700717

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WMR0010.1177/0734242X17700717Waste Management & ResearchChen and Tsai

Original Article

Waste Management & Research

Evaluating the operational risks

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© The Author(s) 2017
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DOI: 10.1177/0734242X17700717
https://doi.org/10.1177/0734242X17700717

mode and effects analysis journals.sagepub.com/home/wmr

Ying-Chu Chen and Pei-Yi Tsai

Abstract
The potential problems and risks of biomedical waste generation have become increasingly apparent in recent years. This study
applied a failure mode and effects analysis to evaluate the operational problems and risks of biomedical waste. The microbiological
contamination of biomedical waste seldom receives the attention of researchers. In this study, the biomedical waste lifecycle was
divided into seven processes: Production, classification, packaging, sterilisation, weighing, storage, and transportation. Twenty
main failure modes were identified in these phases and risks were assessed based on their risk priority numbers. The failure modes
in the production phase accounted for the highest proportion of the risk priority number score (27.7%). In the packaging phase,
the failure mode ‘sharp articles not placed in solid containers’ had the highest risk priority number score, mainly owing to its high
severity rating. The sterilisation process is the main difference in the treatment of infectious and non-infectious biomedical waste.
The failure modes in the sterilisation phase were mainly owing to human factors (mostly related to operators). This study increases
the understanding of the potential problems and risks associated with biomedical waste, thereby increasing awareness of how to
improve the management of biomedical waste to better protect workers, the public, and the environment.

Keywords
Carbon dioxide, disinfection, incineration, medical waste, solid waste, water

Received 15th December 2016, accepted 12th February 2017 by Editor in Chief P Agamuthu.

Introduction
Waste generation has increased significantly with the intensifica-
tion of urbanisation and global population growth. Biomedical
waste (BMW) is one of the most important categories of waste
and poses potential risks to the environment (Kumari et al.,
2013). BMW is defined as ‘all waste materials generated at
healthcare institutions as well as medical research facilities
and laboratories’ (Stankovic et al., 2008; US Environmental
Protection Agency, 2013). Such waste includes needles, syringes,
diagnostic samples, blood, chemicals, pharmaceuticals, medical
instruments, and radioactive materials (Komilis et al., 2012;
Nwachukwu et al., 2013; World Health Organization, 2013).
Approximately 75%–90% of BMW is non-risk or general health-
care waste (HCW), while the remaining 10%–25% includes haz-
ardous waste that can harm human health if it is not managed
correctly (Bazrafshan and Mostafapoor, 2010). The amount of
BMW generated depends on the structure, location and capacity
of the facilities generating the waste, established waste manage-
ment methods, and number of patients treated (Askarian et al.,
2004; Cheng et al., 2009; Da Silva et al., 2005; Eker and Bilgili,
2011; Eleyan et al., 2013; Tudor, 2007).
The generation rate of BMW differs from country to county
(Ferraz et al., 2000; Marinkovic et al., 2008; Oweis et al., 2005;
Tudor et al., 2005). Approximately 700,000 metric tonne (t) =
1000 kg or 2204.6 lb (instead of ton = 1016.05 kg or 2240 lb UK
(907 kg or 2000 lb US)) – please confirm units or re-calculate as
necessary – please check throughout the article.] of BMW are pro-
duced in China annually (Ma et al., 2016). In the Republic of
Serbia, healthcare facilities are estimated to produce approxi-
mately 48,000 metric t of BMW annually, and approximately
10%–25% of this waste is considered hazardous (Makajic-Nikolic
et al., 2016). In Taiwan, approximately 30,000 metric t of BMW
are generated annually (Taiwan Environmental Protection Agency,
2016). Cheng et al. (2009) reported that hospitals are the major
source of BMW in Taiwan, and found that the average rate of
waste generation in Taiwan ranged from 2.41 to 3.26 kg bed-1 day-1
for general BMW, and 0.19 to 0.88 kg bed-1 day-1 for hazardous
Institute of Natural Resources Management, National Taipei
University, Taiwan, ROC
Corresponding author:
Ying-Chu Chen, Institute of Natural Resources Management,
National Taipei University, No. 151 Daxue Road, New Taipei City 237,
Taiwan, ROC.
Email: ycchen@mail.ntpu.edu.tw
2 Waste Management & Research
Figure 1.  Treatment processes for infectious and non-
infectious BMW.
BMW: biomedical waste.
BMW. This level of BMW generation, in relation to the popula-
tion and size of Taiwan, poses serious problems for the country.
Research has been conducted to analyse the risks of BMW
from different perspectives. However, the application of risk
analysis techniques in the literature is limited (Makajic-Nikolic
et al., 2016). Failure mode and effects analysis (FMEA) is a sys-
tematic technique that is frequently applied to prevent failure.
Failure modes include any undesirable outcomes, such as pro-
duction loss, injury, or accident (Ebrahimipour et al., 2010).
FMEA also considers corrective actions to minimise potential
failures and facilitate continuous improvement. The technique
has been applied in a wide range of industries to prevent failures,
including the automotive, aeronautical, military, nuclear,
and electrical industries (Arabian-Hoseynabadi et al., 2010;
Narayanagounder and Gurusami, 2009; Puente et al., 2002). The
risks in healthcare institutions have been widely studied using
the FMEA technique, which can be applied to improve patients’
safety and the quality of medical care received (Gruber et al.,
2006; Zupa et al., 2006). Vannice and Wimmer (2007) used
FMEA to reduce the occurrence of unusual events in the man-
agement of chemotherapy. In another example, FMEA was
applied to successfully improve the dispensing process (Rogers
and Hughes, 2008). Akpieyi et al. (2015) defined risk-based
frameworks for managing HCW and recommended that FMEA
be applied further to mitigate risks related to HCW. Ho and Liao
(2011) used the FMEA technique to evaluate the potential risks
that may occur in medical treatment, administration, and the out-
sourcing of the disposal process. They also used the FMEA tech-
nique to identify and rank the risks in healthcare institutions
(Liao and Ho, 2014). However, although the FMEA method has
been widely used in the field of medical research, the potential
risks associated with medical research facilities and laboratories
have been under-investigated.
The Taiwanese Government has imposed a series of strict
laws and regulations concerning the management of BMW.
Under the Taiwan Waste Disposal Act, institutions and laborato-
ries must voluntarily dispose of any BMW produced or outsource
its disposal to a registered waste disposal company.
The waste lifecycle consists of four main phases:
Classification, disposal, storage, collection and transportation
(Chen and Wu, 2015; Rajor et al., 2012). Rao et al. (2004) found
that the minimisation and effective management of BMW is
related to the classification process. Problems exist around the
proper segregation of types of medical waste (Bazrafshan and
Mostafapoor, 2010). Problems associated with BMW disposal
have increased rapidly around the world (PRISM Bangladesh,
2005). For some types of BMW, strict requirements govern its
storage in environments where bacteria are less likely to grow
(Bazrafshan and Mostafapoor, 2010). The same registered waste
disposal companies often manage the collection and transporta-
tion of BMW. Ho (2011) discussed the outsourcing risks posed by
BMW disposal in Taiwan. If any one of the four main phases fail,
the risks associated with BMW may increase.
The aim of this study was to use the FMEA method to evalu-
ate the operational problems and risks of BMW generated by
medical research facilities and laboratories. The current status
of BMW and its management, government strategies, and regu-
lations are introduced below to provide an understanding of the
Taiwanese context. Next, the FMEA method is used to identify
the operational problems and risks of the BMW lifecycle. The
effectiveness of the FMEA method is demonstrated through a
case study of Academia Sinica, a pre-eminent academic institu-
tion in Taiwan established in 1982. The institution focuses on
the promotion of scholarly research in the sciences and humani-
ties and comprises 24 research institutes and seven research
centres, headed by world-renowned scholars. The intention of
this study is to increase understanding of the operational prob-
lems and risks associated with BMW, thereby increasing aware-
ness of how to properly manage BMW to better protect workers,
the public, and the environment.
Materials and methods
Research framework
The treatment processes for BMW are shown in Figure 1.
According to Taiwan’s Waste Disposal Act, BMW is classified
as either infectious or non-infectious. Because the manage-
ment of BMW is regulated by the government, this study
applied the ‘Industrial Waste Storage, Disposal, and Handling
Methods and Installation Standards’to identify operational
problems and risks. Infectious BMW should be sealed in red
bags and sterilised before weighing, whereas non-infectious
BMW should be weighed after classification. BMW should be
temporarily stored after weighing before transportation by a
registered waste disposal company.
The sterilisation process is the main difference in the treat-
ment of infectious and non-infectious BMW. A physical or
Chen and Tsai 3
chemical treatment is used in the sterilisation process to reduce
the micro-organism content of the BMW by over 99.999%
according to the NIEA R356.00B method. In Taiwan, the pres-
ence of the micro-organism Geobacillus stearothermophilus (as
an indicator) is tested by the NIEA R356.00B method. The bags
of infectious BMW are sent to autoclaves for sterilisation and are
heated to a temperature of more than 394 K for 60 min, or more
than 408 K for 45 minutes. After the heating process, the tem-
perature, pressure, time, and operators are recorded in detail and
kept at least 3 years. In addition, the operators in this process are
required to receive professional training classes periodically.
FMEA procedures
The main operating procedures of the FMEA method are the
establishment of a project team, analysis of the existing process,
potential failure and impact analysis, risk assessment, identifica-
tion of failures, implementation of countermeasures, counter-
measure tracking, and outcome measurements (Day et al., 2006;
Joint Commission on Accreditation of Healthcare Organizations,
2002). More detailed information on FMEA procedures can be
found in our previous article (Chen and Wu, 2015).
The FMEA method was applied in this study to determine the
measures that should be given the highest priority by taking into
account the degrees of severity, occurrence, and detection associ-
ated with them.
The severity (S) value indicates the effect on a system caused
by the failure of an individual component or an operational pro-
cess. Divided into 10 levels, the severity rating definitions and
scoring criteria are given in the supplementary data (Table S1),
available online. The occurrence (O) value indicates the fre-
quency of failure in an individual component or an operational
process. Divided into 10 levels, the occurrence rating definitions
and scoring criteria are given in Table S2. The detection value
(D) indicates the effect on a system caused by the failure of an
individual component or an operational process that cannot be
detected by the customer or the manufacturer. Divided into 10
levels, the detection rating definitions and scoring criteria are
given in Table S3.
The risk priority number (RPN) is calculated using the follow-
ing formula (Puente et al., 2002):
RPN = ( S ) × (O) × ( D) (1)
Based on these evaluations, corrective actions and measures are
recommended to eliminate failures, improve quality management
and design, and address concerns about reliability and safety. In
this study, items that violated laws or ordinances were deemed
hazardous and considered extremely dangerous. They were
ranked by severity with scores ranging from 1 to 10 (10 being the
most severe). The FMEA project team decided the threshold of
the RPN scores above which items were classified as top priori-
ties and considered to be crucial factors.
The FMEA team comprised 10 members: four waste man-
agement specialists, two staff handling autoclaves, and four
members of the Academia Sinica. The team members were first
taught the purpose and method of FMEA. Through consulta-
tive meetings, the team decided to divide the BMW lifecycle
into seven processes: Production, classification, packaging,
sterilisation, weighing, storage, and transportation. Twenty key
failure modes were identified in these seven phases and risk
assessments were subsequently conducted (Table 1). The 20
items were contrasted and their weights were assigned. Finally,
RPN scores were calculated using the S, O, and D values.
Results and discussion
BMW management in Taiwan
According to Taiwan’s Waste Disposal Act, waste is classified
into ‘general waste’ and ‘industrial waste’. General waste
includes garbage, excrement and urine, and animal corpses gen-
erated by households or ‘non-industries’. In other words, general
waste is essentially municipal solid waste (MSW). Industrial
waste is defined as all waste that is not classified as general
waste. BMW is thus classified as industrial waste and further
divided into infectious and non-infectious waste.
BMW can be liquid, solid, or sharp. Sharp BMW should be
packed into specific solid containers and stored for only 1
year, whereas liquid and solid BMW should be sealed in plas-
tic bags without leakage. BMW that requires sterilisation
should be packed into yellow bags or other combustible con-
tainers and infectious BMW should be packed into red bags.
Taiwan mandates strict environmental conditions for the stor-
age of BMW. According to the Waste Disposal Act, BMW can
be stored for 1 day in storage places above 278 K, and for up
to 7 or 30 days in storage places at 273–278 K or below 273
K, respectively. The storage place should be cleaned periodi-
cally with a disinfectant, such as chlorine.
Thermo-treatment of BMW commonly includes incineration,
autoclaving, and microwave techniques (Gupta et al., 2009; Rao
et al., 2004; Verma et al., 2008). Klangsin and Harding (1998)
reported that autoclaving and microwaving are fully adequate
disinfection technologies. Microwaving has the best eco-
efficiency performance for small amounts of BMW (Soares
et al., 2013). Incineration is attractive because it reduces the vol-
ume (by about 90%), mass (by about 80%), and toxicity of
waste, and also recovers energy (Chen and Lo, 2016; Kalyani
and Pandey, 2014; Ouda et al., 2013). However, incinerating
BMW may produce dioxin and furan pollution, partly owing to
the presence of Poly Vinyl Chloride (PVC) products (Malkan
and Nelson, 2005). The ash that is left after incineration generally
contains high concentrations of toxic heavy metals (Rajor et al.,
2012) and should be analysed by a toxicity characteristics leach-
ing procedure (TCLP). Thermo-treatment of BMW can be cho-
sen depending on the environment and the purpose of the user.
In Taiwan, vehicles transporting industrial waste (including
BMW) are required to install a Global Positioning System
(GPS) system that tracks their route (Chen and Wu, 2015).
The Taiwanese Government also requires BMW stakeholders,
Table 1.  BMW failure method and effects assessment. 4

No. System Failure mode Score Recommended actions Current controls

function
Severity Occurrence Detection RPN Improvement
(S) (O) (D) order
1 Production Laboratories did not bulletin 7 6.6 4.9 226 4 Redesign flowchart Written procedures for
procedures for waste treatment to increase reader waste treatment clearly
comprehension
2 Cleaning fees were unfairly paid 4.9 5.7 4 112 18 Use pre-paid trash bags Personal consulting
3 Training classes were not useful 6 5.1 3.7 113 17 Redesign content of training Take other training
classes classes
4 Stakeholder was not responsible 6.8 6.4 3.6 157 13 Take specific training classes Change stakeholders
for stakeholders
5 Workers had bad habits 7.1 6.4 4.5 204 8 Record and punish bad habits Check by personnel
6 Workers did not take professional 5.9 6.1 5.9 212 5 Require workers to take Require workers to take
training classes professional training classes professional training
classes
7 Classification BMW was incorrectly classified 6.9 6.2 5.6 240 3 Written classification for Check by personnel
BMW near containers
8 Containers were incorrectly labelled 7.1 5.9 4.5 189 10 Redesign labels more clearly Label containers properly
9 Packaging Bags were easily broken 7.3 5.9 4.4 190 9 Purchase more durable bags Use two bags to pack
BMW
10 Sharp articles were not placed in 8.4 4.8 6.5 262 1 Set regulations and enforce Check by personnel
solid containers fines for infringements
11 Sterilisation Needles were not sterilised 8.1 4 6.4 207 7 Set regulations and enforce Check by personnel
fines for infringements
12 Autoclaves were operated 8 4.4 6.9 243 2 Operators to take Warn workers
incorrectly by operators professional training
13 Operators did not have licenses 7.3 3.9 6.5 185 11 Do not hire operators without Take training classes to
licenses get licenses
14 Weighing Weights of BMW were recorded 5.3 5.4 5.4 155 14 Computerise records of BMW Check by personnel
incorrectly
15 Scales were not returned to zero 5.7 4.7 5 134 16 Record date of calibrating Calibrate scales regularly
before weighing the BMW scales
16 Storage Containers were overfilled 6.7 5.7 5.5 210 6 Purchase bigger containers Empty out containers
frequently
17 Storage places were unclean 6.5 6.1 4 159 12 Ask workers to clean storage Check by personnel
places more frequently
18 Storage places were limited 5.9 6.5 4.1 157 13 Change to larger storage Clean storage places
places frequently
19 Transportation BMW was not checked by workers 5.9 4.4 5.3 138 15 Computerise records of BMW Check by personnel
before transportation
20 Companies transported BMW 6.8 5 6.1 207 7 Inform the government so Change transportation
unsafely the fidne is paid companies
Waste Management & Research

BMW: biomedical waste; RPN: risk priority number.

Chen and Tsai 5
Figure 2.  The use of triplicate forms in the management of BMW in Taiwan.
BMW: biomedical waste.
including producers, transportation companies, and treatment
companies, to complete a triplicate form. The relationship
between these different stakeholders is shown in Figure 2. The
producers fill in the triplicate form and keep a copy for them-
selves. The other copies are given to the transportation compa-
nies, who are required to transport the BMW to the treatment
companies within 48 hours. The treatment companies receive the
third copy of the form along with the BMW and must treat the
waste properly within 30 days and inform the producers. The pro-
ducers should check the status of the BMW 35 days after giving
it to the transportation companies. All forms should be kept for
further examination. All details must also be lodged on the web-
site of Taiwan’s Environmental Protection Agency (EPA).
FMEA results
Six failure modes were identified in the production phase, two in
classification, two in packaging, three in sterilisation, two in
weighing, three in storage, and two in transportation.
The six failure modes in the production phase were as fol-
lows: (1) laboratories did not bulletin procedures for waste
treatment, (2) cleaning fees were unfairly paid, (3) training
classes were not useful, (4) stakeholder was not responsible,
(5) workers had bad habits, and (6) workers did not take pro-
fessional training classes.
The two main failure modes in the classification phase were:
(1) BMW was incorrectly classified and (2) containers were
incorrectly labelled. In the packaging phase, the two main failure
modes were: (1) bags were easily broken and (2) sharp articles
were not placed in solid containers. The three main failure modes
in the sterilisation phase were: (1) needles were not sterilised,
(2) autoclaves were operated incorrectly by operators, and
(3) operators did not have licenses. In the weighing phase, the
two main failure modes were: (1) weights were recorded incor-
rectly and (2) scales were not returned to zero before weighing
the BMW. The three main failure modes in the storage phase
were: (1) containers were overfilled, (2) storage places were
unclean, and (3) storage places were limited. In the transportation
phase, the two main failure modes were: (1) BMW was not
checked by workers before transportation and (2) companies
transported BMW unsafely.
The project team decided that items with an RPN exceeding
200 were considered priority items. The nine priority items
based on the RPN scores in Table 1 and shown in Figure 3 were
‘laboratories did not bulletin procedures for waste treatment’,
‘workers had bad habits’, and ‘workers did not take profes-
sional training classes’ in the production phase; ‘BMW was
incorrectly classified’ in the classification phase; ‘sharp articles
were not placed in solid containers’ in the packaging phase;
‘needles were not sterilised’ and ‘autoclaves were operated
incorrectly by operators’ in the sterilisation phase; ‘containers
were overfilled’ in the storage phase; and ‘companies trans-
ported BMW unsafely’ in the transportation phase. The scores
for these nine priority items accounted for 54.4% of the sum
of all RPNs. Recommended actions and measurements for
improvement are shown in Table 1.
Production phase.  As shown in Table 1, the scores for the six
failure modes in the production phase accounted for 27.7% of the
total RPN score. Three of the six failure modes were considered
to be priority items: ‘laboratories did not bulletin procedures for
waste treatment’, ‘workers had bad habits’, and ‘workers did not
take professional training classes’. Most of the failure modes in
the production phase were related to human factors, including
6 Waste Management & Research
Figure 3.  Failure modes with a RPN score exceeding 200.
BMW: biomedical waste; RPN: risk priority number.
those related to workers and stakeholders. Workers should take
professional training classes before handling BMW. Training
methods include lectures, workshops, brochures, and face-to-
face training (Bazrafshan and Mostafapoor, 2010). Gupta and
Boojh (2006) emphasized the need to educate workers to reduce
the lack of awareness. About 5%–10% of the interviewed work-
ers reflected that the training classes were not useful. Classes
should thus be redesigned to be more useful and helpful for
workers.
The Taiwanese Government has implemented the ‘General
Waste Clearance and Disposal Fee Collection Regulation’ to
charge fees for managing MSW. The fees for the pre-paid trash
bags are directly related to the volume of waste and thus follow
the principle that polluters pay (‘2P’). However, BMW is not
included under this regulation, resulting in unfair payments. The
flowchart of waste treatment should be clearly displayed in labo-
ratories to ensure the proper management of BMW from the
beginning of the production phase.
Classification phase. As shown in Table 1, the scores for the
two failure modes in the classification phase accounted for 11.6%
of the total RPN score. The ‘BMW was incorrectly classified’
mode was ranked the third highest in this study. BMW can be
classified based on the risks of causing injury and/or infection
(Soliman and Ahmed, 2007). Categories include sharps (needles
or scalpel blades), pathological waste (body parts, microbiology
cultures, and blood samples), and infectious waste (items con-
taminated with body fluids and discharges, such as dressing,
catheters, and IV lines) (Soliman and Ahmed, 2007). All of the
BMW generated by the Academia Sinica was classified as infec-
tious (Taiwan Environmental Protection Agency, 2016) and had
to be packed in red bags.
Classifying BMW into colour-coded plastic bags or containers
is the most appropriate method for identifying BMW categories
(Rao et al., 2004). In India, non-infectious BMW is collected in
black bags, while infectious BMW is collected in red, yellow, and
blue bags (Patil and Pokhrel, 2005). In Iran, infectious waste is
collected in yellow bags, MSW in black bags and sharps in yellow
plastic containers (Bazrafshan and Mostafapoor, 2010). In Taiwan,
infectious BMW is packed in red bags, while BMW requiring
sterilisation treatment is packed in yellow bags. An optic bag sys-
tem (using bags in different colours) has been used in the
Chen and Tsai 7
management of food waste in Hong Kong and Europe (Woon and
Lo, 2016) and could also be applied in BMW management.
Packaging phase. BMW is packed to protect waste handlers
and the public from possible injury and disease (Patil and Pokhrel,
2005). Therefore, a packaging process occurs before treatment.
As shown in Table 1, the scores for the two failure modes in the
packaging phase accounted for 12.2% of the total RPN score.
The failure mode of ‘sharp articles were not placed in solid con-
tainers’ had the largest RPN score, mainly owing to its high
severity rating (Table 1). The main problems arise from the dis-
posal of sharps, such as needles (Gupta et al., 2009). Injuries to
workers by sharp articles can be reduced through the provision of
anti-puncture gloves (Chen and Wu, 2015). Sharp articles can
easily break the bags used to pack BMW. The bags used in optic
bag systems are thicker than common plastic bags and hence are
less easily damaged (Woon and Lo, 2016).
Sterilisation phase.  The Taiwan EPA has approved sterilisation
and incineration as two BMW handling methods (Liao and Ho,
2014). Both of these methods can convert infectious BMW into
non-infectious waste (Miyazaki and Une, 2005). Although the
sterilisation method is relatively complex, healthcare institutions
and medical research laboratories usually have their own sterilis-
ing facilities. As shown in Table 1, the scores for the three failure
modes in the sterilisation phase accounted for 17.2% of the total
RPN score. Two of the failure modes were related to human fac-
tors (mainly operators). One of these, the failure mode ‘auto-
claves were operated incorrectly by operators’, had the second
highest RPN score in the study (Figure 3).
The sterilisation of BMW follows strict procedures defined by
facility manufacturers (Makajic-Nikolic et al., 2016). The BMW
must be sterilised before disposal because it is contaminated with
microbial flora (Verma et al., 2008). The failure mode ‘needles
were not sterilised’ had a high RPN score with high severity.
Highly infectious BMW, such as needles, should be carefully
sterilised (Rao et al., 2004).
When using the incineration method, emissions from incin-
erators may contain chemical pollutants, namely, dioxins and
furan, which may pose a risk to operators (Soliman and Ahmed,
2007; Verma et al., 2008). Zhao et al. (2008) tested ash from
BMW incinerators and found that it contained 1.8–315 g kg-1
metal salts and 1.1–121,411 mg kg-1 heavy metals. If managed
properly, BMW ash may be recycled in cement and concrete sys-
tems, agricultural fertiliser, roads, and asphalt (Rajor et al.,
2012). Therefore, many states in the United States recognise
sterilisation as the accepted method of disinfection prior to dis-
posal (Urbanowicz, 1998).
Weighing phase.  As shown in Table 1, the scores for the three
failure modes in the weighing phase accounted for 7.8% of the
total RPN score. Medical research facilities and laboratories
weigh BMW to know how much they produce. Failures in this
area may be caused by incorrect measurements and scales not
being calibrated before use. These failures could be prevented
by recording weights on computers and recording the calibra-
tion date.
Storage phase. The scores for the three failure modes in the
storage phase accounted for 14.2% of the total RPN score. The
failure mode ‘containers were overfilled’ had a high RPN score
(Figure 3). The current control was to empty out containers fre-
quently or to use larger containers with extra storage places. Stor-
age places are usually located on the basement floor near to the
exit door and/or near incinerators (Soliman and Ahmed, 2007),
which can lead to an unsanitary waste storage environment. Fre-
quent checking by personnel and cleaning of the storage places
are suggested solutions to prevent failures in this phase. Cleaning
and disinfecting storage places may reduce the possibility of
spread of diseases (Bazrafshan and Mostafapoor, 2010).
Transportation phase.  In Taiwan, legally registered waste dis-
posal companies usually transport BMW. They are required to
follow the procedure of using triplicate forms outlined in Figure
2. Failures included ‘BMW was not checked by workers before
transportation’ and ‘companies transported BMW unsafely’. The
scores for these two failures in the transportation phase accounted
for 9.3% of the total RPN score (Table 1). Birpinar et al. (2009)
indicated that 77% of the healthcare institutions in Istanbul pro-
vided inadequate equipment to the waste disposal companies.
Workers of registered waste disposal companies have to weigh
and record the BMW to ensure its quality and quantity before
transportation. These records should be checked against the
records of the producers. The management of BMW for the
safety of workers has become very important (Miyazaki and Une,
2005). Companies may violate laws and regulations if they do
not properly manage BMW. Therefore, the RPN score for ‘com-
panies transported BMW unsafely’ was high in the study.
Conclusions
Evaluating the operational problems and risks of BMW in medi-
cal research facilities and laboratories is important to improve
BMW management. The BMW generated by medical research
laboratories, which is heavily contaminated with microbiological
waste, seldom receives the attention it deserves from researchers.
Therefore, this study evaluated the operational problems and
risks of BMW in medical research facilities and laboratories
using the FMEA method.
The BMW lifecycle was divided into seven processes:
Production, classification, packaging, sterilisation, weighing, stor-
age, and transportation. A total of 20 key failure modes were iden-
tified in these phases and risks were assessed based on the RPN
scores. The failure modes in the production phase made up the
highest proportion of the RPN score (27.7%). The failure mode
‘sharp articles were not placed in solid containers’ had the largest
RPN score, mainly owing to its high severity rating. The sterilisa-
tion process is the main difference between the treatment of infec-
tious and non-infectious BMW. The failure mode ‘autoclaves were
operated incorrectly by operators’ had the second highest RPN
8 Waste Management & Research
score in the sterilisation phase. The failure modes in the sterilisa-
tion phase were mainly related to human factors (mostly opera-
tors). This study provides useful information for workers,
decision-makers, and the public regarding the proper management
of BMW. The results of this study are highly applicable to other
countries seeking to improve the management of BMW and the
sustainable development of waste management.
Declaration of conflicting interests
The authors declared no potential conflicts of interest with respect to
the research, authorship, and/or publication of this article.
Funding
The authors received no financial support for the research, author-
ship, and/or publication of this article.
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