KEY

REFERENCES

Compiled below are relevant and important key journal articles, references & studies on ergonomic issues, hand and foot response times, the accuracy of pedal activation during surgery and others.

 
 

1) Comparison of Reaction Response Time between Hand and Foot Controlled Devices in Simulated Microsurgical Testing

Link to the original journal.

The authors measured eye-hand and foot-hand response times in a setup designed to mimic a real eye surgical environment. They found response time was significantly faster using hand activation when compared with foot activation. They also found that 91% of the 47 subjects preferred the hand (~91%) to the foot (~4%) with the remainder of (~4%) reporting no difference.

US National Library of Medicine - NIH - Published online 2014 Jul 6

 

2) Lessons from Other Massachusetts Providers

Link to the original journal.

Reported an incident of a Bovie burn to a surgical patient when the assisting surgeon was still depressing the foot pedal powering the Bovie when the surgeon placed it on the drape. The hospital eliminated foot-pedal control of Bovies.

Betsy Lehman Center for Patient Safety - News - May 16, 2017

 

3) A Review of the Ergonomic Issues in the Laparoscopic Operating Room

Link to the original journal.

“Due to the foot of the operating table, the foot pedals and cables on the floor, there is little space for the feet of surgical staff, causing a static body position”

 

“Foot pedals may cause several physical ergonomic concerns (e.g., discomfort in the legs and feet) while the surgeon keeps the operating foot dorsiflexed over the pedals and loads the bodyweight on the other foot to prevent losing contact with the pedals [50, 65]. In addition, foot pedals restrict the surgeon from moving around and promote static body postures [45].”

 

“Both the foot pedal for electrosurgery and that for ultrasonic dissection have two switches for different functions. These two switches cannot be distinguished by touch,

Journal of Healthcare Engineering · Vol. 3 · No. 4 · 2012 593

and can possibly result in dangerous situations such as hitting the wrong switch [67]. Also, the pedals can be unintentionally moved (kicked) around under the operating table, that the surgeon loses contact with the pedal and has to look down to restore the right position of the foot [68].”

Journal of Healthcare Engineering - Vol. 3  -  No. 4 - 2012 Page 587-603

 
 
 
 

4) Do illuminated foot pedals improve the speed and accuracy of pedal activation during endoscopic procedures?

Link to the original journal.

Limited working space, surgical drapes, plastic covers, and low-light operating room (OR) settings can risk inaccurate foot pedal activation during these cases. A range of complications can result, including extraneous radiation exposure, accidental cautery, and even patient burns. In fact, OR fires and fatal intraoperative explosions from inaccurate foot pedal activation have been reported. Furthermore, a repetitive search for the correct foot pedal can lead to an increase in operative time with each additional minute costing $66.

Journal of Investigative Medicine. 66(1): A217, January 2018

5) Ergonomic Problems Originating in the Use of High-Frequency and

Ultrasonic Medical Devices

Link to the original journal.

“43 out of 74 (58 percent) surgeons replied in the questionnaire that they often mistook the HF foot pedal controls for coagulation and dissection. In rare cases (four out of 74, five percent) nurses had to operate the pedal controls pursuant to oral commands given by the surgeon”

 

“58 percent (43 out of 74) would have preferred a control integrated in the instrument handle over foot-pedals given similar costs”

 

“Although bipolar HF devices are safer for the patient, monopolar technologies are still prevalent. Due to their easier handling, monopolar devices are more often used and also better rated.”

 

“The wire between the instrument and the foot-pedals can cause members of the OR team to trip themselves up, especially if the surgeon needs a pedestal to compensate for the different body heights of team-members”

Biomed Tech 2012; 57 (Suppl. 1) © 2012 by Walter de Gruyter

7) Electrosurgical Generators and Monopolar and Bipolar Electrosurgery

Link to the original journal.

ABSTRACT

Electrosurgery is the most commonly used and misunderstood technology by all surgical and medical disciplines. A lack of basic knowledge or ignorance of principles of electrosurgery and equipment among obstetricians and gynecologists is reported. As a result, thermal injuries during laparoscopic electrosurgery occur, which frequently lead to significant morbidity and mortality and medicolegal actions. Surveys indicate that up to 90% of general surgeons and gynecologists use monopolar radiofrequency (RF) during laparoscopy, 18% have experienced visceral burns, and 13% admitted 1 or more ongoing cases of litigations associated with such burns.

 

This article describes the basics of electrosurgery beginning with the generation of electrons and their physical characteristics and governing laws before their arrival in the operating room where they are fed to an electrosurgical unit (ESU) to boost their frequency with step-up transformers from 60 Hz to .500 000 Hz. This RF creates heat, resulting in dissection, desiccation, coagulation, and fulguration of tissues without neuromuscular stimulation, pain, or burn to the patient. The ESU delivers power (wattage 5 volts ! amps) in monopolar or bipolar (1 vs 2 high-density electrodes) configuration. Because of RF, monopolar electrosurgery compared with other energy sources is associated with unique characteristics, inherent risks, and complications caused by the requirement of a return/dispersive electrode, inadvertent direct and/or capacitive coupling, or insulation failure of instruments. These dangers become particularly important with the popular and frequent use of monopolar electrodes (hook, needle, and scissors) during cholecystectomy; robot-assisted surgeries; and the re-emergence of single-port laparoscopy, which requires close proximity and crossing of multiple intraabdominal instruments outside the surgeon’s field of view. Presently, we identify all these potential risks and complications associated with the use of electrosurgery and provide suggestions and solutions to mitigate/minimize these risks based on good clinical practice and sound biophysical principles.

 

Journal of Minimally Invasive Gynecology (2013) 20, 279–287 ! 2013 AAGL. All rights reserved.

From the Department of Obstetrics and Gynecology, Division of Reproductive Endocrinology and Infertility, Western University, London, Ontario, Canada

George A. Vilos, MD*, and Chandrew Rajakumar, MD

6) Comparison of monopolar and bipolar electrosurgical modes for restorative dentistry: A review of the literature

Link to the original journal.

This review of the literature was undertaken as part of a wider investigation of effective hemostasis in vital pulp therapy. Two general types of electrosurgical units are available: monopolar and bipolar.

 

This review compares the features of both systems. An important hazard referred to as channeling, funneling, or current crowding is described and associated with pulp therapy injury for the first time. Important safety features of bipolar electrocoagulation are identified and applied to dental procedures. Articles were selected by means of a search of MEDLINE, the U.S. National Library of Medicine’s bibliographic database, for literature published between 1966 and 2001 on the topics of electrosurgery, electrocautery, electrolysis, and lasers.

 

A search also was completed from a pulp therapy perspective to determine the use of electrosurgery on the pulp. Numerous articles and texts published between 1900 and 1965 had been reviewed previously; their bibliographies were explored and cross-referenced for pertinent reports. Laparoscopic applications of electrosurgery were reviewed for general background information and for clarification of safety and hazard issues; no exclusionary criteria or date limitations were imposed.

 

Beyond the literature review, numerous authors and developers in the field of electrosurgery were contacted for clarification of concepts and controversies. More than 120 articles and texts related to electrosurgery were reviewed, and another 100+ articles were reviewed in the area of pulp therapy. (J Prosthet Dent 2001;86:390-9.)

Dental School, Baltimore College of Dental Surgery, University of Maryland, Baltimore, Md. , Gus J. Livaditis, DDS

8) Cost Savings 

Link to reference

Reference "A"

10) Burns related to electrosurgery - Report of two cases

Flora Margarida Barra Bisinotto

"There was an increase in the number of injuries and related complications, such as interference with monitoring devices,4 pacemakers and other cardiac devices, pulse oximeter probes,5 temperature sensors, deep brain stimulation electrodes,6 and, above all, burns. Moreover, other phenomena may be associated, such as stimulation of excitable tissues, leg movement during urological surgery by stimulation of the obturator nerve or direct stimulation of the muscles, causing muscle contractions that can be misinterpreted as inadequate anesthesia, in addition to the potential risk of combustion due to the presence of anesthetic gases.7,8"

Link to the original journal.

Introduction

Electricity is a phenomenon that has been used for many years in operating rooms and its current use during surgery is an intrinsic characteristic of modern surgery. Historically, its use in medicine dates back to the 1920s, when Bovie developed an extremely modern instrument for the time, helped to bring it to the forefront of surgical procedures and revolutionized surgery.1-3 In practical terms, electricity can be used in surgery by means of electrosurgery, also called diathermy, or electrocautery. In the latter, the oldest, the electric current is used to heat filament at the cautery tip, returns by the same route, bypasses the patient. The heat is transmitted directly to tissues in order to obtain therapeutic effects.1-3 In electrosurgery, the most widely used method currently, the electrical current is produced by a generator and reaches the patient's body by an active electrode, acts in target tissues, and exits through a neutral electrode. When this electrical current meets the human tissue resistance, it turns into heat and determines the therapeutic effects, known as cutting or coagulation. The active electrode tip does not undergo heating. When the neutral electrode (pad format) is away from the active electrode, there is the monopolar system. When the positive and neutral electrodes are separated by a small distance and limit the flow of electric current, there is the bipolar system.1-3 However, even with long experience in the use of electrosurgery, the risks and complications are still present despite the incorporation of various security measures. There was an increase in the number of injuries and related complications, such as interference with monitoring devices,4 pacemakers and other cardiac devices, pulse oximeter probes,5 temperature sensors, deep brain stimulation electrodes,6 and, above all, burns. Moreover, other phenomena may be associated, such as stimulation of excitable tissues, leg movement during urological surgery by stimulation of the obturator nerve or direct stimulation of the muscles, causing muscle contractions that can be misinterpreted as inadequate anesthesia, in addition to the potential risk of combustion due to the presence of anesthetic gases.7,8 Despite all the advances in electrosurgery, even with its inherent risks, most surgeons and residents have no formal training for its proper use. The aim of this study is to present two cases of burns related to the use of electrosurgery and use them to promote discussion. Noteworthy, these complications are predictable and preventable; nevertheless, they still haunt the operating rooms.

9) Surgeon Survey

Reference "B"

Link to reference

11) Do we need to establish guidelines for patients with neuromodulation implantable devices, including spinal cord stimulators undergoing nonspinal surgeries?

Author information Article notes Copyright and License information Disclaimer

"Shortwave, microwave, and therapeutic ultrasound diathermy should not be used in patients with implanted SCSs. The energy generated by the diathermy can be transferred through the stimulator system with subsequent severe tissue damage and even death ensuing.[26] Whether the SCS is turned on or off, still a high risk for damage exists.[13,36,40] Instead of the mentioned methods of assuring hemostasis, we recommend that bipolar electrocautery can be used or heat electrocautery with the latter converting electrical energy into thermal energy that heats the metal tip of the device; the heated metal tip produces hemostasis when in contact with the tissue.[17,36]"

Link to the original journal.

Abstract


Background:


Spinal cord stimulation is currently approved to treat chronic intractable pain of the trunk and limbs. However, such implantable electronic devices are vulnerable to external electrical currents and magnetic fields. Within the hospitals and modern operating rooms (ORs), there is an abundance of electrical devices and other types of equipment that could interfere with such devices. Despite the increasing number of patients with neuromodulation implantable devices, there are no written guidelines available or consensus of cautions for such patients undergoing unrelated surgery.

12) Intraoperative pacemaker dysfunction caused by the use of electrocautery during a total hip arthroplasty

Ohannes A.Nercessian,MD HowardWu,MD DavidNazarian,MD FaiqMahmud,MD

"Pacemaker dysfunction encountered during orthopedic procedures is a rare but potentially life-threatening complication. With an increasing number of orthopedic procedures performed on the aging population, it is not uncommon to encounter patients with pacemakers requiring major orthopedic intervention. Most, if not all, major orthopedic procedures performed today require the use of electrocautery for hemostasis. In this article we review the literature for pacemaker complications and report a case of pacemaker failure after a single use of the unipolar electrocautery on a patient undergoing a total hip replacement."

Link to the original journal.

Abstract


Pacemaker dysfunction encountered during orthopedic procedures is a rare but potentially life-threatening complication. With an increasing number of orthopedic procedures performed on the aging population, it is not uncommon to encounter patients with pacemakers requiring major orthopedic intervention. Most, if not all, major orthopedic procedures performed today require the use of electrocautery for hemostasis. In this article we review the literature for pacemaker complications and report a case of pacemaker failure after a single use of the unipolar electrocautery on a patient undergoing a total hip replacement.

Copyright © 1998 Published by Elsevier Inc.

13) The Effect of Operating Time on Surgeons' Muscular Fatigue

Author information Article notes Copyright and License information Disclaimer

A study was completed to determine if operating has an effect on a surgeon's muscular fatigue.

Link to the original journal.

Abstract

 

Results

The percentage changes in mean frequency of muscular contractions were examined; there was no significant difference in fatigue levels between consultants and registrars. Operating led to an increase in fatigue in all subjects, compared to no increase in controls performing desk work. It was also found that the brachioradialis muscle is used more than the mid-deltoid muscle and, hence, fatigues at a faster rate.


Conclusions:


Surgeons should be aware that their muscular fatigue levels will increase as an operation progresses; therefore, if possible, more complex parts of the operation should be performed as early as possible, or, in the case of a very long operation, a change in surgeon may be necessary.

Surgical decision making is the most important factor determining operative success. However, once a decision has been made, the performance of the surgeon comes into play. Similar to any job or task, it is believed that mental and muscular fatigue is developed during a day of operating. It is likely that an increase in arm fatigue causes an increase in hand tremor. This leads to a reduction in the surgeon's fine motor control and, hence, a reduced precision of the surgeon's hand movement. Muscular fatigue manifests itself during and after prolonged voluntary muscular contractions, the level of which can lead to higher or lower endurance times.2 It has been described in some respects as the point at which a specific muscle can no longer sustain a contraction. This can be misleading in practice, as this defines fatigue as a specific point, whereas fatigue is, in fact, a development stage.

 

14) Hanging Foot Switch for Bipolar Forceps: A Device for Surgeons Operating in the Standing Position 

Satoru shimizu, et al, Neurologia medico-chirurgica. 53: (2013) 

Link to the original journal.

Abstract

 

For surgeons operating in the standing position, the manipulation of foot switches involves shifting of the weight to the pivoting leg and the possible loss of contact between the switch and the foot. We solved this problem by changing the position of the switch that operates bipolar forceps. Our novel device is made of aluminum plates. The base plate features a foot strap and a height-adjustable overhang over the switch-operating foot. A commercially-available disc type foot switch is attached to the underside of the overhang in upside-down position, so the switch is operable by the toe. To turn on the switch, the toe is flexed dorsally to push the switch pedal, so the action is limited to the part distal to the metatarsophalangeal joints.  Our switch was used in more than 100 consecutive microsurgeries performed by surgeons operating in the standing position. The switch manipulation required no shifting of the weight and was easier and quicker than the manipulation of conventionally-placed switches.  The surgeons were able to change the foot position freely with the modified switch, thereby avoiding loss of contact with the switch. The modified placement reduced physical fatigue in the lower extremities, annoyance related to the manipulation of conventionally-placed switches, and increased the comfort of surgeon operating in the standing position.

15) Improvement of foot pedals used during surgery based on new
ergonomic guidelines

M.A. van Veelen, C.J. Snijders, E. van Leeuwen, R.H.M. Goossens, G. Kazemier

A study was completed to determine if operating has an effect on a surgeon's muscular fatigue.

Link to the original journal.

Abstract

 

Background: This study aims to create new ergonomic guidelines for the design of foot pedals used during surgery.

Methods: Observations in the operating room, a questionnaire among 45 laparoscopic surgeons/residents, an ergonomic literature study, and clog measurements were used to assess the problems occurring during use and to compile new guidelines for foot pedals. Based on these

guidelines a new foot pedal was designed and a protoype was manufactured.

Results: During the surgical procedure 91% of the subjects occasionally loses contact with the foot pedal, which 56% experience as very annoying. All subjects think that the current foot pedals obstruct their freedom of movement; 75% occasionally hit the wrong switch and 53% experience physical discomfort in their legs and/or feet. Therefore, 93% of the subjects would like to

control the diathermy in a different way. The new prototype of a foot pedal was evaluated in a pilot test and proved to be ergonomically better than the currently used foot pedals.


Conclusion: The new guidelines for foot pedals result in an ergonomic improvement in their design.

16) Sources of pain in laparoendoscopic gynecopolgical surgeons: An analysis of ergonomic factors and proposal of an aid to improve comfort.

Sunah Shim, Taeri Yu, Kyunga Jeong, Hye Won Chung

Link to the original journal.

Abstract

 

Minimally Invasive Surgery (MIS) offers cosmetic benefits to patients; however, surgeons often experience pain during MIS. We administered ergonomic questionnaire to 176 Korean laparoscopic gynecological surgeons to determine potential sources of pain during surgery. Logistic regression analysis was used to identify factors that had a significant impact on gynecological surgeons' pain. Operating table height at the beginning of surgery and during the operation were significantly associated with neck and shoulder discomfort (P<0.001). The ability to control the operating table height was the single factor most significantly associated with neck (P<0.001) and shoulder discomfort (P<0.001). Discomfort of the hand/digits was significantly associated with the trocar site (P=0.035)). The type of electrocautery activation switch and foot pedal were significantly related to surgeons' foot and leg discomfort (P<0.001).  In evaluation the co-occurrence of pain in 4 different site (neck, shoulder, back, hand/digits), the neck and shoulder were determined to have the highest co-occurrence of pain (Spearman's p=0.64, P<0.001). These results provide guidance for identifying ergonomic solutions to reduce gynecological laparoscopic surgeons' pain. Based on our results, we propose the use of an ergonomic surgical step stool to reduce physical pain related to performing laparoscopic operations.

15) FUSE: A Surgeon's Guide to Understanding Energy Devices

Pascal Fuchshuber

Link to the original article.

The fact is that the vast majority of surgical and endoscopic energy devices in use today, including the original and modern versions of the device invented by W.T. Bovie, are far from being cautery devices. Today, very few devices, such as the battery-powered cautery device for hemostasis used in minor surgical office procedures and a few new energy devices coming on the market recently, are based on cautery.

For millennia, medical devices that apply energy to tissue were known throughout the world. Cautery, which is the direct application of heat to tissue, best described by the application of a hot branding iron to the hide of a calf, was the first medical energy device and was used to destroy tumors and achieve hemostasis as early as 3,000 B.C.

Cautery remained the only surgical energy device until the beginning of the 20th century when Dr. Bovie (and others) developed a surgical device in which a high-frequency alternating current was used to create tissue effects.

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