772771

research-article2018
SRIXXX10.1177/1553350618772771Surgical InnovationYamashita et al

Original Article
Surgical Innovation

Evaluation of Surgical Instruments

1­–6
© The Author(s) 2018
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DOI: 10.1177/1553350618772771
https://doi.org/10.1177/1553350618772771

Tags in the Operating Room journals.sagepub.com/home/sri

Kazuhiko Yamashita, DEng1 , Kaori Kusuda, DSci2, Yoshitomo Ito, MD3,

Masaru Komino, RN3, Kiyohito Tanaka, MD4, Satoru Kurokawa, DEng5,
Michitaka Ameya, DEng5, Daiji Eba, BA6, Ken Masamune, DEng2,
Yoshihiro Muragaki, MD2, Yuji Ohta, DEng7, Chugo Rinoie, DPM, ABPO8,
Kenji Yamada, DEng1, and Yoshiki Sawa, MD1

Abstract
Background. Surgical instrument retention and instrument breakage compromise surgery quality and lead to medical
malpractice. We developed an instrument tracking system that could alert surgeons to instrument retention during
surgery and monitor instrument use to reduce the risk of breakage. Methods. This prospective, experimental clinical
trial included 15 patients undergoing inguinal hernia surgery or lumpectomy under general anesthesia at Saiseikai
Kurihashi Hospital. Radiofrequency identification (RFID)-tagged surgical instruments were used, and a detection
antenna was placed on a mayo stand during the operation. We analyzed the 1-loop detection ratio (OLDR)—that is,
the capability of the antenna to detect devices in a single reading—and the total detection rate (TDR)—that is, the
data accumulated for the duration of the operation—of the RFID-tagged instruments. Results. Data analysis revealed
that the OLDR was 95% accurate, whereas the TDR was 100% accurate. The antenna could not detect the RFID tag
when there was interference from electrocautery noise radiation, and 6% of instrument movement was undetected by
the antenna; however, the TDR and instrument use were detected at all times. Conclusions. Surgical instruments can be
tracked during surgery, and this tracking can clarify the usage rate of each instrument and serve as a backup method of
instrument counting. However, this study was conducted on a small scale, and RFID tags cannot be attached to small
surgical instruments used in complex operations such as neurosurgery. Further efforts to develop a tracking system
for these instruments are warranted.

Keywords
surgical instruments with RFID tags, operating room, tracking system

Introduction used to screen for retained instruments after surgery is

rather simple and has remained unchanged: counting the
Retention of surgical instruments inside the body cavity
continues to occur despite preventive measures such as 1
Osaka University, Osaka, Japan
routine manual counting of surgical instruments by oper- 2
Tokyo Women’s Medical University, Tokyo, Japan
ating room nurses. According to incident reports, instru- 3
Saiseikai Kurihashi Hospital, Saitama, Japan
ments or sponges are retained in approximately 1 in every 4
Japanese Red Cross Kyoto Daini Hospital, Kyoto, Japan
10 000 surgical procedures that involve an open cavity.1-4 5
National Institute of Advanced Industrial Science and Technology,
According to Gawande et al,1 one-third of the reported Ibaraki, Japan
6
EBA Corporation, Aichi, Japan
cases had retention of surgical instruments. 7
Ochanomizu University, Tokyo, Japan
Screening systems that detect and prevent potentially 8
Methodist Hospital of Southern California, Arcadia, CA, USA
harmful events are critical for ensuring patient safety. A
Corresponding Author:
guideline published by the World Health Organization Kazuhiko Yamashita, Graduate School of Medicine, Osaka University,
recommends manual counting of surgical instruments by 1-3 Yamadaoka, Suita, Osaka 565-0871, Japan.
2 nurses after the operation.5 The system most widely Email: k-yamashita@obd.med.osaka-u.ac.jp
2 Surgical Innovation 00(0)

instruments before and after use to check for discrepan-

cies.6,7 However, counting is known to be highly prone to
errors because it relies on human consistency and accu-
racy, and the operative setting has time constraints, dis-
tractions, and unexpected interruptions. The rate of
retained instruments has been reported to be 1 per 70 dis-
crepancy cases.3
In addition, malfunctioning of surgical instruments
has led to serious medical accidents during surgery. These
accidents include direct tissue damage and retained pieces
of broken instruments. In a previous study, the breakage
rate of surgical instruments in 2 years was 9.1%, and 2
near-miss incidents (10 in 100 000 operations) were
potentially critical.8 Most practitioners have not paid suf-
ficient attention to defective surgical instruments during
and after the operation.
Because of human limitations, human error is highly
possible when manually counting different surgical
instruments with a similar appearance within a limited
time frame, even if double-checking is done. If a sensing
function is added to surgical instruments, double-check-
ing by a human and a tracking system can be performed,
and improved reliability can be expected. Another advan-
tage of the sensing function is that the frequency of the
use of surgical instruments during an operation can be
automatically calculated. If the type and number of surgi-
cal instruments required for each operation are clarified,
the choice of surgical instruments can be optimized, and
the frequency of counting errors of surgical instruments
can be expected to decrease. The inventory quantity of
surgical instruments can also be optimized in hospitals.
In a previous study, we developed a radiofrequency
identification (RFID) tag for recognition and traceability
of surgical instruments.9 Next, we developed a manage-
ment system composed of a scanning device that func-
tioned as an antenna, which can detect RFID tags and
software to facilitate surgical tray assembly in central
sterile processing departments. This management system
has been successfully tested in a 27-month study con-
ducted in central sterile processing departments.10
However, devices capable of detecting surgical instru-
ments with RFID tags that can be used in the operating
room have not yet been developed.
In this study, we developed an antenna that can be
used in the operating room to detect commonly used sur-
gical instruments with an RFID tag. The goal of this study
was to determine the tracing rate of the antenna in cor-
rectly detecting the RFID attached to the surgical instru-
ments used in the operating room. The purpose of this
feasibility study was to verify the effectiveness of RFID-
tagged surgical instruments. For this reason, we decided
to use the mayo stand in the detection of RFID-tagged
surgical instruments in the operating room. Because the
mayo stand is used in various surgeries and is small in
Figure 1. Radiofrequency identification–tagged instruments.
size, frequently used surgical instruments can be placed
on it during surgery. Therefore, we considered that it
would be suitable for tracking the surgical instruments.
Methods
Participants
The RFID tracing rate was studied in 15 patients who
either underwent unilateral inguinal hernia surgery (2
cases) or lumpectomy with axillary lymph node dissec-
tion and sentinel lymph node biopsy (13 cases) while
under general anesthesia. The Human Studies Ethics
Committees at Tokyo Healthcare University and Saiseikai
Kurihashi Hospital approved this study. The operation
method was in accordance with the ethical guidelines of
the hospital. All participants provided written informed
consent. The participants did not receive any stipend.
Protocols for RFID-Tagged Surgical
Instruments and Research
Figure 1 shows surgical instruments tagged with an RFID
(diameter, 6 mm; width, 2 mm; radiofrequency, 13.56
MHz). Table 1 lists the surgical instruments with an RFID
tag used for inguinal hernia surgery (61 items) and
lumpectomy (46 items). Any practitioner who requested
(Figure 1) RFID-tagged instruments not listed in Table 1
was provided with individually prepared untagged instru-
ments. In this study, an antenna was developed to read the
information from the tag in the operating room. Figure 2
shows the placement of the antenna on the mayo stand
during the operation.
RFID-tagged surgical instruments can be repeatedly
cleaned in the usual manner with disinfectant wash and
sterilized using the same protocol (autoclave sterilization
in the central sterile processing department) implemented
Yamashita et al 3

Table 1. Surgical Instruments Included in the Sets. table, where the instruments are counted. During the
operation, a scrub nurse moves each instrument from the
Inguinal Hernia Lumpectomy
Surgical Instruments (n = 61) (n = 46) instrument table onto the mayo stand, handing the instru-
ments to the surgeon as needed. Therefore, the instru-
1 Saddle-shaped hook 1 ments used change as the operation progresses.
2 Langenbeck retractor 2 2 Under our protocol, the antenna is placed on the mayo
10 × 25 mm stand, with a sterile cloth covering the device. This allows
3 Langenbeck retractor 2 2
practitioners to perform the operation as usual without
13 × 40 mm
distraction while allowing automatic detection of RFID-
4 Langenbeck retractor 2
13 × 60 mm tagged instruments. A video camera was placed above the
5 Long tweezers 2 mayo stand to obtain a visual record of instrument usage.
6 Tweezers 2 2 The data obtained through the automatic detection of
7 Tweezers with hook 2 2 RFID-tagged instruments were compared with the visual
8 Adson tissue forceps 1 2 record to determine accuracy. At the same time, the usage
9 Cloth clamp 2 4 rate of RFID-tagged instruments per operation was calcu-
10 Mosquito pean, curved 10 5 lated using the data obtained.
11 Mosquito Kocher 5
12 Pean, straight 3 1
Characteristics of the Developed Antenna and
13 Pean, curved 10 5
14 Kocher artery forceps 10 5 Analysis Method
15 Kelly forceps, 16 cm, 1 1 The antenna shown in Figure 2 allows the detection of
strong bending RFID tags regardless of its direction. The antenna com-
16 Kelly forceps, 18 cm, 1
bines several small detecting parts and requires 8 to 13 s
strong bending
per detection. The variance in detection time is caused by
17 Mikulicz’s forceps 4
18 Needle holder for gold, 2 2
the number of RFID-tagged instruments placed on top of
16 cm the antenna at a given time. After the antenna records the
19 Mathieu needle holder 2 1 RFID tag information, the ID and time log are exported in
20 Cooper blunt tongs, 1 1 a CSV file.
14 cm The RFID tag information collected within 13 s of
21 Cooper bluff direct, 1 placement was compared with the data obtained through
14 cm video recording, and the detection ratio per instrument
22 Metzenbaum, 16 cm 1 1 was calculated (1-loop detection ratio [OLDR]). The
23 Scalpel handle, No. 3 2 2 detection range of the system was defined by the distance
between the antenna and the RFID tag. When the RFID
tag was positioned face-to-face, or parallel with the
antenna, the detection range was 8 cm. When the tag was
positioned perpendicular to the antenna, the detection
range was 5 cm. The detection range was set at 8 cm for
parallel-positioned tags to ensure the detection of the
RFID-tagged instruments placed above the mayo stand.
RFID-tagged instruments placed on the instrument table
or on the patient’s bed as well as instruments currently in
use are not detected by the antenna. If the detection range
had been very long, the antenna might have erroneously
detected instruments that were not on the antenna, which
would cause data disruption.
The detection range extended vertically from the
antenna; however, the lateral detection range was less
Figure 2. Placement of the antenna on the mayo stand than 1 cm from the outer edge of the antenna. During
(arrow).
operation, instruments were placed at the edge of the
mayo stand, and the instruments could extend past the
for all other devices and then organized in a container. edge, as shown in Figure 2. This placement may affect
Before the operation, the surgical instruments are data detection, which are recorded once every 13 s.
removed from the container and placed on the instrument Accurate detection can be further ensured by educating
4 Surgical Innovation 00(0)

nurses to avoid this practice; however, in this study, no

additional training or orders were given to the nurses,
allowing them to perform their usual operative roles, and
they had no knowledge of the antenna or the RFID tags.
Throughout an operation, the position of the surgical
instruments on the mayo stand changes. Instruments are
often repositioned or even stacked above each other on
the mayo stand after being used in the surgical field or
when preparing new instruments retrieved from the
instrument table. Even if a single detection loop per-
formed every 13 s cannot detect an instrument, it is likely
that the instrument will be detected in a subsequent detec-
tion loop. To evaluate whether the instruments were being Figure 3. Sample detection log of radiofrequency
accurately detected, the total detection rate (TDR) was identification–tagged instruments.
calculated from the data. The OLDR and TDR were cal-
culated and compared with the video image record.
Table 2. Usage Rate of Surgical Instruments Based on
Operative Method.a
Results
Rate of Instrument
Each operation was performed by a surgeon, an assistant Operative Method Usage (%) Number of Items
surgeon, and a scrub nurse, with a total of 4 surgeons and
Case 1 47.5 29
8 scrub nurses. Surgeons included experienced instruc-
Case 2 41.0 25
tors and medical interns, and the nurses also had various Case 3 56.5 26
levels of experience. Case 4 56.5 26
Figure 3 shows the transition in the number of RFID- Case 5 50.0 23
tagged instruments that were detected by the antenna Case 6 60.9 28
placed on the mayo stand. The horizontal axis shows the Case 7 39.1 18
progression of operation by time, and the vertical axis Case 8 41.3 19
shows the number of RFID-tagged instruments. Throughout Case 9 37.0 17
the course of an operation, 6 to 14 RFID-tagged instru- Case 10 37.0 17
ments were placed on the mayo stand. At the end of the Case 11 47.8 22
operation, the instruments decreased from 4 to 0. Case 12 47.8 22
Table 2 shows the operations performed, the usage Case 13 63.0 29
rate, and the number of instruments used. The average Case 14 34.8 16
usage rates of the surgical instruments were 44.3% ± Case 15 37.0 17
3.3% and 47.6% ± 10.9% for inguinal hernia surgery and a
Operative method: cases 1-2, inguinal hernia; cases 3-12, mastectomy
lumpectomy, respectively. The mean operation durations, with lymph node dissection; and cases 13-15, partial or total
measured as the difference between the time when an mastectomy.
RFID-tagged instrument was first placed on the mayo
stand and the time when the last detection was recorded,
were 4151 ± 795 and 5752 ± 2466 s for inguinal hernia the mayo stand. Scrub nurses were not instructed to place
surgery and lumpectomy, respectively. instruments in a specific manner, nor were they required
After verification of the video record and the RFID to perform a specific maneuver for detection. The mayo
detection log, the TDR of the surgical instruments placed stand is usually used only for the instruments that are
at least once on the mayo stand was found to be 100% immediately necessary for the operation. By tracking the
(Table 3). The mean OLDRs were 97.4% ± 1.8% and usage of the surgical instruments, the time of initiation
95.9% ± 1.2% for inguinal hernia surgery and lumpec- and completion of the operation can be approximated.
tomy, respectively. In a previous study, 32% of instruments packaged
for an operation were packaged erroneously.11 The
number of instruments packaged before an operation
Discussion could be optimized by evaluating instrument usage.
The system we developed was able to detect 100% of the Thus, it may be possible to reduce human error when
surgical instruments placed on the mayo stand. The sys- preparing the container of manually counted instru-
tem also collected the usage rate of each instrument, ments. This study revealed that precise tracking of
along with the types and number of instruments placed on instruments during surgery is possible. Through our
Yamashita et al 5

Table 3. OLDR and TDR Between the Video Record and the RFID System.

Instruments Seen in Instruments Detected by OLDR Recognition TDR Recognition

No. Video (n) the System (n) Accuracy (%) Accuracy (%)
1 4665 4515 96.8 100
2 3345 3324 99.4 100
3 7672 7324 95.5 100
4 3771 3524 93.5 100
5 3949 3812 96.5 100
6 4703 4554 96.8 100
7 8309 7916 95.3 100
8 1667 1627 97,6 100
9 3032 2923 96.4 100
10 1423 1346 94.6 100
11 1624 1557 95.6 100
12 3159 3064 97.0 100
13 2956 2788 94.3 100
14 3141 2998 95.5 100
15 1176 1145 97.4 100

Abbreviations: OLDR, 1-loop detection ratio; RFID, radiofrequency identification; TDR, total detection rate.

system, multiple instruments can be accurately detected
with their RFID tags, enabling double-checking by
both the system and humans. This can allow the staff to
focus more on inspecting the instruments for defects
and patient monitoring. Thus, the system can contribute
to improving the operation quality and patient safety.
Furthermore, the system can count the total usage of
surgical instruments, which can alert staff when a spe-
cific instrument has reached a usage rate where defects
can be expected or when devices requiring sterilization
or other maintenance reach their maximum usage.
The antenna requires 13 s to detect the tagged instru-
ments placed above it. There is a possibility that if an
instrument does not remain on the mayo stand for a dura-
tion of 13 s, the instrument will not be detected, thus
affecting the OLDR. However, in the 15 operations per-
formed, this did not occur. Thus, a detection time of 13 s
may still allow accurate detection.
There are several factors that may lower the OLDR,
such as close stacking of the tags of several instruments,
interference from digital noise during electrocautery, or
placement of the RFID tag outside the lateral detection
range of the antenna. The video record showed that elec-
trocautery was frequently performed during breast sur-
geries, and the RFID detection log showed no record
during electrocautery. However, as soon as electrocautery
was stopped, the RFID tag was detected. The RFID tag
detection rate was 100% in these cases as well.
When electrocautery was performed for 300 s, the
antenna was unable to detect for 23 loops. A total of 10
RFID-tagged instruments placed on the mayo stand would
equate to 230 counts, which may be the reason why the
OLDR decreased in some instances during the study. The
lower detection rate in such instances, however, does not
reduce the quality of the instruments or the operation
itself. This study shows that the system can be used in the
operating room to accurately detect instruments.
Retention of surgical instruments or breakage of instru-
ments within the body cavity substantially lowers patient
safety. To prevent retention of surgical instruments within
the body cavity, a reliable method to count and monitor
instruments must be developed. Furthermore, to prevent
breakage of instruments during surgery and to maintain
the quality of the operation, instruments must be managed
so that the rate of disinfection, sterilization, and usage
may be tracked. This detailed management of the instru-
ments cannot be performed by scrub nurses, who are
already required to physically handle the instruments
while simultaneously counting the instruments. A system
is necessary to support these nurses, and the system tested
in this study may provide a solution to these challenges.
The system enabled automated tracing of individual surgi-
cal instruments while scrub nurses were performing their
usual operative roles, without additional distractions.
Limitations
This feasibility study was carried out during 15 inguinal
hernia and lumpectomy surgeries. The risk of surgical
instrument retention in these 2 types of surgeries is not
known to be high. However, other surgeries performed in
the same way as these procedures are performed deep in
the body cavity. Therefore, this system is considered to be
suitable to track RFID-tagged surgical instruments in
these higher-risk surgeries. We plan to apply it to other
types of operations in the future.
6 Surgical Innovation 00(0)
The results of this research are only applicable to surgi-
cal tools with RFID tags attached. Because RFID tags were
not attached to individually prepared instruments, these
were not evaluated. Moreover, RFID tags are not designed
to be attached to small instruments used in complex opera-
tions such as neurosurgery. Hence, tracking of surgical
instruments used in those surgeries cannot be accom-
plished with the system developed in this study. Developing
a more compact RFID tag may be a solution; however, a
smaller RFID tag will have shorter detection range in rela-
tion to the antenna, which may adversely affect the TDR.
However, for the majority of surgical instruments used in
orthopedics or neurosurgery, the RFID tags can be attached
easily, which could help decrease instances of surgical
instrument retention within open cavities.
This research is one of the first to utilize RFID-tagged
surgical instruments in real operations, tracking the usage
of each instrument. The OLDR was shown to be greater
than 96%, whereas the TDR was 100% accurate. Because
the RFID uses electromagnetic waves to communicate, it
becomes undetectable in the presence of interference from
noise radiated during electrocautery. Because of this, the
OLDR decreases as the duration of noise lengthens.
Complete tracking of OLDR remains challenging, even
with the developed system. However, because the TDR
values are more important in tracking the usage rate and
preventing residual instruments, the implications of the
results achieved through this research are relevant. Further
research is warranted to evaluate the effectiveness of this
system in reducing cases of instrument breakage or acci-
dental residual instruments through the tracking of surgi-
cal instrument usage and counts.
Conclusion
An antenna that can detect an RFID-tagged surgical instru-
ment was developed and tested in the operating room. We
found that surgical instruments can be tracked during sur-
gery, and their usage rate can be clarified. The results of this
study suggest that the use of an instrument-tracking system
may contribute to improved accuracy of the instrument
count, thus avoiding instrument retention in the body cav-
ity, and the prevention of instrument breakage during oper-
ation, substantially improving the quality of the operation.
Acknowledgments
We thank Hiroshi Honda, MD, Junya Tamaki, RN, and Michiko
Suzue, RN, for their contributions to this study.
Author Contributions
Study concept and design: Kazuhiko Yamashita, Kaori Kusuda
Acquisition of data: Kazuhiko Yamashita, Kaori Kusuda,
Yoshitomo Ito, Masaru Komino, Kiyohito Tanaka
Analysis and interpretation: Kazuhiko Yamashita, Kaori
Kusuda, Satoru Kurokawa, Mitsutaka Ameya, Daiji Eba, Chugo
Rinoie, Yuji Ohta, Kenji Yamada, Ken Masamune, Yoshihiro
Muragaki, Yoshiki Sawa
Study supervision: Kazuhiko Yamashita, Kaori Kusuda, Ken
Masamune, Yoshihiro Muragaki, Yoshiki Sawa
Declaration of Conflicting Interests
The author(s) declared no potential conflicts of interest with
respect to the research, authorship, and/or publication of this
article.
Funding
The author(s) disclosed receipt of the following financial sup-
port for the research, authorship, and/or publication of this arti-
cle: This study was performed as an exploratory research
performed by KazY (15K12608) and KK (974682).
ORCID iD
Kazuhiko Yamashita, https://orcid.org/0000-0003-1268-7260.
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