Legal Medicine 51 (2021) 101879

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Legal Medicine
journal homepage: www.elsevier.com/locate/legalmed

Case Report

Fire in operating room: The adverse “never” event. Case report,

mini-review and medico-legal considerations
Elvira Ventura Spagnolo a, *, Cristina Mondello b, *, Salvatore Roccuzzo b, Gennaro Baldino a,
Daniela Sapienza b, Patrizia Gualniera b, Alessio Asmundo b
a
Section Legal Medicine, Department of Health Promotion Sciences, Maternal and Infant Care, Internal Medicine and Medical Specialties (PROMISE), University of
Palermo, Italy
b
Section of Legal Medicine, Department of Biomedical and Dental Sciences and Morphofunctional Imaging, University of Messina, Italy

A R T I C L E I N F O A B S T R A C T

Keywords: The patient’s security and safety represent a topic of great importance for public health that led several
Surgical fire healthcare organizations in many Countries to share documents to promote risk management and preventing
Burns adverse events. Surgical Fire (SF) is an infrequent adverse event generally occurring in the operating room (OR)
Healthcare security and safety
and consisting of a fire that occurs in, on, or around a patient undergoing a medical or surgical procedure.
Medical liability
Surgery
Here a medico-legal case involving a 65-year-old woman reporting burns to the neck due to an SF during a
Clinical risk management thyroidectomy was described. A literature review was performed using Pubmed and Scopus databases, focusing
on epidemiology, causes, prevention activities associated with the SF, and the related best practices recom­
mendations. The medico-legal analysis of the case led to admit the professional liability because the suggested
time (3 min) to use the electrocautery after CHG application was not respected.
The case analysis and the literature review suggest the importance of implementing National and Local pro­
cedures to promote the management of SF risk. Finally, it is necessary to highlight the role of incident reporting
and root causes analysis in understanding the cause of the adverse events and thus enforce their prevention.

1. Introduction possibly catastrophic circumstances is represented by the Surgical Fire

In recent years, the worldwide consideration of “Healthcare Security
and Safety” has increased exponentially, defining the topic as a priority.
To this purpose, in 2004, the World Health Organization (WHO) shared
the document “World Alliance for Patient Safety program” [1] followed,
in 2008, by the publication of the paper “WHO Guidelines for Safe
Surgery 2009′′ [2]. Conforming to international standards, the Italian
Government promoted further patient-safety programs with the estab­
lishment of the regional clinical risk management function, the intro­
duction of mandatory monitoring of sentinel events and claims system,
and the emanation of national guidelines concerning safety in the
Operating Room (OR) [3]. Moreover, the improvement and promotion
of the health care system’s quality was confirmed by the recent Italian
Law n. 24/2017.
However, despite the International, National, and Regional imple­
mentation of prevention policies and procedures, adverse events
continue to occur. In this scenario, one of the most infrequent but
(SF). SF is defined as a fire that occurs in, on, or around a patient un­
dergoing a medical or surgical procedure. It is considered, as other
eventualities [4–7], a “sentinel event” due to its potentially severe or
fatal consequences.
Notably, some authors defined SF as a “never event” (together with
the wrong-site surgery and the retained surgical items), which is
described as patient safety violations with potentially devastating out­
comes that should never occur in the OR [8–11].
The “fire triangle” theory is utilized for explaining how the fire has
an origin. It is composed essentially of three elements, which are always
represented in the OR [12,13]:
Ignition – represented by electrosurgical units, lasers, defibrillator,
fiberoptic light source, drills/high-speed Burrs;
Oxider – e.g. oxygen, nitrous oxide, compressed medical air, ambient
air;

* Corresponding authors.
E-mail addresses: elvira.ventura@unipa.it (E. Ventura Spagnolo), mondelloc@unime.it (C. Mondello).

https://doi.org/10.1016/j.legalmed.2021.101879
Received 15 July 2020; Received in revised form 24 February 2021; Accepted 2 April 2021
Available online 9 April 2021
1344-6223/© 2021 Elsevier B.V. All rights reserved.

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E. Ventura Spagnolo et al.
Fuel – e.g. alcohol skin preps, drapes/gowns, gauze/sponges, pa­
tient’s hair/skin, Endotracheal Tube (ETT)/nasal cannula, intestinal
gases.
The authors report a case of a 65-year-old female who suffered an SF
due to the incorrect use of both an alcohol-based disinfectant and the
electrocautery, describing principles of SF, its origin, development,
consequences, and how to prevent it. Then, the authors analyzed the
medico-legal implications of SF, focusing on each phase of the event
before (propriety of informed consent), during (recommendations of
best practices, protocols, and medical liability), and after (the entity of
lesions, the necessity of reactive root cause analysis) ignition.
2. Materials and methods
2.1. Literature review
PUBMED and SCOPUS database were used to search the English
language literature from 1990 to 2020 for articles using the following
key words: “Operating Room Fire”, “Surgical Fire”, “Operating Room
Burns”. We focused on epidemiology, causes and prevention activities
associated with the SF, the related recommendations of best practice, its
clinical and medico-legal consequences. Two of the authors provided
independently to the screening of the results, mainly on the basis of
relevance and appropriateness of the topics in the text; then, other two
authors carried out the selection for the inclusion.
2.2. Case report
A 65-year-old woman was evaluated because of 4 weeks of
dysphonia and dysphagia at the local University Hospital (in Sicily,
Italy). The thyroid Color-flow Doppler Ultrasonography (US) showed a
bilateral multinodular goiter with tracheal compression and normal
vascular flow. US-guided fine-needle aspiration biopsy of thyroid nodule
revealed a low-risk indeterminate lesion (TIR 3A). Total thyroidectomy
was performed according with patient preference and conforming to
national recommendations included in the Consensus Report developed
by Scientific Italian Societies [14]. The surgical procedure was con­
ducted in general anesthesia (with Endo-Tracheal Tube and 2/L min O2
supply), and Chlorhexidine Gluconate (CHG) (2% Chlorhexidine Glu­
conate in 70% isopropyl alcohol) was used for skin disinfection of the
surgical site. Thyroidectomy was correctly performed, preserving the
vagus and recurrent laryngeal nerves integrity by neuromonitoring and
identifying and sparing the parathyroid glands. During the closing sur­
gical wound phase, immediately after an intraoperative CHG skin
disinfection of the neck, an SF occurred involving surgical drapes of the
perioperative field. The fire was most likely produced by the ignition of
the reapplied alcohol-based disinfectant by monopolar electrocautery.
Although the OR team promptly extinguished the fire, the patient re­
ported second-third-degree burns to the anterolateral surface of the
Fig. 1. Burns of first and second grade due to the surgical fire, surrounding the surgical injury for thyroidectomy (A); surgical fire scars (black arrows) after
respectively six and nine months from the adverse event (B and C).
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Legal Medicine 51 (2021) 101879
neck. During the hospitalization, the patient clinical conditions
remained stable, and the burn lesions were treated with topical and
systemic steroid-antibiotic therapy. The subject was discharged on the
5th day of recovery in stable conditions. The medical follow-up did not
reveal any form of sequelae excluding the retracting-hyperchromic-
hypertrophic linear, vertical, cord-like, bilateral, antero-lateral scars
on the neck (Fig. 1); particularly, the two scars were symmetrically in
correspondence of sternocleidomastoid muscles, but without their
involvement. The patient filed a Civil lawsuit for this event.
3. Discussion
The safety in the OR is characterized by an intrinsic complexity that
involves all surgical procedures and, also, for this reason, the surgical
specialties, as well as others, are often involved in malpractice litigation
[10,15–17] Communication processes between the OR team members
are important to ensure an optimal collaboration, which is essential to
reduce the incidence of patient injury due to practitioner errors and,
consequently, to promote the success of the intervention without
adverse events. We described a case of SF, one of the adverse events less
reported in the literature with potentially devastating consequences for
the patient and practitioners [12,18].
The devices and/or components representing the “fire triangle”,
supporting the origin of SF, are commonly used in the modern OR. Thus,
the complete elimination of fire risk is impossible. However, several
American Scientific Societies have provided best practices to reduce the
related risk [19,20]. In the USA, the prevalence of SFs has been esti­
mated at approximately 600 events per year, and the total number of
events is probably underestimated [13]. On the contrary, reports, and
data published in Italy and in Europe are probably lacking due to
inadequate application of hospital incident reporting system [21]. The
SF literature describes the head-neck district, upper body, and pelvis
regions as the most involved areas; general and orthopedic surgery,
gynecology, and otolaryngology are the most frequently involved spe­
cialties [22–42].
The SF-related literature provided recommendations/suggestions
regarding the main actions of the prevention of each OR team member,
as summarized in Fig. 2.
All the surgical staff is generally involved in handling/management
of devices and/or components representing the three different fire ele­
ments: the surgeon usually uses sources of fire (ignition), the anesthe­
siologist administers the oxidants, and the nurse supplies materials
representing the fuel. The most common source of ignition of the blaze is
represented by the electrocautery unit (electrosurgical unit), responsible
for up to 90% of surgical fires [30]. “Fuel” is often the alcohol-based
preparation solution used to disinfect the surgical site [43,44]. Thus, it
appears evident how the complete and shared awareness of all OR team
members is necessary. For this purpose, Mathias J.M. [45] suggested the
compilation of an “SF Risk Score” module before each surgical inter­
vention and based mainly on the surgical site, the presence of open
E. Ventura Spagnolo et al.
Fig. 2. Schematic summary of the main recommendations to prevent SF for the OR team members. SF: surgical fire; OR: operating room; ETT: endotracheal tube.
oxygen source, and the availability of ignition source. Regular simula­
tion activities in the workplace – also known as in situ simulation – can
reduce morbidity and mortality of rarely occurring events like SF [46].
The reported case regards an SF involving the neck area during a
thyroidectomy in which a CHG solution and a monopolar electrocautery
were used. Although alcohol-skin preps are considered a risk factor for
SF origin [13], the use of CHG in the OR is widely recommended as the
first choice option for the prevention of surgical site infections due to its
efficient and effective antimicrobial action compared with other preps
(e.g. iodopovidone or not-alcohol-based disinfectant) [47]. Best practice
recommendations also include avoiding pooling and dripping of solu­
tion and ensuring complete evaporation of the flammable substance by
waiting for not less than 3 min between application of the alcohol-based
disinfectant and activation of the electrocautery [12]. Additionally,
several authors have suggested removing absorptive materials before
the application of the CHG and applying surgical drapes only after
complete evaporation [15]. Indeed, although these items are often rated
as “flame resistant” and/or “nonflammable,” they can still ignite in
normal operating conditions [48,49]. Moreover, it is recommended to
limit the use of the electrocautery device at low levels of voltage and to
use a bipolar rather than a monopolar electrocautery device to prevent/
minimize current leakage during tracheostomy [50]. Other recommen­
dations regard the use of air or FiO2 less than or equal to 30% in case of
open system oxygen supplementation (nasal cannula or mask oxygen
delivery) because of the increased fire risk related to augmented local/
ambient oxygen concentrations [51]. Some researchers also tested a
suction system for excess oxygen under drapes, reporting a significant
reduction of the ambient oxygen concentration, which, in the combined
use of monopolar devices with built-in smoke evacuators, resulted in a
reduction of SF incidence [52,53].
Regarding the reported case, the medico-legal analysis was per­
formed in order to investigate the cause of the SF and to evaluate if the
patient damage was related to medical malpractice. The case examina­
tion was based on clinical records, technical/biomedical engineer
documentation, and incident report. The analysis of both biomedical
engineer documentation and data emerging from nurse pre-operative
check of devices/instruments excluded any electrosurgical unit mal­
function. Useful data and information for the medico-legal evaluation
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Legal Medicine 51 (2021) 101879
were found in the incident report: the CHG was applied on the patient
skin “immediately” before the development of the flash fire. There were
no records describing the implementation of other SF prevention mea­
sures (e.g. removal of surgical drapes before the CHG application and a
low voltage usage of monopolar electrocautery).
In light of the described dynamic of the event resulting from the
analysis of medical records/documentation (including the incident
report), it was observed that the time elapsed from the application of
CHG on the patient’s skin to the use of electrosurgical units was not
sufficient to ensure the complete evaporation of the flammable sub­
stance. The production of the spark caused by the monopolar electro­
surgical unit was the trigger for the development of the fire that burned
the surgical drapes delimiting the operating field and the patient neck
skin.
The reported case offers medico-legal arguments about the assess­
ment of healthcare liability according to the contractual or “tort liability
system” based on the proof of practitioner error/negligence in deter­
mining the patient damage, thus implying the performed activities was
not compliant with the required and generally accepted professional
standard [54].
A complete medico-legal analysis based on a step-by-step evaluation
is very important in this setting, as suggested by the European Academy
of Legal Medicine (EALM) Working group [55]. Particularly, in the
presented case, the analysis of the collected clinical and documentary
data and information allowed us to reconstruct the dynamic event,
which was then compared with the recommended conduct of the
healthcare personnel as emerging from the review of the related litera­
ture. Thus, considering the SF as an expected and preventable event, the
non-observance of required rules of conduct was admitted in relation to
the omission of the recommended cautionary measures to avoid (or at
least reduce) the risk of SF. The omissions represented a lack of prudence
attributable to both surgeons (non-observation of the time elapsed from
the application of CHG to the use of electrosurgical units and the use of
monopolar electrocautery at low voltage) and nurses. Consequently, the
omitted conduct had a causal and direct relationship with the burn in­
juries, and the causal link between practitioner activities and patient
damage was admitted.
Finally, the case suggests some consideration on SF, a potentially
E. Ventura Spagnolo et al.
high-grade surgical complication representing a rare and under­
estimated sentinel event. The SF literature highlights the risk factors and
the main activities that the OR team members should perform to prevent
it. However, it should be necessary to establish related national guide­
lines for “best practice” and intra-hospital protocols, also calculating “SF
risk score” before each surgical intervention and a strategy for efficient
and effective communication inside the surgical team for the prevention
of this phenomenon. In light of this, greater awareness to provide inci­
dent reporting to national monitoring center must be stressed, resulting
in being essential in promoting and improving healthcare security
strategies. Additionally, educational campaigns to sensitize the health­
care community about the SF risk can significantly reduce the associated
hazard. Finally, since the complete elimination of SF risk is impossible, it
may be appropriate to include the “risk probability score” of SF in the
patient’s informed consent. The implementation of these suggestions
can represent a needed step for improving the patient’s security and
safety, the SF-related morbidity and mortality, and consequently dras­
tically reducing the incidence of SF as a source of medico-legal litigation.
Funding
No funding sources.
Informed consent
The consent to use the case for research purpose has been provided
by the patient. All data and images were reported respecting the ano­
nymity of the subject.
Declaration of Competing Interest
The authors declare that they have no known competing financia­
linterests or personal relationships that could have appeared toinfluence
the work reported in this paper.
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