16
IEEE Proof IEEE JOURNAL OF BIOMEDICAL AND HEALTH INFORMATICS, VOL. 00, NO. 00, 2014 1 Preventive Maintenance Prioritization Index of Medical Equipment Using Quality Function Deployment 1 2 3 Neven Saleh, Amr A. Sharawi, Manal Abd Elwahed, Alberto Petti, Daniele Puppato, and Gabriella Balestra 4 5 Abstract—Preventive maintenance is a core function of clinical 6 engineering, and it is essential to guarantee the correct functioning 7 of the equipment. The management and control of maintenance 8 activities are equally important to perform maintenance. As the 9 variety of medical equipment increases, accordingly the size of 10 maintenance activities increases, the need for better management 11 and control become essential. This paper aims to develop a new 12 model for preventive maintenance priority of medical equipment 13 using quality function deployment as a new concept in mainte- 14 nance of medical equipment. We developed a three-domain frame- 15 work model consisting of requirement, function, and concept. The 16 requirement domain is the house of quality matrix. The second 17 domain is the design matrix. Finally, the concept domain gener- 18 ates a prioritization index for preventive maintenance considering 19 the weights of critical criteria. According to the final scores of 20 those criteria, the prioritization action of medical equipment is 21 carried out. Our model proposes five levels of priority for preven- 22 tive maintenance. The model was tested on 200 pieces of medical 23 equipment belonging to 17 different departments of two hospi- 24 tals in Piedmont province, Italy. The dataset includes 70 different 25 types of equipment. The results show a high correlation between 26 risk-based criteria and the prioritization list. 27 Index Terms—Medical equipment, preventive maintenance 28 (PM), prioritization, quality function deployment (QFD). 29 I. INTRODUCTION 30 P REVENTIVE maintenance (PM) is a core function of clin- 31 ical engineering, having as objectives the assurance of 32 ongoing safety and performance of medical devices and the 33 preservation of the investment in the equipment through im- 34 proved longevity [1]. PM is mainly a risk-based approach and 35 considered as a core function of Clinical Engineering Depart- 36 ment [2]. Despite its core role, the design and management of an 37 effective PM program is not a simple matter. Adequate admin- 38 istrative support is a requirement for an effective PM program. 39 Manuscript received November 19, 2013; revised June 12, 2014; accepted July 4, 2014. Date of publication; date of current version. N. Saleh is with the Politecnico di Torino, 10129 Turin, Italy (e-mail: nevensaleh76@ gmail.com). A. Sharawi and M. Abd Elwahed are with the Systems and Biomedical Engineering Department, Faculty of Engineering, Cairo University, Giza, Egypt (e-mail: [email protected]; [email protected]). A. Petti is with ASLBI, 13900 Biella, Italy (e-mail: Alberto.petti@ aslbi.piemonte.it). D. Puppato is with ARESS, 10122 Turin, Italy (e-mail: [email protected]). G. Balestra is with the Electronic and Telecommunication Department, Politecnico di Torino, 10129 Turin, Italy (e-mail: [email protected]). Color versions of one or more of the figures in this paper are available online at http://ieeexplore.ieee.org. Digital Object Identifier 10.1109/JBHI.2014.2337895 The two key issues for PM are the procedures to be executed 40 and execution frequencies [1]–[3]. The procedures indicate the 41 necessary steps that are required to assure the performance of 42 the device, whereas the second key is the frequency at which 43 the set of procedures should be done. 44 Maintenance prioritization is a crucial task in management 45 systems, especially when there are more maintenance work or- 46 ders than available people or resources that can handle those 47 devices [4]. The literature is rich with different prioritization 48 approaches for medical equipment. In [5], Joseph and Mad- 49 hukumar have developed a model for PM index considering 50 risk level coefficient (RLC) of the instrument. RLC was cal- 51 culated through five different classified factors related to the 52 medical equipment electrical risk. The factors are static risk, 53 degree and quality of safety arrangements, insulation, physical 54 risk, and equipment contact with the patient. 55 In another work [6], the authors developed the system of infor- 56 mation technology and support system for maintenance actions 57 (SISMA). The system considers two aspects for PM evaluation: 58 technical and economic needs to assess PM plan for medical 59 equipment. Analytical Hierarchy Process was used in [7] as 60 a multicriteria decision making tool to develop a maintenance 61 priority index for medical equipment. 62 II. BACKGROUND 63 Quality function deployment (QFD) is one of the total qual- 64 ity management quantitative tools and techniques that could be 65 used to translate customer requirements and specifications into 66 appropriate technical or service requirements [8]. QFD was con- 67 ceived in Japan at the end of 1960s by Yoji Akao. The first usage 68 of QFD was implemented by Mizuno in 1972 to Mitsubishi’s 69 Kobe shipyard site [9]. 70 QFD uses visual matrices that link customer requirements, de- 71 sign requirements, target values, and competitive performance 72 into one chart [8]. Therefore, QFD is considered a quantitative 73 tool that facilitates evaluation of customer’s satisfaction. Typi- 74 cally, a QFD system can be broken into four interlinked phases 75 to fully deploy the customer needs phase by phase [10]. The 76 four-phase model consists of house of quality (HOQ) matrix, 77 design matrix, process planning matrix, and finally production 78 matrix [10], [11]. 79 Among the various matrices, the HOQ is commonly used in 80 the different applications. The HOQ matrix displays the voice of 81 customers (VOC) or customer requirements that are known as 82 2168-2194 © 2014 IEEE. Personal use is permitted, but republication/redistribution requires IEEE permission. See http://www.ieee.org/publications standards/publications/rights/index.html for more information.

Preventive Maintenance Prioritization Index of Medical ...scholar.cu.edu.eg/?q=manal_abdel_wahed/files/jbhi-saleh-2337895-pr… · 14 using quality function deployment as a new concept

  • Upload
    others

  • View
    3

  • Download
    0

Embed Size (px)

Citation preview

Page 1: Preventive Maintenance Prioritization Index of Medical ...scholar.cu.edu.eg/?q=manal_abdel_wahed/files/jbhi-saleh-2337895-pr… · 14 using quality function deployment as a new concept

IEEE

Proo

f

IEEE JOURNAL OF BIOMEDICAL AND HEALTH INFORMATICS, VOL. 00, NO. 00, 2014 1

Preventive Maintenance Prioritization Indexof Medical Equipment Using Quality

Function Deployment

1

2

3

Neven Saleh, Amr A. Sharawi, Manal Abd Elwahed, Alberto Petti, Daniele Puppato,and Gabriella Balestra

4

5

Abstract—Preventive maintenance is a core function of clinical6engineering, and it is essential to guarantee the correct functioning7of the equipment. The management and control of maintenance8activities are equally important to perform maintenance. As the9variety of medical equipment increases, accordingly the size of10maintenance activities increases, the need for better management11and control become essential. This paper aims to develop a new12model for preventive maintenance priority of medical equipment13using quality function deployment as a new concept in mainte-14nance of medical equipment. We developed a three-domain frame-15work model consisting of requirement, function, and concept. The16requirement domain is the house of quality matrix. The second17domain is the design matrix. Finally, the concept domain gener-18ates a prioritization index for preventive maintenance considering19the weights of critical criteria. According to the final scores of20those criteria, the prioritization action of medical equipment is21carried out. Our model proposes five levels of priority for preven-22tive maintenance. The model was tested on 200 pieces of medical23equipment belonging to 17 different departments of two hospi-24tals in Piedmont province, Italy. The dataset includes 70 different25types of equipment. The results show a high correlation between26risk-based criteria and the prioritization list.27

Index Terms—Medical equipment, preventive maintenance28(PM), prioritization, quality function deployment (QFD).29

I. INTRODUCTION30

PREVENTIVE maintenance (PM) is a core function of clin-31

ical engineering, having as objectives the assurance of32

ongoing safety and performance of medical devices and the33

preservation of the investment in the equipment through im-34

proved longevity [1]. PM is mainly a risk-based approach and35

considered as a core function of Clinical Engineering Depart-36

ment [2]. Despite its core role, the design and management of an37

effective PM program is not a simple matter. Adequate admin-38

istrative support is a requirement for an effective PM program.39

Manuscript received November 19, 2013; revised June 12, 2014; acceptedJuly 4, 2014. Date of publication; date of current version.

N. Saleh is with the Politecnico di Torino, 10129 Turin, Italy (e-mail:nevensaleh76@ gmail.com).

A. Sharawi and M. Abd Elwahed are with the Systems and BiomedicalEngineering Department, Faculty of Engineering, Cairo University, Giza, Egypt(e-mail: [email protected]; [email protected]).

A. Petti is with ASLBI, 13900 Biella, Italy (e-mail: [email protected]).

D. Puppato is with ARESS, 10122 Turin, Italy (e-mail: [email protected]).G. Balestra is with the Electronic and Telecommunication Department,

Politecnico di Torino, 10129 Turin, Italy (e-mail: [email protected]).Color versions of one or more of the figures in this paper are available online

at http://ieeexplore.ieee.org.Digital Object Identifier 10.1109/JBHI.2014.2337895

The two key issues for PM are the procedures to be executed 40

and execution frequencies [1]–[3]. The procedures indicate the 41

necessary steps that are required to assure the performance of 42

the device, whereas the second key is the frequency at which 43

the set of procedures should be done. 44

Maintenance prioritization is a crucial task in management 45

systems, especially when there are more maintenance work or- 46

ders than available people or resources that can handle those 47

devices [4]. The literature is rich with different prioritization 48

approaches for medical equipment. In [5], Joseph and Mad- 49

hukumar have developed a model for PM index considering 50

risk level coefficient (RLC) of the instrument. RLC was cal- 51

culated through five different classified factors related to the 52

medical equipment electrical risk. The factors are static risk, 53

degree and quality of safety arrangements, insulation, physical 54

risk, and equipment contact with the patient. 55

In another work [6], the authors developed the system of infor- 56

mation technology and support system for maintenance actions 57

(SISMA). The system considers two aspects for PM evaluation: 58

technical and economic needs to assess PM plan for medical 59

equipment. Analytical Hierarchy Process was used in [7] as 60

a multicriteria decision making tool to develop a maintenance 61

priority index for medical equipment. 62

II. BACKGROUND 63

Quality function deployment (QFD) is one of the total qual- 64

ity management quantitative tools and techniques that could be 65

used to translate customer requirements and specifications into 66

appropriate technical or service requirements [8]. QFD was con- 67

ceived in Japan at the end of 1960s by Yoji Akao. The first usage 68

of QFD was implemented by Mizuno in 1972 to Mitsubishi’s 69

Kobe shipyard site [9]. 70

QFD uses visual matrices that link customer requirements, de- 71

sign requirements, target values, and competitive performance 72

into one chart [8]. Therefore, QFD is considered a quantitative 73

tool that facilitates evaluation of customer’s satisfaction. Typi- 74

cally, a QFD system can be broken into four interlinked phases 75

to fully deploy the customer needs phase by phase [10]. The 76

four-phase model consists of house of quality (HOQ) matrix, 77

design matrix, process planning matrix, and finally production 78

matrix [10], [11]. 79

Among the various matrices, the HOQ is commonly used in 80

the different applications. The HOQ matrix displays the voice of 81

customers (VOC) or customer requirements that are known as 82

2168-2194 © 2014 IEEE. Personal use is permitted, but republication/redistribution requires IEEE permission.See http://www.ieee.org/publications standards/publications/rights/index.html for more information.

Page 2: Preventive Maintenance Prioritization Index of Medical ...scholar.cu.edu.eg/?q=manal_abdel_wahed/files/jbhi-saleh-2337895-pr… · 14 using quality function deployment as a new concept

IEEE

Proo

f

2 IEEE JOURNAL OF BIOMEDICAL AND HEALTH INFORMATICS, VOL. 00, NO. 00, 2014

Fig. 1. HOQ of function deployment [12].

WHATs against the technical requirements or voice of engineers83

(VOE) that are known as HOWs [8]–[11].84

In Fig. 1, a simplified matrix of HOQ is presented depicting85

the main parts of the matrix. The order suggested by letters86

A to F is normally followed during the process. Room “A”87

contains a list of customer needs, each of which is assessed88

against competitors, and the results which are absolute and rela-89

tive weights for customer needs prioritization are reported in to90

room “B.” Room “C” has the information necessary to transform91

the customer expectations into technical characteristics, and the92

correlation between each customer requirements and technical93

response is put into “D.” The roof, room “E,” considers the ex-94

tent to which the technical responses support each other. The95

prioritization of the technical characteristics, information on the96

competition, and technical targets weights all go into “F” [12].97

The most important parts in HOQ are “B” and “F,” respec-98

tively; more details can be found in [12]. The planning matrix99

“B” is calculated based on a comparison between the intended100

service within a hospital and other hospitals. In this matrix,101

the importance of customer requirements is evaluated, and the102

actual evaluations of the customer requirements are assigned.103

The goal is the expected value for each requirement, and then,104

the improvement ratio is calculated by dividing the goal to the105

evaluation of the intended requirements. The absolute weight106

is calculated by multiplication of goal and importance ratio,107

while the relative weight is the normalization of the absolute108

weight. Technical targets, room “F,” are prioritized through cal-109

culating the absolute weight of HOWs as given in (1) and then110

normalizing it to determine the relative weight [13]111

Absolute weight =∑

id WHAT XRWH (1)

where id WHAT is the importance degree of WHAT and RWH112

is the relationship value between WHAT and HOW.113

According to the characteristics of the QFD technique,114

our objective is to employee QFD as a new approach in115

medical equipment management to solve the problem of116

PM prioritization of medical equipment considering a set of117

influential criteria.118

Fig. 2. Proposed three-domain framework for PM of medical equipment pri-oritization.

III. METHODOLOGY 119

By using QFD, we proposed a three-domain framework for

Q1

120

PM priority, as illustrated in Fig. 3: requirement domain, func- 121

tion domain, and concept domain. 122

The first domain considers the customer requirements and the 123

technical characteristics that meet the customer requirements, 124

i.e., HOQ of the model. The second domain is the function 125

domain, in which the top technical criteria that resulted in first 126

domain will be measured through new criteria to identify the 127

critical criteria for PM prioritization, i.e., top HOWs of the first 128

domain becomes the new WHATs of the second domain. In 129

last domain, the concept domain, a priority score (PS) index is 130

generated considering the weights of critical criteria in order to 131

determine PM priority of medical equipment. 132

A. Requirement Domain 133

The HOQ of PM prioritization model is the requirement do- 134

main of this framework. First, customer needs and technical 135

characteristics should be identified. In general, the customers 136

of medical equipment in hospitals include all customers that 137

have a direct interface with medical equipment and who ex- 138

pect a range of services. In particular, the patients and clinical 139

staff are considered the customers (WHATs) of medical equip- 140

ment, whereas the Clinical Engineering Department is consid- 141

ered the one who is responsible to satisfy those requirements 142

(HOWs). 143

For patient’s requirements, no doubt that safety and avail- 144

ability of medical equipment are essential needs. Clinical staff 145

requirements were chosen based upon the literature [14] and 146

experience. Table I depicts the proposed customer’s require- 147

ments and technical characteristics. Prioritization of customer’s 148

requirements is performed considering a comparison between 149

Italian hospital and Jordanian hospital [14]. 150

Table I shows that customer’s requirements are met by ad- 151

dressing five technical characteristics: risk, performance assur- 152

ance, user competence, costs, and standard compliance, which 153

are presented with its subcriteria in this table. The requirement 154

domain (HOQ) is shown in Fig. 3. 155

The matrix is organized referring to Fig. 1; the left column 156

contains customer requirements (VOC), whereas the main part 157

Page 3: Preventive Maintenance Prioritization Index of Medical ...scholar.cu.edu.eg/?q=manal_abdel_wahed/files/jbhi-saleh-2337895-pr… · 14 using quality function deployment as a new concept

IEEE

Proo

f

SALEH et al.: PM PRIORITIZATION INDEX OF MEDICAL EQUIPMENT USING QFD 3

TABLE ICUSTOMER REQUIREMENTS AND TECHNICAL CHARACTERISTICS OF HOQ

OF THE PROPOSED FRAMEWORK

Customer Requirements Technical Requirements

Criteria Subcriteria

Safety of medical.equipment.Efficiency.Durability.Quick response oftechnical team.Back up availability.Check the device aftermaintenance.Regular monitoring ofthe devices.

Risk Physical risk FunctionMaintenancerequirements

Priority based onimportance.Obvious operatinginstructions.Knowledge ofmaintained devices.Existence of a contactperson 24 h.Avoiding suspension ofservices.

PerformanceAssurance

Mission criticalityFunction verification AgeLabeling Electrical safety

Parts replacementRegular inspection

UserCompetence

Qualification oftechnicians Complexity

of devices Equippedworkshop Test equipment

availability Servicemanual availabilityActivities recording

Costs Updating or loan Spareparts availability Service

provider typeStandards Meet standards

of the matrix contains the technical characteristics (VOE) seg-158

mented into five columns and the relationship matrix. The right159

column is the planning matrix of HOQ. The bottom room is160

the technical target matrix. The relationships between WHATs161

and HOWs are indicated by scores 9 for strong relation, 3162

for medium relation, 1 for low relation, and blank for no163

relation [11]–[13].164

In order to demonstrate how customer needs are prioritized,165

consider “safety” requirement as an example, by using five-166

point scale, we evaluate 5 for importance, 3 for Italian hospital,167

5 for Jordanian hospital, and 5 for goal. Regarding our per-168

spective to Italian hospital, the improvement ratio is calculated169

by dividing the goal to Italian hospital, i.e., 5/3. The absolute170

weight is calculated through multiplication of improvement ra-171

tio by importance, i.e., 1.7 × 5; meanwhile, the relative weight172

is obtained by normalizing the absolute weight, i.e., (8.3/91.5)173

∗ 100. As such for technical targets, to explain how technical174

criteria priority is identified, we consider “physical risk” as an175

example. Utilizing formula (1), the absolute weight of “physical176

risk” equals 9 × 9.1 + 9 × 7.3 + 9 × 4.4 + 3 × 8.7 = 213.3,177

and the relative weight is calculated also by normalization178

to become 5.03.179

B. Function Domain180

The next stage of our proposed model is to identify the critical181

criteria among the technical criteria for PM priority. We selected182

the top 11 criteria of technical terms based upon their weights 183

and importance to become the inputs (WHATs) of the second 184

matrix as illustrated in Fig. 4. The design matrix is constructed 185

with the same way that is followed in building the HOQ in 186

Fig. 3, except the planning matrix; it is the top 11 output relative 187

weights of HOQ. 188

For better representation of five addressing criteria dimen- 189

sions, we propose all subcriteria with relative weight greater 190

than 4.5% to be selected as top criteria in order to cover a wide 191

range of criteria ranging from risk criteria with its clear impact 192

in PM to a regular inspection since it is not regularly followed by 193

a lot of hospitals especially in developing countries. The criteria 194

are function, mission criticality, service provider type, standards 195

compliance, maintenance requirements, age, functional verifi- 196

cations, team qualification, device complexity, physical risk, and 197

regular inspection. 198

We classified the critical criteria into three categories for 199

HOWs of the second matrix: risk-based criteria including func- 200

tion, physical risk, and maintenance requirements; mission- 201

based criteria including utilization level, area criticality, and 202

device criticality; and finally maintenance-based criteria incor- 203

porating, failure rate, useful life ratio, device complexity, num- 204

ber of missed maintenance, and downtime ratio. The criteria 205

were selected based upon the literature [3], [5]–[7], [14], in 206

addition to the authors experience. 207

The matrix roof depicts the relations among HOWs [15]. 208

Strong relation is indicated by •, medium by �, and low by 209

o. The relationships are proposed according to author’s expe- 210

rience. As shown in Fig. 4, the planning part of design matrix 211

(importance of WHATs) is the resultant relative weight of top 212

11 criteria of first domain. The critical targets of the technical 213

criteria are considered based upon the proposed thresholds as 214

presented in Table II. On the other hand, the technical targets, 215

i.e., the absolute weight and relative weight of the technical 216

criteria are calculated as the same for requirement domain. In 217

fact, the resultant ranking of most critical criteria for PM prior- 218

itization point to risk-based criteria is topping the list of criteria 219

(44.9%) that it is logical with previous survey, followed by 220

mission-based and maintenance-based. 221

C. Concept Domain 222

The concept domain is the output of the design matrix. The 223

output is a prioritization equation considering the 11 most crit- 224

ical factors with the resultant weights. Equation (2) generates 225

the priority index of PM that is presented as scores. Table II 226

illustrates a brief description of the critical criteria and their 227

proposed scores. 228

PS = 11.7(FN) + 12.8(PR) + 20.4(MR) + 11(UL)

+ 6.5(AC) + 11.4(DC) + 8.3(FR) + 5.1(LR)

+ 6.3(CM) + 3.4(MM) + 3.1(DR) (2)

where 229

PS priority score; 230

FN function of equipment; 231

PR physical risk; 232

MR maintenance requirements; 233

Page 4: Preventive Maintenance Prioritization Index of Medical ...scholar.cu.edu.eg/?q=manal_abdel_wahed/files/jbhi-saleh-2337895-pr… · 14 using quality function deployment as a new concept

IEEE

Proo

f

4 IEEE JOURNAL OF BIOMEDICAL AND HEALTH INFORMATICS, VOL. 00, NO. 00, 2014

Fig. 3. HOQ matrix of the QFD model for PM prioritization of medical equipment (requirement domain).

Fig. 4. Design matrix of the QFD model for pm prioritization of medical equipment (function domain).

Page 5: Preventive Maintenance Prioritization Index of Medical ...scholar.cu.edu.eg/?q=manal_abdel_wahed/files/jbhi-saleh-2337895-pr… · 14 using quality function deployment as a new concept

IEEE

Proo

f

SALEH et al.: PM PRIORITIZATION INDEX OF MEDICAL EQUIPMENT USING QFD 5

TABLE IIBRIEF DESCRIPTION OF CRITICAL PARAMETERS AND THEIR PROPOSED SCORES

Parameter Description Thresholds Scores

Function Device function Life supportTherapeuticDiagnostic /monitoringAnalytical

Miscellaneous

543

21

Physical risk Probable harmscaused byequipment

failure

DeathInjury

MisdiagnosisEquipment

damageNo risk

5432

1Maintenancerequirements

Maintenanceactivities

depending onequipment type

ExtensiveA above average

AverageBelow average

Minimal

54321

Utilization level Number ofworking days a

week

4 days3/4 days<3 days

321

Area criticality Assessment ofarea criticality

for patients

UrgentIntensity care

unitsDiagnostic areaLaw intensity

areaNon clinical area

54

32

1Device criticality The importance

level ofequipment inserviced area

CriticalImportantNecessary

321

Failure rate Number offailures a year

based on devicecriticality level

�2 for critical,�4 for

important, �5for necessary

1 for critical, 2/3for important,

3/4 for necessary0 for critical, �1

for important,�2 for necessary

3

2

1

Useful life ratio Ratio betweenage to expected

life time of adevice

Ratio > 80 %50% < Ratio

�80%Ratio � 50 %

32

1Device complexity Technical

complexitybased on a

model

Score 6—8Score 3—5Score 0—2

321

Missed maintenance Number ofmissed

maintenance ayear

� 210

321

Downtime ratio Ratio betweenthe duration ofdowntime in

days to days ayear

Ratio � 20 %10% � Ratio <

20%Ratio < 10 %

32

1

UL utilization level;234

AC area criticality;235

DC device criticality;236

FR failure rate;237

LR useful life ratio;238

CM device complexity;239

MM missed maintenance;240

DR downtime ratio.241

TABLE IIIDATA SAMPLE OF INVESTIGATED EQUIPMENT FOR PM PRIORITY

Equipment FN PR MR UL AC DC FR LR CM MM DR PS PS %

Ventilator 5 5 5 2 5 3 2 3 3 3 1 377 93C-arm 3 3 4 2 5 3 3 3 3 2 2 316 78Monitor 3 3 3 3 3 2 3 3 2 1 1 269 66Centrifuge 2 3 3 3 2 2 1 3 1 1 1 228 56Scale 1 1 1 1 3 1 1 2 1 2 1 121 30

Fig. 5. PM priority index groups based on PS value of the proposed QFDmodel.

The complexity model [16] assesses the technical complexity 242

of a device considering four factors: equipment maintainability, 243

installation requirements, repair, and connectivity. The scores 244

are given for each factor range from 0 to 2 for evaluation based 245

upon the complexity level for each device in the list. 246

IV. RESULTS 247

For model verification, we utilized a dataset of 200 medical 248

equipment of two hospitals with one management system in 249

Piedmont province, Italy. Seventy different types of equipment 250

belonging to 17 different kinds of departments were analyzed 251

along data collected for one year (2012). Table III shows a 252

sample data of various types of investigated equipment along 253

with PS based upon our proposed model. 254

The scores in Table III are obtained referring to the scores that 255

are given in Table II. For instance, considering the “Ventilator” 256

device, and according to concept domain, “Function” is life sup- 257

port, “Physical Risk” is death, “Maintenance Requirements” is 258

extensive, “Area Criticality” is urgent, and “Device Criticality” 259

is critical; meanwhile, other parameters “Failure Rate,” “Useful 260

Life,” “Missed Maintenance,” and “Downtime Ratio” are de- 261

pending on the actual status of each device. Device complexity 262

is calculated relied on complexity model [16]. Accordingly, by 263

utilizing formula (2), the PS for every device is calculated as 264

shown in Table III. 265

By using the result of PS percentages, the PM priority is 266

classified into five categories as illustrated in Fig. 5. The first 267

class is very high-priority class and includes equipment that 268

supposed to be maintained within two weeks with PS percentage 269

equal or greater than 80. In second class, high-priority PM 270

should be performed within one month if priority percentage 271

in range 70–80. Class 3 is medium priority and contains all 272

Page 6: Preventive Maintenance Prioritization Index of Medical ...scholar.cu.edu.eg/?q=manal_abdel_wahed/files/jbhi-saleh-2337895-pr… · 14 using quality function deployment as a new concept

IEEE

Proo

f

6 IEEE JOURNAL OF BIOMEDICAL AND HEALTH INFORMATICS, VOL. 00, NO. 00, 2014

Fig. 6. Results of the PM prioritization index for investigated medical equip-ment.

equipment that should be considered for PM within two months273

in case of priority percentage in range 60–70.274

Class 4 is low priority and includes all equipment with pri-275

ority percentage of 50 to 60, and in this case, PM should be276

performed within three months. Finally, all equipment with pri-277

ority percentage less than 50 could be visually inspected and278

considered for next PM as minimal PM.279

In our dataset of equipment and according to the proposed280

model and priority classification, the results indicate that 30281

devices (15%) need very high priority PM, 39 devices (19%)282

should be included as high priority, 59 devices (30%) should be283

considered for medium priority, 54 devices (27%) for low prior-284

ity, and finally, 18 devices (9%) should be with minimal priority285

PM. Fig. 6 presents dataset output classification considering the286

QFD model.287

By analyzing the results, very high priority class incor-288

porates all equipment with high-risk criteria, relatively high-289

mission-based criteria, and also with high-complexity level.290

High-priority class contains relatively high-risk criteria and291

mission-based criteria in addition to high missed maintenance.292

Medium priority class is considered for equipment with rela-293

tively high utilization level, area criticality, and old equipment.294

Low-priority class contains old not risky devices. Relatively sta-295

ble equipment does not need PM. The results are consistent with296

the classification given by an experienced clinical engineer. In297

other words, the devices that pose risk for patients and users in298

case of PM omission, old devices, and complex devices such as299

radiology equipment are highly considered for PM; meanwhile,300

low risk devices, reliable devices, and relatively new devices are301

modestly considered for PM. Moreover, as indicated in Fig. 5,302

the risk-based criteria contribute to approximately 45% of the303

weight of priority index. In fact, this contribution reflects high304

correlation existence between risk assessment and PM manage-305

ment of medical equipment.306

V. CONCLUSION307

In this study, QFD is presented for the first time to solve the308

problem of PM prioritization of medical equipment. The pro-309

posed model has proven its validity in real environment correctly310

separating equipment that needs PM from those that do not need311

it. The model was tested based upon the periodical schedule of312

the hospitals. It is important to note that the classification is 313

founded considering the requirements of patients and clinical 314

staff. By analyzing the results, we can state that the risk-based 315

criteria have a great impact on PM prioritization decision in ad- 316

dition to criticality and age of medical equipment. Also, the work 317

highlights the importance of existence of a detailed history for 318

every device that helps the decision makers to manage the med- 319

ical equipment obviously. The model can be used every time a 320

PM is to be planned modifying only the instruments data. More- 321

over, the model development could be improved by addressing 322

the customer requirements according to Kano’s model to clar- 323

ify the attitudes of customer satisfactions in medical equipment 324

PM. In addition, the developed QFD model can be implemented 325

in other stages of management of medical equipment such as 326

acquisition and procurement of medical equipment. The model 327

could be extended to maintenance agencies in order to organize 328

their PM programs. 329

REFERENCES 330

[1] W. A. Hyman, “The Theory and practice of preventive maintenance,” 331J. Clin. Eng., vol. 28, no. 1, pp. 31–36. Jan.–Mar. 2003. 332

[2] M. Ridgway, “Optimizing our PM programs,” Biomed. Instrum. Technol., 333vol. 43, no. 3, pp. 244–254. May/Jun. 2009. 334

[3] R. B. Arslan and Y. Ulgen, “Smart IPM: An adaptive tool for the preventive 335maintenance of medical equipment,” in Proc. IEEE 23rd Annu. Int. Conf. 336Eng. Med. Biol. Soc., Istanbul, Turkey, 2001, vol. 4, pp. 3950–3953. 337

[4] J. Ni and X. Jin, “Decision support systems for effective maintenance 338operations,” CIRP Ann.—Manuf. Technol., vol. 61, pp. 411–414, 2012. 339

[5] J. Joseph and S. Madhukumar, “A novel approach to data driven preventive 340maintenance scheduling of medical instruments,” in Proc. Int. Conf. Syst. 341Med. Biol., Kharagpur, India, 2010, pp. 193–197. 342

[6] R. Miniati, F. Dori, and G. B. Gentili, “Design of a decision support system 343for preventive maintenance planning in health structures,” Technol. Health 344Care J., vol. 20, pp. 205–214, 2012. 345

[7] S. Taghipour, D. Banjevic, and A. K. S. Jardine, “Prioritization of medical 346equipment for maintenance decisions,” J. Oper. Res. Soc., vol. 62, no. 9, 347pp. 1666–1687, 2010. 348

[8] S. O. Duffuaa, A. H. Al-Ghamdi, and A. Al-Amer, “Quality function 349deployment in maintenance work planning process,” in Proc. 6th Saudi 350Eng. Conf., 2002, vol. 4, pp. 503–512. 351

[9] B. M. Deros, N, Rahman, M. N. A. Rahman, A. R. Ismail, and 352A. H. Said, “Application of quality function deployment to study criti- 353cal service quality characteristics and performance measures,” Eur. J. Sci. 354Res., vol. 33, no. 3, pp. 398–410, 2009. 355

[10] S. Bennur and B. Jin, “A conceptual process of implementing quality 356apparel retail store attributes: An application of Kano’s model and the 357quality function deployment approach,” Int. J. Bus., Humanities Technol., 358vol. 2, no. 1, pp. 174–183, 2012 359

[11] X. X. Shen, K. C. Tan, and M. Xie, “An integrated approach to innovative 360product development using Kano’s model and QFD,” Eur. J. Innovative 361Manag., vol. 3, no. 2, pp. 91–99, 2000. 362

[12] D. J. Delgado, K. E. Bampton, and E. Aspinwall, “Quality function 363deployment in construction,” Constr. Manag. Econ. J., vol. 24, no. 6, 364pp. 597–609, 2007. 365

[13] L.K. Chan and M.-L. Wu, “A systematic approach to quality function 366deployment with a full illustrative example,” Int. J. Manag. Sci., vol. 33, 367no. 2, pp. 119–139, 2005. 368

[14] A. Al-Bashir, M. Al-Rawashdeh, R. Al-Hadithi, A. Al-Ghandoor, and M. 369Barghash, “Building medical devices maintenance system through quality 370function deployment,” Jordan J. Mech. Ind. Eng., vol. 25, no. 1, pp. 25–36, 371Feb. 2012. 372

[15] N. Z. Haron and F. L. M. Kairudin, “The application of quality function 373deployment (QFD) in the design phase of industrialized building system 374(IBS) apartment construction project,” Eur. Int. J. Sci. Technol., vol. 1, 375no. 3, pp. 56–66, 2012. 376

[16] N. F. Youssef and W. A. Hyman, “A medical device complexity model: A 377new approach to medical equipment management,” J. Clin. Eng., vol. 34, 378no. 2, pp. 94–98, 2009. 379

Page 7: Preventive Maintenance Prioritization Index of Medical ...scholar.cu.edu.eg/?q=manal_abdel_wahed/files/jbhi-saleh-2337895-pr… · 14 using quality function deployment as a new concept

IEEE

Proo

f

SALEH et al.: PM PRIORITIZATION INDEX OF MEDICAL EQUIPMENT USING QFD 7

Neven Saleh received the B.Sc. degree in electronics and electrical commu-380nication and the diploma degree in electrical communication from Mansoura381University, Mansoura, Egypt, in 1999 and 2001, respectively, and the M.Sc.382degree in systems and biomedical engineering from Cairo University, Giza,383Egypt, in 2011. She is currently working toward the Ph.D. degree in Biomedical384Engineering from Cairo University, and also from the Politecnico di Torino,385Turin, Italy, since she was granted a channel scholarship.386

Since 2001, she has been a Clinical Engineer with Mansoura University387Children Hospital, Mansoura.388

389

Amr A. Sharawi received the B.Sc. degree in electronics and communication390and the M.Sc. and Ph.D. degrees in systems and biomedical engineering, all391from Cairo University, Giza, Egypt, in 1976, 1981, and 1991, respectively.392

Since 2001, he has been an Associate Professor in biomedical engineering,393Faculty of Engineering, Cairo University.394

395

Manal Abd Elwahed received the B.Sc., M.Sc., and Ph.D. degrees in biomedi-396cal engineering from the Faculty of Engineering, Cairo University, Giza, Egypt,397in 1987, 1992, and1999, respectively.398

She is currently an Associate Professor in the Systems and Biomedical En-399gineering Department, Faculty of Engineering, Cairo University.400

401

Alberto Petti received the first M.Sc. degree in biomedical engineering and 402the second M.Sc. degree in management and health technologies from the 403Politecnico di Torrino, Torino, Italy, in 2007 and 2008, respectively. 404

Since 2000, he has been responsible for the clinical engineering service in 405the Public Hospital of Biella, Italy. He is currently involved in realization of the 406new hospital of the city. He is currently a Mechanical Engineer. His research 407interests include the applications of methods for better organizations of the 408public health system, involving technologies and ICT tools, particularly related 409to management of health technologies. 410

411

Daniele Puppato received the B.Sc. and M.Sc. degrees in biomedical engineer- 412ing from the Politecnico di Torrino, Torino, Italy, in 2003 and 2005, respectively. 413

From 2006 to June 2013, he was with AReSS Piemonte as a Health Care 414Technology Management Leader. He is currently working as a Consultant in a 415leading Italian company developing software solutions for technical manage- 416ment of hospitals. 417

Mr. Puppato is a Member of the Italian Association of Clinical Engineers. 418419

Gabriella Balestra received the M.Sc. degree in computer science from the 420University of Turin, Turin, Italy, in 1980, and the Ph.D. degree in computer and 421system engineering from the Politecnico di Torino, Turin, in 1989. 422

She is currently an Assistant Professor in the Department of Electronics 423and Telecommunications, Politecnico di Torino, where she is a Lecturer for 424the Biomedical Engineering course. She also teaches decision support systems, 425biomedical data classification techniques, and medical informatics. 426

Dr. Balestra is a member of GNB, the Italian National Group of Bioengi- 427neering, and the Association for the Advancement of Medical Instrumentation. Q2428

429

Page 8: Preventive Maintenance Prioritization Index of Medical ...scholar.cu.edu.eg/?q=manal_abdel_wahed/files/jbhi-saleh-2337895-pr… · 14 using quality function deployment as a new concept

IEEE

Proo

f

QUERIES430

Q1. Author: Fig. 2 is not cited in the text. Please cite it at an appropriate place.431

Q2. Author: Please provide the expansion of “GNB.”432

Page 9: Preventive Maintenance Prioritization Index of Medical ...scholar.cu.edu.eg/?q=manal_abdel_wahed/files/jbhi-saleh-2337895-pr… · 14 using quality function deployment as a new concept

IEEE

Proo

f

IEEE JOURNAL OF BIOMEDICAL AND HEALTH INFORMATICS, VOL. 00, NO. 00, 2014 1

Preventive Maintenance Prioritization Indexof Medical Equipment Using Quality

Function Deployment

1

2

3

Neven Saleh, Amr A. Sharawi, Manal Abd Elwahed, Alberto Petti, Daniele Puppato,and Gabriella Balestra

4

5

Abstract—Preventive maintenance is a core function of clinical6engineering, and it is essential to guarantee the correct functioning7of the equipment. The management and control of maintenance8activities are equally important to perform maintenance. As the9variety of medical equipment increases, accordingly the size of10maintenance activities increases, the need for better management11and control become essential. This paper aims to develop a new12model for preventive maintenance priority of medical equipment13using quality function deployment as a new concept in mainte-14nance of medical equipment. We developed a three-domain frame-15work model consisting of requirement, function, and concept. The16requirement domain is the house of quality matrix. The second17domain is the design matrix. Finally, the concept domain gener-18ates a prioritization index for preventive maintenance considering19the weights of critical criteria. According to the final scores of20those criteria, the prioritization action of medical equipment is21carried out. Our model proposes five levels of priority for preven-22tive maintenance. The model was tested on 200 pieces of medical23equipment belonging to 17 different departments of two hospi-24tals in Piedmont province, Italy. The dataset includes 70 different25types of equipment. The results show a high correlation between26risk-based criteria and the prioritization list.27

Index Terms—Medical equipment, preventive maintenance28(PM), prioritization, quality function deployment (QFD).29

I. INTRODUCTION30

PREVENTIVE maintenance (PM) is a core function of clin-31

ical engineering, having as objectives the assurance of32

ongoing safety and performance of medical devices and the33

preservation of the investment in the equipment through im-34

proved longevity [1]. PM is mainly a risk-based approach and35

considered as a core function of Clinical Engineering Depart-36

ment [2]. Despite its core role, the design and management of an37

effective PM program is not a simple matter. Adequate admin-38

istrative support is a requirement for an effective PM program.39

Manuscript received November 19, 2013; revised June 12, 2014; acceptedJuly 4, 2014. Date of publication; date of current version.

N. Saleh is with the Politecnico di Torino, 10129 Turin, Italy (e-mail:nevensaleh76@ gmail.com).

A. Sharawi and M. Abd Elwahed are with the Systems and BiomedicalEngineering Department, Faculty of Engineering, Cairo University, Giza, Egypt(e-mail: [email protected]; [email protected]).

A. Petti is with ASLBI, 13900 Biella, Italy (e-mail: [email protected]).

D. Puppato is with ARESS, 10122 Turin, Italy (e-mail: [email protected]).G. Balestra is with the Electronic and Telecommunication Department,

Politecnico di Torino, 10129 Turin, Italy (e-mail: [email protected]).Color versions of one or more of the figures in this paper are available online

at http://ieeexplore.ieee.org.Digital Object Identifier 10.1109/JBHI.2014.2337895

The two key issues for PM are the procedures to be executed 40

and execution frequencies [1]–[3]. The procedures indicate the 41

necessary steps that are required to assure the performance of 42

the device, whereas the second key is the frequency at which 43

the set of procedures should be done. 44

Maintenance prioritization is a crucial task in management 45

systems, especially when there are more maintenance work or- 46

ders than available people or resources that can handle those 47

devices [4]. The literature is rich with different prioritization 48

approaches for medical equipment. In [5], Joseph and Mad- 49

hukumar have developed a model for PM index considering 50

risk level coefficient (RLC) of the instrument. RLC was cal- 51

culated through five different classified factors related to the 52

medical equipment electrical risk. The factors are static risk, 53

degree and quality of safety arrangements, insulation, physical 54

risk, and equipment contact with the patient. 55

In another work [6], the authors developed the system of infor- 56

mation technology and support system for maintenance actions 57

(SISMA). The system considers two aspects for PM evaluation: 58

technical and economic needs to assess PM plan for medical 59

equipment. Analytical Hierarchy Process was used in [7] as 60

a multicriteria decision making tool to develop a maintenance 61

priority index for medical equipment. 62

II. BACKGROUND 63

Quality function deployment (QFD) is one of the total qual- 64

ity management quantitative tools and techniques that could be 65

used to translate customer requirements and specifications into 66

appropriate technical or service requirements [8]. QFD was con- 67

ceived in Japan at the end of 1960s by Yoji Akao. The first usage 68

of QFD was implemented by Mizuno in 1972 to Mitsubishi’s 69

Kobe shipyard site [9]. 70

QFD uses visual matrices that link customer requirements, de- 71

sign requirements, target values, and competitive performance 72

into one chart [8]. Therefore, QFD is considered a quantitative 73

tool that facilitates evaluation of customer’s satisfaction. Typi- 74

cally, a QFD system can be broken into four interlinked phases 75

to fully deploy the customer needs phase by phase [10]. The 76

four-phase model consists of house of quality (HOQ) matrix, 77

design matrix, process planning matrix, and finally production 78

matrix [10], [11]. 79

Among the various matrices, the HOQ is commonly used in 80

the different applications. The HOQ matrix displays the voice of 81

customers (VOC) or customer requirements that are known as 82

2168-2194 © 2014 IEEE. Personal use is permitted, but republication/redistribution requires IEEE permission.See http://www.ieee.org/publications standards/publications/rights/index.html for more information.

Page 10: Preventive Maintenance Prioritization Index of Medical ...scholar.cu.edu.eg/?q=manal_abdel_wahed/files/jbhi-saleh-2337895-pr… · 14 using quality function deployment as a new concept

IEEE

Proo

f

2 IEEE JOURNAL OF BIOMEDICAL AND HEALTH INFORMATICS, VOL. 00, NO. 00, 2014

Fig. 1. HOQ of function deployment [12].

WHATs against the technical requirements or voice of engineers83

(VOE) that are known as HOWs [8]–[11].84

In Fig. 1, a simplified matrix of HOQ is presented depicting85

the main parts of the matrix. The order suggested by letters86

A to F is normally followed during the process. Room “A”87

contains a list of customer needs, each of which is assessed88

against competitors, and the results which are absolute and rela-89

tive weights for customer needs prioritization are reported in to90

room “B.” Room “C” has the information necessary to transform91

the customer expectations into technical characteristics, and the92

correlation between each customer requirements and technical93

response is put into “D.” The roof, room “E,” considers the ex-94

tent to which the technical responses support each other. The95

prioritization of the technical characteristics, information on the96

competition, and technical targets weights all go into “F” [12].97

The most important parts in HOQ are “B” and “F,” respec-98

tively; more details can be found in [12]. The planning matrix99

“B” is calculated based on a comparison between the intended100

service within a hospital and other hospitals. In this matrix,101

the importance of customer requirements is evaluated, and the102

actual evaluations of the customer requirements are assigned.103

The goal is the expected value for each requirement, and then,104

the improvement ratio is calculated by dividing the goal to the105

evaluation of the intended requirements. The absolute weight106

is calculated by multiplication of goal and importance ratio,107

while the relative weight is the normalization of the absolute108

weight. Technical targets, room “F,” are prioritized through cal-109

culating the absolute weight of HOWs as given in (1) and then110

normalizing it to determine the relative weight [13]111

Absolute weight =∑

id WHAT XRWH (1)

where id WHAT is the importance degree of WHAT and RWH112

is the relationship value between WHAT and HOW.113

According to the characteristics of the QFD technique,114

our objective is to employee QFD as a new approach in115

medical equipment management to solve the problem of116

PM prioritization of medical equipment considering a set of117

influential criteria.118

Fig. 2. Proposed three-domain framework for PM of medical equipment pri-oritization.

III. METHODOLOGY 119

By using QFD, we proposed a three-domain framework for

Q1

120

PM priority, as illustrated in Fig. 3: requirement domain, func- 121

tion domain, and concept domain. 122

The first domain considers the customer requirements and the 123

technical characteristics that meet the customer requirements, 124

i.e., HOQ of the model. The second domain is the function 125

domain, in which the top technical criteria that resulted in first 126

domain will be measured through new criteria to identify the 127

critical criteria for PM prioritization, i.e., top HOWs of the first 128

domain becomes the new WHATs of the second domain. In 129

last domain, the concept domain, a priority score (PS) index is 130

generated considering the weights of critical criteria in order to 131

determine PM priority of medical equipment. 132

A. Requirement Domain 133

The HOQ of PM prioritization model is the requirement do- 134

main of this framework. First, customer needs and technical 135

characteristics should be identified. In general, the customers 136

of medical equipment in hospitals include all customers that 137

have a direct interface with medical equipment and who ex- 138

pect a range of services. In particular, the patients and clinical 139

staff are considered the customers (WHATs) of medical equip- 140

ment, whereas the Clinical Engineering Department is consid- 141

ered the one who is responsible to satisfy those requirements 142

(HOWs). 143

For patient’s requirements, no doubt that safety and avail- 144

ability of medical equipment are essential needs. Clinical staff 145

requirements were chosen based upon the literature [14] and 146

experience. Table I depicts the proposed customer’s require- 147

ments and technical characteristics. Prioritization of customer’s 148

requirements is performed considering a comparison between 149

Italian hospital and Jordanian hospital [14]. 150

Table I shows that customer’s requirements are met by ad- 151

dressing five technical characteristics: risk, performance assur- 152

ance, user competence, costs, and standard compliance, which 153

are presented with its subcriteria in this table. The requirement 154

domain (HOQ) is shown in Fig. 3. 155

The matrix is organized referring to Fig. 1; the left column 156

contains customer requirements (VOC), whereas the main part 157

Page 11: Preventive Maintenance Prioritization Index of Medical ...scholar.cu.edu.eg/?q=manal_abdel_wahed/files/jbhi-saleh-2337895-pr… · 14 using quality function deployment as a new concept

IEEE

Proo

f

SALEH et al.: PM PRIORITIZATION INDEX OF MEDICAL EQUIPMENT USING QFD 3

TABLE ICUSTOMER REQUIREMENTS AND TECHNICAL CHARACTERISTICS OF HOQ

OF THE PROPOSED FRAMEWORK

Customer Requirements Technical Requirements

Criteria Subcriteria

Safety of medical.equipment.Efficiency.Durability.Quick response oftechnical team.Back up availability.Check the device aftermaintenance.Regular monitoring ofthe devices.

Risk Physical risk FunctionMaintenancerequirements

Priority based onimportance.Obvious operatinginstructions.Knowledge ofmaintained devices.Existence of a contactperson 24 h.Avoiding suspension ofservices.

PerformanceAssurance

Mission criticalityFunction verification AgeLabeling Electrical safety

Parts replacementRegular inspection

UserCompetence

Qualification oftechnicians Complexity

of devices Equippedworkshop Test equipment

availability Servicemanual availabilityActivities recording

Costs Updating or loan Spareparts availability Service

provider typeStandards Meet standards

of the matrix contains the technical characteristics (VOE) seg-158

mented into five columns and the relationship matrix. The right159

column is the planning matrix of HOQ. The bottom room is160

the technical target matrix. The relationships between WHATs161

and HOWs are indicated by scores 9 for strong relation, 3162

for medium relation, 1 for low relation, and blank for no163

relation [11]–[13].164

In order to demonstrate how customer needs are prioritized,165

consider “safety” requirement as an example, by using five-166

point scale, we evaluate 5 for importance, 3 for Italian hospital,167

5 for Jordanian hospital, and 5 for goal. Regarding our per-168

spective to Italian hospital, the improvement ratio is calculated169

by dividing the goal to Italian hospital, i.e., 5/3. The absolute170

weight is calculated through multiplication of improvement ra-171

tio by importance, i.e., 1.7 × 5; meanwhile, the relative weight172

is obtained by normalizing the absolute weight, i.e., (8.3/91.5)173

∗ 100. As such for technical targets, to explain how technical174

criteria priority is identified, we consider “physical risk” as an175

example. Utilizing formula (1), the absolute weight of “physical176

risk” equals 9 × 9.1 + 9 × 7.3 + 9 × 4.4 + 3 × 8.7 = 213.3,177

and the relative weight is calculated also by normalization178

to become 5.03.179

B. Function Domain180

The next stage of our proposed model is to identify the critical181

criteria among the technical criteria for PM priority. We selected182

the top 11 criteria of technical terms based upon their weights 183

and importance to become the inputs (WHATs) of the second 184

matrix as illustrated in Fig. 4. The design matrix is constructed 185

with the same way that is followed in building the HOQ in 186

Fig. 3, except the planning matrix; it is the top 11 output relative 187

weights of HOQ. 188

For better representation of five addressing criteria dimen- 189

sions, we propose all subcriteria with relative weight greater 190

than 4.5% to be selected as top criteria in order to cover a wide 191

range of criteria ranging from risk criteria with its clear impact 192

in PM to a regular inspection since it is not regularly followed by 193

a lot of hospitals especially in developing countries. The criteria 194

are function, mission criticality, service provider type, standards 195

compliance, maintenance requirements, age, functional verifi- 196

cations, team qualification, device complexity, physical risk, and 197

regular inspection. 198

We classified the critical criteria into three categories for 199

HOWs of the second matrix: risk-based criteria including func- 200

tion, physical risk, and maintenance requirements; mission- 201

based criteria including utilization level, area criticality, and 202

device criticality; and finally maintenance-based criteria incor- 203

porating, failure rate, useful life ratio, device complexity, num- 204

ber of missed maintenance, and downtime ratio. The criteria 205

were selected based upon the literature [3], [5]–[7], [14], in 206

addition to the authors experience. 207

The matrix roof depicts the relations among HOWs [15]. 208

Strong relation is indicated by •, medium by �, and low by 209

o. The relationships are proposed according to author’s expe- 210

rience. As shown in Fig. 4, the planning part of design matrix 211

(importance of WHATs) is the resultant relative weight of top 212

11 criteria of first domain. The critical targets of the technical 213

criteria are considered based upon the proposed thresholds as 214

presented in Table II. On the other hand, the technical targets, 215

i.e., the absolute weight and relative weight of the technical 216

criteria are calculated as the same for requirement domain. In 217

fact, the resultant ranking of most critical criteria for PM prior- 218

itization point to risk-based criteria is topping the list of criteria 219

(44.9%) that it is logical with previous survey, followed by 220

mission-based and maintenance-based. 221

C. Concept Domain 222

The concept domain is the output of the design matrix. The 223

output is a prioritization equation considering the 11 most crit- 224

ical factors with the resultant weights. Equation (2) generates 225

the priority index of PM that is presented as scores. Table II 226

illustrates a brief description of the critical criteria and their 227

proposed scores. 228

PS = 11.7(FN) + 12.8(PR) + 20.4(MR) + 11(UL)

+ 6.5(AC) + 11.4(DC) + 8.3(FR) + 5.1(LR)

+ 6.3(CM) + 3.4(MM) + 3.1(DR) (2)

where 229

PS priority score; 230

FN function of equipment; 231

PR physical risk; 232

MR maintenance requirements; 233

Page 12: Preventive Maintenance Prioritization Index of Medical ...scholar.cu.edu.eg/?q=manal_abdel_wahed/files/jbhi-saleh-2337895-pr… · 14 using quality function deployment as a new concept

IEEE

Proo

f

4 IEEE JOURNAL OF BIOMEDICAL AND HEALTH INFORMATICS, VOL. 00, NO. 00, 2014

Fig. 3. HOQ matrix of the QFD model for PM prioritization of medical equipment (requirement domain).

Fig. 4. Design matrix of the QFD model for pm prioritization of medical equipment (function domain).

Page 13: Preventive Maintenance Prioritization Index of Medical ...scholar.cu.edu.eg/?q=manal_abdel_wahed/files/jbhi-saleh-2337895-pr… · 14 using quality function deployment as a new concept

IEEE

Proo

f

SALEH et al.: PM PRIORITIZATION INDEX OF MEDICAL EQUIPMENT USING QFD 5

TABLE IIBRIEF DESCRIPTION OF CRITICAL PARAMETERS AND THEIR PROPOSED SCORES

Parameter Description Thresholds Scores

Function Device function Life supportTherapeuticDiagnostic /monitoringAnalytical

Miscellaneous

543

21

Physical risk Probable harmscaused byequipment

failure

DeathInjury

MisdiagnosisEquipment

damageNo risk

5432

1Maintenancerequirements

Maintenanceactivities

depending onequipment type

ExtensiveA above average

AverageBelow average

Minimal

54321

Utilization level Number ofworking days a

week

4 days3/4 days<3 days

321

Area criticality Assessment ofarea criticality

for patients

UrgentIntensity care

unitsDiagnostic areaLaw intensity

areaNon clinical area

54

32

1Device criticality The importance

level ofequipment inserviced area

CriticalImportantNecessary

321

Failure rate Number offailures a year

based on devicecriticality level

�2 for critical,�4 for

important, �5for necessary

1 for critical, 2/3for important,

3/4 for necessary0 for critical, �1

for important,�2 for necessary

3

2

1

Useful life ratio Ratio betweenage to expected

life time of adevice

Ratio > 80 %50% < Ratio

�80%Ratio � 50 %

32

1Device complexity Technical

complexitybased on a

model

Score 6—8Score 3—5Score 0—2

321

Missed maintenance Number ofmissed

maintenance ayear

� 210

321

Downtime ratio Ratio betweenthe duration ofdowntime in

days to days ayear

Ratio � 20 %10% � Ratio <

20%Ratio < 10 %

32

1

UL utilization level;234

AC area criticality;235

DC device criticality;236

FR failure rate;237

LR useful life ratio;238

CM device complexity;239

MM missed maintenance;240

DR downtime ratio.241

TABLE IIIDATA SAMPLE OF INVESTIGATED EQUIPMENT FOR PM PRIORITY

Equipment FN PR MR UL AC DC FR LR CM MM DR PS PS %

Ventilator 5 5 5 2 5 3 2 3 3 3 1 377 93C-arm 3 3 4 2 5 3 3 3 3 2 2 316 78Monitor 3 3 3 3 3 2 3 3 2 1 1 269 66Centrifuge 2 3 3 3 2 2 1 3 1 1 1 228 56Scale 1 1 1 1 3 1 1 2 1 2 1 121 30

Fig. 5. PM priority index groups based on PS value of the proposed QFDmodel.

The complexity model [16] assesses the technical complexity 242

of a device considering four factors: equipment maintainability, 243

installation requirements, repair, and connectivity. The scores 244

are given for each factor range from 0 to 2 for evaluation based 245

upon the complexity level for each device in the list. 246

IV. RESULTS 247

For model verification, we utilized a dataset of 200 medical 248

equipment of two hospitals with one management system in 249

Piedmont province, Italy. Seventy different types of equipment 250

belonging to 17 different kinds of departments were analyzed 251

along data collected for one year (2012). Table III shows a 252

sample data of various types of investigated equipment along 253

with PS based upon our proposed model. 254

The scores in Table III are obtained referring to the scores that 255

are given in Table II. For instance, considering the “Ventilator” 256

device, and according to concept domain, “Function” is life sup- 257

port, “Physical Risk” is death, “Maintenance Requirements” is 258

extensive, “Area Criticality” is urgent, and “Device Criticality” 259

is critical; meanwhile, other parameters “Failure Rate,” “Useful 260

Life,” “Missed Maintenance,” and “Downtime Ratio” are de- 261

pending on the actual status of each device. Device complexity 262

is calculated relied on complexity model [16]. Accordingly, by 263

utilizing formula (2), the PS for every device is calculated as 264

shown in Table III. 265

By using the result of PS percentages, the PM priority is 266

classified into five categories as illustrated in Fig. 5. The first 267

class is very high-priority class and includes equipment that 268

supposed to be maintained within two weeks with PS percentage 269

equal or greater than 80. In second class, high-priority PM 270

should be performed within one month if priority percentage 271

in range 70–80. Class 3 is medium priority and contains all 272

Page 14: Preventive Maintenance Prioritization Index of Medical ...scholar.cu.edu.eg/?q=manal_abdel_wahed/files/jbhi-saleh-2337895-pr… · 14 using quality function deployment as a new concept

IEEE

Proo

f

6 IEEE JOURNAL OF BIOMEDICAL AND HEALTH INFORMATICS, VOL. 00, NO. 00, 2014

Fig. 6. Results of the PM prioritization index for investigated medical equip-ment.

equipment that should be considered for PM within two months273

in case of priority percentage in range 60–70.274

Class 4 is low priority and includes all equipment with pri-275

ority percentage of 50 to 60, and in this case, PM should be276

performed within three months. Finally, all equipment with pri-277

ority percentage less than 50 could be visually inspected and278

considered for next PM as minimal PM.279

In our dataset of equipment and according to the proposed280

model and priority classification, the results indicate that 30281

devices (15%) need very high priority PM, 39 devices (19%)282

should be included as high priority, 59 devices (30%) should be283

considered for medium priority, 54 devices (27%) for low prior-284

ity, and finally, 18 devices (9%) should be with minimal priority285

PM. Fig. 6 presents dataset output classification considering the286

QFD model.287

By analyzing the results, very high priority class incor-288

porates all equipment with high-risk criteria, relatively high-289

mission-based criteria, and also with high-complexity level.290

High-priority class contains relatively high-risk criteria and291

mission-based criteria in addition to high missed maintenance.292

Medium priority class is considered for equipment with rela-293

tively high utilization level, area criticality, and old equipment.294

Low-priority class contains old not risky devices. Relatively sta-295

ble equipment does not need PM. The results are consistent with296

the classification given by an experienced clinical engineer. In297

other words, the devices that pose risk for patients and users in298

case of PM omission, old devices, and complex devices such as299

radiology equipment are highly considered for PM; meanwhile,300

low risk devices, reliable devices, and relatively new devices are301

modestly considered for PM. Moreover, as indicated in Fig. 5,302

the risk-based criteria contribute to approximately 45% of the303

weight of priority index. In fact, this contribution reflects high304

correlation existence between risk assessment and PM manage-305

ment of medical equipment.306

V. CONCLUSION307

In this study, QFD is presented for the first time to solve the308

problem of PM prioritization of medical equipment. The pro-309

posed model has proven its validity in real environment correctly310

separating equipment that needs PM from those that do not need311

it. The model was tested based upon the periodical schedule of312

the hospitals. It is important to note that the classification is 313

founded considering the requirements of patients and clinical 314

staff. By analyzing the results, we can state that the risk-based 315

criteria have a great impact on PM prioritization decision in ad- 316

dition to criticality and age of medical equipment. Also, the work 317

highlights the importance of existence of a detailed history for 318

every device that helps the decision makers to manage the med- 319

ical equipment obviously. The model can be used every time a 320

PM is to be planned modifying only the instruments data. More- 321

over, the model development could be improved by addressing 322

the customer requirements according to Kano’s model to clar- 323

ify the attitudes of customer satisfactions in medical equipment 324

PM. In addition, the developed QFD model can be implemented 325

in other stages of management of medical equipment such as 326

acquisition and procurement of medical equipment. The model 327

could be extended to maintenance agencies in order to organize 328

their PM programs. 329

REFERENCES 330

[1] W. A. Hyman, “The Theory and practice of preventive maintenance,” 331J. Clin. Eng., vol. 28, no. 1, pp. 31–36. Jan.–Mar. 2003. 332

[2] M. Ridgway, “Optimizing our PM programs,” Biomed. Instrum. Technol., 333vol. 43, no. 3, pp. 244–254. May/Jun. 2009. 334

[3] R. B. Arslan and Y. Ulgen, “Smart IPM: An adaptive tool for the preventive 335maintenance of medical equipment,” in Proc. IEEE 23rd Annu. Int. Conf. 336Eng. Med. Biol. Soc., Istanbul, Turkey, 2001, vol. 4, pp. 3950–3953. 337

[4] J. Ni and X. Jin, “Decision support systems for effective maintenance 338operations,” CIRP Ann.—Manuf. Technol., vol. 61, pp. 411–414, 2012. 339

[5] J. Joseph and S. Madhukumar, “A novel approach to data driven preventive 340maintenance scheduling of medical instruments,” in Proc. Int. Conf. Syst. 341Med. Biol., Kharagpur, India, 2010, pp. 193–197. 342

[6] R. Miniati, F. Dori, and G. B. Gentili, “Design of a decision support system 343for preventive maintenance planning in health structures,” Technol. Health 344Care J., vol. 20, pp. 205–214, 2012. 345

[7] S. Taghipour, D. Banjevic, and A. K. S. Jardine, “Prioritization of medical 346equipment for maintenance decisions,” J. Oper. Res. Soc., vol. 62, no. 9, 347pp. 1666–1687, 2010. 348

[8] S. O. Duffuaa, A. H. Al-Ghamdi, and A. Al-Amer, “Quality function 349deployment in maintenance work planning process,” in Proc. 6th Saudi 350Eng. Conf., 2002, vol. 4, pp. 503–512. 351

[9] B. M. Deros, N, Rahman, M. N. A. Rahman, A. R. Ismail, and 352A. H. Said, “Application of quality function deployment to study criti- 353cal service quality characteristics and performance measures,” Eur. J. Sci. 354Res., vol. 33, no. 3, pp. 398–410, 2009. 355

[10] S. Bennur and B. Jin, “A conceptual process of implementing quality 356apparel retail store attributes: An application of Kano’s model and the 357quality function deployment approach,” Int. J. Bus., Humanities Technol., 358vol. 2, no. 1, pp. 174–183, 2012 359

[11] X. X. Shen, K. C. Tan, and M. Xie, “An integrated approach to innovative 360product development using Kano’s model and QFD,” Eur. J. Innovative 361Manag., vol. 3, no. 2, pp. 91–99, 2000. 362

[12] D. J. Delgado, K. E. Bampton, and E. Aspinwall, “Quality function 363deployment in construction,” Constr. Manag. Econ. J., vol. 24, no. 6, 364pp. 597–609, 2007. 365

[13] L.K. Chan and M.-L. Wu, “A systematic approach to quality function 366deployment with a full illustrative example,” Int. J. Manag. Sci., vol. 33, 367no. 2, pp. 119–139, 2005. 368

[14] A. Al-Bashir, M. Al-Rawashdeh, R. Al-Hadithi, A. Al-Ghandoor, and M. 369Barghash, “Building medical devices maintenance system through quality 370function deployment,” Jordan J. Mech. Ind. Eng., vol. 25, no. 1, pp. 25–36, 371Feb. 2012. 372

[15] N. Z. Haron and F. L. M. Kairudin, “The application of quality function 373deployment (QFD) in the design phase of industrialized building system 374(IBS) apartment construction project,” Eur. Int. J. Sci. Technol., vol. 1, 375no. 3, pp. 56–66, 2012. 376

[16] N. F. Youssef and W. A. Hyman, “A medical device complexity model: A 377new approach to medical equipment management,” J. Clin. Eng., vol. 34, 378no. 2, pp. 94–98, 2009. 379

Page 15: Preventive Maintenance Prioritization Index of Medical ...scholar.cu.edu.eg/?q=manal_abdel_wahed/files/jbhi-saleh-2337895-pr… · 14 using quality function deployment as a new concept

IEEE

Proo

f

SALEH et al.: PM PRIORITIZATION INDEX OF MEDICAL EQUIPMENT USING QFD 7

Neven Saleh received the B.Sc. degree in electronics and electrical commu-380nication and the diploma degree in electrical communication from Mansoura381University, Mansoura, Egypt, in 1999 and 2001, respectively, and the M.Sc.382degree in systems and biomedical engineering from Cairo University, Giza,383Egypt, in 2011. She is currently working toward the Ph.D. degree in Biomedical384Engineering from Cairo University, and also from the Politecnico di Torino,385Turin, Italy, since she was granted a channel scholarship.386

Since 2001, she has been a Clinical Engineer with Mansoura University387Children Hospital, Mansoura.388

389

Amr A. Sharawi received the B.Sc. degree in electronics and communication390and the M.Sc. and Ph.D. degrees in systems and biomedical engineering, all391from Cairo University, Giza, Egypt, in 1976, 1981, and 1991, respectively.392

Since 2001, he has been an Associate Professor in biomedical engineering,393Faculty of Engineering, Cairo University.394

395

Manal Abd Elwahed received the B.Sc., M.Sc., and Ph.D. degrees in biomedi-396cal engineering from the Faculty of Engineering, Cairo University, Giza, Egypt,397in 1987, 1992, and1999, respectively.398

She is currently an Associate Professor in the Systems and Biomedical En-399gineering Department, Faculty of Engineering, Cairo University.400

401

Alberto Petti received the first M.Sc. degree in biomedical engineering and 402the second M.Sc. degree in management and health technologies from the 403Politecnico di Torrino, Torino, Italy, in 2007 and 2008, respectively. 404

Since 2000, he has been responsible for the clinical engineering service in 405the Public Hospital of Biella, Italy. He is currently involved in realization of the 406new hospital of the city. He is currently a Mechanical Engineer. His research 407interests include the applications of methods for better organizations of the 408public health system, involving technologies and ICT tools, particularly related 409to management of health technologies. 410

411

Daniele Puppato received the B.Sc. and M.Sc. degrees in biomedical engineer- 412ing from the Politecnico di Torrino, Torino, Italy, in 2003 and 2005, respectively. 413

From 2006 to June 2013, he was with AReSS Piemonte as a Health Care 414Technology Management Leader. He is currently working as a Consultant in a 415leading Italian company developing software solutions for technical manage- 416ment of hospitals. 417

Mr. Puppato is a Member of the Italian Association of Clinical Engineers. 418419

Gabriella Balestra received the M.Sc. degree in computer science from the 420University of Turin, Turin, Italy, in 1980, and the Ph.D. degree in computer and 421system engineering from the Politecnico di Torino, Turin, in 1989. 422

She is currently an Assistant Professor in the Department of Electronics 423and Telecommunications, Politecnico di Torino, where she is a Lecturer for 424the Biomedical Engineering course. She also teaches decision support systems, 425biomedical data classification techniques, and medical informatics. 426

Dr. Balestra is a member of GNB, the Italian National Group of Bioengi- 427neering, and the Association for the Advancement of Medical Instrumentation. Q2428

429

Page 16: Preventive Maintenance Prioritization Index of Medical ...scholar.cu.edu.eg/?q=manal_abdel_wahed/files/jbhi-saleh-2337895-pr… · 14 using quality function deployment as a new concept

IEEE

Proo

f

QUERIES430

Q1. Author: Fig. 2 is not cited in the text. Please cite it at an appropriate place.431

Q2. Author: Please provide the expansion of “GNB.”432