Technology and Health Care 20 (2012) 205–214 205

DOI 10.3233/THC-2012-0670
IOS Press

Design of a decision support system for

preventive maintenance planning in health
structures

Roberto Miniatia,∗, Fabrizio Dorib and Guido Biffi Gentilic

a Department of Electronics and Telecommunications, Biomedical Lab, University of Florence,
Florence, Italy
b Clinical Engineering Contract, University of Florence, Florence, Italy
c Full Professor of Electromagnetic Theory and Techniques, University of Florence, Florence, Italy

Received 6 February 2012

Accepted 21 February 2012

Abstract. The appropriate maintenance of medical devices, including performance inspections and preventive maintenance, is
fundamental in mitigating clinical risk caused by adverse events in health care.
Although several models for managing and planning preventive maintenance have been developed, the problem is lacking in
standard methodology and still presents an open challenge for today’s health experts.
This paper aims to provide and develop methodology together with support systems able to assist decision makers in
constructing preventive maintenance and performance inspection plans, taking into account both the technical and economic
needs of hospital clinical engineering departments. Interventions by decision makers are of crucial importance within complex
situations where large numbers, types of devices and different contractual situations are involved. SISMA system has achieved
optimal results with minimum expense and maximum security for patients and technicians at the University Hospital of Florence
where it has been applied in actual case studies.

Keywords: Technology in healthcare, clinical engineer, preventive maintenance, decision support system

1. Introduction

Efficient maintenance of medical devices in hospitals is fundamental in mitigating clinical risk caused
by adverse events in healthcare. Several studies on risk management have indicated that the inappropriate
maintenance of medical equipment is one of the main causes of medical device failure, especially within
hospitals where both new and older models of equipment are used [1].
Technical regulations indicate that Clinical Engineering (CE) departments are responsible for the
correct and safe use of medical devices, and require that the appropriate management of technology
includes the evaluation of efficiency, the provision of appropriate maintenance and elimination of broken
equipment from medical areas [2–4].

∗
Corresponding author: Roberto Miniati, Department of Electronics and Telecommunications, Biomedical Lab, University
of Florence, Via S. Marta 3, 50139 Florence, Italy. E-mail: roberto.miniati@unifi.it.

0928-7329/12/$27.50  2012 – IOS Press and the authors. All rights reserved
206 R. Miniati et al. / Design of a decision support system for preventive maintenance planning

Maintenance activity no longer involves only corrective action as in the past [6] but aims towards a
more complete risk management approach [7–9] which deals with reducing risk caused by negligent use
of devices, reducing repair stoppage time and providing failure prevention for specific clinical activities.
Preventive maintenance is essential to efficient management in healthcare and is seriously considered by
technical managers who are currently implementing various solutions and methods [10–13].
Furthermore complex healthcare structures such as hospitals present a more complicated situation in
that specific interventions must be projected in pre-established situations involving both old and new
equipment with differing contracts.
The aim of this paper is to develop a system which aids decision makers in planning preventive
maintenance and safety controls by defining new technical indicators with a simple database.
A software interface has been developed and applied to actual case studies at the University Hospital
of Florence, AOU Careggi.

2. Methods

Medical equipment failures due to lack of or inappropriate maintenance actions increase clinical risk
in healthcare [1]. Three main types of maintenance are defined according to technical standards [6,7,14]
as follows:
1. Corrective maintenance
2. First Level preventative maintenance
3. Second Level preventative maintenance
Corrective maintenance must be provided after failure in order to repair malfunctions and restore safety
to the device. This type of maintenance is not predictable in terms of time and type of intervention.
First Level preventive maintenance consists of visual controls and simple calibration procedures carried
out by the users. Usually the user guide indicates frequency and types of interventions required.
The second level of preventive maintenance is a planned activity which includes technical intervention
for equipment calibration, safety and performance control. These activities are carried out by technicians
in order to guarantee a correct and safe use of the device. Health structures are obligated to define a
maintenance plan [1] which takes into consideration preventive maintenance actions as well as corrective
maintenance in terms of goals, resource availability and economic expenditure.
Three main divisions have been designated in organizing efficient maintenance plans within hospital
structures as follows:
1. Internal Clinical Engineering department
2. External technical assistance and consultation
3. Mixed solution (internal Clinical Engineering departments along with external assistance)
The first two modalities exclusively manage both planning and practical activities whereas the mixed
solution requires efficient synergy and coordination between the Clinical Engineering departments and
external assistance.
Usually the Clinical Engineering department is responsible for the planning and execution of all
maintenance activities of low and medium technology and the calling and supervision of external
interventions.
The methodology here developed follows the latest Italian recommendations regarding prevention
of adverse events [1] and the necessity to define performance priority ranks for all devices so as to
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optimize resources and actions which guarantee appropriate and rational maintenance. This requires a
maintenance plan which aims to control and perform all the maintenance actions previously designated.
The methodology is composed of the following three main steps:
A. Definition of a Maintenance Priority Index (MPI)
B. Economic evaluation of Maintenance Plan (MP)
C. Software interface development for easy and efficient decision making

2.1. The Maintenance Priority Index (MPI)

This index defines the priority needs for maintenance actions regarding medical devices, while taking
into consideration the functional importance of the specific device in clinical activities (criticality), the
technology type and complexity and failure trend [15].
The MPI provides four levels:
1. High-MPI – performance checks and preventive maintenance actions carried out at least once a
year;
2. Medium-MPI – performance checks and preventive maintenance actions carried out at least once
every two years;
3. Low-MPI – performance checks and preventive maintenance actions carried out at least once every
three years;
4. Null-MPI – performance checks and preventive maintenance actions are not suggested by the
manufacturer.
High-MPI considers all devices intended for life support, large and critical machines. Medium-MPI
refers to medium-critical equipment whereas Low-MPI deals only with low-critical devices. Null-MPI
devices are those that are unnecessary for preventive actions in medical performance, such as printers or
surgical instruments.
According to national and international regulations [16] it is relatively easy to individualize both large
and life support devices. The large equipment category includes radiology, radio- and cobalt-therapy,
hyperbaric and magnetic resonance while the life support category contains defibrillators, monitor
defibrillators, respiratory equipment, all anesthesia device components and extra circulation machines.
The term “critical” indicates the relative importance of each single device in the medical process and
performance according to its specific use.
It is important to evaluate each device according to its clinical context. User-device interaction [17] is
of major importance when considering the clinical destination area. An ultrasound device in surgery is
obviously more critical than it would be in an examining room.
The higher the criticality of the device, the more attention is given by the technology manager to the
reliability and maintenance of the device.
A new index, the Criticality Index (CI), has been defined which qualifies device criticality according
to the complexity of the technology within the specific hospital area where the device is used.
Previous analyses [18] indicate that the failure trend is proportional to the level of technological
complexity; that is, the more complex the equipment, the higher the failure rate. In order to properly
evaluate device criticality in hospitals, the Activity Area, the area where the device is used, and the
Complexity Level of the corresponding technology, have been taken into consideration.
The Activity Areas are categorized as follows:
– Urgent: all operating theatres and emergency areas
208 R. Miniati et al. / Design of a decision support system for preventive maintenance planning

Table 1
Numerical matrix for the Criticality Index calculation
Criticality index (Activity Area) Complexity level
X (Complexity Level) High “3” Medium “2” Low “1” Very low tech “0”
Activity Area Urgent – “9” 27 18 9 0
High Intensity – “3” 9 6 3 0
Medium Intensity – “2” 6 4 2 0
Low Intensity – “1” 3 2 1 0
Clinical activity support – “0” 0 0 0 0

Fig. 1. Boolean operator used for the evaluation of Maintenance Priority Index.

– High care intensity: all those areas within the hospital which furnish high intensity care such as ICU
and resuscitation
– Medium care intensity: diagnostic areas and day hospitals
– Low care intensity: in-patient wards, ambulatories and laboratories
– Clinical activity support: all areas that are considered non- clinical such as sterilization units or
administration offices;
The Complexity Levels are categorized as follows:
– High tech: includes imaging, medical systems and miniaturized technology with high use of inte-
grated software
– Medium tech: ultra-sounds, diagnostic and electrosurgical devices;
– Low tech: simple equipment such as ECGs or defibrillators
– Very low tech: Tables, accessories, probes or scialytic lamps
The product of the above two categories defines the Criticality Index as indicated in Table 1.
As shown in Table 1, high Criticality Index is obtained for those values of 6 or more. A medium
Criticality Index is defined for values between 4 and 3, whereas values between 1 and 2 are classified as
low criticality. The value 0 represents non critical devices.
Once the CI is defined for all devices it is possible to evaluate the Maintenance Priority Index with the
Boolean operator or as reported in Fig. 1.
Both Life support and large equipment devices are defined by the flag Yes/No.
As shown in Table 2, High-MPI is obtained if one of the two flags is of positive value “Yes” or if the
Criticality Index is high.
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Table 2
Logic structure for evaluating the Maintenance Priority Index
Criticality index Big equipment Life support Maintenance Priority Index
H/M/L/N Y/N Y H
H/M/L/N Y Y/N H
H/M/L/N N N H/M/L/N

Fig. 2. Boolean operator used for assessing the devices needing a PM planning.

Fig. 3. Database development for the general economic assessment of the procedure.

Medium- and Low-MPIs are obtained by low and medium CIs and both negative flags value “No”.
The category Null-MPI is defined by both negative flags value “No” and the presence of a non critical
device.

2.2. Economic evaluation

In the majority of cases technicians are asked to intervene and manage an already existing and complex
situation which usually consists of new and old equipment either purchased or with leasing contracts.
The model provides a new option whereby only the devices effectively needing a new agreement are
considered. Those devices which are under contract but not directly purchased by the hospital are not
considered in the planning, see Fig. 2.
When the actual number of devices is obtained, it is possible for hospital managers to economically
evaluate the expenditure referring to the preventive maintenance plan in effect.
The economic assessment phase is reported in Fig. 3.
The economic evaluation includes the annual cost derived by preventive maintenance actions and
safety control activities.
The total cost is assessed by evaluating the complexity level of the technology, from the highest cost
in high technology to the lowest in low technology equipment.
210 R. Miniati et al. / Design of a decision support system for preventive maintenance planning

Fig. 4. Final framework for the total cost assessment of the procedure.

Applied to the case of the University Hospital of Florence, the estimated values reported below
were calculated according to the analysis of current contracts at regional level and using the following
proportions: 12% of the whole acquisition value for large devices, microscopic operators and ventilation
technology and incubators, 10% for regular high tech, 8% for medium technology and 6% for low tech.
The monetary values for the preventive actions are as follows:
– 4,000 – includes large devices such as magnetic resonance, radiology and cobalt therapy equipment
with safety/performance controls;
– 1,500 – Microscopic operators;
– 720 – Ventilation technology and incubators;
– 250 – Regular high technology;
– 120 – Regular medium technology;
– 60 – Regular low technology.
– 15 – Safety/performance controls for every type of device including high, medium and low
technology.
As shown in Fig. 4, the last phase estimates the total cost of the plan per year.
The technology complexity first defines the specific type of device and cost and the MPI indicates
the frequency of the maintenance actions per year to include the total cost for High-MPI, half value for
Medium-MPI (which corresponds to half of the actions provided by High-MPI) and one third of the
value for Low-MPI.
Secondly, the cost obtained must be multiplied by the effective number of devices needed to be inserted
into the plan and thirdly, the sum of all contributions (High-, Medium- and Low-MPIs) must be calculated
in order to obtain the total cost per year of the preventive maintenance plan.
The cost per year is considered only for those devices with MPI levels not covered by any contractual
agreement or guarantee.

2.3. Informatic decision system development

Three main processes have been included in S.I.S.M.A. (System of Information Technology and
Support System for Maintenance Actions) which include the creation of a database using Microsoft
Access 2000, the use of SQL programming and interface development using Microsoft Visual Basic 6.0.
The database is composed of twenty data tables connected to the central core of the medical devices’
database present within the CE department. As shown in Fig. 5, it is linked to other tables which can
be grouped into six main macro-systems: those typical for the device such as technology, destination
of use, those typical for manufacturers such as type of contract, PM and safety costs; and the last one
typical for the health structure such as hospital area.
 R. Miniati et al. / Design of a decision support system for preventive maintenance planning 211

Fig. 5. The database organization and composition built for the DSS.

Fig. 6. The DSS interface by considering the starting page of the system with the data management section (I) and the Preventive
Maintenance (PM) analysis (II).

Using the existing database from the CE department as a basis, the new database provides all the vital
information for the SQL program to define, for every device, the necessary technical indices and the
economic estimation for an appropriate maintenance plan: Criticality Index (by the use of Hospital Area
and Technology tables), the Maintenance Preventive Index (Criticality Index query and the Destination
of Use table), the real need to be inserted in the maintenance plan (the MPI query and the Contract table)
and finally the economic evaluation (MPI query, Contract, Safety Cost and PM Cost tables).

3. Results

The starting page of the system reports the two main functions, namely the data management section
(I) and the Preventive Maintenance (PM) analysis (II), as described in Fig. 6.
The data management is further divided in to four sub-areas: sub-section “a” includes all the possible
actions regarding the devices’ inventory, consisting of new record insertion, record deleting, editing and
record fields clearing. Sub-section “b” is connected to the technology data (complexity, life support);
sub-section “c” is linked to the hospital areas, while sub-section “d” refers to the contractual aspects of
the device.
212 R. Miniati et al. / Design of a decision support system for preventive maintenance planning

Fig. 7. Example of report containing the supporting data for the Preventive Maintenance Planning.

Figure 6 (II) refers to the preventive maintenance (a, b and c) and economic analysis (d). In sub-section
‘a’, the devices to be included in the planning are selected according to the different MPI levels. In
the case of High-MPI, distinction is also made between life support and/or critical devices and/or big
machines. Sub-section “c” and “d” present the results in terms of number of devices included in the plan
and the cost estimation respectively.
Finally, by the use of Crystal Reports, the REPORT button in sub-section “d” provides users with the
supporting data form (A4 format), as reported in Fig. 7.
The model has been applied to the CE Database of the University Hospital of Florence, which is
composed by 9,221 devices, with almost half considered High and Medium-CI (see Fig. 7a).
 R. Miniati et al. / Design of a decision support system for preventive maintenance planning 213

Table 3
DSS simulated options for the Hospital PM and QP Planning
Cost [ /Year] PM devices coverage [%] QP devices coverage [%]
Option 1 170.535 100 100
Option 2 131.285 65 100
Option 3 116.590 56 100

According to the PMI, 4,146 devices are Null-MPI and 5,075 are categorized as follows: 1,832 devices
are High-MPI, 650 Medium- and 2,593 Low-MPI devices, see Fig. 7b. Most of the devices not covered
by the PMI belong to the Low-MPI category.
The general situation shows how more than half of the devices need a preventive maintenance plan, with
estimated costs of 91,330 /Year. The cost of devices already under preventive maintenance coverage is
75,000 /Year. Indeed, the assessment estimates the total cost for a new preventive maintenance plan to
be around 166,330 /Year.
The necessary costs are distributed as follows: 37,385 /Year for High-MPI devices, 14,695 /Year
for Medium-MPI equipment and 39,250 /Year for Low-MPI.
The last section (Fig. 7c) analyzes the High-MPI devices in detail: there are 1039 High-CI devices,
with an estimated cost of 20,185 /Year, 785 devices belong to the life support category, needing
16,400 /Year for preventive maintenance coverage and 1 large device with an estimated coverage cost
of 4,000 /Year.
The report regarding Quality & Performance controls follows the same format as Fig. 7, with an
estimated cost of 76,005 /Year for full coverage. The devices’ distribution and the subsequent costs are
divided as follows:
– 1.824 High-MPI with an economic need for coverage of 27,360 /Year;
– 650 Medium-MPI with an estimated cost of 9,750 /Year;
– 2593 Low-MPI with an assessed value of 38,895 /Year.
The total amount to cover all devices classified higher than Null-MPI for both PM and Quality &
Performance controls is 167,335 /Year.
Finally, three different options were simulated for the presented scenario according to the number of
devices covered and the economic resources necessary for the PM and Quality & Performance plans (see
Table 3):
– Option 1: covering all the non Null-MPI devices for both PM and Quality & Performance controls
by assuming an economic estimation of 170,535 /Year and a total device coverage for both PM and
Safety controls of 100%;
– Option 2: covering High- and Medium-MPI devices for the PM actions and all MPI types for the
Quality & Performance controls with an economic assessed expenditure of 131,285 /Year and a
total PM coverage of 65% and 100% for Safety controls;
– Option 3: considering only High-MPI for PM actions and all MPI types for the Quality & Perfor-
mance controls with an economic evaluated cost of 116,590 /Year and a total PM coverage of 56%
and 100% for Quality & Performance controls.

4. Conclusion

The developed tool functions not only as a data management software, but it also provides technical
support to assist hospital managers with typical technology issues such as preventive maintenance and
quality control planning.
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The implemented methodology considers the typical risk management approach where the main risk
(safety loss) is analyzed by keeping in consideration the economic resource availability. The priority
index for preventive maintenance takes into account both intrinsic aspects of the device and environmental
factors such as area of use, thus objectively defining the frequency of maintenance intervention.
Furthermore, the automatic system SISMA allows the application of the methodology in different
hospitals. While the monetary values reported refer specifically to the Florence hospital study, when
applied to the case of other general hospitals, the results of the system should show a similar ratio in
terms of proportionality to technology cost. In this way the SISMA system provides an efficient support
to decision makers who can carry out all analysis and comparisons necessary for a rational planning
which aims to minimize the cost/efficiency ratio by providing the best solution for guaranteeing operator
and patient safety.
Finally, the informatics system’s flexibility can provide the decision maker with scenario simulations
by assessing specific needs existing from one health facility to the other, or different needs according to
different periods.
Future development consists of accuracy improvement regarding the economic assessment and the
development of a second parallel system which could support decision makers in equipment acquisition
planning, a process which is not yet completely based on objective needs and criteria.

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