This is a discussion on Recommended practices for electrosurgery.(Recommended Practices) within the Medical Articles and Abstracts forum; Journal: AORN 3/1/2005 The following recommended practices were developed by the AORN Recommended Practices Committee ...
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Recommended practices for electrosurgery.(Recommended Practices)
Journal:
AORN 3/1/2005 The following recommended practices were developed by the AORN Recommended Practices Committee and have been approved by the AORN Board of Directors. They were presented as proposed recommended practices for comment to members and others. These recommended practices are effective Jan 1, 2005. These recommended practices are intended as achievable recommendations representing what is believed to be an optimal level of practice. Policies and procedures will reflect variations in practice settings and/or clinical situations that determine the degree to which the recommended practices can be implemented. AORN recognizes the various settings in which perioperative nurses practice. These recommended practices are intended as guidelines adaptable to various practice settings. These practice settings include traditional ORs, ambulatory surgery units, physician's offices, cardiac catheterization laboratories, endoscopy suites, radiology departments, and all other areas where surgery may be performed. PURPOSE: These recommended practices provide guidance to perioperative nurses in the use and care of electrosurgical equipment. Proper care and handling of electrosurgical equipment is essential to patient and personnel safety. Electrosurgery is used routinely to cut, coagulate, dissect, fulgurate, ablate, and shrink body tissue with high frequency (ie, radio frequency) electrical current. Ultrasonic dissectors dissect tissue by vibration. Vessel sealing devices use a combination of pressure and heat to permanently occlude vessels. These recommended practices address all of these technologies and do not endorse any specific product. RECOMMENDED PRACTICE I Personnel selecting the electrosurgical unit (ESU) and accessories for purchase or use should make decisions based on safety features to minimize risks to patients and personnel. 1. Equipment selected should include technology to detect stray current that could result in patient injury and to alert the user of this condition. Electrosurgical units are high-risk equipment. Historically, the most frequently reported patient injury has been a skin injury (eg, burn) at the dispersive electrode site. (1) The risk of this type of injury has been minimized through advances in dispersive pad design (eg, nondrying conductive material, dual-contact dispersive electrodes) and the use of return electrode contact quality monitoring. (2) Minimum safety standards for ESU systems have been developed by the Association for the Advancement of Medical Instrumentation and approved by the American National Standards Institute. (3) 2. Equipment should be designed to minimize the risk of alternate site injuries. These injuries can result from use of ground-referenced (ie, spark-gap) ESUs that allow electrical current to seek alternate pathways to complete the circuit) (3,4) The use of isolated (ie, solid-state) ESUs has minimized this risk. 3. Equipment should be designed to minimize the risk of capacitive coupling injuries. During minimally invasive procedures, alternate site injuries have resulted from insulation failure and capacitive coupling. (4,5-11) These injuries are very serious and have increased in number with the increased use of laparoscopic surgery. (12) The use of active electrode monitoring has minimized these risks. (13-17) 4. Equipment should be designed to minimize unintentional activation that could result in patient and personnel injury. Audible activation tones minimize this risk. (3,18,19) 5. Electrosurgical accessories selected should be compatible with the equipment and other accessories. Injuries have resulted when equipment intended for bipolar use is inserted into monopolar connectors and, subsequently, inadvertently activated. (20) Appropriate matching and use of accessories minimizes this risk. 6. Electrosurgical technology continues to evolve, changing the way in which surgical hemostasis is achieved. It is the responsibility of each facility to stay abreast of evolving technology and its impact on patient care and safety. RECOMMENDED PRACTICE II Personnel should demonstrate competence in the use of the ESU and accessories. 1. Personnel working with electrosurgery equipment should be knowledgeable about the principles of electrosurgery, risks to patients and personnel, measures to minimize these risks, and corrective actions to employ in the event of a fire or injury. Electrosurgical equipment and accessories have been associated with numerous fires and patient injuries?, (1,11,21,22) The National Fire Protection Association has identified ESUs as high-risk equipment, warranting training and retraining of personnel. (23) Personnel should be instructed in the proper operation, care, and handling of the ESU and accessories before use. (23) Initial education on the underlying principles of electrosurgical safety provides direction for personnel in providing a safe environment. Additional, periodic educational programs provide reinforcement of principles of electrosurgery and new information on changes in technology, its application, compatibility of equipment and accessories, and potential hazards. 2. Administrative personnel should assess and document annual competency of personnel in the safe use of the ESU and accessories according to hospital and department policy. Incorrect use can result in serious injury to patients and personnel. A regular competency assessment provides a record that personnel have a basic understanding of electrosurgery, its risks, and appropriate corrective action to take in the event of a fire or injury. This knowledge is essential to minimize the risks of misuse of the equipment and providing a safe environment of care. RECOMMENDED PRACTICE III The ESU and accessories should be used according to manufacturers' written instructions. 1. Instructions for ESU use, warranties, and a manual for maintenance and inspections should be obtained from the manufacturer and be readily available to users. (23) Equipment manuals assist in developing operational, safety, and maintenance guidelines, as well as serve as a reference for appropriate use. (23) 2. Each type of ESU has specific manufacturer's written operating instructions to be followed for safe operation of the unit. A brief set of clearly readable operating instructions should be readily accessible with each system. (24) These instructions should be placed on or attached to each ESU for reference. 3. Accessories should be used, handled, cleaned, and processed according to manufacturers' instructions. RECOMMENDED PRACTICE IV The ESU system should be used in a manner that minimizes the potential for injuries. 1. The ESU should be securely mounted on a shelf or tip-resistant cart. The ESU electrical cord should be adequate in length and flexibility to reach the electrical outlet without stress or the use of an extension cord. (25) Applying tension on the electrical cord increases the risk that it will become disconnected, frayed, or move the equipment, which may result in injuries to patients and personnel. 2. The ESU should be tested before initial use, inspected periodically, and receive preventive maintenance by a designated individual responsible for equipment maintenance (eg, bioengineering services personnel). (26) Personnel should visually inspect the ESU and test the return electrode contact monitor before each use (eg, attempt to use the device with the dispersive electrode not connected). (25,27,28) The manufacturer's written precautions should be followed for the safety of the patient and personnel involved in the procedure. 3. An ESU that is not working properly or is damaged should be removed from service immediately and reported to the designated individual responsible for equipment maintenance (eg, bioengineering services personnel). Each ESU should be assigned an identification or serial number. This number allows designated personnel to track function problems and document maintenance performed on individual ESUs. (29) 4. Safety/warning alarms should be operational at all times. Lights should be operational and visible. Audible activation indicator(s) and alarms should be present and loud enough to be heard above other sounds in the OR. The volume of the activation indicator should be maintained at an audible level to immediately alert personnel when the ESU is activated inadvertently. (3,18,19) 5. The ESU should be protected from spills. Fluids should not be placed on top of the ESU. Fluids entering the ESU can cause unintentional activation or device failure. Liquids seeping into the ESU pose an electrical hazard. Personnel should encase the ESU foot pedal in a clean, impervious cover when there is a potential for fluid spills. 6. The operator should confirm the power settings before activation. Settings should be based upon the manufacturer's written instructions and the intended application. The ESU should be operated at the lowest effective power setting to achieve the desired effect. If the operator requests a continual increase in power, personnel should check the entire ESU and accessories circuit, beginning with checking the dispersive electrode. If a single-use electrode is used, it should be replaced, not repositioned. (30) Prolonged current at high power can cause patient injury. The most common cause for ineffective coagulation and cutting is high impedance at the dispersive electrode. (30) Replacing the dispersive electrode provides an opportunity to examine the electrode and the patient's skin condition. 7. After use, personnel should turn off the ESU, clean all reusable parts, and inspect these parts according to the manufacturer's written instructions. RECOMMENDED PRACTICE V The electrical cords and plugs of the ESU should be handled in a manner that minimizes the potential for damage and subsequent patient injuries. 1. The ESU should be placed near the sterile field, and the cord should reach the wall or column outlet without stress on the cord and without blocking a traffic path. (25) Stress on the cord may cause damage to the cord, posing an electrical hazard. The cord should be free of kinks, knots, and bends that could damage the cord or cause leakage, current accumulation, and overheating of the cord's insulation. 2. The ESU plug, not the cord, should be held when it is removed from the outlet. Pulling on the cord may cause cord breakage, which poses a fire hazard. 3. The ESU and cord should be kept away from fluids. Fluids dripping into the ESU or connections cause an electrical hazard. RECOMMENDED PRACTICE VI The active electrode should be used in a manner that minimizes the potential for injuries. 1. The active electrode should be connected directly into a designated receptacle on the ESU. If an adapter is used, it should be approved by the manufacturers of both the ESU and the accessory and not compromise the ESU's safety features. Incomplete circuitry, unintentional activation, and incompatibility of the active electrode to the ESU may result in patient and personnel injuries. (19, 20) 2. The active electrode should be visually inspected at the surgical field, before use, to identify any apparent damage to the cord or hand piece (eg, impaired insulation). (25) Insulation failure allows an alternate pathway for current to leave the electrode. Additional information about use of electrosurgery for endoscopic procedures can be found in the AORN "Recommended practices for endoscopic minimally invasive surgery." (31) 3. If securing the active electrode cord to the drapes, plastic or another nonconductive material should be used. The cord should not be coiled. This minimizes the risk of patient or staff member injury from conduction of stray current. 4. Active electrodes should not be used in the presence of flammable agents, including vapors (eg, antimicrobial skin prep or hand antisepsis agents, tinctures, defatting agents, collodian, petroleum-based lubricants, phenol, aerosol adhesives, uncured methyl methacrylate). (29,32) Opened suture packages containing alcohol should be removed from the sterile field as soon as possible. (19,32) Ignition of flammable substances by active electrodes has caused fires and patient injuries. (19,32,39) Alcohol-based skin prep agents are particularly hazardous because the surrounding hair or fabric can become saturated. Pooling can occur in body folds and crevices (eg, umbilicus, sternal notch). Vapors can become trapped under an incise drape or surgical drapes. This has led to fires and patient injuries. (37,39) Using nonflammable prep agents eliminates this risk. (19,32,34,38) 5. The active electrode should be placed in a clean, dry, well-insulated safety holster when not in use to minimize the risk of injury from unintentional activation. Injuries have resulted when the active electrode has been left lying on the patient between uses. (18) Electrodes that do not fit in the holster should be placed in a designated location with tips away from flammable material (eg, drapes). When battery-powered, hand-held cautery is used, the protective cap should be reapplied when the cautery is not in use, thus preventing inadvertent pressure on the activation button. (40) 6. The active electrode tips should be securely seated into the handpiece. A loose tip may cause a spark or burn to tissue contacting the exposed, noninsulated section of the tip. (41) Tips should be used according to the manufacturer's instructions and not be altered (eg, bent) unless specified by the manufacturer. If insulation is desired, it should be acquired from a medical device manufacturer. Fires and patient injuries have resulted when insulating sheaths have been made from inappropriate material (eg, rubber catheters). (42,43) 7. The active electrode tip should be cleaned frequently, away from the incision, to remove eschar. Eschar buildup on the active electrode tip impedes the desired current flow, causing the entire unit to function less effectively and serving as a fuel source, which can lead to fires. (42) Debris on the electrode tip can tear tissue and cause rebleeding. (1) Abrasive electrode cleaning pads are commercially available for noncoated electrodes. Electrosurgical tips also are available with a special coating that minimizes eschar buildup. 8. Sponges used close to the active electrode tip should be moist to prevent unintentional ignition. Active electrodes should not be cleaned with a dry sponge. Fires have resulted from ignition of dry sponges near the incision site and when they are used to clean the active electrode. (34,44,46) 9. The active electrode should not be used in the presence of intestinal gases. These gases contain hydrogen and methane, which are highly flammable. Fires and patient injuries have occurred. (47-51) 10. The active electrode should not be used in an oxygen-enriched environment. (22,52) Caution should be exercised during surgery on the head and neck near combustible anesthetic gases. The active electrode should be used as far from the oxygen source as possible. The lowest practical level of oxygen should be administered to the patient. When administering oxygen in an open system (eg, nasal prongs), drapes should be tented or a scavenging system used to prevent buildup of oxygen under the drapes. Fires, including airway fires, have resulted from the active electrode sparking in the presence of concentrated oxygen. (22,52-58) 11. If the active electrode is being used in a fluid-filled cavity, the fluid used should be an electrically inert, near isotonic solution (eg, dextran 10, dextran 70, Glycine 1.5%, sorbitol, mannitol) unless the manufacturer of the equipment instructs otherwise. (1,59-63) Using an electrolyte solution instead of a nonconductive medium may render the active electrode less effective. Subsequent increases in the power setting have resulted in burns at the dispersive (ie, return) electrode site. (1,64) 12. If the active electrode becomes contaminated, it should be disconnected from the ESU. This minimizes the risk of unintentional activation and reduces the potential for patient and personnel injuries. 13. When battery-powered, hand-held cautery units are used, the batteries should be removed before disposal of the cautery unit. Inadvertent activation after disposal has caused fires. (40,65) Batteries are hazardous waste. 14. Personnel should be prepared to immediately extinguish flames should they occur. Saline or water should be available on the sterile field. A carbon dioxide (C[O.sub.2]) fire extinguisher should be readily available. (19,66) This type of fire extinguisher can extinguish fires involving cloth and paper, and it is safe to use in the presence of electrical current. Fire blankets should not be used in the OR. (19) Using a fire blanket on a patient traps the fire around the patient. Fire blankets should be used only on conscious fire victims who can roll and pinpoint the location of the fire under the blanket so responders can extinguish the fire by vigorously patting the blanket at the identified site. If a fire blanket is present in the OR, staff members may assume it is safe for patient use, thereby placing the patient at further risk. Fire blankets will burn if used in oxygen-enriched atmospheres. RECOMMENDED PRACTICE VII When monopolar electrosurgery is used, a dispersive electrode should be used in a manner that minimizes the potential for injuries. 1. The patient's skin condition should be assessed and documented before and after ESU use. The most frequently reported patient injury from electrosurgery has been tissue damage (eg, burn) at the dispersive electrode site. (25) With advances in technology in return electrode monitors and increased use of laparoscopy, this may be changing to other types of injuries (eg, direct coupling, capacitive coupling); however, burns at the site of the dispersive electrode continue to occur. Preoperative and postoperative assessments allow evaluation of the patient's skin condition for possible injuries. 2. Dispersive electrodes should be compatible with the ESU. 3. Single-use dispersive electrodes should be used according to the manufacturer's written instructions for safe operation; in addition to instructions on the electrode package, additional instructions may be located in the box of electrode packages. * Electrodes should be an appropriate size for the patient (eg, neonate, infant, pediatric, adult) and not altered (eg, cut, folded). Using the appropriately sized dispersive electrode is important for preventing patient injuries. Using a large dispersive electrode prevents concentration of current and minimizes the potential for electrosurgical injuries. (28,30) * Personnel should verify that the electrode is intact; conductive gel, if present, is moist; and the manufacturer's expiration date has not been reached. (28,30) * The conductive and adhesive surfaces of the electrode should be placed on clean, dry skin, over a large, well-perfused muscle mass on the surgical side, and close to the surgical site. Muscle is a better conductor of electricity than adipose tissue. (28,30) * Electrodes should not be placed over bony prominences, scar tissue, hairy surfaces, or areas distal to tourniquets and pressure points. (28,30) Fatty tissues, tissue over bone, scar tissue, and hair can impede electrosurgical return current flow. High impedance leads to heating of the tissue, arcing to the tissue under the dispersive electrode, and subsequent burns. (67) Burns have resulted when electrodes have been positioned over hairy surfaces. (68) Hair removal may be necessary. Adequate tissue perfusion cannot be assured if the dispersive electrode is placed distal to tourniquets or over scar tissue. * The electrode should not be placed over an implanted metal prosthesis. (1) The tissue over prostheses contains scar tissue, which impedes return of the electric current. Although there has been no reported injury from superheating of the implant causing a tissue burn, this is a theoretical risk; therefore, it is prudent to avoid placing a dispersive electrode on the patient's skin over the site of a metal implant or prosthesis. * Avoid placing the dispersive electrode over a tattoo, many of which contain metallic dyes. Although there have been no reported electrosurgery injuries from dispersive electrodes placed over tattoos, superheating of the tissue has occurred during magnetic resonance imaging; (69,70) therefore, it is prudent to avoid this site when possible. * The single-use dispersive electrode should maintain uniform body contact. Potential problems include tenting, gaping, and moisture, all of which interfere with adhesion to the patient's skin. Injuries have been associated with inadequate adhesion of the dispersive electrode, (71-73) * The single-use dispersive electrode should be placed on the patient after final positioning for the surgical procedure to prevent buckling of the electrode and to maintain good skin contact with the electrode. If any tension is applied to the dispersive electrode cord or if the surgical team repositions the patient, personnel should reassess the integrity of the dispersive electrode, its contact with the patient's skin, and its connection to the ESU. If the patient is repositioned, personnel should verify that the dispersive electrode remains in full contact with the patient's skin to avoid burns resulting from inadequate contact with the dispersive electrode. * The dispersive electrode should be removed carefully. Skin injuries can result when the adhesive border pulls on the skin during electrode removal. (74) Holding the adjacent skin in place and peeling the dispersive electrode back slowly will avoid denuding the surface of the skin. 4. Large, reusable, capacitive-coupled return electrode systems should be used according to manufacturers' written instructions for safe operation in conjunction with a compatible ESU. * These electrodes are inappropriate for patients under 25 lbs. A patient injury has been reported when the electrode was used on a smaller patient. (75) * When using a reusable, capacitive-coupled return electrode, personnel should ensure adequate contact (ie, weight-bearing area) with the patient and use minimal materials between the pad and patient. Thick foam, gel pads, and extra linen increase the distance between the patient and electrode and should not be used. Some complex patient positioning also decreases contact between the skin and the electrode. Distance and barriers between the patient and electrode increase impedance, which can result in an alternate site injury. (26) * Personnel should verify that no small metal material (eg, snaps on gowns) is in contact with the patient's skin. Current can concentrate at the site of metal contact. Snaps on patient gowns have resulted in patient injuries when the capacitive-coupled return electrode was used. (77) 5. Dispersive electrodes should be kept dry and protected from seeping or pooling of fluids under the dispersive electrode. (30) Liquids may prevent the electrode from adequately contacting the skin. These solutions also can cause skin injury from prolonged skin exposure. 6. There should be no contact between the patient and metal devices that could offer potential alternate return paths for the electrical current (eg, OR beds, stirrups, positioning devices, safety strap buckles). Patient monitoring electrodes (eg, electrocardiogram, oximetry, fetal) should be placed as far away from the surgical site as possible. Alternate pathway bums have been reported at electrocardiogram (ECG) electrode sites and temperature probe entry sites with ground-referenced electrosurgery units. (4) 7. The patient's metal jewelry should be removed if it is within the activation range of the active electrode. Metallic jewelry, including that used in body piercing, presents a potential risk of burn from directed current (ie, active electrode touching it), heat conducted before an electrode cools, and leakage current. Eliminating metal near the activation site minimizes this risk. Although there may be other reasons for removal of all patient jewelry (eg, risk of swelling, theft), the risk of an alternative site injury from stray current is negligible. (78) When using a reusable, capacitive-coupled return electrode, all of the patient's metal jewelry should be removed. Small metal objects touching the return electrode can concentrate current and result in patient injury. (77) Eliminating contact with metal minimizes this risk. 8. If multiple ESUs are used simultaneously during a surgical procedure, the applicable instructions from the manufacturer should be followed. Compatibility of equipment and proper functioning of corresponding electrode monitoring systems should be verified with the manufacturer. Separate dispersive electrodes should be used for each ESU. Personnel should place the dispersive electrodes as close as possible to their respective surgical sites and ensure that single-use dispersive electrodes do not overlap. 9. Two dispersive electrodes should be used in unique situations when high impedance is reasonably anticipated (eg, very obese patients) or during prolonged application of current at high power settings (eg, ablation). (30,64) Users should refer to the manufacturer's recommendations for these applications. RECOMMENDED PRACTICE VIII Personnel should take special precautions when using the ESU during endoscopic procedures. 1. Personnel should understand the risks of electrosurgery during endoscopic procedures. Electrosurgical injuries are caused by direct coupling of current, insulation failure, and capacitive coupling. Direct coupling is caused by the surgeon touching the laparoscopic active electrode to another anatomic structure. This can cause necrosis of underlying tissue. Insulation failure of the laparoscopic electrode can be caused by trauma during use or reprocessing. Current leaves the electrode through this alternate pathway This can cause serious patient injury, particularly when the injury is internal. Capacitively coupled radio frequency currents can cause undetected burns to nearby tissue and organs outside the endoscope's viewing field. Severe patient injuries have resulted. (7,9,11,79) 2. Endoscopic trocar cannula systems should meet safety criteria established for the practice setting. When an all-metal system is used, capacitive current is safely dispersed through the greater surface area provided by the chest or abdominal wall, thereby reducing current concentration. Metal cannula systems are best for the port of electrosurgical instruments. (6,11,79,80) An all-plastic system is another alternative. Using this system, the capacitor is the patient, which minimizes the concern of concentrated capacitively coupled current; (81) however, a risk of direct coupling injuries remains. Hybrid trocar (ie, combination plastic and metal) systems should not be used. (1,5,11,80) Each trocar and cannula can act as an electrical conductor, thereby inducing an electrical current from one to the other, which could cause capacitive coupling injuries. 3. Personnel should verify that the insufflation gas is nonflammable (ie, carbon dioxide). An intraabdominal fire has occurred when a carbon dioxide-oxygen mixture was attached inadvertently to an insufflator rather than the intended carbon dioxide tank. (82) 4. All electrodes should be examined for impaired insulation before use. Insulation failure of electrodes caused by trauma during use or reprocessing provides an alternate pathway for the electrical current to leave the active electrode. Some insulation failures are not visible. This has resulted in serious patient injuries. (4,6,11,13-15,17,79,80) These injuries may be outside the endoscope's visual field. Use of active electrode shielding and monitoring minimizes the risks of insulation failure and capacitive coupling injuries. (4,6,11,13-15,17,79,80) 5. When active electrode monitoring is not used, additional precautions should be employed to minimize the risks associated with insulation failure and direct and capacitive coupling. * The lowest power setting that achieves the desired result should be selected, and * the low-voltage cutting waveform setting should be selected whenever clinically feasible. Lower power settings for both cut and coagulation reduce the likelihood of insulation failure and capacitive-coupling injuries. Lower power settings also minimize damage from direct coupling when the active electrode is activated while in close proximity to another metal device inserted in an adjacent trocar port. (6) 6. The active electrode should not be activated until it is in close proximity to the tissue; this minimizes the risk of contacting unintended tissue. (6,11) Activating the electrode when it is not in very close proximity to the targeted tissue increases the risk of capacitive coupling. Capacitance is reduced during closed-circuit activation. 7. Patients should be taught to immediately report any signs or symptoms of infection, excessive pain, bleeding, or inability to void. Symptoms of a laparoscopic electrosurgical injury can occur days after discharge from the perioperative setting and may include infection from an injured intestinal tract. Lower gastrointestinal bleeding and inability to void may be early manifestations of a bowel injury. (11) Patients should understand what symptoms to look for and report to ensure prompt treatment that minimizes the adverse outcome. (79) RECOMMENDED PRACTICE IX Personnel should take special precautions when using the ESU with patients who have pacemakers, internal cardioverter-defibrillators (ICDs), or other electrical implants. 1. Patients with pacemakers should be continuously monitored (ie, minimally, ECG, peripheral pulse) during electrosurgery use. Electrosurgery can interfere with both the pacemaker's circuitry and function and create ECG artifact. (1,83) Monitoring the peripheral pulse provides a mechanism to evaluate peripheral perfusion in the presence of ECG artifact. Although modern pacemakers are designed to be shielded from radio frequency current, they are subject to interference during electrosurgery use. (1,83,84) For patients with pacemakers, personnel should take additional precautions, which include, but are not limited to, * checking with the pacemaker manufacturer or the patient's cardiologist regarding its function during use of electrosurgery and discussing reprogramming the pacemaker to an asynchronous mode during surgery; * having a pacemaker programmer unit (or magnet if appropriate for the type of pacemaker) available to place the pacemaker in an asynchronous mode; * having a defibrillator immediately available for emergencies during surgery; * keeping all electrosurgical cords and cables away from the pacemaker and its leads; * using bipolar electrosurgery whenever possible; * using the lowest possible power setting on the electrosurgical generator; * if monopolar electrosurgery is deemed necessary, ensuring that the distance between the active and dispersive electrodes is as short as possible (place both electrodes as far away from the pacemaker as possible, and ensure that the current path does not pass through the vicinity of the patient's heart or the implanted pacemaker device); (1,83) and * having the proper functioning of the pacemaker evaluated by an individual trained in the use of the pacemaker programmer immediately postoperatively. The patient's pacemaker may interpret radio frequency from electrosurgery as cardiac activity and inhibit the pacemaker from initiating a heartbeat. This can result in life-threatening arrhythmia. Reprogramming demand pacemakers to an asynchronous mode protects the patient from this risk. A magnet placed over the pacemaker is effective in temporarily placing some models of pacemaker in asynchronous mode. Other models require the use of a pacemaker programmer unit. (83) Monopolar electrical current seeks a ground through the patient's body. This ground may be through the pacemaker wire, which can result in inadvertent reprogramming of the pacemaker, permanent damage to the pacemaker, or an electrical burn in the heart; therefore, having a programmer and defibrillator readily available is advisable. Short bursts of energy also minimize the risk of injury. Placing as much distance as possible between both the active and dispersive electrode and the pacemaker encourages the energy to return to the ESU through the dispersive electrode, rather than the pacemaker wire. There is a risk of reprogramming or damage to the pacemaker, so evaluation of the pacemaker is warranted. 2. Precautions for a patient with an ICD should include * preoperatively obtaining a cardiology consultation to evaluate the correct functioning of the ICD and determine the risks associated with temporarily deactivating the ICD intraoperatively; * having a defibrillator immediately available; * having the ICD device deactivated by trained personnel before the ESU is activated--using electrosurgery on a patient with an activated ICD may trigger an electrical shock to the patient; (85) * having continuous ECG and peripheral pulse monitoring; * using bipolar electrosurgery as an alternative whenever possible; * if monopolar electrosurgery is deemed necessary, ensuring that the distance between the active and dispersive electrodes is as short as possible (place both electrodes as far away from the ICD as possible, and ensure that the current path from the surgical site to the dispersive electrode does not pass through the vicinity of the patient's heart or the implanted ICD); (83,85) and * immediately postoperatively, having the correct functioning of the ICD verified by an expert in electrophysiology. 3. Precautions for patients with other electric stimulators (eg, bone growth, cochlear implants) should include the following. * Use bipolar electrosurgery as an alternative whenever possible. If monopolar electrosurgery is deemed necessary, ensure that the distance between the active and dispersive electrodes is as short as possible, place both electrodes as far away from the stimulator and wire as possible, and ensure that the current path from the surgical site to the dispersive electrode does not pass through the vicinity of the stimulator or lead wire. * In the presence of a cochlear implant, use bipolar electrosurgery at least 1 cm away from the implant. (22) * Immediately postoperatively, have the proper functioning of the device verified by a trained individual. 4. Precautions for patients with an implantable mechanical pump (eg, morphine, Baclofen) should include * using bipolar electrosurgery as an alternative whenever possible, and * immediately postoperatively, having the proper functioning of the pump verified by an individual trained in the programming of the pump. RECOMMENDED PRACTICE X Bipolar active electrodes (including vessel occluding devices) should be used according to manufacturers' written instructions. 1. Unlike the monopolar ESU, bipolar technology incorporates an active (ie, efferent) electrode and a return (ie, afferent) electrode into a two-poled instrument, such as forceps or scissors. (5,22,86) Current flows only through the tissue contacted between two poles of instruments; thus, the need for a dispersive grounding pad is eliminated. (86) This also eliminates the chance of stray or alternate pathways for current flow. (86) The bipolar ESU provides precise hemostasis at the surgical site without stimulation or current spread to nearby body structures. (86) 2. Connection of a bipolar active electrode to a monopolar receptacle may activate current, causing a short circuit. Plugs should be differentiated to prevent misconnections of active and inactive electrodes. (20) Molded, fixed-positioned pin placement bipolar cords also are available. RECOMMENDED PRACTICE XI Ultrasonic electrosurgical devices function differently from monopolar active electrodes and should be used according to manufacturers' written instructions. 1. When using an ultrasonic electrosurgical device, a dispersive electrode is not necessary. An ultrasonic device has a generator that produces electrical energy that is sent to the hand piece, where it is converted into mechanical energy. This energy is transmitted through a hand piece to a blade or probe that can be used for sharp or blunt dissection, coagulation, or breaking apart of tissue, without damage to adjacent tissues. Some ultrasonic dissectors incorporate an aspirator to remove tissue or fluids from the surgical field. Because no electrical current enters the tissue, current does not need to be returned to the generator by a dispersive electrode. (87) 2. Inhalation of aerosols generated by an ultrasonic electrosurgical hand piece should be minimized by implementing control measures that include, but are not limited to, the use of * smoke evacuation systems, and * wall suctions with in-line filters, which are only appropriate for a minimal amount of aerosol (aerosols generated using ultrasonic electrosurgery are within the respirable range and include blood, blood by-products, and tissue). (88) 3. Biomedical personnel should routinely inspect ultrasonic electrosurgical equipment to reduce the potential for equipment malfunction. RECOMMENDED PRACTICE XII Argon enhanced coagulation (AEC) technology poses unique risks to patient and personnel safety and should be used according to manufacturers' written instructions. 1. All safety measures for monopolar electrosurgery should be used when using AEC technology. The AEC unit uses monopolar alternating current delivered to the tissue through ionized argon gas. (89,90) The risks of monopolar electrosurgery are present. Additional risks are associated with application of argon gas. Precautions should be taken to minimize these risks. 2. Air should be purged from the argon gas line and electrode by activating the system before use after moderate delays between activations and between uses. (89,90) Argon gas pressure exceeds venous pressure in the circulating system, and application to bleeding vessels has resulted in gas emboli in open surgical procedures. (91,92) Activating without adequately purging may present the greatest risk of embolism when operating in an open cavity. (89,90) 3. The coagulation or blended cutting current, which contains coagulation, should be used. The coagulation waveform seals the venous blood vessels, minimizing the risk of gas emboli entering the blood stream. Purging the argon gas line prevents delays in coagulation and reduces the potential for the operator to move the hand piece, thus minimizing the risk of gas embolism. (89,90) 4. The argon gas flow should be limited to the lowest level possible. Argon gas flow is most likely to be directed to tissue without simultaneous coagulation when the initiation of ionization of the argon gas is delayed due to air bubbles in the argon gas line. (89,90) 5. The electrode should not be placed in direct contact with tissue and should be moved away from the patient's tissue after each activation. (89,90) There is a risk of gas emboli when the active electrode is placed in direct contact with tissue. 6. Personnel using the AEC technology should be knowledgeable about signs, symptoms, and treatment of venous emboli. 7. Patient monitoring should include devices that are considered effective for early detection of gas emboli (eg, end-tidal carbon dioxide). (89,90) RECOMMENDED PRACTICE XIII When using the AEC unit with endoscopic procedures, personnel should follow the manufacturer's written instructions and recommendations for use. 1. When using the AEC unit during endoscopic procedures, personnel should * follow all safety measures identified for AEC technology, * flush the patient's intraabdominal cavity with several liters of C[O.sub.2] between extended activation periods, (93) * use endoscopic C[O.sub.2] insufflators equipped with audible and visual overpressurization alarms that cannot be deactivated. (93) The AEC system acts as a secondary source of pressurized argon gas that can cause the patient's intraabdominal pressure to rise rapidly and exceed venous pressure, possibly creating argon-enriched gas emboli formation. This has resulted in gas emboli. (93) Using the lowest argon gas flow setting, purging the active electrode and argon gas line of air according to the manufacturer's recommendations, and flushing the intraabdominal cavity with several liters of C[O.sub.2] between extended periods of deactivation reduces the potential for argon gas emboli formation. (93) RECOMMENDED PRACTICE XIV Exposure to smoke plume generated during electrosurgery should be minimized. 1. Inhalation of smoke generated by electro-surgery should be minimized by implementing control measures that include, but are not limited to, the use of * smoke evacuation systems and * wall suction with in-line filters, which is only appropriate for a minimal amount of plume. Smoke plume generated from electro-surgery is the same as laser plume. This smoke has been found to contain toxic gases and vapors (eg benzene, hydrogen cyanide, formaldehyde); bioaerosols, including blood fragments; and viruses. In high concentrations, the smoke causes ocular and upper respiratory tract irritation in health care personnel. (94) The smoke generated from electrosurgery contains chemical by-products. (94,95) The National Institutes of Occupational Safety and Health recommends that smoke evacuation systems be used to reduce potential acute and chronic health risks to patients and personnel. (94) The Occupational Safety and Health Administration (OSHA) has no separate standard related to surgical smoke. The OSHA addresses such safety hazards in the General Duty Clause and Bloodborne Pathogen Standard. (95) 2. Smoke evacuation systems and accessories should be used according to manufacturers' written instructions. Health care facilities should consult AORN's "Recommended practices for product selection in perioperative practice settings" to assist in selecting a smoke evacuation system. (96) When a smoke evacuation system is used, the suction wand should be placed as close to the source of the smoke as possible. This will maximize smoke capture and enhance visibility at the surgical site. RECOMMENDED PRACTICE XV Health care facilities' policies and procedures for electrosurgery must be in compliance with the Safe Medical Devices Act of 1990. 1. If patient or personnel injuries or equipment failures occur, the ESU and the active and dispersive electrodes should be handled in accordance with the Safe Medical Devices Act of 1990, amended in March 2000. (97) Device identification, maintenance and service information, and adverse event information should be included in the report from the practice setting. Retaining the ESU, the active and dispersive electrodes, and packaging allows for a complete systems check to determine electrosurgical system integrity. RECOMMENDED PRACTICE XVI Policies and procedures for electrosurgery should be developed, reviewed periodically, revised as necessary, and readily available in the practice setting. 1. Policies and procedures for electrosurgery should include, but are not limited to, * safety features required on ESUs; * equipment maintenance programs; * supplemental safety monitors required; * equipment checks before initial use; * reporting and impounding malfunctioning equipment; * preoperative, intraoperative, and postoperative patient assessments; * precautions during use; * reporting of injuries; * ESU sanitation; and * documentation. 2. Documentation should include, but not be limited to, * electrosurgical system identification serial number, * range of settings used, * dispersive electrode placement and patient's skin condition before and after electrosurgery, and * adjunct electrical devices used (eg, ultrasonic scalpel, bipolar forceps). Documentation of details of the electrosurgical equipment and supplies allows for retrievable information for investigation into an adverse event. 3. These recommended practices should be used as guidelines for the development of policies and procedures in the perioperative practice setting. Policies and procedures establish authority, responsibility, and accountability within the facility. They also serve as operational guidelines. 4. An introduction and review of policies and procedures for electrosurgery should be included in orientation and ongoing education of personnel to assist in the development of knowledge, skills, and attitudes that affect surgical patient outcomes. Policies and procedures also assist in the development of quality assessment and improvement activities. 5. Information about adverse patient outcomes and near misses associated with electrosurgery should be collected, analyzed, and used for performance improvement as part of the institution-wide performance improvement program. To evaluate the quality of patient care and formulate plans for corrective action, it is necessary to maintain a system of evaluation. Quality improvement standards for perioperative nurses that may be used for evaluating electrosurgical safety have been published. (98) GLOSSARY ACTIVE ELECTRODE: The electrosurgical unit (ESU) accessory that directs current flow to the surgical site (eg, pencils, various tips). ACTIVE ELECTRODE MONITORING: A dynamic process of searching for insulation failures and capacitive coupling during monopolar surgery. If the monitor detects an unsafe level of stray energy, it signals the generator to deactivate. ARGON ENHANCED COAGULATION: Radio frequency coagulation from an electrosurgical generator that is capable of delivering monopolar current through a flow of ionized argon gas. BIOENGINEERING SERVICES PERSONNEL: Those individuals in an institution who are trained and qualified to check, troubleshoot, and repair medical equipment. BIPOLAR ELECTROSURGERY: Electrosurgery in which current flows between two tips of a bipolar forceps that is positioned around tissue to create a surgical effect. Current passes from the active electrode of one tip of the forceps through the patient's desired tissue to the dispersive electrode of the other forceps' tip--thus completing the circuit without entering another part of the patient's body. No dispersive electrode is required. CAPACITANCE: Ability of an electrical circuit to transfer an electrical charge from one conductor to another, even when separated by an insulator. CAPACITIVE COUPLING: Transfer of electrical current from the active electrode through intact insulation to adjacent conductive items (eg, tissue, trocars). CAPACITIVELY COUPLED RETURN ELECTRODE: A large, nonadhesive, return electrode placed close to and forming a capacitor with the patient, returning electrical current from the patient back to the ESU. CURRENT: A movement of electrons analogous to the flow of a stream of water. DIRECT COUPLING: The contact of an energized metal active electrode tip with another metal instrument or object within the surgical field. DISPERSIVE ELECTRODE: The accessory that directs electrical current flow from the patient back to the electrosurgical generator--often called the patient plate, return electrode, inactive electrode, or grounding pad. ELECTROSURGERY: The cutting and coagulation of body tissue with a high frequency (ie, radio frequency) current. ELECTROSURGICAL ACCESSORIES: For the purposes of this document, electrosurgical accessories are defined as the active electrode with tip(s), dispersive electrode, adapters, and connectors to attach these devices to the generator. ELECTROSURGICAL UNIT: For the purposes of this document, the ESU includes the generator that produces the high frequency current waveform that is delivered to tissues, the foot switch with cord (if applicable), the electrical plug, cord, and connections. ESCHAR: Charred tissue residue. GENERATOR: The machine that produces radio frequency waves (eg, ESU, power unit). GROUND-REFERENCED ELECTROSURGICAL UNIT: A system in which electrical current is sent to the patient and follows the path of least resistance back to the ground. This technology, which no longer is manufactured, produces high frequency, high voltage current and sometimes is referred to as a "spark gap" unit. INSULATOR: A material that does not conduct electricity. INSULATION FAILURE: Damage to the insulation of the active electrode that provides an alternate pathway for the current to leave that electrode as it completes the circuit to the dispersive electrode. ISOLATED ELECTROSURGICAL UNIT: A system in which electrical current is sent to the patient and selectively returns and is grounded through the generator. MONOPOLAR ELECTROSURGERY: Electrosurgery in which only the active electrode is in the surgical wound, and the electrical current is directed through the patient's body, received by the dispersive pad, and transferred back to the generator, completing the monopolar circuit. OXYGEN-ENRICHED ENVIRONMENT: Atmosphere containing more than 23% oxygen, frequently occurring in the oropharynx, trachea, lower respiratory tract, and near the head and neck during administration of oxygen to the patient. RETURN ELECTRODE CONTACT QUALITY MONITORING: A dynamic monitoring circuit measuring impedance of the dispersive return electrode. If the dispersive electrode becomes compromised, the circuit inhibits the ESU's output. ULTRASONIC SCALPEL: A cutting/coagulation device that converts electrical energy into mechanical energy, providing a rapid ultrasonic motion. VESSEL SEALING DEVICE: Bipolar technology that fuses collagen and elastin in the vessel walls and permanently obliterates the lumen of the vessel. NOTES (1.) "Electrosurgery," (Operating Room Risk Management) ECRI (January 1999) 7. (2.) "Electrosurgical units," Health Devices 27 (March 1998) 93-96. (3.) ANSI/AAMI, "Electrosurgical devices," HF18: 2001, 1-26. (4.) R C Odell, "Pearls, pitfalls, and advancements in the delivery of electrosurgical energy during laparoscopy," Problems in General Surgery 19 no 2 (2002) 5-17. (5.) "Laparoscopic electrosurgery risks," (Operating Room Risk Management) ECRI (May 1999) 1-11. (6.) "Guidance section: Ensuring monopolar electrosurgical safety during laparoscopy," Health Devices 24 (January 1995) 207,27. (7.) J T Bischoff et al, "Laparoscopic bowel injury: Incidence and clinical presentation," The Journal of Urology 161 (March 1999) 888-890. (8.) B J Carroll, M Birth, E H Phillips, "Common bile duct injuries during laparoscopic cholecystectomy that result in litigation," Surgical Endoscopy 12 (April 1998) 310-314. (9.) K A Kern, "Malpractice litigation involving laparoscopic cholecystectomy: Cost, cause, and consequences," Archives of Surgery 132 (April 1997) 392-398. (10.) R D Tucker, C E Platz, S K Landas, "A laparoscopic complication? A medical legal case analysis. Part I," Journal of Gynecologic Surgery 11 no 2 (1995) 113-121. (11.) M P Wu et al, "Complications and recommended practices for electrosurgery in laparoscopy," American Journal of Surgery 179 (January 2000) 67-73. (12.) Laparoscopic Injury Study (Rockville, Md: Physician Insurers Association of America, August 2000) 1-5. (13.) "Evaluation of electroscope electroshield system," (Guidance Article) Health Devices 24 (January 1995) 11-19. (14.) V Dennis, "Implementing active electrode monitoring: A perioperative call," Surgical Services Management 7 (April 2001) 32-38. (15.) R D Tucker, CR Voyles, S E Silvis, "Capacitive coupled stray currents during laparoscopic and endoscopic electrosurgical procedures," Biomedical Instrumentation and Technology 26 (July/August 1992) 303-311. (16.) T G Vancaillie, "Active electrode monitoring: How to prevent unintentional thermal injury associated with monopolar electrosurgery at laparoscopy," Surgical Endoscopy 12 (August 1998) 1009-1012. (17.) C R Voyles, R D Tucker, "Education and engineering solutions for potential problems, with laparoscopic monopolar electrosurgery," The American Journal of Surgery 164 (July 1992) 56-62. (18.) "Burns and fires from electrosurgical active electrodes," (Hazard Update) Health Devices 22 (August-September 1993) 421-422. (19.) "Fires in the operating room," (Healthcare Hazard Control) ECRI (February 2003) 1-10. (20.) "Misconnection of bipolar electrosurgical electrodes," (Hazard Report) Health Devices 24 (January 1995) 34-35. (21.) National Fire Protection Association, NFPA 99: Standard for Health Care Facilities, sec D.5.2.1 (Quincy, Mass: NFPA International, 2002) 200. (22.) T L Smith, J M Smith, "Electrosurgery in otolaryngology-head and neck surgery: Principles, advances, and complications," The Laryngoscope 111 (May 2001) 769-780. (23.) National Fire Protection Association, NFPA 99: Standard for Health Care Facilities, sec D.5.2.5 (Quincy, Mass: NFPA International, 2002) 200. (24.) National Fire Protection Association, NFPA 99: Standard for Health Care Facilities, sec D.5.2.3 (Quincy Mass: NFPA International, 2002) 200. (25.) National Fire Protection Association, NFPA 99: Standard for Health Care Facilities, sec D.7.3 (Quincy, Mass: NFPA International, 2002) 203. (26.) National Fire Protection Association, NFPA 99: Standard for Health Care Facilities, sec D.5.3.1 (Quincy, Mass: NFPA International, 2002) 200. (27.) National Fire Protection Association, NFPA 99: Standard for Health Care Facilities, sec D.5.3.3 (Quincy, Mass: NFPA International, 2002) 200. (28.) "Electrosurgery checklist," (Operating Room Risk Management) ECRI (January 1999) 1. (29.) Joint Commission on Accreditation of Health Care Organizations, 2003 Hospital Accreditation Standards, section EC.2.10.3 (Oakbrook Terrace, Ill: Joint Commission Resources, 2003) 236. (30.) "ESU burns from poor dispersive electrode site preparation," (Hazard Update) Health Devices 22 (August-September 1993) 423. (31.) "Recommended practices for endoscopic minimally invasive surgery," in Standards, Recommended Practices and Guidelines (Denver: AORN, Inc, 2004) 267-271. (32.) National Fire Protection Association, NFPA 99: Standard for Health Care Facilities, sec C.13.1.3.2.2 (Quincy, Mass: NFPA International, 2002) 182. (33.) T D Datta, "Flash fire hazard with eye ointment," (Letters to the Editor) Anesthesia and Analgesia 63 (July 1984) 700-701. (34.) "The patient is on fire! A surgical fires primer," (Guidance) Health Devices 21(January 1992) 19-34. (35.) "Medical devices: Reclassification of polymethylmethacrylate (PMMA) bone cement," Federal Register 67 (July 17, 2002) 46852-46855. (36.) MAUDE database, (Feb 2, 2000), 9610726-2000-00003; (Aug 30, 2002), 435173 (Washington, DC: Center for Devices and Radiological Health). (37.) S J Barker, J S Polson, "Fire in the operating room: A case report and laboratory study," Anesthesia and Analgessia 93 (October 2001) 960-965. (38.) "Fire hazard created by the misuse of DuraPrep solution," (Hazard Report) Health Devices 27 (November 1998) 400-401. (39.) MAUDE database, (July 31, 1995), 32071; (Sept 12, 1997) 119838; (March 21 2002), 384493; (April 15, 2002), 1720159-2002-00032 (Washington, DC: Center for Devices and Radiological Health). (40.) "Fire caused by improper disposal of electrocautery units," (Hazard Report) Health Devices 23 (March 1994) 98. (41.) "Alternate-site burns from improperly seated electrosurgical pencil active electrodes," (Hazard Report) Health Devices 29 (January 2000) 24-27. (42.) "Ignition of debris on active electrosurgical electrodes," (Hazard Report) Health Devices 27 (September-October 1998) 367-370. (43.) Center for Devices and Radiological Health, MAUDE database (May 7, 2002), 393590. (44.) MAUDE database, (Aug 23, 2002), 441523 (Washington, DC: Center for Devices and Radiological Health). (45.) R A Ortega, "A rare cause of fire in the operating room," Anesthesiology 89 (December 1998) 1608. (46.) D K Wood, R Hollis, "Thermal cautery causes a gauze pad fire," (Letters) JAMA 270 (Nov 17, 1993) 2299-2300. (47.) Y Y Bonnet et al, "Explosion of intestinal gas during surgery," Annales Francaises d'Anesthesie et de Reanimation 2 no 6 (1983) 431-435. (48.) E Gross, O Jurim, M Krausz, "Diathermy-induced gas explosion in the intestinal tract," Harefuah 123 no 1-2 (1992) 12-13, 71-72. (49.) F S Joyce, T N Rasmussen, "Gas explosion during diathermy gastrotomy," Gastroenterology 96 (February 1989) 530-531. (50.) E B Soussan et al, "Bowel explosion with colonic perforation during argon plasma coagulation for hemorrhagic radiation-induced proctitis," Gastrointestinal Endoscopy 57 (March 2003) 412-413. (51.) E Zinsser, et al "Bowel gas explosion during argon beam coagulation," (Unusual Cases and Technical Notes) Endoscopy 31 (May 1999) S26. (52.) "Electrosurgical airway fires still a hot topic," Health Devices 25 (July 1996) 260-261. (53.) J A Bennett, M Agree, "Fire in the chest," Anesthesia and Analgesia 78 (February 1984) 406. (54.) "$40 million sought after electrosurgery burn death," Biomedical Safety and Standards 15 (December 1995) 170. (55.) W K Chee, J L Benumof, "Airway fire during tracheostomy: Extubation may be contraindicated," Anesthesiology 89 (December 1998) 1576-1578. (56.) R J Greco et al, "Potential dangers of oxygen supplementation during facial surgery," Plastic Reconstructive Surgery 95 (May 1995) 978-984. (57.) M J Lucarelli, B N Lemke, "Monopolar electrosurgical flash fire," Ophthalmic Surgery and Lasers 29 (March 1998) 249-250. (58.) K F Mattucci, C J Militana, "The prevention of fire during oropharyngeal electrosurgery," Ear, Nose and Throat Journal 82 (February 2003)-107-109. (59.) A M J Michels, S Stott, "Explosion of tracheal tube during tracheostomy," (Correspondence) Anaesthesia 49 (December 1994) 1104. (60.) R J Reyes et al, "Supplemental oxygen: Ensuring. its safe delivery during facial surgery," Plastic and Reconstructive Surgery 95 (April 1995) 924-928. (61.) J W Thompson et al, "Fire in the operating room during tracheostomy," Southern Medical Journal 91 (March 1998) 243-247. (62.) E S Wegrzynowicz et al, "Airway fire during jet ventilation for laser excision of vocal cord papillomata," (Case Reports) Anesthesiology 76 (March 1992) 468-469. (63.) P T J Wilson, U Igbaseimokumo, J Martin, "Ignition of the tracheal tube during tracheostomy," (Correspondence) Anaesthesia 49 (August 1994), 734-735. (64.) "Skin burns resulting from the use of electrolyte distention/irrigation media during electrosurgery with a rollerblation electrode," (Hazard Report) Health Devices 27 (June 1998) 233-235. (65.) MAUDE database, (Oct 9, 2002), 421908 (Washington, DC: Center for Devices and Radiological Health). (66.) 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MAUDE database (October 15, 2003) 2110898-2003-00016 (Washington DC: Center for Devices and Radiological Health). Also available at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cf MAUDE/Detail.cfm?MDRFOI_ID=495428 (accessed 24 Sept 2004). (72.) MAUDE database (November 25, 2003) 1643264-2003-00066 (Washington, DC: Center for Devices and Radiological Health). Also available at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cf MAUDE/Detail.cfm?MDRFOI_ID=499965 (accessed 24 Sept 2004). (73.) MAUDE database (February 16, 2004) 21108982004-00004 (Washington DC: Center for Devices and Radiological Health). Also available at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cf MAUDE/Detail.cfm?MDRFOI_ID=516905 (accessed 24 Sept 2004). (74.) "Skin lesions from aggressive adhesive on electrosurgical return electrode pads," Health Devices 24 (April 1995) 159-161. (75.) MAUDE database, (June 24, 2002), 401617 (Washington, DC: Center for Devices and Radiological Health). (76.) "MegaDyne Mega 2000 return electrode," Health Devices 29 (December 2000) 445-460. (77.) MAUDE database, (May 16, 2002), 396295; (July 6, 2002), 286226 (Washington, DC: Center for Devices and Radiological Health). (78.) "Allowing patients to wear jewelry during surgical (and electrosurgical) procedures," Health Devices 26 (November 1997) 441-443. (79.) G J Harrell, D R Kopps, "Minimizing patient risk during laparoscopic electrosurgery," AORN Journal 67 (June 1998) 1194-1205. (80.) T G Vancaillie, "Electrosurgery at laparoscopy: Guidelines to avoid complications," Gynaecological Endoscopy 3 (1994) 143-150. (81.) P D Willson et al, "Port site electrosurgical (diathermy) burns during surgical laparoscopy," Surgical Endoscopy 11 (June 1997) 653-654. (82.) P E Greilich, N B Greilich, E G Froelich, "Intraabdominal fire during laparoscopic cholecystectomy," Anesthesiology 83 (October 1995) 871-874. (83.) 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"Laser/electrosurgery plume," US Department of Labor, Occupational Safety and Health Administration (Feb 13, 2002), http://www.osha.gov/SLTC /laserelectrosurgeryplume (accessed 25 April 2003). (96.) "Recommended practices for product selection in perioperative practice settings," in Standards, Recommended Practices, and Guidelines (Denver: AORN, Inc, 2004) 347-350. (97.) "Medical device reporting: Manufacturer reporting, importer reporting, user facility reporting, distributor reporting," Federal Register 65 (Jan 26, 2000) 4112-4121. (98.) "Quality and performance improvement standards for perioperative nursing," in Standards, Recommended Practices, and Guidelines (Denver: AORN, Inc, 2004) 187-196. Originally published March 1985, AORN Journal. Revised April 1991; revised July 1993. Revised November 1997; published January 1998, AORN Journal. Reformatted July 2000. Revised, published February 2004. Revised, November 2004; scheduled for publication in the AORN Journal in 2005. 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