Can I Upload a Picture of an Surgical Instrument for Identifying
Abstract
Objective
Surgical instrument oversupply drives cost, confusion, and workload in the operating room. With an estimated 78%–87% of instruments being unused, many health systems have recognized the need for supply refinement. By manually recording instrument utilize and tasking surgeons to review instrument trays, previous quality improvement initiatives accept achieved an boilerplate 52% reduction in supply. While demonstrating the caste of instrument oversupply, previous methods for identifying required instruments are qualitative, expensive, lack scalability and sustainability, and are prone to homo error. In this work, we aim to develop and evaluate an automated system for measuring surgical instrument use.
Materials and Methods
We present the first system to our noesis that automates the collection of existent-fourth dimension musical instrument utilise information with radio-frequency identification (RFID). Over 15 breast surgeries, 10 carpometacarpal (CMC) arthroplasties, and 4 craniotomies, musical instrument use was tracked past both a trained observer manually recording instrument use and the RFID system.
Results
The average Cohen'south Kappa agreement between the system and the observer was 0.81 (nigh perfect understanding), and the system enabled a supply reduction of 50.8% in chest and orthopedic surgery. Over 10 monitored breast surgeries and 1 CMC arthroplasty with reduced trays, no eliminated instruments were requested, and both trays keep to be used every bit the supplied standard. Setup time in breast surgery decreased from 23 min to 17 min with the reduced supply.
Determination
The RFID organisation presented herein achieves a novel data stream that enables authentic instrument supply optimization.
Lay Summary
Surgical instrument oversupply drives cost, confusion, and workload in the operating room. With an estimated 78%–87% of instruments existence unused, many wellness systems have recognized the demand for supply refinement. By manually recording musical instrument utilize and tasking surgeons to review musical instrument trays, previous quality comeback initiatives take achieved an average 52% reduction in supply. Despite these successes, methods for identifying required instruments are expensive, qualitative, lack scalability and sustainability, and are decumbent to man error. In this work, we develop and evaluate an automated radio-frequency identification (RFID) system for measuring surgical musical instrument use. Over xv breast surgeries, ten carpometacarpal (CMC) arthroplasties, and 4 craniotomies, musical instrument use was tracked by both a trained observer manually recording instrument use and the RFID system. The RFID system accomplished virtually perfect agreement with the observer and enabled an musical instrument supply reduction of 50.8% in breast and orthopedic surgery. Over 10 monitored chest surgeries and ane CMC arthroplasty with reduced trays, no eliminated instruments were requested, and both trays continue to be used as the supplied standard. Furthermore, setup time in chest surgery decreased from 23 min to 17 min with the reduced supply.
Background AND SIGNIFICANCE
Surgical instruments are central to surgical procedures, which are the leading revenue commuter for health systems. 1 Despite their criticality, near health systems struggle to manage this essential asset. Instruments are typically stored in trays, some containing upward to 188 instruments. 2 While hospitals monitor when a preconfigured tray is sterilized, where it is stored, and when it is sent to an operating room (OR), no information is gathered on the utilization of private instruments. As such, instrument supply is predominantly determined historically. The surgical team is expected to refine instrument trays/supply (preference cards), yet while instruments are often added, few are removed. This trend toward backlog incurs a big efficiency cost. An estimated 78%–87% of instruments in the OR get unused, introducing unnecessary costs in the class of cleaning and processing, delayed surgical operations due to missing, muddied, or broken instruments, increased workload of nursing administration, and increased instrument wear. three
Many health systems are experiencing these challenges. Over the past 6 years, at least xv quality comeback initiatives across 10 dissimilar hospitals and 14 service lines documented cost savings past identifying and eliminating unused instruments. 4–15 On average, a 52% reduction in supply was realized (35%–37% fixed effects and 41%–65% random effects (95% CI)) (Effigy 1). Central to the success of all musical instrument supply optimization initiatives is the acquisition of data describing instrument usage. In the past, necessary instruments have been identified by enlisting observers to manually record apply (ethnographers) and/or organizing committees to review musical instrument supplies. Despite the successes of these initiatives, toll savings take been macerated by the investment required to support personnel in monitoring operations, the opportunity cost of diverting surgeon effort, and their limited scalability. Optimizing instrument supply across an unabridged institution requires precise knowledge of the needs of each surgeon completing every procedure. For a full general tray used in iv service lines by 10 surgeons, organizing all stakeholders to review supply or sponsoring the ascertainment of every relevant operation is logistically challenging and can exist cost prohibitive. xvi These methods are further hindered by subjectivity and lack quantitative data to guide reduction and bulldoze adoption.
Figure 1.
Surgical instrument reduction studies.
Figure 1.
Surgical instrument reduction studies.
RFID as a foundational engineering science is well positioned to automate intraoperative instrument tracking. RFID hardware consists of a reader, reader antennas, and tags. The reader adheres to a communication protocol that sends signals through antennas. Signals are focused past antenna proceeds and activate tags inside range. The tags respond through backscatter, where an impedance is switched on and off, encoding identity. The reader receives the signal and decodes the tags' identity. RFID does non crave line of sight, is economical, and is already used in the OR, making information technology well suited for tracking surgical instrument use. Despite these advantages, adoption of RFID by health systems has been express. Well-nigh all RFID systems in healthcare target the tracking of big equipment and patients. 17–21 Few RFID systems for instruments have been commercialized, and all target either the identification of retained surgical instruments or the automation of musical instrument counts. 22 , 23 While these solutions tin improve patient prophylactic and surgical workflow, they exercise not identify which instruments are used in an operation.
While previous enquiry has focused on improving the accuracy of the preference card (a list of instrument trays and supplies to be provided for a procedure), very petty piece of work has gone downwards to the instrument level. 24 Yoshikawa et al. 25 leveraged RFID-tagged surgical instruments to collect proximity data at 13.56 MHz. The organization recorded musical instrument use only required the surgical team to browse each instrument. Similarly, Yamashita et al. 26 used a 13.56 MHz mat antenna on the Mayo stand for intraoperative tracking. Mayo stands act equally a staging area for instruments that are anticipated equally beingness necessary past the scrub nurse. However, instruments that are used past the surgeon may never touch the Mayo stand and instruments that are not used are often placed on the stand, making information technology a poor proxy for utilize. Moreover, a system monitoring the Mayo stand is only applicable to operations with Mayo stands.
OBJECTIVE
With this understanding, the goal of this study was to develop an automated RFID arrangement that measures intraoperative surgical instrument use.
Arrangement design
Our team observed craniotomy for tumor operations, Chiari malformation decompressions, CMC arthroplasties, breast excisional biopsies, breast lumpectomies, axillary sentinel lymph node biopsy, sentinel lymph node biopsies, pelvic ring fracture repairs, kidney transplants, acetabulum fracture repairs, and radial fracture repairs. By documenting the surgical approach for each performance and interviewing stakeholders at all levels of the hospital ecosystem, we accrued a list of design criteria:
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The RFID system must not impede workflow;
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Line of sight is not guaranteed (instruments are often covered by a surgeon'south hand or biomaterial);
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The surgical site is varied, and Mayo stands are non ubiquitous;
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Indistinguishable instruments must be uniquely identified;
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The functionality of the instrument must not be impacted;
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All hardware must exist sterile or outside the sterile field; and
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The tracking technology must be economical to apply to thousands of instruments.
These criteria informed design choices and were leveraged in evaluating system prototypes.
At that place are two types of RFID: passive and active. In agile RFID, both the reader and the tag have onboard power supplies. Both components tin can amplify signals that enable communication over greater distances; however, active tags are larger than passive tags. Every bit attachment to a surgical instrument necessitates size minimization, passive RFID was chosen for this piece of work. Passive RFID communication range is bounded by the radiated ability limit and the maximum size of the tag. The Federal Communications Commission (FCC) regulates multiple RFID bands: low frequency (130 kHz), high frequency (13.5 MHz), ultrahigh frequency (UHF) (915 MHz), and microwave frequency (ii.4 and 5.6 GHz). Hardware is more than accessible and affordable at lower frequencies, and at 2.4 and 5.6 GHz, passive tags are not commercially bachelor. However, as antennas are designed around the wavelength of communication, and wavelength is inversely proportional to frequency, lower frequencies mostly require larger antennas. To enable tags modest enough to fit on surgical instruments while minimizing price, UHF is currently best. Autoclavable tags purchased for this study cost $iii.79/ea, 2 antennas cost $46.99/ea, and the reader cost $922.00. Thus, the brunt of musical instrument mismanagement far outweighs the cost of an RFID organisation. The FCC limits the output power of UHF readers to 1 W, with a maximum reader antenna gain of 6 dBi. 27 Antennas in proximity to humans are farther limited to take an effective isotropic radiated power of less than 0.61 mW/cm2. 28 With a 2 × 3 × ten mm tag, reliable communication range over FCC-compliant transmit ability is limited to well-nigh one m.
With these principles in mind, the UHF RFID organization was designed to exist remote of the sterile field while viewing only the surgical site. Before surgery, RFID tags (Xerafy Ltd. 29 ) were attached to instruments and a decoder database pairing the tag ID to musical instrument data was adult. The tagged instruments were steam-sterilized, and the antenna organization was installed in the OR before each operation. As instruments were used at the surgical site during the operation, the proximity between the tags and the reader antennas enabled reads. Throughout the performance, tag read data were written to an SD carte du jour past the reader. Afterwards monitoring multiple surgeries, software was written to generate a master list of all previously used instruments to be supplied in subsequent surgeries. The process catamenia for optimizing instrument supplies with the RFID system is shown in Effigy ii.
Effigy 2.
Workflow schematic of RFID-informed instrument supply optimization.
Figure 2.
Workflow schematic of RFID-informed instrument supply optimization.
MATERIALS AND METHODS
Data drove
To characterize the accuracy of the system, 4 craniotomies, 10 CMC arthroplasties, and 25 breast surgeries were monitored. These operations were targeted because the equipment and surgical approaches are unique. By refining the organization for ease-of-use in this varied subset of surgeries, nosotros aimed to better the generalizability of the system and results in application to operations outside the scope of this work.
For each targeted surgery, we obtained the preference card from the surgeon, identified the tray that contained the almost instruments, and attached RFID tags with surgical musical instrument marking record (Figure 3). Each tagged instrument was scanned into a database pairing tag ID numbers to instrument information. Tags and instrument tape are autoclave-compatible, and tagged instruments were processed through the conventional instrument sterilization cycle at Knuckles University Hospital. Before each surgery, the scrub nurse retrieved the tagged tray from the designated storage area, set upwards the instruments in standard fashion, and a team member placed the antennas to view the surgical site. Later on surgery, our team retrieved the antenna system, collected the SD card from the reader, and uploaded the information to a secure storage site.
Figure 3.
RFID-tagged surgical instrument.
Effigy 3.
RFID-tagged surgical instrument.
Concurrent with each surgery, a squad member manually recorded the onset-of-employ for each instrument. Onset-of-employ was defined as an instrument entering the operative field in the operator'south manus. A new apply was recorded every fourth dimension an instrument re-entered the field. Ethnographers were trained to identify instruments individually and leveraged color-coded instrument record to improve the ease and accurateness of their recording. The surgeon's proper name and procedure type were as well recorded, and the operation proceeded per standard methods. The study was deemed exempt past Knuckles's institution review board (Pro00100079), and no patient wellness information was collected.
Information processing
Four data types were collected: the decoder database linking tag IDs to instruments, the database of RFID data from each monitored surgery, the database of ethnography (onset-of-use) logs, and the database of surgical data (instance times, functioning type, observer notes, and surgical team names). Prior to analysis, RFID information logs were cropped to remove reads recorded before the outset time and afterwards the end time of each surgery. From the cropped RFID data and ethnography logs, we calculated the true positive rate (TPR) and false positive charge per unit (FPR) of the organization past because the observer'south ethnography as ground truth and every RFID read as an case of use. The Cohen'south Kappa understanding between the observer and the system was calculated from each positive or negative use recording over all 39 cases (3272 events). 30 To determine the number of surgeries necessary to monitor before eliminating excess supply, we too calculated the number of new instruments added to an inclusive list of instruments used in whatever prior surgery and plotted the number of new instruments past the chronological case number. All analysis was completed in MATLAB R2019b or Python 3.7.
Reduced supply evaluation report
In breast surgery, we configured a tray to contain but instruments the system recorded as being used over the first 15 cases and supplied the reduced tray during the subsequent ten surgeries. 31 Congruently, a reduced tray was also supplied in a 10th CMC arthroplasty performance. The instruments that were removed from each of the trays were made available in a separate, unopened tray. If the surgeon requested an eliminated instrument, the instrument could exist retrieved from the excess tray. To gauge the effects of a reduced supply, we weighed instruments before and after supply reduction and compared the setup durations from operative timestamps in chest surgery. We also informally evaluated the experience of the surgical squad: Did RFID tags impact the utility of a surgical instrument in any manner? Did the RFID system arrive your way?
RESULTS
Of the iii surgeons and 6 nurses who interacted with the RFID system, none found the RFID tags or system to be obtrusive to surgical workflow. No unsterile equipment entered the sterile field, and there were no instances of postoperative infection. In breast surgery, the organization identified 37 out of 62 (59.7%) supplied instruments as being used over the first 15 operations. Over 9 CMC arthroplasties, 53 out of 121 (43.8%) supplied instruments were recorded as used by the RFID system. Due to hospital-mandated restrictions put in identify for COVID-nineteen, only 4 neurosurgeries were monitored, making the used instrument list inconclusive. From breast and orthopedic surgery, 50.8% supply reduction was identified and implemented. In the orthopedic surgery and 10 breast surgeries with a reduced supply that were monitored, no eliminated instruments were required. Furthermore, the optimized trays in both breast and orthopedic surgery take been adopted as the standard supply and go along to be used in operations.
All reads from a single breast lumpectomy and sentinel lymph node biopsy operation are displayed in Figure 4. The vertical axis contains each surgical musical instrument that was logged throughout the operation. Employ instances for each musical instrument are plotted on a timeline with surgical events depicted by vertical lines. Blue circles represent to reads from the RFID arrangement, while greenish 'x's correspond the ethnographer's observed onset of instrument use. Of the 62 tagged instruments supplied in this performance, only 27 are plotted here equally the remaining 35 were neither recorded past the RFID arrangement nor the observer. The security clamp was recorded as used by an observer only was missed past the RFID system. This is a false negative of the organization. Similarly, faux positives of the system correspond to RFID reads that were not recorded as used past the ethnographer. To gauge the sensitivity and specificity of the system, Figure v plots the TPR by the FPR calculated from each individual surgery (small circles) on a receiver operating characteristic plot. Large circles stand for cumulative results from all surgeries accomplished by the same surgeon in a service line (chest, neuro, ortho). Over all 39 monitored cases, the system accomplished a sensitivity of 93.8% and specificity of lxxx.viii%. The agreement between the RFID system and human ethnography was virtually perfect, with a Cohen's Kappa statistic of 0.81 (95% CI, 0.790–0.83). To judge the precision of ethnography, ii observers simultaneously monitored 2 CMC arthroplasties. Their average interrater understanding was 0.95 (near perfect agreement).
Figure 4.
Surgical musical instrument RFID and observer log from a chest lumpectomy and watch lymph node biopsy.
Figure 4.
Surgical instrument RFID and observer log from a breast lumpectomy and sentry lymph node biopsy.
Effigy 5.
Receiver operating feature of the RFID system.
Effigy five.
Receiver operating feature of the RFID arrangement.
While not statistically pregnant, median setup time in chest surgeries decreased from 23 min to 17 min after eliminating unused instruments (P = .23). Similarly, the weight of the instruments was reduced from 2.7 kg (62 instruments) to 1.9 kg (37 instruments) in breast surgery and from 5.5 kg (121 instruments) to two.4 kg (53 instruments) in orthopedic surgery. This measurement does not include the weight reduction made possible by using a smaller tray.
To business relationship for variation in surgical instrument apply between congruent operations, multiple operations were monitored before optimized instrument trays were configured. To gauge how many surgeries are necessary to monitor before supplies can be reduced, we plotted the number of new instruments used in each chronological surgery (Effigy 6). New musical instrument use follows an exponential decay in all surgery types with an average one-half-life occurring between surgeries 2 and three.
Figure vi.
Number of monitored surgeries necessary to capture surgeon variation in musical instrument utilize.
Effigy vi.
Number of monitored surgeries necessary to capture surgeon variation in musical instrument employ.
Give-and-take
Eliminating unused surgical instruments
The system achieved an average supply reduction of 50.viii%, and no eliminated instruments were required in post-obit cases. While this level of reduction is on par with the reduction achieved by similar quality improvement initiatives, 4–xv a previous quality improvement initiative in chest surgical oncology may take impacted the caste of reduction. The full general chest tray had been previously paired down from 113 to 62 instruments based on the surgical teams' anecdotal knowledge of musical instrument use. Despite applying the RFID system to an already-refined tray, the system realized a further reduction of 40.3% (62 to 37 instruments). This effect suggests that current methods for determining instrument utility could be improved with quantitative data describing instrument use.
Eliminating unused surgical instruments from supply increases the efficiency of surgery past reducing workload and cost. While this study did not include a toll assay, savings are anticipated to stalk from reducing musical instrument processing brunt (direct cost estimated at $0.77/per instrument per bike), instrumentation errors (rust, contamination, missing/cleaved, etc), count discrepancies, the prevalence of retained surgical instruments, the frequency of instrument maintenance and acquisition, the number of instruments and respective storage infrastructure, and expediting OR setup and takedown. 3 , iv , ten , 32–34 Rates of infection may decrease due to decreased traffic in and out of the OR from nurses retrieving missing instruments and an improved quality of sterilization due to reduced workload. 3 , 35 Staff turnover may also decrease every bit instrumentation fault frequently catalyzes conflict between the sterile processing department and the OR. Eliminating instrumentation could help maintain tray weights beneath the 25 lbs. mandate, 31 , 36 and operative capacity may increase due to faster OR setup and takedown and fewer musical instrument-related delays. Ultimately, accurately eliminating unused instrumentation improves the value of healthcare by reducing cost and improving quality.
The accuracy of intraoperative RFID apply tracking
Equally none of the surgeons requested eliminated instruments in follow-on surgeries with reduced supplies, the RFID system accurately identified unnecessary instruments. When measured against manual ethnography, the system achieved a Cohen'due south Kappa statistic of 0.81 (95% CI, 0.790–0.83), or nigh perfect agreement. Congruently, the cumulative sensitivity of the system was 93.8%, and the specificity of the organisation was 80.8%. Therefore, most all instruments that were used were recorded by the RFID organisation, while some that were non used were also recorded. We explored false positives of the system and linked many of them to operational abnormalities. For example, over the kickoff fifteen breast surgeries, three instruments were singularly recorded as used past the organisation. During the operation, a medical student had brought the instruments near the surgical site without applying them. The proximity was sufficient for the RFID system to record each instrument. False negatives of the system appeared to correlate with specific instrument geometries. As metallic reflects RF, flat geometries that are oriented to shield the tag from the receiver effectively limit advice. Consequently, apartment knife handles were missed more than any other instrument. To improve their readability, tags should exist mounted on the side contour rather than the confront, something that was not done in this study.
The relative importance of specificity in implementing supply change with RFID data is less than sensitivity. If an unnecessary instrument remains in supply, the cost is the opportunity toll of its removal. If the arrangement misses an instrument that is used and it is removed, subsequent surgeries may require the missing instrument, potentially impacting patient prophylactic and surgical workflow. Yet, equally more surgeries are monitored and the body of data grows, the risk of eliminating necessary instruments decreases. To further reduce the possibility of eliminating necessary instruments, we provided surgeon stakeholders with a list of instruments that would be removed. In the orthopedic and breast surgical oncology pilots, the supply change was approved, and reduced trays were configured.
Implementing instrument supply modify with RFID data
In this study, every RFID read was interpreted as an case of utilize and every used instrument accounted necessary to futurity supply. Some other style to interpret this information is past computing a usage percentage for each instrument from the fraction of operations it was used in. For example, if an instrument was recorded in 1 of 15 operations, its usage percent would exist 6.7%. By eliminating instruments used in less than 10% of operations, instruments that were erroneously recorded could exist eliminated from hereafter supply. Furthermore, instruments with a usage percentage betwixt x% and 25% could be supplied in a divide tray or pare pack and would demand to exist reprocessed merely if the tray or peel pack were opened for utilize. This methodology caters to institutional preferences and gains power with a growing body of data. A large dataset of monitored surgeries would amend the cumulative TPR. The FPR would also increase, but by leveraging a usage per centum cutoff, its effects could be negated.
The variation of used instrumentation is largely the aforementioned betwixt surgery types. In Effigy 6, the exponential decay of new instruments used past each surgeon for each service has approximately the same half-life. This allows for an approximate forecast of the number surgeries that are necessary to monitor before reducing supplies. In practice, the number of new instruments can exist evaluated after each operation, and supply modify tin can be implemented after several cases with no new instruments logged.
In this study, we engaged each surgeon to review the list of instruments to be removed from their trays before making the change. Their experience facilitated the review and presenting the data describing their history of use helped garner support for eliminating unused instruments. Engaging surgeons in this way is critical when the number of monitored cases is low. If a seldomly used instrument was not applied in any of the monitored cases, it could be eliminated despite its indispensability to rare surgical occurrences. Surgeons' approval of the supply modify allows for a bank check before unused instruments are removed. Equally more cases are monitored and the body of nerveless data grows to cover rare surgical occurrences, usage statistics begin to business relationship for all use cases. In this way, RFID-captured usage information have the potential to become a critical tool for administrative stakeholders to engage their clinical teams equally they perform supply optimizations.
The full value of the organization is achieved when permanently applied to an OR and run in the groundwork during all operations. A major limitation to quality improvement initiatives is their lack of sustainability. After the initiative, instruments seep back into supply every bit preferences change. Without recurring diligence, in that location will always exist an imperfect supply. With an automated system collecting a history of use, musical instrument supply can be continuously updated to facilitate changing preferences while minimizing waste.
Limitations
The greatest limitation of this report is that only three surgeons were monitored. General trays are used by many surgeons for many types of operations, and all relevant procedures would demand to exist monitored earlier an optimized supply could be realized. Therefore, the chief goal of this work is to demonstrate the utility of the RFID system in measuring intraoperative instrument use. With this system, all procedures relevant to an instrument tray can be monitored efficiently and supplies tin can be optimized beyond surgeon populations.
Limitations of the RFID system revolve around attaching RFID tags to surgical instruments. While tape provides an autoclavable method for fixation, concerns with sterilizability, degradation, and possibility for patient-retained record have been voiced across the manufacture. 37 Applying tags to instruments with record is also time consuming. A surgeon and medical student required v h to tag 124 instruments. Developing a more efficient and reliable method for affixing tags to instruments is a future direction of this work.
CONCLUSION
In this study, we adult an automated RFID system for recording surgical musical instrument use. We demonstrated the utility of the system in identifying unused instruments, characterized the accurateness of the organization in 3 types of surgery, developed a framework for implementing supply modify with intraoperative RFID data, and identified limitations and future directions of this piece of work.
FUNDING
This piece of work was supported in part past the Duke Institute for Health Innovation.
AUTHOR CONTRIBUTIONS
IH conceived and designed the RFID surgical instrument tracking system. Authors IH, LO, JH, WH, MJR, LHR, and PJC designed this study. Ethnography was performed by IH, LO, JH, EL, JW, PK, and JG. The original manuscript was drafted by IH, and all authors revised this work.
ACKNOWLEDGMENTS
This work would not have been possible without the support from clinical stakeholders at all levels of Duke Academy Hospital, the Duke Ambulatory Surgery Center, and the Davis Ambulatory Surgical Center. In item, we would like to thank Tempo Chan, Grace Fabito, and Wendy Webster for assisting in the neurosurgery pilot and offering feedback throughout the iterative pattern procedure, Denise James for assisting with the orthopedic surgery pilot, and Sharilyn Gasparrelli, Melissa Gilliam, and Katherine Wrzesniewska, for their support during the breast surgical oncology airplane pilot.
CONFLICT OF INTEREST Argument
Authors Ian Hill, Patrick J. Codd, and Westin Hill have ownership interest in Mente Inc.
Information AVAILABILITY
The RFID data underlying this article will be shared on asking to the corresponding author. OR data cannot exist shared publicly to protect the privacy of the surgical team.
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