School of Management and Medical Informatics, Tabriz University of Medical Sciences, Tabriz, IranFull list of author information is available at the end of the article

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of 23Arab‑Zozani et al. BioMed Eng OnLine (2021) 20:49

BackgroundToday’s modern hospital is highly dependent on various types of medical equipment to assist in the diagnosis, monitoring and treatment of patients. It is impractical to provide health services without them [1, 2]. Medical equipment deals with patient care including ranging from small and simple devices to complex and big devices. This ranking can be found in different types of hospitals and primary care settings [3]. According to the stud-ies conducted in Iran, about one-third of the costs of setting up and equipping the hospi-tal is allocated for purchasing medical equipment [4]. Therefore, it should be maintained in good working condition and higher safety level to prevent from injuries occurred in patients as well as in users [5].

The maintenance of medical equipment is important for reducing dispatch costs, reducing patient dissatisfaction, timely patient treatment, and reducing mortality and risks during patients care [4]. It is an integral part of the life cycle of the device. Usually, much more money is spent on maintaining equipment over than on its procurement [6]. Maintenance is defined as any action which helps hospitals to provide an adequate level of service and to protect or promote the performance of their equipment to operate regularly and efficiently. Therefore, maintenance management is a fundamental aspect of hospital management [7].

Good maintenance management to have well planned and implemented programs that hospitals can minimize breakdowns or failures of the medical device. This is par-ticularly critical in developing countries for providing good healthcare services and sav-ing scarce resources and alternatives. The equipment maintenance management of the hospital not only makes them easily accessible when needed but also increases their reli-ability and reduces their failure rate [4, 8]. Despite the importance of maintenance, there was no clear system of maintenance. The guidelines are not properly performed in many countries including Iran. In addition, there is a lack of information about the assessment and evaluation of medical equipment decisions [9].

A survey indicated that nearly 60% of the total cost of a hospital involves medical equipment [8]. Wang et al. have demonstrated that the most common cause of medical equipment downtime is poor maintenance, planning, and management [3]. One study indicates that nearly 1% of the total hospital budget is spent on maintenance costs [10]. The literatures have indicated that a 500-bed hospital spends typically around $5 mil-lion/year [6]. A study of world health organization (WHO) has shown that nearly half of medical devices in developing countries are operated incorrectly or are not maintained properly due to inappropriate management policy. On the other hand, the potential to manage and maintain medical equipment in these countries remains rather weak [11].

Medical equipment plays a significant role in the hospital system; hence, the pur-chase, maintenance and replacement of medical equipment are key factors in hospitals to implement medical care service. Thus, to assure the quality of healthcare delivery medical devices, use-safety assessment of the maintenance management in hospitals is imperative [12]. To achieve these objectives, hospitals must develop assessment check-lists which identify the performance status of medical equipment maintenance. It is essential for managers and engineers, not only to enhance hospital capability but also to predict the risks related to sudden failure. Given the lack of single and comprehensive checklists for maintenance management, the purpose of the current research is to design


and develop assessment checklists for medical equipment maintenance management (MEMM).

ResultsOf 309 potentially relevant articles searched, 29 articles were included in this systematic review. Finally, 89 factors were identified that affect the medical equipment maintenance management. These factors categorized based on MOHME framework [13]. Five of the factors were found related to resources, 12 factors related to service, 4 factors related to education, 15 of these factors regarding to quality control, 19 factors related to inspec-tion, 12 factors related to information bank and 22 factors was dedicated to management [14].

The results of qualitative study were categorized into seven main themes (resources, quality control, documentation, education, service, inspection and preventive mainte-nance (IPM), designing and implementation) [15].

Based on the findings of the first and second steps, a medical equipment maintenance management assessment checklist was developed as follows (Table 1).

The checklists have seven dimensions, each of which includes sub-categories, such as the provision of variety of financial, human and physical resources, which means physical resources to provide a safe and secure environment equipped with the neces-sary facilities. Human resources refer to the provision and allocation of experienced and skilled manpower based on need. Financial resources also include the allocation of suf-ficient and necessary funds and budgets, which should be based on the goal and be allo-cated to priority goals according to the operational plan of the medical engineer unit.

The dimension of quality control tests in the three sub-categories of safety test, per-formance test and calibration refer to all technical tests that require special equipment and are of special importance for the health of the patient and staff. The Inspection and Preventive Maintenance Item refers to the importance and priority of PM than repairing and assessing the user and performance of personnel. In this section, there are topics such as periodic inspections, development of maintenance standards, the existence of external supervisors, and the existence of written and comprehensive guidelines.

In the field of information bank, all activities related to the process of documentation and identification of medical equipment is listed. In the training section, both techni-cal and user training for medical engineers and users are mentioned. The sub-categories of the service sector include after-sales service, repair and maintenance contracts, out-sourcing of the decommissioning process, and so on. The last dimension is design and implementation, which refers to issues such as defining the level of user access, organ-izing joint committees, establishing inter-sectorial communication, policy development, purchasing medical equipment based on needs, and so on.

The scoring method is in three categories of zero, one and two. If the item meets the criteria, score 2, in case of partial compliance, one score and in case of mismatch, no points are awarded. For some items, one score is not included. That is, only two match-ing or mismatch modes are applicable and no intermediate states. Part of the checklist is about data collection that depending on the nature of the item, the collection method involves interview, observation and documentation review. Thus, the interview will


Tabl

e 1

Dim

ensi

on o

f pro

pose

d m

edic

al e

quip

men

t mai

nten

ance

man

agem

ent a

sses

smen

t che

cklis

t

Sub-

cate

gori

esSt

anda

rds

Dat

a co

llect

ion

met

hod

Dat

a co

llect

ion

sour

ceSc

ores

01

2

Reso

urce

s

Phys

ical

reso

urce

sPr

ovid

ing

appr

opria

te

phys

ical

spa

ceO

bser

vatio

nH

ead

of M

edic

al E

ngin

eer‑

ing

Uni

tLa

ck o

f spa

ce w

ith

adeq

uate

acc

ess

Enou

gh s

pace

but

inap

‑pr

opria

teEx

iste

nce

of a

pla

ce w

ith

adeq

uate

and

suffi

cien

t ac

cess

Prov

idin

g a

spec

ial p

lace

fo

r rep

airin

g de

vice

s in

ho

spita

ls

Obs

erva

tion

Hea

d of

Med

ical

Eng

inee

r‑in

g U

nit

Ther

e is

no

spec

ific

plac

eTh

ere

is s

peci

fic p

lace

Allo

catio

n of

mai

nten

ance

un

it in

med

ical

eng

i‑ne

erin

g un

it

Obs

erva

tion

Hea

d of

Med

ical

Eng

inee

r‑in

g U

nit

The

mai

nten

ance

uni

t is

not

ass

igne

d to

the

med

ical

eng

inee

ring

unit

The

mai

nten

ance

uni

t is

assi

gned

to th

e m

edic

al

engi

neer

ing

unit

Prov

idin

g a

safe

and

he

alth

y w

ork

envi

ron‑

men

t

Obs

erva

tion

Hea

d of

Med

ical

Eng

inee

r‑in

g U

nit

The

wor

k en

viro

nmen

t is

not s

afe

and

heal

thy

The

wor

k en

viro

nmen

t is

safe

and

hea

lthy

Requ

irem

ent o

f com

pute

r an

d ne

cess

ary

faci

litie

s in

med

ical

eng

inee

ring

unit

Obs

erva

tion

Hea

d of

Med

ical

Eng

inee

r‑in

g U

nit

Lack

of m

inim

um n

eces

‑sa

ry fa

cilit

ies

(tel

epho

ne

line,

fax

and

inte

rnet

)

The

nece

ssar

y fa

cilit

ies

(tel

epho

ne li

ne, f

ax a

nd

inte

rnet

) are

not

eno

ugh

Equi

pped

with

tele

phon

e lin

e, fa

x an

d in

tern

et, w

ith

the

nece

ssar

y ad

min

istr

a‑tiv

e fa

cilit

ies

Prov

idin

g lo

caliz

ed m

edi‑

cal e

quip

men

t mai

nte‑

nanc

e so

ftw

are

Obs

erva

tion

Hea

d of

Med

ical

Eng

inee

r‑in

g U

nit

The

mai

nten

ance

sof

twar

e av

aila

ble

in th

e w

orld

is

not u

sed

acco

rdin

g to

th

e na

tive

cond

ition

s of

th

e co

untr

y

The

mai

nten

ance

sof

twar

e av

aila

ble

in th

e w

orld

is

used

acc

ordi

ng to

the

nativ

e co

nditi

ons

of th

e co

untr

y

The

esta

blis

hmen

t of a

m

aint

enan

ce c

ompu

ter

syst

em

Obs

erva

tion–

docu

men

ta‑

tion

revi

ewH

ead

of M

edic

al E

ngin

eer‑

ing

Uni

tTh

ere

are

not e

noug

h co

nditi

ons

to s

et u

p a

com

pute

r mai

nten

ance

sy

stem

(CM

MS)

Ther

e ar

e en

ough

co

nditi

ons

to s

et u

p a

com

pute

r mai

nten

ance

sy

stem

(CM

MS)

Prov

isio

n of

som

e te

chni

‑ca

l che

cklis

ts (t

est a

nd

repa

irs c

heck

lists

)

Obs

erva

tion

Hea

d of

Med

ical

Eng

inee

r‑in

g U

nit

Lack

of c

heck

lists

nee

ded

for s

afet

y te

stin

g an

d re

pairs

Inco

mpl

ete

avai

labi

lity

of

safe

ty a

nd re

pair

test

ch

eckl

ists

Exis

tenc

e of

com

plet

e ch

eckl

ists

requ

ired

for

safe

ty te

st a

nd re

pairs


Tabl

e 1

(con

tinue

d)Su

b-ca

tego

ries

Stan

dard

sD

ata

colle

ctio

n m

etho

dD

ata

colle

ctio

n so

urce

Scor

es

01

2

Exis

tenc

e of

a s

peci

fic

syst

em fo

r rec

ordi

ng

failu

res

Obs

erva

tion–

inte

rvie

wH

ead

of M

edic

al E

ngin

eer‑

ing

Uni

tTh

ere

is n

o sp

ecifi

c sy

stem

fo

r rec

ordi

ng fa

ilure

sTh

ere

is s

peci

fic s

yste

m fo

r re

cord

ing

failu

res

Acc

ess

to u

p‑to

‑dat

e so

ftw

are

in th

e fie

ld o

f m

aint

enan

ce

Inte

rvie

wH

ead

of M

edic

al E

ngin

eer‑

ing

Uni

tIt

is n

ot p

ossi

ble

to a

cces

s up

‑to‑

date

sof

twar

e in

th

e m

aint

enan

ce a

rea

It is

pos

sibl

e to

acc

ess

up‑

to‑d

ate

soft

war

e in

the

mai

nten

ance

are

a

Hum

an re

sour

ces

Prov

idin

g a

stab

le a

nd

trai

ned

forc

e fo

r the

m

edic

al e

ngin

eerin

g un

it

Obs

erva

tion–

inte

rvie

wH

ead

of M

edic

al E

ngin

eer‑

ing

Uni

t—m

edic

al e

ngi‑

neer

s an

d te

chni

cian

s

The

avai

labl

e m

anpo

wer

ha

s no

t bee

n fix

ed a

nd

they

hav

e no

t rec

eive

d th

e ne

cess

ary

trai

ning

The

avai

labl

e m

anpo

wer

ha

s be

en fi

xed

but h

as n

ot

rece

ived

the

nece

ssar

y tr

aini

ngO

RTh

e av

aila

ble

man

pow

er h

as

rece

ived

the

nece

ssar

y tr

aini

ng b

ut is

not

fixe

d

The

avai

labl

e m

anpo

wer

ha

s be

en fi

xed

but h

as

rece

ived

the

nece

ssar

y tr

aini

ng

Allo

catio

n of

med

ical

en

gine

erin

g fo

rce

base

d on

nee

d

Obs

erva

tion–

inte

rvie

wH

ead

of M

edic

al E

ngin

eer‑

ing

Uni

tTh

ere

are

not e

noug

h sk

illed

man

pow

er (f

or

ever

y 10

0 ho

spita

l bed

s, at

leas

t one

eng

inee

r an

d on

e te

chni

cal

tech

nici

an)

Ther

e is

ski

lled

man

pow

er,

but n

ot e

noug

h. (F

or

ever

y 10

0 ho

spita

l bed

s, at

leas

t one

eng

inee

r an

d on

e te

chni

cal

tech

nici

an)

Ther

e is

eno

ugh

skill

ed

man

pow

er. (

For e

very

100

ho

spita

l bed

s, at

leas

t one

en

gine

er a

nd o

ne te

chni

‑ca

l tec

hnic

ian)

Fina

ncia

l res

ourc

esA

lloca

tion

fund

s to

m

edic

al e

quip

men

t m

aint

enan

ce

Inte

rvie

w–d

ocum

enta

tion

revi

ewH

ead

of M

edic

al E

ngin

eer‑

ing

Uni

tTh

e re

quire

d bu

dget

or

cred

it is

not

est

imat

ed

and

prov

ided

eac

h ye

ar

in a

ccor

danc

e w

ith th

e M

edic

al E

quip

men

t M

aint

enan

ce R

egul

a‑tio

ns

The

requ

ired

budg

et o

r cr

edit

is e

stim

ated

and

pr

ovid

ed e

ach

year

in

acco

rdan

ce w

ith th

e M

edic

al E

quip

men

t Mai

n‑te

nanc

e Re

gula

tions

Ass

igni

ng a

revo

lvin

g fu

nd

to th

e m

edic

al e

ngin

eer‑

ing

unit

Inte

rvie

w–d

ocum

enta

tion

revi

ewH

ead

of M

edic

al E

ngin

eer‑

ing

Uni

tTh

e re

volv

ing

fund

is n

ot

allo

cate

d fo

r the

med

ical

en

gine

erin

g un

it

The

revo

lvin

g fu

nd is

al

loca

ted

for t

he m

edic

al

engi

neer

ing

unit

Econ

omet

rics

and

cost

–be

nefit

cal

cula

tion

of

equi

pmen

t mai

nten

ance

Inte

rvie

w–d

ocum

enta

tion

revi

ewH

ead

of M

edic

al E

ngin

eer‑

ing

Uni

tD

ocum

ents

are

not

ava

il‑ab

leD

ocum

ents

are

inco

m‑

plet

eD

ocum

ents

are

com

plet

e


Tabl

e 1

(con

tinue

d)

Dim

ensi

onSt

anda

rds

Dat

a co

llect

ion

met

hod

Dat

a co

llect

ion

sour

ceSc

ores

01

2

Qua

lity

cont

rol t

ests

Safe

ty te

stPe

rfor

m s

afet

y te

sts

Obs

erva

tion–

inte

rvie

wH

ead

of M

edic

al E

ngin

eer‑

ing

Uni

tN

one

of th

e sa

fety

test

s (e

lect

rical

, phy

sica

l–m

echa

nica

l, ra

diat

ion,

ch

emic

al, u

ser,

etc.

) are

pe

rfor

med

acc

ordi

ng to

th

e re

gula

tions

for t

he

mai

nten

ance

of m

edic

al

equi

pmen

t

Som

e sa

fety

test

s (e

lect

rical

, phy

sica

l–m

echa

nica

l, ra

diat

ion,

ch

emic

al, u

ser,

etc.

) are

pe

rfor

med

acc

ordi

ng to

th

e re

gula

tions

for t

he

mai

nten

ance

of m

edic

al

equi

pmen

t

All

safe

ty te

sts

(ele

ctric

al,

phys

ical

–mec

hani

cal,

radi

atio

n, c

hem

ical

, us

er, e

tc.)

are

perf

orm

ed

acco

rdin

g to

the

regu

la‑

tions

for m

aint

aini

ng

med

ical

equ

ipm

ent

Calib

ratio

nEn

surin

g qu

ality

con

trol

s pe

rfor

med

by

com

pa‑

nies

Inte

rvie

w–d

ocum

enta

tion

revi

ewH

ead

of M

edic

al E

ngin

eer‑

ing

Uni

tQ

ualit

y co

ntro

ls p

er‑

form

ed b

y co

mpa

nies

ar

e no

t gua

rant

eed

(no

spec

ific

oblig

atio

ns)

Qua

lity

cont

rols

per

form

ed

by c

ompa

nies

are

gu

aran

teed

(hav

e ce

rtai

n ob

ligat

ions

)

Plan

ning

and

con

duct

ing

qual

ity c

ontr

ol te

sts

Inte

rvie

w–d

ocum

enta

tion

revi

ewH

ead

of M

edic

al E

ngin

eer‑

ing

Uni

tTh

ere

are

no s

peci

fic

prog

ram

qua

lity

cont

rol

test

s

Qua

lity

cont

rol t

ests

hav

e a

spec

ific

prog

ram

Labe

ling

of c

alib

rate

d eq

uipm

ent

Obs

erva

tion–

docu

men

ta‑

tion

revi

ewH

ead

of M

edic

al E

ngin

eer‑

ing

Uni

tCa

libra

ted

equi

pmen

t is

not r

egul

arly

labe

led

Calib

rate

d eq

uipm

ent i

s la

bele

d bu

t not

regu

larly

Calib

rate

d eq

uipm

ent i

s re

gula

rly la

bele

d

Perf

orm

ance

test

Perf

orm

tech

nica

l tes

tsO

bser

vatio

n–do

cum

enta

‑tio

n re

view

Hea

d of

Med

ical

Eng

inee

r‑in

g U

nit

Tech

nica

l tes

ts a

re n

ot

perf

orm

ed b

y al

low

ed

agen

cies

or s

ervi

ce

prov

ider

s

Tech

nica

l tes

ts a

re n

ot p

er‑

form

ed b

y al

low

ed a

gen‑

cies

or s

ervi

ce p

rovi

ders


Tabl

e 1

(con

tinue

d)

Dim

ensi

onSt

anda

rds

Dat

a co

llect

ion

met

hod

Dat

a co

llect

ion

sour

ceSc

ores

01

2

Perf

orm

pra

ctic

al te

sts

Obs

erva

tion–

docu

men

ta‑

tion

revi

ewH

ead

of M

edic

al E

ngin

eer‑

ing

Uni

tTh

e re

leva

nt te

st is

not

pe

rfor

med

by

the

trai

ned

user

and

is

not a

ccor

ding

to th

e ch

eckl

ist p

rovi

ded

by

the

man

ufac

ture

r or

lega

l rep

rese

ntat

ive

and

unde

r the

sup

ervi

sion

of

the

Med

ical

Eng

inee

r‑in

g U

nit

The

rele

vant

test

is p

er‑

form

ed b

y th

e tr

aine

d us

er a

nd is

acc

ordi

ng to

th

e ch

eckl

ist p

rovi

ded

by

the

man

ufac

ture

r or l

egal

re

pres

enta

tive

and

unde

r th

e su

perv

isio

n of

the

Med

ical

Eng

inee

ring

Uni

t

Perf

orm

labo

rato

ry te

sts

Obs

erva

tion–

docu

men

ta‑

tion

revi

ewH

ead

of M

edic

al E

ngin

eer‑

ing

Uni

tTh

e re

leva

nt te

st is

not

pe

rfor

med

by

the

trai

ned

user

and

is

not a

ccor

ding

to th

e ch

eckl

ist p

rovi

ded

by

the

man

ufac

ture

r or

lega

l rep

rese

ntat

ive

and

unde

r the

sup

ervi

sion

of

the

Med

ical

Eng

inee

r‑in

g U

nit

The

rele

vant

test

is p

er‑

form

ed b

y th

e tr

aine

d us

er a

nd is

acc

ordi

ng to

th

e ch

eckl

ist p

rovi

ded

by

the

man

ufac

ture

r or l

egal

re

pres

enta

tive

and

unde

r th

e su

perv

isio

n of

the

Med

ical

Eng

inee

ring

Uni

t

Perf

orm

clin

ical

test

sO

bser

vatio

n–do

cum

enta

‑tio

n re

view

Hea

d of

Med

ical

Eng

inee

r‑in

g U

nit

The

rele

vant

test

is n

ot

perf

orm

ed b

y th

e tr

aine

d us

er a

nd is

no

t acc

ordi

ng to

the

chec

klis

t pro

vide

d by

th

e m

anuf

actu

rer o

r le

gal r

epre

sent

ativ

e an

d un

der t

he s

uper

visi

on o

f th

e M

edic

al E

ngin

eer‑

ing

Uni

t

The

rele

vant

test

is p

er‑

form

ed b

y th

e tr

aine

d us

er a

nd is

acc

ordi

ng to

th

e ch

eckl

ist p

rovi

ded

by

the

man

ufac

ture

r or l

egal

re

pres

enta

tive

and

unde

r th

e su

perv

isio

n of

the

Med

ical

Eng

inee

ring

Uni

t


Tabl

e 1

(con

tinue

d)

Dim

ensi

onSt

anda

rds

Dat

a co

llect

ion

met

hod

Dat

a co

llect

ion

sour

ceSc

ores

01

2

Insp

ectio

n an

d pr

even

tive

mai

nten

ance

(IPM

)

Man

agem

ent p

roce

sses

to

ext

end

the

life

of th

e de

vice

Perf

orm

tim

ely

and

regu

lar

prev

entiv

e m

aint

enan

ceO

bser

vatio

n–do

cum

enta

‑tio

n re

view

Hea

d of

Med

ical

Eng

inee

r‑in

g U

nit

A p

reve

ntiv

e m

aint

enan

ce

prog

ram

is n

ot d

evel

‑op

ed a

nd im

plem

ente

d

A p

reve

ntiv

e m

aint

enan

ce

prog

ram

is d

evel

oped

bu

t it r

uns

inco

mpl

etel

y

A p

reve

ntiv

e m

aint

enan

ce

prog

ram

is d

evel

oped

an

d im

plem

ente

d

Insu

ffici

ent k

now

ledg

e in

th

e fie

ld o

f pre

vent

ive

mai

nten

ance

Inte

rvie

wH

ead

of M

edic

al E

ngin

eer‑

ing

Uni

t—m

edic

al e

ngi‑

neer

s an

d te

chni

cian

s

Non

e of

the

empl

oyee

s of

th

e M

edic

al E

ngin

eer‑

ing

Uni

t hav

e su

f‑fic

ient

kno

wle

dge

and

awar

enes

s in

the

field

of

prev

entiv

e m

aint

enan

ce

Som

e em

ploy

ees

of th

e M

edic

al E

ngin

eerin

g U

nit h

ave

suffi

cien

t kn

owle

dge

and

info

r‑m

atio

n in

the

field

of

prev

entiv

e m

aint

enan

ce

All

empl

oyee

s of

the

Med

i‑ca

l Eng

inee

ring

Uni

t hav

e su

ffici

ent k

now

ledg

e an

d in

form

atio

n in

the

field

of

prev

entiv

e m

aint

enan

ce

Prev

entiv

e m

aint

enan

ce

prio

rity

over

qua

lity

cont

rol a

nd re

pair

Inte

rvie

wH

ead

of M

edic

al E

ngin

eer‑

ing

Uni

tPr

even

tive

mai

nten

ance

is

not

a p

riorit

y in

the

med

ical

eng

inee

ring

unit’

s ac

tion

plan

Prev

entiv

e m

aint

enan

ce is

a

prio

rity

in th

e m

edic

al

engi

neer

ing

unit’

s ac

tion

plan

Perio

dic,

inte

rnal

, cas

e,

prac

tical

insp

ectio

nEx

iste

nce

of s

ome

sub‑

rule

sIn

terv

iew

Hea

d of

Med

ical

Eng

inee

r‑in

g U

nit

The

exis

ting

rule

s an

d re

gula

tions

rega

rdin

g m

aint

enan

ce a

re n

ot

nece

ssar

y an

d ap

prop

ri‑at

e

The

exis

ting

rule

s an

d re

gula

tions

rega

rdin

g m

aint

enan

ce a

re n

eces

‑sa

ry b

ut n

ot a

ppro

pria

te

The

exis

ting

rule

s an

d re

gula

tions

rega

rdin

g m

aint

enan

ce a

re n

eces

‑sa

ry a

nd a

ppro

pria

te

Usi

ng a

ccre

dita

tion

mea

sure

s to

ass

ess

the

mai

nten

ance

of m

edic

al

equi

pmen

t

Inte

rvie

wH

ead

of M

edic

al E

ngin

eer‑

ing

Uni

tFr

om a

ccre

dita

tion

mea

sure

s ar

e no

t use

d to

ass

ess

mai

nten

ance

ac

tiviti

es a

nd p

roce

sses

From

acc

redi

tatio

n m

easu

res

are

not u

sed

to a

sses

s m

aint

enan

ce

activ

ities

and

pro

cess

es


Tabl

e 1

(con

tinue

d)

Dim

ensi

onSt

anda

rds

Dat

a co

llect

ion

met

hod

Dat

a co

llect

ion

sour

ceSc

ores

01

2

Exam

inat

ion

of m

edic

al

equi

pmen

t thr

ough

hu

man

sen

ses

and

spec

ializ

ed c

heck

lists

Inte

rvie

wH

ead

of th

e U

nive

rsity

M

edic

al E

quip

men

t O

ffice

or

Expe

rts

intr

oduc

ed b

y hi

m a

nd th

e he

ad o

f th

e m

edic

al e

ngin

eer‑

ing

unit

Lack

of i

nves

tigat

e an

d su

perv

isio

n of

all

oper

a‑tio

ns (r

evie

w a

nd m

oni‑

torin

g of

qua

lity

cont

rol

test

s of

med

ical

equ

ip‑

men

t, re

view

of f

acili

ties

and

anci

llary

faci

litie

s re

late

d to

equ

ipm

ent,

revi

ew o

f the

env

iron‑

men

t aro

und

med

ical

eq

uipm

ent,

asse

ssm

ent

of d

evic

e us

age

by u

ser

and

asse

ssm

ent o

f the

pe

rfor

man

ce o

f tec

hni‑

cal p

erso

nnel

)(B

y ch

eckl

ist)

Inve

stig

ate

and

supe

rvi‑

sion

of s

ome

oper

a‑tio

ns (i

nves

tigat

e an

d m

onito

ring

of q

ualit

y co

ntro

l tes

ts o

f med

ical

eq

uipm

ent,

inve

stig

ate

of fa

cilit

ies

and

anci

l‑la

ry fa

cilit

ies

rela

ted

to

equi

pmen

t, in

vest

igat

e of

the

envi

ronm

ent

arou

nd m

edic

al e

quip

‑m

ent,

asse

ssm

ent o

f de

vice

usa

ge b

y us

er

and

asse

ssm

ent o

f the

pe

rfor

man

ce o

f tec

hni‑

cal p

erso

nnel

)(B

y ch

eckl

ist)

Inve

stig

ate

and

supe

rvis

ion

of a

ll op

erat

ions

(inv

es‑

tigat

e an

d m

onito

ring

of q

ualit

y co

ntro

l tes

ts

of m

edic

al e

quip

men

t, in

vest

igat

e of

faci

litie

s an

d an

cilla

ry fa

cilit

ies

rela

ted

to e

quip

men

t, in

vest

igat

e of

the

envi

ron‑

men

t aro

und

med

ical

eq

uipm

ent,

asse

ssm

ent

of d

evic

e us

age

by u

ser

and

asse

ssm

ent o

f the

pe

rfor

man

ce o

f tec

hnic

al

pers

onne

l)(B

y ch

eckl

ist)

Det

erm

inin

g th

e tim

e pe

riod

of p

erio

dic

visi

tsIn

terv

iew

–doc

umen

tatio

n re

view

Hea

d of

Med

ical

Eng

inee

r‑in

g U

nit

Not

acc

ordi

ng to

the

actio

n pl

anA

ccor

ding

to th

e ac

tion

plan

Dev

elop

ing

plan

for p

eri‑

odic

vis

itsD

ocum

enta

tion

revi

ewH

ead

of M

edic

al E

ngin

eer‑

ing

Uni

tA

n ac

tion

plan

has

not

be

en d

evel

oped

An

actio

n pl

an h

as b

een

deve

lope

d

Exis

tenc

e of

an

exte

rnal

ob

serv

erIn

terv

iew

Hea

d of

Med

ical

Eng

inee

r‑in

g U

nit a

nd H

ospi

tal

Man

ager

The

exte

rnal

sup

ervi

sor

has

not b

een

appo

inte

d to

insp

ect a

nd o

vers

ee

the

affai

rs o

f the

med

ical

en

gine

erin

g un

it

The

exte

rnal

sup

ervi

sor

has

been

app

oint

ed to

in

spec

t and

ove

rsee

the

affai

rs o

f the

med

ical

en

gine

erin

g un

it

Dev

elop

ing

stan

dard

s in

m

aint

enan

ce c

ontr

acts

Doc

umen

tatio

n re

view

Hea

d of

Med

ical

Eng

inee

r‑in

g U

nit

The

serv

ice,

mai

nten

ance

an

d re

pair

cont

ract

hav

e no

t a s

peci

fic fr

ame‑

wor

k. (A

ccor

ding

to

regu

latio

ns)

The

serv

ice,

mai

nten

ance

an

d re

pair

cont

ract

hav

e a

spec

ific

fram

ewor

k.

(Acc

ordi

ng to

regu

latio

ns)


Tabl

e 1

(con

tinue

d)

Dim

ensi

onSt

anda

rds

Dat

a co

llect

ion

met

hod

Dat

a co

llect

ion

sour

ceSc

ores

01

2

Prep

arin

g a

list o

f ess

entia

l eq

uipm

ent

Doc

umen

tatio

n re

view

Hea

d of

Med

ical

Eng

inee

r‑in

g U

nit

The

list o

f ess

entia

l equ

ip‑

men

t has

not

bee

n pr

epar

ed a

nd is

not

av

aila

ble

to th

e de

part

‑m

ents

A li

st o

f ess

entia

l equ

ip‑

men

t has

bee

n pr

epar

ed

but i

s no

t ava

ilabl

e to

th

e de

part

men

ts

The

list o

f ess

entia

l equ

ip‑

men

t has

bee

n pr

epar

ed

and

is a

vaila

ble

to th

e de

part

men

ts

Ensu

ring

the

exis

tenc

e of

sa

fe e

lect

ricity

(eve

ry s

ix

mon

ths,

the

hosp

ital’s

el

ectr

icity

is c

ontr

olle

d by

an

elec

tric

ian

and

the

avai

labl

e do

cum

ents

)

Obs

erva

tion

Hea

d of

Med

ical

Eng

inee

r‑in

g U

nit

The

item

s m

entio

ned

in

the

regu

latio

ns re

gard

‑in

g el

ectr

ical

saf

ety

are

not o

bser

ved

and

perf

orm

ed

The

item

s m

entio

ned

in

the

regu

latio

ns re

late

d to

ele

ctric

al s

afet

y ar

e in

com

plet

ely

obse

rved

an

d pe

rfor

med

The

item

s m

entio

ned

in

the

regu

latio

ns re

gard

‑in

g el

ectr

ical

saf

ety

are

com

plet

ely

obse

rved

and

pe

rfor

med

Perio

dic

revi

ew o

f the

co

rrec

t ope

ratio

n of

the

devi

ce b

y th

e us

er

Inte

rvie

w–d

ocum

enta

tion

revi

ewH

ead

of M

edic

al E

ngin

eer‑

ing

Uni

tTh

e co

rrec

t ope

ratio

n of

the

devi

ce is

not

ch

ecke

d pe

riodi

cally

by

the

user

The

corr

ect o

pera

tion

of th

e de

vice

is c

heck

ed p

erio

di‑

cally

by

the

user

Lack

of u

nifo

rmity

of

asse

ssm

ent c

heck

lists

Doc

umen

tatio

n re

view

Hea

d of

Med

ical

Eng

inee

r‑in

g U

nit

The

med

ical

eng

inee

r‑in

g un

it do

es n

ot h

ave

a sp

ecifi

c ch

eckl

ist t

o as

sess

the

mai

nten

ance

st

atus

of m

edic

al e

quip

‑m

ent

The

med

ical

eng

inee

r‑in

g un

it ha

s a

spec

ific

chec

klis

t to

asse

ss th

e m

aint

enan

ce s

tatu

s of

m

edic

al e

quip

men

t

Mor

e vi

sitin

g to

def

ectiv

e de

vice

sIn

terv

iew

–doc

umen

tatio

n re

view

Hea

d of

Med

ical

Eng

inee

r‑in

g U

nit

Def

ectiv

e de

vice

s ar

e no

t ch

ecke

d re

gula

rly b

y a

med

ical

eng

inee

r (ex

ist‑

ence

of a

ctio

n pl

an)

Def

ectiv

e de

vice

s ar

e ch

ecke

d re

gula

rly b

y a

med

ical

eng

inee

r (ex

ist‑

ence

of a

ctio

n pl

an)

Cla

rifica

tion

of re

gula

tions

an

d no

tifica

tion

inst

ruc‑

tions

Inte

rvie

w–d

ocum

enta

tion

revi

ewH

ead

of M

edic

al E

ngin

eer‑

ing

Uni

t—m

edic

al e

ngi‑

neer

s an

d te

chni

cian

s

Non

e of

the

med

ical

en

gine

erin

g st

aff a

re

awar

e of

the

regu

latio

ns

and

inst

ruct

ions

issu

ed

by th

e D

epar

tmen

t of

Med

ical

Equ

ipm

ent/

not

all e

mpl

oyee

s kn

ow th

e ru

les

clea

rly

Som

e of

the

med

ical

en

gine

erin

g st

aff a

re

awar

e of

the

regu

latio

ns

and

inst

ruct

ions

issu

ed

by th

e D

epar

tmen

t of

Med

ical

Equ

ipm

ent/

som

e of

em

ploy

ees

know

the

rule

s cl

early

All

of th

e m

edic

al e

ngi‑

neer

ing

staff

are

aw

are

of th

e re

gula

tions

and

in

stru

ctio

ns is

sued

by

the

Dep

artm

ent o

f Med

ical

Eq

uipm

ent/

all e

mpl

oyee

s kn

ow th

e ru

les

clea

rly


Tabl

e 1

(con

tinue

d)

Dim

ensi

onSt

anda

rds

Dat

a co

llect

ion

met

hod

Dat

a co

llect

ion

sour

ceSc

ores

01

2

Requ

irem

ent t

o fo

llow

or

ders

from

hig

h le

vels

Inte

rvie

wH

ead

of M

edic

al E

ngin

eer‑

ing

Uni

tO

rder

s is

sued

by

the

Dep

artm

ent o

f Med

ical

Eq

uipm

ent a

re n

ot

prop

erly

com

plie

d

Ord

ers

issu

ed b

y th

e D

epar

tmen

t of M

edic

al

Equi

pmen

t are

pro

perly

co

mpl

ied

Acc

ess

to th

e bo

okle

t of

the

set o

f mai

nten

ance

ru

les

and

regu

latio

ns

Inte

rvie

w–d

ocum

enta

tion

revi

ewH

ead

of M

edic

al E

ngin

eer‑

ing

Uni

tN

one

of th

e st

aff m

em‑

bers

hav

e ac

cess

to th

e bo

okle

t

Som

e of

the

staff

mem

‑be

rs h

ave

acce

ss to

the

book

let

All

of th

e st

aff m

embe

rs

have

acc

ess

to th

e bo

okle

t

Com

plet

ion

and

obse

r‑va

nce

of a

ccre

dita

tion

mea

sure

s

Inte

rvie

wH

ead

of M

edic

al E

ngin

eer‑

ing

Uni

tTh

e un

it do

es n

ot m

eet

any

of th

e cr

iteria

on

a re

gula

r bas

is

The

unit

mee

ts s

ome

of

the

crite

ria o

n a

regu

lar

basi

s

The

unit

mee

ts a

ny o

f the

cr

iteria

on

a re

gula

r bas

is

Impl

emen

tatio

n of

m

aint

enan

ce ru

les

and

regu

latio

ns

Inte

rvie

wH

ead

of M

edic

al E

ngin

eer‑

ing

Uni

tTh

e ru

les

anno

unce

d by

th

e O

ffice

of M

edic

al

Equi

pmen

t do

not r

un

regu

larly

The

rule

s an

noun

ced

by th

e O

ffice

of M

edic

al E

quip

‑m

ent r

un re

gula

rly

Exis

tenc

e of

writ

ten

and

com

preh

ensi

ve in

stru

c‑tio

ns

Doc

umen

tatio

n re

view

Hea

d of

Med

ical

Eng

inee

r‑in

g U

nit

Ther

e ar

e no

com

pre‑

hens

ive

guid

elin

es fo

r m

aint

aini

ng m

edic

al

equi

pmen

t

Ther

e ar

e w

ritte

n gu

ide‑

lines

for m

aint

enan

ce

med

ical

equ

ipm

ent,

but

they

are

not

com

pre‑

hens

ive

Ther

e ar

e co

mpr

ehen

sive

gu

idel

ines

for m

aint

aini

ng

med

ical

equ

ipm

ent

Info

rmat

ion

bank

Prov

idin

g m

edic

al d

evic

es

ID (i

dent

ifica

tion)

Elec

tron

ic, c

ompr

ehen

sive

an

d in

telli

gent

ele

ctro

nic

med

ical

ID

Obs

erva

tion–

docu

men

ta‑

tion

revi

ewH

ead

of M

edic

al E

ngin

eer‑

ing

Uni

tM

edic

al ID

are

not

re

gula

rly p

repa

red

and

upda

ted

Med

ical

equ

ipm

ent I

D h

as

been

pre

pare

d bu

t not

up

to d

ate

Med

ical

ID a

re re

gula

rly

prep

ared

and

upd

ated

Easy

acc

ess

to ID

info

rma‑

tion

Inte

rvie

w–d

ocum

enta

tion

revi

ewH

ead

of M

edic

al E

ngi‑

neer

ing

Uni

t, M

edic

al

Engi

neer

s an

d Te

chni

cal

Tech

nici

ans/

Dep

art‑

men

t Em

ploy

ees

Empl

oyee

s do

not

hav

e ac

cess

to ID

info

rmat

ion

Empl

oyee

s ha

ve a

cces

s to

ID

info

rmat

ion


Tabl

e 1

(con

tinue

d)

Dim

ensi

onSt

anda

rds

Dat

a co

llect

ion

met

hod

Dat

a co

llect

ion

sour

ceSc

ores

01

2

Use

of i

ndig

enou

s an

d gl

obal

evi

denc

eCo

mm

unic

ate

with

sta

nd‑

ard

scie

ntifi

c re

fere

nces

Inte

rvie

w–d

ocum

enta

tion

revi

ewH

ead

of M

edic

al E

ngin

eer‑

ing

Uni

tTh

e he

ad o

f the

med

ical

en

gine

erin

g un

it do

es

not h

ave

acce

ss to

sci

en‑

tific

stan

dard

refe

renc

es

(sci

entifi

c ar

ticle

s, sc

ien‑

tific

site

s, in

tern

atio

nal

stan

dard

s, et

c.)

The

head

of t

he m

edic

al

engi

neer

ing

unit

does

not

ha

ve a

cces

s to

sci

entifi

c st

anda

rd re

fere

nces

(s

cien

tific

artic

les,

scie

n‑tifi

c si

tes,

inte

rnat

iona

l st

anda

rds,

etc.

)

Util

izin

g th

e in

form

atio

n of

the

man

ufac

ture

r in

the

asse

ssm

ent

Inte

rvie

wH

ead

of M

edic

al E

ngin

eer‑

ing

Uni

tTh

ere

is n

o ac

cess

to th

e m

anuf

actu

rer’s

info

rma‑

tion

and

it is

not

ope

r‑at

ed a

ccor

ding

ly

Ther

e is

acc

ess

to th

e m

anuf

actu

rer’s

info

rma‑

tion,

but

it is

not

ope

r‑at

ed a

ccor

ding

ly

Ther

e is

acc

ess

to th

e m

anuf

actu

rer’s

info

rma‑

tion

and

it is

ope

rate

d ac

cord

ingl

y

Cond

uctin

g st

udie

s an

d re

sear

ch in

the

field

of

med

ical

equ

ipm

ent

mai

nten

ance

Doc

umen

tatio

n re

view

Hea

d of

Med

ical

Eng

inee

r‑in

g U

nit

The

med

ical

eng

inee

ring

unit

does

not

con

‑du

ct re

sear

ch o

n th

e m

aint

enan

ce o

f med

ical

eq

uipm

ent

The

med

ical

eng

inee

ring

unit

cond

ucts

rese

arch

on

the

mai

nten

ance

of

med

ical

equ

ipm

ent

Use

r gui

dePr

epar

ing

and

inst

allin

g qu

ick

user

labe

lsO

bser

vatio

n–do

cum

enta

‑tio

n re

view

Hea

d of

Med

ical

Eng

inee

r‑in

g U

nit

Qui

ck u

ser t

ags

are

not

prov

ided

and

inst

alle

d on

all

devi

ces

Qui

ck u

ser t

ags

are

pro‑

vide

d an

d in

stal

led

on a

ll de

vice

s

Prep

arat

ion

of m

anua

ls in

bo

th P

ersi

an a

nd E

nglis

h fo

r eac

h de

vice

Obs

erva

tion–

docu

men

ta‑

tion

revi

ewH

ead

of M

edic

al E

ngin

eer‑

ing

Uni

tTh

e m

anua

l of e

ach

devi

ce h

as n

ot b

een

prep

ared

and

has

not

be

en p

rovi

ded

to th

e us

er o

f the

dev

ice

The

man

ual o

f eac

h de

vice

has

bee

n pr

e‑pa

red

but h

as n

ot b

een

prov

ided

to th

e us

er o

f th

e de

vice

The

man

ual o

f eac

h de

vice

ha

s be

en p

repa

red

and

prov

ided

to th

e us

er o

f th

e de

vice

Doc

umen

tatio

nA

rchi

ve o

f exe

cutiv

e pr

oces

ses

(repa

ir, q

ualit

y co

ntro

l and

PM

doc

u‑m

enta

tion)

Obs

erva

tion–

docu

men

ta‑

tion

revi

ewH

ead

of M

edic

al E

ngin

eer‑

ing

Uni

tM

aint

enan

ce p

roce

dure

s ar

e no

t ful

ly d

ocu‑

men

ted

and

arch

ived

Som

e of

mai

nten

ance

pr

oced

ures

are

fully

do

cum

ente

d an

d ar

chiv

ed

Mai

nten

ance

pro

cedu

res

are

fully

doc

umen

ted

and

arch

ived

Use

of H

IS s

yste

m in

mai

n‑te

nanc

eO

bser

vatio

nH

ead

of M

edic

al E

ngin

eer‑

ing

Uni

tTh

e m

edic

al e

ngin

eerin

g un

it is

not

equ

ippe

d w

ith th

e H

IS s

yste

m

The

med

ical

eng

inee

ring

unit

is e

quip

ped

with

the

HIS

sys

tem


Tabl

e 1

(con

tinue

d)

Dim

ensi

onSt

anda

rds

Dat

a co

llect

ion

met

hod

Dat

a co

llect

ion

sour

ceSc

ores

01

2

Educ

atin

g

Use

r and

tech

nica

l edu

ca‑

tion

Educ

atio

nal s

uper

viso

r pa

rtic

ipat

ion

in u

ser

trai

ning

Inte

rvie

w–d

ocum

enta

tion

revi

ewH

ead

of M

edic

al E

ngin

eer‑

ing

Uni

t/Ed

ucat

iona

l su

perv

isor

Educ

atio

nal s

uper

viso

rs

do n

ot c

oope

rate

with

m

edic

al e

ngin

eers

in

educ

atin

g us

ers

Educ

atio

nal s

uper

viso

rs

coop

erat

e w

ith m

edic

al

engi

neer

s in

edu

catin

g us

ers

Targ

eted

trai

ning

cou

rses

Inte

rvie

wH

ead

of M

edic

al E

ngi‑

neer

ing

Uni

t, M

edic

al

Engi

neer

s an

d Te

chni

cal

Tech

nici

ans/

Dep

art‑

men

t Em

ploy

ees

Trai

ning

cou

rses

are

not

pu

rpos

eful

or u

sefu

lTr

aini

ng c

ours

es a

re p

ur‑

pose

ful o

r use

ful

Acq

uain

tanc

e of

the

offici

als

of th

e m

edic

al

engi

neer

ing

unit

with

th

e m

anag

emen

t

Inte

rvie

wH

ead

of M

edic

al E

ngi‑

neer

ing

Uni

t, M

edic

al

Engi

neer

s an

d Te

chni

cal

Tech

nici

ans

Non

e of

the

med

ical

en

gine

erin

g offi

cers

are

fa

mili

ar w

ith m

edic

al

equi

pmen

t mai

nten

ance

m

anag

emen

t

Som

e of

the

med

ical

en

gine

erin

g offi

cers

are

fa

mili

ar w

ith m

edic

al

equi

pmen

t mai

nte‑

nanc

e m

anag

emen

t

All

of th

e m

edic

al e

ngin

eer‑

ing

office

rs a

re fa

mili

ar

with

med

ical

equ

ipm

ent

mai

nten

ance

man

age‑

men

t

The

effec

tiven

ess

of tr

ain‑

ing

cour

ses

Inte

rvie

wH

ead

of M

edic

al E

ngi‑

neer

ing

Uni

t, M

edic

al

Engi

neer

s an

d Te

chni

cal

Tech

nici

ans/

Dep

art‑

men

t Em

ploy

ees

The

trai

ning

s ar

e no

t eff

ectiv

eTh

e tr

aini

ngs

are

effec

tive

Prov

idin

g th

e po

ssib

ility

fo

r all

med

ical

eng

inee

rs

to p

artic

ipat

e in

trai

ning

w

orks

hops

Inte

rvie

wH

ead

of M

edic

al E

ngi‑

neer

ing

Uni

t, M

edic

al

Engi

neer

s an

d Te

chni

cal

Tech

nici

ans

It is

not

pos

sibl

e fo

r all

engi

neer

s an

d te

chni

‑ci

ans

to p

artic

ipat

e in

tr

aini

ng w

orks

hops

It is

pos

sibl

e fo

r all

engi

‑ne

ers

and

tech

nici

ans

to p

artic

ipat

e in

trai

ning

w

orks

hops

Nur

se’ le

vel o

f edu

catio

n in

the

field

of g

ener

al

equi

pmen

t

Inte

rvie

wU

sers

Med

ical

equ

ipm

ent u

sers

ha

ve n

ot b

een

trai

ned

in

gene

ral e

quip

men

t

Med

ical

equ

ipm

ent u

sers

ha

ve n

ot b

een

trai

ned

in

gene

ral e

quip

men

t

Use

r ret

rain

ing

abou

t es

sent

ial e

quip

men

tIn

terv

iew

Use

rsU

sers

are

not

retr

aine

d ab

out e

ssen

tial e

quip

‑m

ent

Use

rs a

re re

trai

ned

abou

t es

sent

ial e

quip

men

t


Tabl

e 1

(con

tinue

d)

Dim

ensi

onSt

anda

rds

Dat

a co

llect

ion

met

hod

Dat

a co

llect

ion

sour

ceSc

ores

01

2

Invi

tatio

n of

exp

ert p

rofe

s‑so

rs to

teac

hIn

terv

iew

Hea

d of

Med

ical

Eng

inee

r‑in

g U

nit

Expe

rt p

rofe

ssor

s ar

e no

t in

vite

d to

teac

hEx

pert

pro

fess

ors

are

invi

ted

to te

ach

Visi

ting

the

prod

uctio

n lin

es o

f med

ical

equ

ip‑

men

t and

sup

plie

s co

mpa

nies

Obs

erva

tion

Hea

d of

Med

ical

Eng

i‑ne

erin

g U

nit,

Med

ical

En

gine

ers

and

Tech

nica

l Te

chni

cian

s

Med

ical

eng

inee

rs a

nd

tech

nici

ans

do n

ot

visi

t man

ufac

turin

g co

mpa

nies

Med

ical

eng

inee

rs a

nd

tech

nici

ans

visi

t man

ufac

‑tu

ring

com

pani

es

Part

icip

ate

in in

‑ser

vice

tr

aini

ng fo

r offi

cial

and

co

ntra

ct fo

rces

Inte

rvie

w–d

ocum

enta

tion

revi

ewH

ead

of M

edic

al E

ngi‑

neer

ing

Uni

t, M

edic

al

Engi

neer

s an

d Te

chni

cal

Tech

nici

ans

Med

ical

eng

inee

rs a

nd

tech

nici

ans

do n

ot

part

icip

ate

in in

‑ser

vice

tr

aini

ng

Med

ical

eng

inee

rs a

nd

tech

nici

ans

part

icip

ate

in

in‑s

ervi

ce tr

aini

ng

Cond

uctin

g cl

asse

s an

d tr

aini

ng c

ours

es fo

r m

anag

ers,

engi

neer

s an

d us

ers

Inte

rvie

w–d

ocum

enta

tion

revi

ewH

ead

of M

edic

al E

ngi‑

neer

ing

Uni

t, M

edic

al

Engi

neer

s an

d Te

chni

cal

Tech

nici

ans/

Use

rs

Cla

sses

and

trai

ning

co

urse

s ar

e no

t sch

ed‑

uled

Cla

sses

and

trai

ning

cou

rses

ar

e he

ld a

s sc

hedu

led

Dev

elop

ing

a tr

aini

ng

prog

ram

bas

ed o

n th

e tr

aini

ng n

eeds

of u

sers

an

d en

gine

ers

Inte

rvie

w–d

ocum

enta

tion

revi

ewH

ead

of M

edic

al E

ngin

eer‑

ing

Uni

tTh

e tr

aini

ng p

rogr

am is

no

t dev

elop

ed b

ased

on

educ

atio

nal n

eeds

The

trai

ning

pro

gram

is

deve

lope

d ba

sed

on

educ

atio

nal n

eeds

Serv

ice

Repa

ir (c

orre

ctiv

e m

aint

e‑na

nce)

Repa

ir of

med

ical

equ

ip‑

men

t acc

ordi

ng to

the

regu

latio

ns a

nd s

uper

vi‑

sion

of d

evic

e re

pair

Inte

rvie

wH

ead

of M

edic

al E

ngin

eer‑

ing

Uni

tTh

e re

pair

of m

edic

al

equi

pmen

t is

not i

n ac

cord

ance

with

the

regu

latio

ns a

nd th

e m

edic

al e

ngin

eer d

oes

not o

bser

ve th

eir r

epai

r by

com

pani

es

Med

ical

equ

ipm

ent i

s re

paire

d ac

cord

ing

to

the

regu

latio

ns, b

ut th

e m

edic

al e

ngin

eer d

oes

not o

bser

ve th

eir r

epai

r by

com

pani

es

The

repa

ir of

med

ical

eq

uipm

ent i

s in

acc

ord‑

ance

with

the

regu

latio

ns

and

the

med

ical

eng

inee

r do

es o

bser

ve th

eir r

epai

r by

com

pani

es

Nec

essi

ty o

f war

rant

y an

d af

ter‑

sale

s se

rvic

e in

re

pair

Doc

umen

tatio

n re

view

Hea

d of

Med

ical

Eng

inee

r‑in

g U

nit

Med

ical

equ

ipm

ent h

as n

o w

arra

nty

or a

fter

‑sal

es

serv

ice

Som

e m

edic

al d

evic

es

have

a w

arra

nty

and

afte

r‑sa

les

serv

ice

Med

ical

equ

ipm

ent h

as

war

rant

y or

aft

er‑s

ales

se

rvic

e

Repa

ir of

vita

l and

cap

ital

equi

pmen

t by

allo

wed

ag

enci

es

Inte

rvie

w–d

ocum

enta

tion

revi

ewH

ead

of M

edic

al E

ngin

eer‑

ing

Uni

tCa

pita

l equ

ipm

ent i

s no

t re

paire

d by

allo

wed

ag

enci

es

Som

e of

the

capi

tal e

quip

‑m

ent i

s re

paire

d by

al

low

ed a

genc

ies

Capi

tal e

quip

men

t is

repa

ired

by a

llow

ed

agen

cies


Tabl

e 1

(con

tinue

d)

Dim

ensi

onSt

anda

rds

Dat

a co

llect

ion

met

hod

Dat

a co

llect

ion

sour

ceSc

ores

01

2

Mak

e it

poss

ible

to re

pair

the

devi

ce in

side

the

hosp

ital

Inte

rvie

wH

ead

of M

edic

al E

ngin

eer‑

ing

Uni

tIt

is n

ot p

ossi

ble

to re

pair

som

e m

edic

al e

quip

‑m

ent i

nsid

e th

e ho

spita

l

It is

pos

sibl

e to

repa

ir so

me

med

ical

equ

ipm

ent i

nsid

e th

e ho

spita

l

Dec

omm

issi

onin

gO

bser

ving

the

deco

m‑

mis

sion

ing

proc

ess

in

mai

nten

ance

man

age‑

men

t

Obs

erva

tion–

docu

men

ta‑

tion

revi

ew–i

nter

view

Hea

d of

Med

ical

Eng

inee

r‑in

g U

nit

The

deco

mm

issi

onin

g pr

oces

s is

not

follo

wed

ac

cord

ing

to th

e in

stru

c‑tio

ns a

nd n

otifi

catio

n ru

les

The

deco

mm

issi

onin

g pr

o‑ce

ss is

follo

wed

acc

ordi

ng

to th

e in

stru

ctio

ns a

nd

notifi

catio

n ru

les

Out

sour

cing

Com

mun

icat

ion

with

re

puta

ble

com

pani

esIn

terv

iew

–doc

umen

tatio

n re

view

Hea

d of

Med

ical

Eng

inee

r‑in

g U

nit

Med

ical

eng

inee

ring

unit

is n

ot a

ssoc

iate

d w

ith

repu

tabl

e co

mpa

nies

Med

ical

eng

inee

ring

unit

is

asso

ciat

ed w

ith re

puta

ble

com

pani

es

inve

stig

ate

the

per‑

form

ance

of p

rivat

e co

mpa

nies

Inte

rvie

wH

ead

of M

edic

al E

ngin

eer‑

ing

Uni

tTh

e pe

rfor

man

ce o

f pr

ivat

e co

mpa

nies

is

not m

onito

red

by th

e D

epar

tmen

t of M

edic

al

Equi

pmen

t

The

perf

orm

ance

of p

rivat

e co

mpa

nies

is m

onito

red

by th

e D

epar

tmen

t of

Med

ical

Equ

ipm

ent

The

role

of t

hird

par

ties

in

qual

ity c

ontr

olIn

terv

iew

Hea

d of

Med

ical

Eng

inee

r‑in

g U

nit

Qua

lity

cont

rol i

s no

t don

e by

priv

ate

com

pani

esQ

ualit

y co

ntro

l is

done

by

priv

ate

com

pani

es

Buy

mai

nten

ance

sof

twar

e fro

m p

rivat

e co

mpa

nies

Obs

erva

tion–

docu

men

ta‑

tion

revi

ewH

ead

of M

edic

al E

ngin

eer‑

ing

Uni

tM

aint

enan

ce s

oftw

are

is n

ot p

urch

ased

from

pr

ivat

e co

mpa

nies

Mai

nten

ance

sof

twar

e is

pu

rcha

sed

from

priv

ate

com

pani

es

Coop

erat

ion

and

coor

di‑

natio

n of

min

istr

ies

and

univ

ersi

ties

with

priv

ate

com

pani

es

Inte

rvie

wM

inis

try

and

univ

ersi

ty

offici

als

The

Min

istr

y an

d th

e U

ni‑

vers

ity d

o no

t coo

pera

te

with

priv

ate

com

pani

es

The

Min

istr

y an

d th

e U

nive

rsity

coo

pera

te w

ith

priv

ate

com

pani

es

Out

sour

cing

of s

ervi

ce,

mai

nten

ance

and

repa

irD

ocum

enta

tion

revi

ewH

ead

of M

edic

al E

ngin

eer‑

ing

Uni

tO

utso

urci

ng d

oes

not

have

a g

ener

al fr

ame‑

wor

k ac

cord

ing

to th

e re

gula

tions

Out

sour

cing

doe

s no

t hav

e a

gene

ral f

ram

ewor

k ac

cord

ing

to th

e re

gula

‑tio

ns


Tabl

e 1

(con

tinue

d)

Dim

ensi

onSt

anda

rds

Dat

a co

llect

ion

met

hod

Dat

a co

llect

ion

sour

ceSc

ores

01

2

Des

igni

ng a

nd im

plem

enta

tion

Proc

ess

man

agem

ent

Form

atio

n of

join

t co

mm

ittee

s by

the

Dep

artm

ent o

f Med

ical

Eq

uipm

ent

Doc

umen

tatio

n re

view

Hea

d of

Med

ical

Eng

inee

r‑in

g U

nit

The

com

mitt

ee’s

min

utes

ar

e no

t ava

ilabl

eTh

e m

inut

es o

f the

com

‑m

ittee

are

ava

ilabl

e, b

ut

not c

ompl

ete

The

min

utes

of t

he c

omm

it‑te

e ar

e co

mpl

ete

Defi

ne th

e le

vel o

f use

r ac

cess

to m

edic

al e

quip

‑m

ent

Inte

rvie

wH

ead

of M

edic

al E

ngi‑

neer

ing

Uni

t, M

edic

al

Engi

neer

s an

d Te

chni

cal

Tech

nici

ans/

Use

rs

The

user

acc

ess

leve

l po

licy

is n

ot d

efine

dTh

e us

er a

cces

s le

vel i

s de

fined

acc

ordi

ng to

the

rele

vant

pol

icy

Inte

r‑se

ctor

ial c

omm

uni‑

catio

n in

hos

pita

lsIn

terv

iew

–obs

erva

tion

Hea

d of

Med

ical

Eng

i‑ne

erin

g U

nit,

Med

ical

En

gine

ers

and

Tech

nica

l Te

chni

cian

s/U

sers

The

Med

ical

Eng

inee

r‑in

g U

nit d

oes

not h

ave

a sp

ecifi

c pr

otoc

ol fo

r co

mm

unic

atin

g w

ith

othe

r dep

artm

ents

and

un

its

The

Med

ical

Eng

inee

ring

Uni

t has

a s

peci

fic p

roto

‑co

l for

com

mun

icat

ing

with

oth

er d

epar

tmen

ts

and

units

Plan

ning

for m

aint

enan

ce

in th

e offi

ce o

f med

ical

eq

uipm

ent

Inte

rvie

w–d

ocum

enta

tion

revi

ewH

ead

of M

edic

al E

quip

‑m

ent D

epar

tmen

tTh

e M

edic

al E

ngin

eerin

g U

nit h

as n

o pl

ans

for

any

med

ical

equ

ipm

ent

mai

nten

ance

act

iviti

es

The

Med

ical

Eng

inee

ring

Uni

t has

pla

ns fo

r som

e m

edic

al e

quip

men

t m

aint

enan

ce a

ctiv

ities

The

Med

ical

Eng

inee

r‑in

g U

nit h

as p

lans

for

all m

edic

al e

quip

men

t m

aint

enan

ce a

ctiv

ities

Dev

elop

and

defi

ne in

ter‑

nal p

olic

ies

Doc

umen

tatio

n re

view

Hea

d of

Med

ical

Eng

inee

r‑in

g U

nit

No

polic

y ha

s be

en

deve

lope

d fo

r the

m

aint

enan

ce o

f med

ical

eq

uipm

ent

A p

olic

y ha

s be

en d

evel

‑op

ed to

mai

nten

ance

m

edic

al e

quip

men

t

Dev

elop

an

actio

n pl

an fo

r th

e m

edic

al e

ngin

eer‑

ing

unit

Doc

umen

tatio

n re

view

Hea

d of

Med

ical

Eng

inee

r‑in

g U

nit

An

actio

n pl

an fo

r m

aint

aini

ng m

edic

al

equi

pmen

t has

not

bee

n de

velo

ped

An

actio

n pl

an fo

r mai

ntai

n‑in

g m

edic

al e

quip

men

t ha

s be

en d

evel

oped

Man

agem

ent i

nfra

stru

c‑tu

re in

the

med

ical

eq

uipm

ent d

epar

tmen

t

Inte

rvie

wH

ead

of M

edic

al E

quip

‑m

ent D

epar

tmen

t/H

ead

of M

edic

al E

ngin

eerin

g U

nit

The

Dep

artm

ent o

f Med

i‑ca

l Equ

ipm

ent d

oes

not

have

a s

tron

g in

frast

ruc‑

ture

The

Dep

artm

ent o

f Med

ical

Eq

uipm

ent h

ave

a st

rong

in

frast

ruct

ure


Tabl

e 1

(con

tinue

d)

Dim

ensi

onSt

anda

rds

Dat

a co

llect

ion

met

hod

Dat

a co

llect

ion

sour

ceSc

ores

01

2

Exis

tenc

e of

a s

peci

fic

asse

ssm

ent s

truc

ture

fo

r mai

ntai

ning

med

ical

eq

uipm

ent

Inte

rvie

w–o

bser

vatio

nH

ead

of M

edic

al E

quip

‑m

ent D

epar

tmen

t/H

ead

of M

edic

al E

ngin

eerin

g U

nit

Med

ical

equ

ipm

ent m

ain‑

tena

nce

does

not

hav

e a

clea

r str

uctu

re fo

r ass

ess‑

ing

this

pro

cess

Med

ical

equ

ipm

ent m

ain‑

tena

nce

does

not

hav

e a

clea

r str

uctu

re fo

r ass

ess‑

ing

this

pro

cess

Prol

onge

d ad

min

istr

ativ

e pr

oces

ses

Inte

rvie

wH

ead

of M

edic

al E

quip

‑m

ent D

epar

tmen

t/H

ead

of M

edic

al E

ngin

eerin

g U

nit

The

adm

inis

trat

ive

proc

ess

is lo

ng a

nd c

umbe

rsom

eTh

e ad

min

istr

ativ

e pr

oces

s is

not

long

and

cum

ber‑

som

e

Cre

atin

g un

ity o

f pro

‑ce

dure

in th

e m

edic

al

engi

neer

ing

unit

Inte

rvie

w–o

bser

vatio

nH

ead

of M

edic

al E

ngin

eer‑

ing

Uni

tTh

e M

edic

al E

ngin

eerin

g U

nit d

oes

not h

ave

the

unity

of p

roce

dure

in

the

impl

emen

tatio

n of

aff

airs

The

Med

ical

Eng

inee

ring

Uni

t has

the

unity

of p

ro‑

cedu

re in

the

impl

emen

‑ta

tion

of a

ffairs

Know

ledg

e an

d at

titud

eM

edic

al p

rofe

ssio

nal

dom

inan

ce in

hos

pita

lsIn

terv

iew

Hea

d of

Med

ical

Equ

ip‑

men

t Dep

artm

ent/

Hea

d of

Med

ical

Eng

inee

ring

Uni

t

Ther

e is

Med

ical

pro

fes‑

sion

al d

omin

ance

in

hosp

itals

to b

uy a

nd

choo

se m

edic

al e

quip

‑m

ent

Ther

e is

not

Med

ical

pro

fes‑

sion

al d

omin

ance

in h

os‑

pita

ls to

buy

and

cho

ose

med

ical

equ

ipm

ent

Invo

lvem

ent o

f non

‑ex

pert

s in

the

med

ical

eq

uipm

ent d

epar

tmen

t

Inte

rvie

wH

ead

of M

edic

al E

quip

‑m

ent D

epar

tmen

t/H

ead

of M

edic

al E

ngin

eerin

g U

nit

Non

‑exp

erts

are

invo

lved

in

dec

isio

n‑m

akin

g an

d po

licy‑

mak

ing

in th

e fie

ld o

f med

ical

equ

ip‑

men

t

Expe

rts

are

invo

lved

in

deci

sion

‑mak

ing

and

polic

y m

akin

g in

the

field

of

med

ical

equ

ipm

ent

The

corr

ect u

nder

stan

ding

of

man

agem

ent a

nd

user

s ho

spita

l abo

ut

mai

nten

ance

man

age‑

men

t

Inte

rvie

wH

ospi

tal m

anag

emen

t an

d us

ers

Hos

pita

l man

agem

ent a

nd

user

s ar

e no

t fam

iliar

w

ith m

aint

enan

ce m

an‑

agem

ent

Hos

pita

l man

agem

ent a

nd

user

s ar

e fa

mili

ar w

ith

mai

nten

ance

man

age‑

men

t

Cha

nge

the

view

of t

he

offici

als

to th

e m

edic

al

engi

neer

ing

unit

Inte

rvie

wH

ead

of M

edic

al E

quip

‑m

ent D

epar

tmen

t/H

ead

of M

edic

al E

ngin

eerin

g U

nit

The

med

ical

eng

inee

ring

unit

in th

e ho

spita

l doe

s no

t hav

e a

spec

ific

and

esta

blis

hed

posi

tion

The

med

ical

eng

inee

ring

unit

in th

e ho

spita

l has

a

spec

ific

and

esta

blis

hed

posi

tion


Tabl

e 1

(con

tinue

d)

Dim

ensi

onSt

anda

rds

Dat

a co

llect

ion

met

hod

Dat

a co

llect

ion

sour

ceSc

ores

01

2

Purc

hasi

ng m

anag

emen

tBu

y th

e de

vice

from

the

web

site

of r

eput

able

co

mpa

nies

Doc

umen

tatio

n re

view

Hea

d of

Med

ical

Equ

ip‑

men

t Dep

artm

ent/

Hea

d of

Med

ical

Eng

inee

ring

Uni

t

Med

ical

equ

ipm

ent i

s no

t pu

rcha

sed

from

repu

ta‑

ble

com

pani

es

Med

ical

equ

ipm

ent i

s pu

rcha

sed

from

repu

tabl

e co

mpa

nies

To b

uy e

quip

men

t bas

ed

on n

eed

Doc

umen

tatio

n re

view

Hea

d of

Med

ical

Equ

ip‑

men

t Dep

artm

ent/

Hea

d of

Med

ical

Eng

inee

ring

Uni

t

Med

ical

equ

ipm

ent i

s no

t pu

rcha

sed

base

d on

the

need

s of

the

area

and

th

e ta

rget

Med

ical

equ

ipm

ent i

s pu

rcha

sed

base

d on

the

need

s of

the

area

and

the

targ

et


be used if we are looking for the views and attitudes of stakeholders. Dimensions that require documentation will be assessed through documentation review. The observation method is also for assessing physical items.

DiscussionIn the field of medical equipment maintenance management, there is no single and standard checklist that includes all hospitals in the country. The only available check-lists include accreditation measures that generally assess the tasks and activities of the medical engineering unit. Since the issue of maintenance management includes a wide variety of topics, and in the low- and middle-income countries, there is major weakness in this regard, so we decided to design a checklist for uniformity and accurate and com-prehensive assessment using Iranian context. The Departments of Medical Equipment of some provinces in Iran have designed a checklist natively for its affiliated hospitals, the dimension and method of which are different. For example, the maintenance man-agement evaluation checklist of Tabriz Medical Equipment Office includes 15 indica-tors (technical force, medical engineering unit, medical equipment ID, quality control tests, PM, training, medical equipment and spare parts storage, service and maintenance contract, the existence of purchase process, the existence of decommissioning process, the existence of recall system and reporting of adverse events, ensuring sound electric-ity, implementing a continuous maintenance improvement process, familiarizing with the general administration’s rules and website, management and allocating a separate budget for maintenance).

According to the medical equipment maintenance management criteria of the MOHME, some of these dimensions can be merged into one dimension and some can be separated. In addition, each of the indicators and sub-indicators can be expanded. That is, not all maintenance management issues are addressed. The scoring and classification of dimensions in this checklist does not have a specific standard and does not include all dimensions of maintenance according to the maintenance criteria of the MOHME and is generally designed.

Herrera-Galán [16] evaluated the performance of the maintenance function through management audits and their implementation in five hospitals. The aspects evaluated include equipment availability, response to a service request, monitoring and control of biomedical equipment, staff training, quality of work executed by the maintenance technicians, the workload of maintenance technicians, control of the work executed by the maintenance technicians, the effectiveness of annual maintenance planning and department performance. The results of this research show that the audit technique is a valuable checklist in the performance assessment of a hospitals. The application of the proposed method evidenced that the most critical component in the results of a man-agement audit is the human resource [16].

An effective medical equipment maintenance program consists of three main ele-ments. (1) Identifying the medical devices that need to maintenance program by the Ministry of Health. (2) Financial management, personal management, performance monitoring, operational management and performance improvement. (3) Proper imple-mentation of the maintenance program. These three elements are also considered in the


designed checklists in different dimensions such as resources, designing and implemen-tation [17].

The maintenance and its management constitute a checklist that ensures the equip-ment performance. There exist four criteria in which the hospitals coincide that they should improve, even though each of them in different measure and sub-criterion. These criteria are an organization of maintenance; human resources; planning, pro-gramming and control of the maintenance and corrective maintenance. These crite-ria are among the sub-categories of maintenance management assessment checklists [18].

Amerion et al. [19] identified effective factors on the MEMM in a military hospital. Among effective factors on the MEMM, 26 components were extracted. User training components, human resources, commitment and the experience of users, the foreign exchange market, periodic visits, and trade name were the most important components which had more than 75% of the relative abundance. According to the results, factors with high importance on the management of medical equipment maintenance should be supported by the center’s directors. Attention to the use of these components can reduce maintenance costs, and therefore, increase the life of medical equipment. User training and human resources are the two main dimensions of this checklist [19].

According to the current results, documentation and service are two dimensions of MEMM. The problems of some hospitals in MEMM were introduced from the aspects of maintenance time, maintenance record, maintenance service and self-maintenance. Some measures were proposed including simplifying maintenance process through PDCA, information maintenance record, cooperating with the third-party maintainer and establishing self-maintenance team, so that precision and infor-mation medical equipment management can be realized to maximize the benefit of medical equipment management [20].

The medical equipment requires maintenance (both scheduled and unscheduled) during its useful life. The medical equipment maintenance process should be planned, implemented, monitored, and improved continually. This process requires careful supervision by healthcare administrators, many of whom may not have the technical background to understand all of the relevant factors. Maintenance management is the most important function in overall medical equipment management. In this regard, implementation of appropriate maintenance strategies requires the following types of resources: human resources, material resources, financial resources and documenta-tion. Our findings also point to the importance of these resources [21].

We need a comprehensive assessment checklist that covers all aspects of medical equipment maintenance management in hospitals. In this regard, the identification of influential factors is essential. Eighty-nine factors were identified that affect MEMM. Five of the factors were found related to resources item, 12 factors related to service, 4 factors related to education, 15 of these factors regarding quality control, 19 fac-tors related to inspection, 12 factors related to information bank and 22 factors were dedicated to management. These factors are implicated in decision-making in sup-port of selection, purchase, repair and maintenance of medical equipment, especially for capital equipment managers and medical engineers in hospitals and also for the assessment of this process. Identification and classification of influential factors can


be of help for raising critical alerts about the types of equipment more prone to main-tenance problems [14].

Strengths and limitationsIn our knowledge, this study is the first comprehensive study of-its-kind addressing all of the factors affecting an effective and efficient MEMM. It offers comprehensive check-lists for assessing the status of MEMM. In addition, the present compiled checklist is the result of multi-method research in such a way that its components are determined through systematic review and obtaining the views of experts and specialists in this field. This indicates the validity and comprehensiveness of the checklists developed.

Lack of enough information concerning the concept of maintenance management, lack of specific guidelines and instructions were the most notable limitations.

ConclusionEffective maintenance management of medical devices increases the efficiency and pro-ductivity of health technology resources, which is especially important when resources are limited. This allows patients to access medical equipment that can provide an accu-rate diagnosis, effective treatment, or appropriate rehabilitation. Several factors affect the management of medical equipment maintenance, and it is important to follow each of them to improve the performance of devices and provide medical services to patients. Therefore, before designing an assessment checklist, we need to consider a specific framework for the maintenance management process to include all maintenance activi-ties. The medical equipment maintenance management assessment checklists allow for the timely identification of deficiencies and gaps in the medical equipment maintenance management process so that the necessary steps can be taken. It also can help managers and engineers to assess maintenance status and provide solutions and interventions for the decision makers and policymakers to improve its.

MethodsThe present study was a multi-methods study in four stages. In the first stage, a sys-tematic review on data related to factors which affect the assessment of MEMM was conducted. Then, a qualitative study was designed to investigate these factors from expert view and related documents. In the end, the results of the first and second stages were combined using content analysis and the final checklist was developed.

Stage 1

A systematic search of the following databases was conducted during October 2015 in the PubMed, ProQuest, Scopus, Embase, and Web of Science. The search was updated in June 2017. Our search strategy was as follow: ((“medical device*”[Title/Abstract]) OR “medical equipment”[Title/Abstract]) AND “maintenance management”[Title/Abstract])) [14]. At first, we extracted the items, then categorized the extracted items based on the Ministry of Health and Medical Education of Iran (MOHME) framework in each category [13].


Stage 2

In the qualitative step, semi-structured interviews and documents review were used for data collection. The collected data consisted of the perspectives of medical and biomedical engineers concerning factors influencing MEMM. Related documents were regulations of MEMM, MEMM guidelines and other related regulations or reports developed by MOHME. The content analysis approach (inductive and deduc-tive) was used to analyze the data. The extracted codes were sorted into both themes and subthemes based on comparisons between similarities and differences that were categorized into 7 main themes and 22 subthemes [15].

Stages 3

In this stage, the researchers combined the extracted data from systematic review and qualitative study using a content analysis and devised the first draft of the checklist. The primary checklist was developed in the form of assessment checklists in seven dimen-sions (providing resources, quality control tests, preventive inspection and maintenance, database, training, service, design and implementation).

Stages 4

We sent the primary draft of checklist through a Delphi to 20 experts who had sufficient scientific and information background in the field of MEMM for assessing the validity and reliability. Of them seven experts participated in this stages and send their com-ments. In the first round, experts commented on the content, dimensions, writing and appearance of the primary checklist. The research team modified the primary version based on expert’s comments and sends it again to experts. Eventually, the proposed checklist was finalized after approving the experts.AcknowledgementsThe current study is a part of MSc thesis in Healthcare Management, Rona Bahreini. The authors appreciate Tabriz Univer‑sity of Medical Sciences for its financial support.

Authors’ contributionsRB conceived of the presented idea. AI and LD were in charge of overall direction and planning. RB and MAZ drafted the manuscript. AI, LD, RB and MAZ contributed to the design and implementation of the research. All the authors discussed the results and commented on the manuscript. RB and MAZ revised the manuscript based on the reviewer’s comments. All the authors read and approved the final manuscript.

FundingThis study was funded by Tabriz University of Medical Sciences. This study is a part of MSc thesis that has been done with the ethical code TBZMED.REC.1394.570.

Availability of data and materialsThe datasets of this study are available from the corresponding authors upon reasonable request.

Declarations

Ethics approval and consent to participateThis study is a part of MSc. thesis that has been done under the support of Tabriz University of Medical Sciences with the ethical code TBZMED.REC.1394.570.

Consent for publicationAll the authors confirmed the consent for publication.

Competing interestsThe authors declare that they have no conflict of interest.


Author details1 Social Determinants of Health Research Center, Birjand University of Medical Sciences, Birjand, Iran. 2 Health Econom‑ics Department, Tabriz Health Services Management Research Center, School of Management and Medical Informatics, Tabriz University of Medical Sciences, Tabriz, Iran. 3 Tabriz Health Services Management Research Center, Iranian Center of Excellence in Health Management, School of Management and Medical Informatics, Tabriz University of Medical Sciences, Tabriz, Iran. 4 Department of Health Sciences (HLV), Public Health Science, Mid Sweden University, Sundsvall, Sweden. 5 Higher School of Public Health, Al Farabi Kazakh National University, Almaty, Kazakhstan. 6 Tabriz Health Ser‑vices Management Research Center, Iranian Center of Excellence in Health Management, Student Research Committee, School of Management and Medical Informatics, Tabriz University of Medical Sciences, Tabriz, Iran.

Received: 6 October 2020 Accepted: 30 December 2020

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