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Accepted Manuscript

Classical and Fuzzy FMEA Risk Analysis in a Sterilization Unit

Cansu Dasuyu, Elifcan G men, Mfide Narl, Ali Kokangl

PII: S0360-8352(16)30355-2
DOI: http://dx.doi.org/10.1016/j.cie.2016.09.015
Reference: CAIE 4471

To appear in: Computers & Industrial Engineering

Received Date: 20 October 2015


Revised Date: 5 August 2016
Accepted Date: 13 September 2016

Please cite this article as: Dasuyu, C., G men, E., Narl, M., Kokangl, A., Classical and Fuzzy FMEA Risk
Analysis in a Sterilization Unit, Computers & Industrial Engineering (2016), doi: http://dx.doi.org/10.1016/j.cie.
2016.09.015

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Classical and Fuzzy FMEA Risk Analysis in a Sterilization Unit

Cansu Dasuyu, Elifcan Gmen, Mfide Narl, Ali Kokangl*

* Corresponding author

Name: Research Assistant Cansu Dasuyu


Address: Department of Industrial Engineering, Cukurova University, 01330, Adana,
Turkey.
Phone: +90 322 338-6084/2074/121
Fax: +90 322 338-7239
E-mail: cdagsuyu@cu.edu.tr
Affiliation: Cukurova University

Name: Research Assistant Elifcan Gmen


Address: Department of Industrial Engineering, Cukurova University, 01330, Adana, Turkey.

Phone: +90 322 338-6084/2074/117


Fax: +90 322 338-7239
E-mail: egocmen@cu.edu.tr
Affiliation: Cukurova University

Name: Teaching Staff Mfide Narl


Address: Department of Industrial Engineering, Cukurova University, 01330, Adana, Turkey.

Phone: +90 322 338-6084/2074/117


Fax: +90 322 338-7239
E-mail: znarli2000@yahoo.com
Affiliation: Cukurova University

1
Name: Professor Ali Kokangul
Address: Department of Industrial Engineering, Cukurova University, 01330, Adana, Turkey.

Phone: +90 322 338-6084/2074/127


Fax: +90 322 338-7239
E-mail: kokangul@cu.edu.tr
Affiliation: Cukurova University

Classical and Fuzzy FMEA Risk Analysis in a Sterilization Unit

ABSTRACT
Global system pressures prompt hospitals to consider the risk factors of the healthcare
system. The sterilization unit is a focal point of the healthcare system in regards to risk
factors, and these units should be properly managed. Therefore, to study risk factors in
sterilization units, we utilized failure mode and effects analysis (FMEA), which is a proactive
risk assessment method for examining all failure modes and eliminating or reducing the
highest risk priority failures. In this study, a 5x5 matrix and both classical and fuzzy
approaches of FMEA were developed for a sterilization unit to assess and identify the hazards
discussed in prior studies and new hazards discovered during this study. The method proposed
in this study provided both accurate risk assessments and effective responses to those risks.
Finally, a case study of the sterilization unit of a large hospital is presented to demonstrate the
effectiveness of the proposed methods.

Keywords: FMEA, fuzzy FMEA, sterilization unit, healthcare.


1. Introduction
The sterilization unit where hospital items are sanitized is one of the most important
units in regards to risk analysis. Managing sterilization units is difficult because of contagion
and the high level risk structure. These units work in coordination with other units of a
hospital, and they are a focal point in fighting microorganisms and pathogens, which is
important to ensure the units safety. Any risk factor that may arise in this unit is vital because
it affects all of the other units within the hospital (Negrichi et al.,2012).

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Sterilization is a highly effective process that removes all microorganisms from
medical devices. This process includes steps such as decontamination, preparation and
packaging, sterilization, quality control, sterile storage and distribution. In general, service
processes in hospitals are unstructured, largely because they are based on patient feedback
(Shukla et al., 2014). Instruments used in the sterilization unit are freed of microorganisms by
sterilization. After this process, these pieces of equipment are used again for the patients;
therefore, all activities should be precisely conducted in this unit because of its importance to
all patients and hospital staff. In the sterilization unit, blood of a staff member may spread
infection through medical devices to other staff members and patients in the hospital.
Transmission of infection to patients extends the duration of their treatment and possibly their
length of stay. Long-term patient stays lead to new risks encountered by the patients. A new
approach has been investigated for the length of stay and used a risk measure in bed planning
for five units of a hospital (Papi et al., 2016). Application of a risk analysis method is
extremely important to prevent occupational accidents and diseases.
Risk analysis may be summarized as the determination of the priorities of the risks
after identifying the hazards at a specific location. Numerous methods, including the Fine
Kinney, the X type Matrix, the L-type Matrix and FMEA, are used to determine these
priorities. For all of these methods, the potential hazards are identified in the first step of the
risk analysis. In this first step ,, accident or job disease registries, near-miss registries and
environment measurement results are used for the analysis. Disclosed hazards are scored
according to each parameter of the preferred risk analysis method, and a hazard score is
obtained. Then, for each hazard, a risk class is determined based on the hazard score.
Identifying the hazards has greater importance than prioritizing the hazards in prior
occupational health and safety studies. . According to prior studies that prioritize hazards, the
level of hazard acceptance, precaution decisions and priority measures of the precaution may
be determined.
Classical FMEA is widely used in risk analysis studies conducted in hospitals. The
scale used by classical FMEA depends on the absolute values. The lack of historical data
often leads to difficulties for experts that conduct risk analyses. In such cases, fuzzy logic can
provide more realistic results than using absolute values.
This is the first study to use fuzzy FMEA for a sterilization unit, and we propose a
new approach that uses a 5-class FMEA to overcome the limitations of the classical FMEA.
First, the hazards described in prior studies and new hazards identified by this study were
determined for the sterilization unit. Then, 125 decision rules were created for five classes,

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and the risk class for each determined hazard was compared using both approaches. In
addition, the sensitivity for classification of the hazards was increased by increasing the
number of classes from three to five. The remainder of this paper is organized as follows. The
next section presents a literature review regarding FMEA, and Section 3 describes prior
studies regarding fuzzy FMEA. Section 4 presents the ranges of new risk classes. Section 5
presents an application of FMEA, and Section 6 presents an application of fuzzy FMEA.
Section 7 presents a discussion, and Section 8 describes the conclusions of this study.

2. FMEA
FMEA is a proactive method that prevents system faults before they occur.
FMEA uses three risk factors including occurrence (O), detectability (D) and severity
(S). O indicates the frequency of the risks, D indicates the possibility of predicting risks
before they occur, and S is the seriousness of the risk to the system. The output parameter
denoted as the risk priority number (RPN) is the product of the three input parameters ranking
the failure modes. The three input parameters are scored using a 10-point scale. After
multiplying these input parameters, the highest RPNs are focused on. These results help
analysts to identity failures and their causes. Analysts assign a threshold value to classify
failures, and corrective actions are required for the failures that are have a value greater than
100 RPN.
2.1. Literature Review on FMEA
FMEA was first published as FME(C)A in the documentation of the US Armed Forces
Military Procedures. In the 1960s, NASA worked on FMEA applications with different
names for spacecrafts (Baig and Prasanthi, 2013). The application of FMEA was first applied
by the U.S. Army; then, it was generally applied to the automotive industry and was first
performed within the healthcare system in the 1990s. In the mid-1990s the Institute for Safe
Medication Practices recommended that FMEA be used to prevent errors that occur when
dispensing medications (Chiozza and Ponzetti 2009). The Joint Commission (JC), formerly
called the Joint Commission on Accreditation of Health Care Organization (JCAHO), now
requires all acute care hospitals to perform FMEA regularly (Standard LD 5.2 Accreditation
Manual, 2001 Edition). The Technical Committee of the International Organization for
Standardization (ISO) also suggests FMEA as a method for reducing high medical risks
(ISO/TS 22367).
There are numerous studies that use FMEA in the healthcare sector (Soykan et al.,
2014; Khasha et al., 2013; Wetterneck et al., 2004; Reiling et al., 2003). Soykan et al. (2014)

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used the FMEA method to study nine infectious diseases using risk factor parameters such as
O, D and S. They ranked the RPNs according to the three risk factors and evaluated the risks
beginning with those that had the highest RPN. Khasha et al. (2013) studied the risk
management approach for prioritizing surgery cancel factors. The study results determined
that insufficient beds, lack of intensive care unit beds, high risk surgery, high blood pressure
and diabetes were the primary factors that resulted in surgery cancellation. Wetterneck et al.
(2004) applied the FMEA method for a new infusion pump and provided recommendations.
Reilingen et al. (2003) studied FMEA to ensure the safety of patients and minimize errors and
demonstrated that FMEA was a beneficial tool to increase the safety of patients. Liu et al.
(2014) used hybrid weighted distance measures to develop the classical FMEA. This method
provides an effective solution for environments where information is vague and incomplete.
The effectiveness and success of this method was demonstrated by application to a blood
transfusion event. Lin et al. (2014) examined qualitative and quantitative methods to analyse
medical devices. First, they evaluated the shell method denoted as Software, Hardware,
Environment, Live-ware and Central live-ware for qualitative analysis; then, they evaluated
the FMEA using quantitative analysis to determine the risk factors and improve the safety of
medical devices.
Although FMEA is used in numerous fields, particularly in the health sector, it has
numerous shortcomings.
2.2 Drawbacks of traditional FMEA
Classical FMEA is used widely in current studies; however, this analysis has certain
drawbacks. The primary drawbacks of FMEA include the following (Khasha et al. 2013);
Different combinations of O, S and D may lead to an identical RPN value;
however, failure modes with an identical RPN may correspond to different risk
factors.
In traditional FMEA, O, S and D are assumed to be of the same significance.
However, in reality, the degree of their importance may vary.
RPN is simply calculated by multiplying the three input factors, and the
possible indirect relationships between these factors are not considered.
The three parameters used in FMEA calculations do not encompass the entire
range of causative factors leading to a failure mode, which may include
mistakes, contradictions, uncertainties and ambiguities

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These drawbacks are eliminated by fuzzy logic, which uses linguistic variables.
Linguistic variables are easier to use than numerical assignments to describe the failure
modes. The input parameters are fuzzied using membership functions. These fuzzy
parameters are evaluated by decision rules.

3. Fuzzy FMEA
In the literature, there are many applications of fuzzy FMEA. Guimaraes and Lapa
(2004) used FMEA to analyse the chemical and volume control system in a nuclear power
plant application. They applied the fuzzy inference system to the problem and evaluated both
the RPNs and fuzzy RPNs using a practical example.
Xu et al. (2002) developed a fuzzy FMEA technique for a turbocharger system in a
diesel engine. In this study, despite the failure information and the interdependencies among
failure modes, the failures were explored using linguistic variables. Sharma et al. (2005)
proposed an FMEA approach for prioritizing failure modes for a hydraulic system. In this
approach, input parameters were represented as members of a fuzzy set that were fuzzied and
evaluated by a fuzzy inference engine. Keskin and zkan (2009) introduced a method
denoted as fuzzy adaptive resonance theory to evaluate RPNs in FMEA. The adaptive
resonance theory was developed for clustering failures. This new approach addressed the
drawbacks of classical FMEA. Vencheh and Aghajani (2013) investigated a new fuzzy model
based on alpha () level sets. This study allowed the failure factors to be represented by
linguistic variables. The fuzzy RPN was explored as fuzzy weighted-level sets. Compared to
the traditional RPN and its various fuzzy improvements, the proposed fuzzy FMEA has
certain advantages.
Although the applications of fuzzy FMEA in the health system are not common, some
studies are available. Kahraman et al. (2013) used FMEA with linguistic variables and fuzzy
if-then rules to prioritize healthcare problems. They also applied the fuzzification process with
the aid of MATLAB 2007 software. Wang et al. (2009) used fuzzy linguistic terms and fuzzy
rating to evaluate the risk factors O, S and D as fuzzy variables and ranked the fuzzy RPN
using centroid defuzzification based on level sets. Jamshidi et al. (2015) studied
prioritization using fuzzy FMEA to select the optimal protection strategy with the concept that
certain medical devices, such as infant incubators, infusion pumps and computed tomography
scanners, should adhere to certain standards of safety.
4. Determining the Ranges of New Risk Classes for FMEA

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For the risk analysis conducted in this study, both the classical and fuzzy approaches
are used. In these two approaches, the hazards are grouped according to their risk scores.
The risk scores are divided into three classes, such as 0-40, 40-100 and 100-1000, in classical
FMEA (Ford Motor Company, 1998). The number of classes to be created in fuzzy FMEA is
also three; however, in prior studies regarding fuzzy FMEA, five classes were generally
preferred (Petrovic et al. (2014) ; Meng Tay and Peng Lim, (2006) ; Guimares and Lapa
(2007) ; Gargama and Chaturvedi (2011)). This classification makes it difficult to compare
the two different approaches. To compare the classes of both approaches accurately, the risk
scores must be accurately obtained and the number of classes used must be identical. In this
context, either the number of classes in classical FMEA should be increased from three to five
or the fuzzy FMEA rules should be decreased to three. In our study, five classes have been
created to more accurately determine the classes of risk scores and more clearly reveal the
differences between hazards..
Petrovic et al. (2014) specified that O, S and D parameters assume values between 1
and 5 or 1 and 7. In addition, they described RPN values according to a 5-class. The class
ranges of RPN values were 1-15, 16-30, 31-60, 61-150 and 151-343. In case of a change in
the O, S, D parameters between 1 and 7 values, a top value has been determined as 343
(7x7x7) because of a maximum RPN value. A 1-7 scale may not be sufficient for more
precise grouping in the field of health and risk analysis, particularly in sterilization units.
Because of the severity of an event that may result in a disaster or multiple deaths, taking a
value of 10 for the severity is very important to be more accurate and provide a more realistic
risk analysis. In this study, the number of classes was increased to from three to five and the
minimum and maximum risk score values (0-1000) and new lower and upper limits were
determined. Therefore, the first step of our study was to increase the number of classes of
classical FMEA from three to five and determine the upper and lower limits of each class.
Determination of the level of importance of the hazards in relation to each other was
carried out more precisely. The lower and upper limits remain unchanged, but the number of
classes were increased to five and intermediate values were obtained from the exponential
equation. No scientific rule exists to determine the threshold of each class (Carbone, 2004).
An upper limit indicates that mandatory precautions should be taken, but a lower limit may be
overlooked when necessary.
In this study, Equation 1 was obtained based on given limit values (40, 100 and 1000)
in classical FMEA using regression analysis. For this approach, the R2 value was 0.942. An
R2 value that is approximately equal to 1 indicates that Equation (1) sufficiently represents the

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three class approach. In Figure 1, the regression chart from the regression model (Equation
(1)) is provided. In Equation (1), x represents the number of the classes and Y represents the
RPN.
In classical FMEA, x assumes one, two or three values because of the three classes. In
this study, FMEA included five classes; therefore, x consists of three units divided into five
groups, and the rate of increase was determined to be 0.6 (3/5= 0.6). In this case, the x values
used in this study assume the values of 0.6, 1.2, 1.8, 2.4 and 3. The risk scores obtained from
Equation 1 are provided for each x value in Table 1.

Y=6.35(e1.609x) (1)

<<Insert Figure 1 Here>>

Table 1
FMEA 5- class values based on the regression model

Class No x y

1 0.6 16.67

2 1.2 43.78

3 1.8 114.9

4 2.4 301.8

5 3 792.7

As noted in Table 1, the upper limit value (y) of the 5th risk class obtained from
Equation (1) for x=5 is 792.7. However, changes in the upper and lower limit values in the
classical FMEA for x=5 y have been recognised as 1000. The parameters (O, S and D) are
integers; thus, the product of these parameters must also be integers. Therefore, floating point
numbers (y values) obtained as a result of the regression model were rounded to the nearest
integer number. Accordingly, the class widths for the 5-class FMEA used in our study are
presented in Table 2.

Table 2
Class widths and explanations for 5-scale FMEA

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Class No Class Width Explanation

1 0-17 Very Low

2 18-44 Low

3 45-115 Medium

4 116-302 High

5 303-1000 Very High

5. Application of FMEA to a Sterilization Unit

Our study was conducted in a hospital that has a capacity of 136 beds and five
operating rooms. High bed capacity, continuous surgical operations and heavy daily patient
circulation increase the workload of the sterilization unit. Due to an excessive workload,
quickly sterilizing equipment may lead to an increase in the number of work accidents, which
demonstrates the importance of risk analysis studies regarding sterilization units. The
sterilization unit used for this study employes three medical technicians and two nurses. The
nurses work on rotating shifts.
For risk analyses conducted in the healthcare field, the 5x5 matrix has been used more
commonly; however, the use of the FMEA technique has been suggested by numerous
scholars and institutions such as JC, JCAHO and ISO. In this study, FMEA and fuzzy FMEA
methods were applied. We applied both classical FMEA and fuzzy FMEA to compare the
results of the two applications and to interpret the differences. However, the obtained results
of assigning different classes in the classical FMEA are also compared with each other for
evaluating the novelty of the approach. Since Fuzzy FMEA eliminates previously mentioned
shortcomings of classical approach, we have showed that it is better tool like these cases.
In the hospital setting used for this study, materials and toll-equipment were sterilized
after each use in the intensive care unit, operating rooms and clinics. In our risk analysis study
of the sterilization unit, 26 unit hazards in 10 classes were considered. These hazards were
grouped. The hazards considered in our study that were added by the hospital are indicated by

the symbol, the hazards that were included from prior studies are indicated by the
symbol (Gen 2011 and Da l et al. 2010)
2010), and the hazards revealed in this study are indicated
by the symbol; all hazards are listed in Table 3. For all of these hazards, scoring was
conducted using the opinions of experts. Thus, managers that analyse the risks that may occur
in sterilization units may benefit from both prior studies and the risks that our application

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identified; they were ranked using a 5x5 matrix and both the classical FMEA and fuzzy
FMEA.
The hazards considered in this study were ranked according to a 5x5 risk matrix
method by a risk analysis team . This team consisted of risk analysis experts (including one of
the authors of this study), two medical technicians and a nurse; for each hazard, the O, S and
D parameters were ranked during a brainstorm session overseen by the leader of the risk
analysis team. The risk class obtained by the product of these two parameters is provided in
the last column of Table 3. The 5x5 matrix approach separates the risk scores into five classes
that include very low, low, medium, high and very high.
The hazards listed in Table 3 were also ranked according to the FMEA in the same
manner. The O, S, D and risk scores consisting of the products of these parameters are
provided in Table 3. The FMEA risk scores obtained were classified according to the classical
FMEA and the 5-class approaches as noted in Table 2.

Table 3
FMEA Risk Analysis for the Sterilization Unit
Risk Risk Risk
Risk Class Class Class
Hazard Class Hazards O S D RPN
No. 3- 5- 5x5
Scale Scale Matrix
Contamination of blood and
body fluids through contact R1 3 4 1 12 VL VL L

with skin
Contamination of blood and
body fluids through contact R2 2 4 1 8 VL VL L

with eye
Transmission of infection-
VH M
Infection Risks

induced physical R3 3 4 9 108 L



environment

Stab wounds R4 4 5 1 20 VL L M
Transmission of infection
due to medical waste R5 4 5 2 40 VL L M

accidents
Transmission of infection
due to chemical waste R6 9 6 8 432 VH VH H
accidents (gluteraldehit)
Transmission of infection
due to inappropriate use of R7 7 5 5 175 VH H M

a bag or stab waste

10

Noise
Risk Exposure to noise R8 9 6 1 54 M M H

Risks related to mutagenic


Risks related to hazardous substances

risks/carcinogenic risks
R9 VH H
or carcinogenic and mutagenic

related to hazardous 4 6 9 216 M



substances
Inhalation of formaldehyde
R10 9 6 9 486 VH VH H
or ethylene oxide
substances

The formation of burns due


to hot water from an R11 1 7 1 7 VL VL L
autoclave
The burns due to steam
from an autoclave

(explosion) R12 5 8 1 40 VL L M

Allergic reaction of
workers due to accidents
R13 1 6 1 6 VL VL L
Allergy risks

depending on the

chemical spilt
Skin allergies related to
the use of allergy-causing
R14 10 5 1 50 M M H
materials (latex, gloves,
etc.)
Injury of employees due to
falling, overturning or rolling
of equipment or materials R15 4 4 1 16 VL L L
not properly secured to the
Ergonomic risks


floor or wall
Musculoskeletal system or
cardiovascular diseases due
to standing for long periods
R16 9 3 1 27 VL L M

of time
Sprain or injury to limbs due
to slipping, stumbling, falling
or jamming induced by a
R17 1 4 1 4 VL VL L

wet or slippery floor

VL L
Communication

Growing anger and nerves R18 6 3 1 18 L


risks


Claim of employees R19 1 2 1 2 VL VL L

Exposure to physical
violence (assault, battery, R20 1 4 1 4 VL VL L
Violence risks


etc.)
Exposure to verbal violence
(insults, threats, slander, R21 2 3 1 6 VL VL L

etc.)
Exposure to sexual
R22 1 2 1 2 VL VL L
harassment (verbal or

11

physical)
Electrical fault and leak of a
Risks related
R23 1 9 9 81 M M L
to electric
shock gas control detector
Electric shock due to
electrical leakage in devices R24 1 9 9 81 M M L

The formation of a biological


VL VL
Risks related

R25 1 5 2 10 L
growth
to a sterile
workplace

Increasing particles in the


environment due to the lack R26 9 4 9 324 VH VH M
of positive air pressure

Hazards considered in the current risk VL: Very Low;


analysis L: Low;
Hazards added from prior studies M: Medium;
Hazards disclosed in this study H: High;
VH: Very High

As noted in Table 3, the hazards analysed using the 5x5 matrix approach were
generally in the same class. Therefore, it is difficult to determine whether measures should be
taken in regard to those hazards. In the 5-scale FMEA, it was noted that the hazards were
distributed throughout all classes; therefore, the risk analysis has been applied in a more
precise manner. The hazard of infection caused by transmission in the infection risk group is
classified in the Low class according to the 5x5 matrix approach. This same hazard when
analysed by the FMEA method is classified in the Very High class based on the 3-class
scale and in the Medium class based on the 5-class scale.
As a result of the risk analysis of the 5x5 matrix approach and a comparison of the 5x5
matrix and 5-scale FMEA as demonstrated in Table 3, the R18 number hazard was
unchanged, the class of 10 hazards (R1, R2, R3, R6, R7, R9, R10, R23, R24 and R26) shifted
to lower risk classes, and the remaining 15 hazards moved to higher classes.
.
6. Application of Fuzzy FMEA to a Sterilization Unit

In our study, a fuzzy FMEA scale was constructed based on the classical FMEA scale
for a sterilization unit and was coded using the Fuzzy Logic Designer Tool in Matlab 14a.
O, S and D parameters were used as inputs, and the RPN was the output. The fuzzy
design developed in this study is provided in Figure 2 including the inputs and output. As
demonstrated in Figure 2, the Mamdani min max method was used.
The inputs and the output consist of five levels in the fuzzy FMEA including three
inputs and a single output. The triangular membership function was used at each level, the

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membership function prepared for input is provided in Figure 3, and the membership function
prepared for output is provided in Figure 4. In both Figure 3 and Figure 4, the triangular
membership function consists of very low, low, medium, high and very high. Membership
function values generated by the fuzzy FMEA scale are provided in Table 4.

<<Insert Figure 2 Here>>

<<Insert Figure 3 Here>>

<<Insert Figure 4 Here>>

Table 4
Fuzzy Scale for Occurrence, Severity and Detectability
Defining Fuzzy Number

Very Low (0,1,3)

Low (1,3,5)

Medium (3,5,7)

High (5,7,9)

Very High (7,9,10)

Considering the five levels of O, S and D inputs, 125 decision rules were formed for
the sterilization unit. Severity has been identified as the most important parameter because
high severity for the healthcare sector results in death. Therefore, the decision rules have been
established to affect the RPN of the high severity value.
According to the decision rules developed, the risks of the sterilization unit were
calculated by using classical FMEA considering five classes as noted in Table 3 and were
scored by the same risk assessment team using the fuzzy FMEA. As a result, the classical
FMEA, the fuzzy FMEA and the risk classification system obtained in this study are provided
in Table 5.

Table 5
Classical and Fuzzy FMEA Risk Scores and Priorities for the Sterilization Unit

Classical Fuzzy
Classical Fuzzy
FMEA Risk FMEA Risk
Risk No FMEA FMEA
Score Score
Score Score
Priority Priority

13
R1 12 15 2,38 8
R2 8 17 2,38 8
R3 108 6 6 3
R4 20 12 3 7
R5 40 10 4 5
R6 432 2 7,62 1
R7 175 5 5 4
R8 54 8 5 4
R9 216 4 7 2
R10 486 1 7,62 1
R11 7 18 3 7
R12 40 10 5 4
R13 6 19 3,45 6
R14 50 9 5 4
R15 16 14 2,38 8
R16 27 11 3 7
R17 4 20 1,39 9
R18 18 13 2,38 7
R19 2 21 1,39 9
R20 4 20 1,39 9
R21 6 19 1,39 9
R22 2 21 1,39 9
R23 81 7 7 2
R24 81 7 7 2
R25 10 16 2,38 8
R26 324 3 6 3

As demonstrated in Table 5, the sorting of the hazards may be different for the
classical FMEA and the fuzzy FMEA. The hazards are classified according to their scores and
displayed in Table 5, and the classification is provided in Table 6.

Table 6
Risk Classification of Sterilization Unit
3-scale FMEA 5-scale FMEA Fuzzy FMEA
Explanation
Risk No Explanation Explanation
Risk Risk Membership of
of Risk of Risk
Class Class Class Membership
Class Class
Class
Very Low-
R1 1 Very Low 1 Very Low 1-2
Low

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Very Low-
R2 1 Very Low 1 Very Low 1-2
Low
Medium-
R3 3 Very High 3 Medium 3-4
High
R4 1 Very Low 2 Low 2 Low
Low-
R5 1 Very Low 2 Low 2-3
Medium
High-Very
R6 3 Very High 5 Very High 4-5
High
R7 3 Very High 4 High 3 Medium
R8 2 Medium 3 Medium 3 Medium
Medium-
R9 3 Very High 4 High 3-4
High
High-Very
R10 3 Very High 5 Very High 4-5
High
R11 1 Very Low 1 Very Low 2 Low
R12 1 Very Low 2 Low 3 Medium
Very Low-
R13 1 Very Low 1 Very Low 1-2
Low
R14 2 Medium 3 Medium 3 Medium
Very Low-
R15 1 Very Low 1 Very Low 1-2
Low
R16 1 Very Low 2 Low 2 Low
R17 1 Very Low 1 Very Low 1 Very Low
Very Low-
R18 1 Very Low 2 Low 1-2
Low
R19 1 Very Low 1 Very Low 1 Very Low
R20 1 Very Low 1 Very Low 1 Very Low
R21 1 Very Low 1 Very Low 1 Very Low
R22 1 Very Low 1 Very Low 1 Very Low
R23 2 Medium 3 Medium 4 High
R24 2 Medium 3 Medium 4 High
Very Low-
R25 1 Very Low 1 Very Low 1-2
Low
Medium-
R26 3 Very High 5 Very High 3-4
High

7. Discussion

A comparison of the 3-scale and 5-scale FMEA changes may be summarized as


follows.
Table 7
Comparison of the 3-class and 5-class FMEA

15
5-scale FMEA

VL L M H VH

3-scale VL 10 6
FMEA
M 4

VH 1 2 3

Based on the results, the 3- and 5-scale classical FMEA comparison matrix was
developed and is provided in Table 7. In regard to class changes of hazards when comparing
the 3-scale FMEA and the 5-scale FMEA, 17 unit hazards were unchanged, the class of three
unit hazards (R3, R7 and R9) decreased to a lower risk class, and the remaining six unit
hazards (R4, R5, R12, R15, R16 and R18) moved to a higher class.

The comparison of the 5-scale and fuzzy FMEA class changes can be summarized as
follows.
Table 8
Comparison of the 5-scale and fuzzy FMEA
Fuzzy FMEA

VL VL-L L L-M M M-H H H-VH VH

VL 5 5 1

L 1 2 1 1
5-
scale M 2 1 2
FMEA
H 1 1

VH 1 2

Based on the results, the classical and fuzzy FMEA comparison matrix is created and
provided in Table 8. In regard to class changes of hazards when comparing the 5-scale FMEA
and fuzzy FMEA, nine unit hazards were unchanged, the class of six hazards decreased to a
lower risk class, and the remaining eleven unit hazards moved to a higher class.

Considering all of the hazards in the FMEA, the most important hazards of the 3-scale
approach included the infection induced physical environment, transmission of infections due
to chemical waste (gluteraldehit) accidents, transmission of infections due to the inappropriate

16
use of bag/stab wastes, carcinogenic risks due to hazardous materials/risks related to
mutagenic substances, breathing formaldehyde and ethylene oxide and an increase in particles
in the environment due to air pressure failure.
For the 5-scale FMEA approach, the transmission of infections due to chemical waste
(gluteraldehit) accidents, breathing formaldehyde and ethylene oxide and the increase of
particles in the environment due to air pressure failure are the hazards that resulted in the
highest priority classification. For the fuzzy FMEA approach, the highest priority hazards
included the transmission of infection due to chemical waste (gluteraldehit) accidents and
breathing formaldehyde and ethylene oxide.
For the sterilization unit analysed in this study, R6 and R10 have the highest priority
according to all the methods of analysis.

Limitations of study;

In this study, certain aspects may be considered to be limitations. The fuzzy decision
rules that were established for the sterilization unit were only applied in a hospital setting. The
hospital is a private healthcare foundation and oversees the sterilization unit. The model
established in this study may be applied to different hospitals (private, government, clinics,
etc.) in different regions, and the results may be generalized and compared.

8. Conclusions
The application of FMEA in engineering is widespread; however, there are few
studies regarding its use in the healthcare system. When FMEA has been studied in this field,
it appears to have been beneficial. The application of FMEA in the healthcare system is not
new; however, this study provides an initial investigation from the perspective of a
sterilization unit that operates within a hospital setting. In this study, the hazards that were
considered in the current risk analysis (), found in current studies () and disclosed in this
study () were identified for the sterilization unit. All of these hazards were evaluated
using the 5x5 matrix approach and 3-scale, 5-scale and fuzzy FMEA.

The following conclusions resulted from this study:

1. When using the 5x5 matrix risk analysis approach, the importance level of the hazard
cannot be revealed due to the lack of the detectability parameter. The 5x5 matrix

17
approach has been the preferred method because of easy applicability. Results from
this study indicated that the 5-scale provided more precise classification than the 3-
scale, so it effects the measures priority against the hazards. Although the 5-scale
FMEA is an appropriate method, the O, S and D parameters are equally important.
The unit-specific fuzzy membership functions and decision rules were developed for a
more accurate risk analysis of the sterilization unit. A fuzzy FMEA risk approach was
developed for assessing and identifying the hazards noted in prior studies, and new
hazards were identified during this study. O, S and D parameters were divided into
five groups, and fuzzy FMEA rules and triangular membership functions were
identified for each group. According to these rules, the RPN values of the hazards
were calculated. All hazards identified in the sterilization unit were prioritized, and the
most important hazards were determined. The results support the notion that it is more
appropriate to use the FMEA method in the health sector, as the JC, JCAHO and ISO
have proposed.
Recommendations and future direction
Improved fuzzy rules and class widths for the 5-scale FMEA generated in this study
may be used in other units of the hospital. Utilizing more than five classes may be considered
in future studies. Future studies can apply new fuzzy FMEA rules according to the increased
number of classes.

For future studies, the hazards created by action plans may be classified using both
classical and fuzzy risk analysis. Thus, results of the implementation of the action plans may
be considered according to both approaches.

The proposed FMEA may be combined with other tools (Fault Tree Analysis,
Theory of The Resolution of Invention-Related Tasks, etc.). This model may also be extended
by preparing action plans to address the risks and different decision rules for the different risk
classes that may be considered in future research.

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Fig. 1. The graph of risk values.

Fig. 2. Design of Fuzzy FMEA.


Fig. 3. Membership function plots of input variables.

Fig. 4. Membership function plots of output variable.


Highlights

Hazards of a sterilization unit of a large hospital determined.


Number of FMEA classes was increased from 3 to 5.
Fuzzy FMEA rules for the sterilization unit were created.
Fuzzy FMEA was applied in a sterilization unit.
Classic FMEA and Fuzzy FMEA were compared.

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Acknowledgement

In this study, we offer our thanks to the hospital administration and Metin Paylamaz for
supporting us to demonstrate the hazards that occur in the sterilization unit, score these hazards
with FMEA and establish of the decision rules.

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