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S. E. Regenbogen and S. J. Rivard
routine use of these dedicated lms, despite reportedly correct surgical counts [8].
However, mandatory, even selective, radiology policies may not be cost effective or
viable on the institution level. In a cost-effective analysis, both mandatory and
selective policies had a relative cost-effectiveness ratio of over $1,000,000 per
retained surgical sponge prevented, as compared with manual surgical counting
alone [21]. Another study showed that performing intraoperative X-rays for every
CABG in the United States would cost $42.4million per year [19]. Additionally,
mandatory or selective radiographs expose patients and healthcare providers to
unnecessary radiation. When compared to newer technologies, which tend to focus
only on surgical sponges, radiographs offer an added benet in that they can identify a broader range of RSIs, including instruments and needles.
Some have advocated for the use of routine intraoperative radiographs in emergency operations, especially those in which the surgical count was bypassed due to
patient condition. Although these cases involve signicantly higher risk of RSI, an
estimated 300 radiographs would still be required to prevent one retained surgical
sponge in these high-risk procedures, at a cost of approximately $700 per emergency
case [7, 15]. Nevertheless, intraoperative radiography has been considered by some
to be less costly than a traditional counting strategy because of the avoided institutional costs (OR time, readmissions) and litigation expenses associated with RSIs
[15]. Strategies for decreasing false-negative intraoperative radiographs include hav-
ing attending surgeons conrm that the radiograph includes the area of interest, and
direct contact with the radiologists to alert them of the RSI concern [15].
Technological Adjuncts
The frequency of counting discrepancies, high percentage of falsely correct manual
surgical counts, and low sensitivity of intraoperative radiographs have fueled interest in technological adjuncts to help eliminate the occurrence of retained surgical
items. Because sponges represent the majority (48–69%) of retained surgical items,
they have been the target of almost all of the new technologies introduced commercially [7, 8, 11]. Devices brought to market have included bar-coded sponges and
radio-frequency technology incorporated into surgical sponges. It should be noted
that none of the following advances have been advocated as replacements for standard manual counts recommended by AORN, but instead have been used as supplements to current practices. These technologies are prone to electronic interference,
mechanical failure, and operator-dependent error [12, 25].
Bar-Coded Sponges
To supplement manual counting, bar codes have been placed on surgical sponges to
allow for computer-assisted sponge counting. Each sponge contains a unique data
matrix code that is scanned prior to being added to the sterile eld and again as each
sponge is removed [21, 22, 26].
In 2008, Greenberg etal. performed a randomized controlled trial of a bar-coded
sponge system in elective surgery and evaluated the incidence of count discrepancies in cases using bar coding versus traditional counting alone. The bar-coded
sponge system detected count discrepancies twice as often as manual counting
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protocols. The detection of misplaced and miscounted sponges was signicantly
increased with the bar-coded sponge system. The technology did increase time
devoted to counting by 3min per case and did not decrease the likelihood of obtaining an intraoperative radiograph. By the end of the study, the majority of providers
found the system easy to use, felt condent in its performance to track sponges, and
believed that it had a positive effect on the counting process [22]. This study concluded that there was a potential to decrease the risk of retained sponges.
The Mayo Clinic implemented a similar bar-coded sponge counting system, and
its institutional impact was published after 18months of experience. Cima and colleagues also reported an increase in time spent counting sponges per operation, but
no overall increase in operative time. The learning curve was reported as short,
averaging four cases. After 18months, the bar-code system eliminated retained surgical sponges, which previously occurred about every 64days on average [26]. Staff
surveys revealed that many staff believed that the system decreased the stress
involved in manual counts and recognized the improved accuracy. Additionally, the
reported increased cost per case was only $11.63 [26].
Using these data in a decision-analytic simulation, the bar-coding system was
estimated to prevent about 97.5% of retained surgical sponges as compared to manual counting alone [21]. There was an incremental additional cost of $95,000 per
retained surgical sponge prevented [21]. While bar-coded systems add value by preventing RSI cases at a reasonable cost, its limitations include its focus on sponges,
with no effect on retained instruments or needles. Additionally, bar-coded systems
cannot give insight about where a missing sponge is located, whether it be inside a
patient, within the surgical eld, or in the trash. Instead, it serves as a technological
backup to counting [26].
Radio-Frequency Technology
The U.S.Food and Drug Administration-approved radio-frequency detection systems (RFDS) include radio-frequency-tagged sponges, a console with power source
and monitor, and a detection wand or mat [26]. The radio-frequency chip embedded
into surgical sponges is small enough not to interfere with typical sponge functionality. A detection wand with sterile cover is connected via a wire to the detection
console, which generates visual and audible alarms when a sponge is detected while
being passed over a patient. A variation on this technology utilizes a surgical mat,
which is placed on the operating room table prior to the patient’s arrival. On completion of surgery, pressing a button on the console activates the mat to scan the
patient for a retained sponge. The mat technology avoids the potential of human
scanning error introduced by the wand, as scanning too far from the patient may
lead to false-negative results. Unlike the mat, the wand will also detect sponges
located in other areas of the operating suite, including the surgical drapes and trash.
The benet of the RFDS over bar-coded sponges is that it can be used for invivo
detection of any radio-frequency-labeled item. It should be noted that RF energy at
wavelengths used by this technology has not been shown to expose humans to any
deleterious effects [26]. Several prospective trials have sought to evaluate the value
of radio-frequency technology on reducing retained surgical sponges.
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S. E. Regenbogen and S. J. Rivard
Steelman etal. utilized a prospective, crossover, observer-blinded study design at
the Veterans Affairs Medical Center in Iowa City in 2011, in which surgical sponges
were placed behind patients’ torsos to evaluate RFDS technology. Sensitivity and
specicity of sponge detection by the RFDS technology were both 100%, with no
false negatives or false positives. This indicates a much higher sensitivity and specicity than typical surgical counts and intraoperative radiographs. The scanning process lasted under 3min, with an alarm sounding in less than 30s when a sponge was
detected. RFDS can indicate the presence of a sponge but not its exact location,
evidenced by alarms when a sponge was located on the contralateral side of the
body. Therefore, an alarm should prompt a thorough exploration of the cavity and
not a dedicated quadrant search. There were some technical errors within this study
when the console would alarm with name badges, proximity access cards, and,
occasionally, pagers. However, software has since been updated to eliminate technical interference. Importantly, various internal metal implants and jewelry did not
falsely activate the alarm [25].
Another prospective, crossover, double-blinded study was performed to investigate the RFDS utilizing the radio-frequency detection mat system. Notably, the RF
mat is narrower than the operating room table, and the patient’s abdominal cavity
may exceed this width, especially in patients with higher BMIs. In patients with
morbid obesity, the sensitivity of the RF mat was 96.9%, which decreased overall
sensitivity to 98.1%, while specicity remained 100%. The RF wand was reevaluated in the morbidly obese as well but maintained 100% sensitivity and specicity.
Therefore, the RF wand is preferable to the use of RF mat in patients with high BMI
due to the mat’s narrow width compared to body habitus [27].
University of North Carolina hospitals performed another study to evaluate the
RFDS system, which included 2285 patients. All surgical sponge miscounts, with a
rate of 1.53%, were successfully resolved with the use of RFDS technology. Sponges
were ultimately found in surgical site (31.4%), within operative suite, surgical
drapes, and emergency protocol deviations. No retained surgical sponges were
encountered during the study period, but one near miss was detected by the RFDS
technology. An additional $13.54 of added cost was associated with the implementation of the RFDS technology. Operating room staff reported an overall positive
response to the technology, with high condence of its ability to prevent retained
surgical sponges [28].
When implemented among high-risk open-cavity emergency operations in a
large county hospital, radio-frequency technology was found to be effective at preventing retained surgical sponges. Each case underwent traditional standardized
manual counting, RFDS wand scanning, and intraoperative radiographic evaluation
for detection of retained sponges, regardless of the count status. RFDS detected
retained sponges in 0.5% of cases prior to cavity closure. Eleven near-miss events
(sponges identied by RFDS and successfully retrieved before closure) were
detected by the RFDS technology; 63.6% of these near misses occurred in trauma
cases, specically in those with sternotomies and then laparotomies. Sponge counts
were recorded as incorrect 36.4% of the time and not performed in 45.5% of the
time. In 18.2% of near-miss events, counts were recorded as correct, but RFDS
22 “I’m Missing a Sponge!” New Techniques in the Prevention of Foreign Body…
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367
technology identied retained sponge. All subsequent intraoperative radiographs
had no evidence of RSS, indicating that RFDS missed no retained sponges. The
additional cost of RFDS disposables was calculated at $0.17 for a 4×18 laparotomy
sponge and $0.46 for 10-pack of 12-ply, 4×8 [29].
A cost-benet analysis of radio-frequency technology was performed in 2014.
Overall, radio-frequency technology implementation was associated with a 93%
reduction in the rate of reported RSI when compared to a 77% reduction in places
without RF technology implemented. Total additional cost to transition from radiographic detection to RF technology was estimated at $191,352 annually or $17.09
per case [30]. Similarly, in 2017, the estimated cost increase of $13–$17 per case
was associated with radio-frequency technology implementation [31]. Generally,
savings from decreased operating room time, intraoperative radiographs, and medical and legal costs were believed to outweigh the expenses associated with radiofrequency implementation. Overall, it is estimated to lead to more than $400,000in
savings per year after a switch to RFDS [30].
Conclusion
Retained surgical items represent a preventable and devastating adverse event. For
decades, policies have focused on manual surgical counting, with supplemental
intraoperative radiographs in cases of count discrepancies. Surgical sponge innovations, specically bar-coded sponges and radio-frequency technology, have shown
promise in preventing RSIs and should be considered for clinical use. However,
only about 20% of hospitals in the United States have implemented these new technologies in existing standard protocols [31]. When implementing any new technology, institutions must consider their priorities including ease of use, cost-to-benet
ratio, availability of technology, implementation learning curve, and experience and
preference of OR and hospital leadership.
References
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8. Cima RR, Kollengode A, Garnatz J, Storsveen A, Weisbrod C, Deschamps C.Incidence and
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Principles ofPerioperative Safety
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andQuality ontheGlobal Stage
MeenaNathanCherian, JyotsnaAgarwal,
RaymondR.Price, JanetMartin, AdrianW.Gelb,
andDavyCheng
Patient Safety
Once the patient is scheduled for any surgical intervention, it is of paramount importance that we ensure the safety of the patient in the entire journey from admission
until discharge from the hospital. In the healthcare delivery, while we accept that “to
err is human,” to deliberately ignore or skip the safety standards is unacceptable.
This chapter focuses on what the entire perioperative team must know about
anesthesia and surgery to ensure patient safety and healthcare quality. An interesting
quote from the International Committee of the Red Cross (ICRC) Anaesthesia
Guidelines emphasizes the important role of anesthesia services, even in austere
23
M. N. Cherian (*)
Department of Global Health New Challenges, Geneva Foundation for Medical Education
and Research, Versoix, Switzerland
J. Agarwal
Department of Anesthesiology and Pain Medicine, Hamdard Institute of Medical Sciences
and Research, New Delhi, India
R. R. Price
Center for Global Surgery, University of Utah, Salt Lake City, UT, USA
J. Martin
Department of Anesthesia & Perioperative Medicine, Epidemiology & Biostatistics, London
Health Sciences Centre, London, ON, Canada
A. W. Gelb
Department of Anesthesia and Perioperative Care, University of California San Francisco,
San Francisco, CA, USA
D. Cheng
Schulich School of Medicine & Dentistry, Western University, London, ON, Canada
© Springer Nature Switzerland AG 2024
J. J. Hoballah et al. (eds.), Principles of Perioperative Safety and Efciency,
https://doi.org/10.1007/978-3-031-41089-5_23
371
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environments. “Surgeons perform big operations and small operations. There is no
such thing as a small anaesthesia. Every anaesthesia is potentially fatal. The limits
of operational activity in the theatre are not those of the surgeon’s expertise. They
are determined far more by the level of competency and sophistication of the anaesthesia department. There is only one other limiting factor that is as important as
anaesthesia, if not more so, in determining the level of sophistication of surgery to
be performed: postoperative nursing care” [1].
Some practical approaches that can guide both policy makers and healthcare
providers (doctors, nurses, technicians, and support staff) are elaborated toward
evidence-based strategies at the global stage to ensure patient safety in the perioperative care. These approaches for all surgical interventions including childbirth and
injuries are applicable even in resource-limited settings and humanitarian
emergencies.
The existing international standards of the World Health Organization (WHO),
World Federation of Societies of Anaesthesiologists (WFSA), and recommendations from ICRC and Médecins Sans Frontières (MSF)—known also as Doctors
without Borders—will be discussed toward ensuring perioperative quality and safety.
M. N. Cherian et al.
Background
It is often presumed that high-quality care is a luxury in low- and middle-income
countries (LMICs) and difcult to measure, particularly in limited-resource healthcare settings. Safe and quality care can be delivered across geographical regions and
resource settings with seven measurable and desired health outcomes [2]:
1. Effectiveness
2. Safety
3. People-centeredness
4. Timeliness
5. Equity
6. Integration of care
7. Efciency
Universal health coverage (UHC) means that all individuals and communities
receive the health services they need without suffering nancial hardship. It includes
the full spectrum of essential, quality health services, from health promotion to
prevention, treatment, rehabilitation, and palliative care [3].
Safe Surgical andAnesthesia Services: Critical
Component ofUHC
UHC includes ensuring that surgical and anesthesia services are available to all
when needed, also promoting equity, social justice, and human rights [4].
23 Principles ofPerioperative Safety andQuality ontheGlobal Stage
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The unanimous passing of the World Health Assembly 68.15 Resolution in May
2015 by all 194 World Health Organization (WHO) member states (countries) on
“Strengthening emergency and essential surgical care and anesthesia as a component of UHC” was a landmark in the global public health stage. It highlighted the
global burden of surgical diseases and requested actions from the WHO and the
member countries for providing safe surgical and anesthesia services, particularly in
primary health care and rst referral hospitals. It emphasized policies to set costeffective priorities and minimum standards for skilled health workforce, infrastructure, equipment, medicines, supplies, infection control, pain management,
perioperative mortality data, monitoring, and evaluation as a critical element of
ensuring quality and safety [5].
Considering the magnitude of the global burden of surgical conditions—in
pregnancy- related complications, injuries, congenital anomalies, cancer, acute
abdomen, non-acute surgical conditions, and humanitarian crisis—access to safe,
timely, and affordable surgical care and anesthesia is a critical component of
UHC.Successfully reaching the specic health-related targets of the Sustainable
Development Goals (SDGs) requires high-quality surgical services that ensure
patient safety [6].
The surgical care community needs to focus on the wider population in the UHC
context. Global efforts can be streamlined to improve safe and timely access to
simple procedures that are cost effective and appropriate to perform in rst-level
hospitals that could reduce a signicant proportion of the burden of surgical disease
in LMICs [7]. The G4 Alliance, a coalition of more than 75 civil society organizations, collectively established its unifying global target as “Safe Surgical and
Anaesthesia Care for 80% of the World by 2030” [8].
373
Global Situation ofPerioperative Care
Even if surgery is provided, unsafe anesthesia will add to death or disability [9]. To
improve patient safety and outcomes, successful anesthesia initiatives must be
developed or expanded, including airway management (maintain airway, breathing,
oxygenation); management of cardiac disturbances; and comprehensive perioperative care (comorbidities, pain management). These anesthesia initiatives are critical
issues in many LMICs due to lack of investments in training, procurement, and
maintenance of anesthesia and monitoring equipment, oxygen, and medicines,
including opioids [9].
In the last 50years, there has been a steady decline in the perioperative mortality
rate (POMR) and anesthetic-related mortality (ARM) rates, despite taking higher
risk patients for anesthesia. The greatest decline in POMR was in high-income countries (HICs), but the POMR incidence was two to three times higher in LMICs. Over
the years, the risk of mortality solely due to anesthesia decreased progressively from
357 per million (before the 1970s) to 34 per million (in the 1990s–2000s). This could
be attributed to the efforts to improve patient safety in the perioperative period over
the years and suggested that it could become an indicator for patient safety.
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6
2007
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M. N. Cherian et al.
In order to reduce this inequity, global priority should be given to utilizing
evidence- based interventions in the LMICs’ context in reducing the POMR and
ARM [10] (Fig.23.1).
A recent study on the global burden of postoperative death suggests that at least
4.2million people worldwide die within 30days of surgery each year, and half of
these deaths occur in LMICs. This number of postoperative deaths accounts for
7.7% of all deaths globally, making it the third greatest contributor to deaths, after
ischemic heart disease and stroke (Fig.23.2). More people die within 30days of
surgery annually than from all causes related to HIV, malaria, and tuberculosis combined (2.97million deaths) [11].
The May 2019 Report by the WHO Director General on Implementation of the
2030 Agenda for Sustainable Development emphasized that access to safe, timely,
and affordable emergency and essential surgical and anesthesia care is a critical
component of UHC.
Globally, 5billion people lack access to this; 1.7billion are children under the
age of 15years. This report also highlighted that 830 women die each day from
complications of childbirth (commonly caused by obstructed labor and postpartum
hemorrhage). A total of 6.3million children under 15years old died in 2017; many
)
1000
100
10
Anaeshetic sole mortality (deaths/10
1
1937
Fig. 23.1 Event rates for anaesthetic sole mortality by year. Every circle represents a study; the
circle size is representative of the study’s population size. The year represents the median year if
the study reported a range of years. Low-income and middle-income countries are shown in light
red (human development index [HDI]<0.8) and high income countries in dark red (HDI < 0.8).
Reprinted from The Lancet, Vol. 380, Issue 9847, Bainbridge D, Martin J, Arango M, Cheng D;
Evidence-based Peri-operative Clinical Outcomes Research (EPiCOR) Group, Perioperative and
anaesthetic-related mortality in developed and developing countries: a systematic review and
meta-analysis, 1075-81, Copyright (2012), with permission from Elsevier
1947 1957
1967 1977
1987
1997
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