esu safety

414 HEALTH DEVICES December 2005 ■ www.ecri.org ©2005 ECRI. Member hospitals may reproduce this page for internal distribution only.

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Electrosurgical SafetyConducting a Safety Audit

UMDNS terms. Electrosurgical Units [11-490] ■ Electrosurgical Units,Monopolar [18-229] ■ Electrodes, Electrosurgical, Active [16-860] ■ Electrodes,Electrosurgical, Return [11-500] ■ Radiofrequency Therapy Systems [18-800]

Summary. ECRI detailed some of the lesser-known risks of electrosurgery ina collection of articles published in the August 2005 Health Devices. However,it’s also important to recognize that even hazards that are well understood byclinical personnel can lead to injury if appropriate safety measures aren’t appliedconsistently.

In this follow-up to our August 2005 articles, we offer guidance to helphealthcare facilities conduct a safety audit that examines critical aspects of thefacility’s use of electrosurgical technology. ECRI recommends that healthcarefacilities periodically conduct such an audit to ensure that the appropriate equip-ment and procedures are in place to protect patients and staff from injury. Thisarticle reviews some of the key questions to ask during a safety audit, and itincludes detailed guidance for developing an electrosurgical safety checklist.

10 Key Questions to Ask during anElectrosurgical Safety Audit

To help healthcare facilities conduct an effective audit,we examine below the critical safety measures that facili-ties should take to avoid some of the most commonelectrosurgery-related adverse incidents. While most ofthese measures are basic, ECRI has found that too oftenthey are misunderstood, forgotten, or ignored. In addition,some users may be unfamiliar with the special risks asso-ciated with laparoscopic monopolar electrosurgery andhigh-current, long-duration activations (e.g., as used fortissue ablation).

The audit might be conducted by members of a safetycommittee; by clinical engineering, risk management, orsurgical staff; or by some combination of personnel fromthese groups. Periodic reexamination of the issues coveredin the safety audit is advised.

1. Are safe practices emphasized in user training andreinforced in daily practice?

The safety of electrosurgery depends largely on cliniciansand their adherence to good practices. Ensuring that surgi-cal staff members are properly trained in these practiceswill significantly improve safety.

Verify that user training covers the following (many ofthese topics are described in subsequent items):

■ The operating principles of electrosurgical units(ESUs), including devices used for argon-enhancedelectrosurgery (where relevant)

■ The causes of return-electrode-site, active-electrode-site, and alternate-site injuries and the preventive mea-sures that can be taken to minimize associated risks

■ Fire safety

■ Surgical smoke evacuation

■ The unique causes of injuries during laparoscopicelectrosurgery and high-current ablation and the preven-tive measures that can be taken to minimize the risks

2. Have you developed an electrosurgical safetychecklist to reinforce safe practices?

Using a checklist will reinforce safe practices by remind-ing clinical staff of each safety step while they are prepar-ing for or performing electrosurgery. In the next section,Developing an Electrosurgical Safety Checklist, we pres-ent a starter list with safety practices that you can use to

create a checklist that addresses your facility’s specificneeds.

3. Is RECQM technology used to prevent return-electrode-site injuries?

Return-electrode contact-quality monitor (RECQM) tech-nology has proven to be an effective tool for helping toprevent patient burns at the site of the return electrode dur-ing most electrosurgical procedures.

Ensure that RECQM capability is provided on allgeneral-purpose ESUs in your inventory. In addition, youshould verify that dual-foil return electrodes, which areneeded to enable contact-quality monitoring, are availableand are being used. (Note that RECQM is unnecessarywhen large-area capacitive return electrodes are used in-stead of adhesive return electrodes. For a discussion, referto the December 2000 Health Devices Evaluation of theMegadyne Mega 2000 Return Electrode.)

4. Are safeguards in place and followed to protectagainst active-electrode-site injuries?

For all ESUs in your inventory, verify, at minimum, thatvisual activation indicators illuminate and that audible ac-tivation indicators are clearly audible. Also ensure thatduring surgical procedures, all active electrodes are insafety holsters (see the photos on the bottom of page 419)or otherwise placed safely away from the surgical fieldand patient when they are not in active use.

5. Are reusable accessories replaced on time?

If your hospital employs reusable cables or active elec-trodes, ensure that a replacement policy has been estab-lished and is followed for these accessories to minimizethe risk of failure during use. Internal failure of a cable’sconductor may cause sparking and fires, and employingreusable active electrodes until they fail may result inpatient injury (e.g., tonsillectomy burns inside apatient’s mouth).

Because cable and electrode failures are not easilydetected by normal inspections, ECRI recommends peri-odically replacing these reusable accessories. If the equip-ment manufacturer does not publish a recommendedreplacement schedule, consider replacing the devices afterone year of use.

©2005 ECRI. Member hospitals may reproduce this page for internal distribution only. www.ecri.org ■ HEALTH DEVICES December 2005 415

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6. Is surgical smoke evacuated to ensure safety andcomfort?

Ensure that a policy is established and followed regardingsurgical smoke evacuation. ECRI recommends that, atminimum, surgical smoke be evacuated in the followingcircumstances: (1) when tissue is being ablated in patientsinfected with human papillomavirus (HPV), (2) whenthere is expected to be enough smoke to obscure visionand therefore diminish staff performance, or (3) whensmoke causes staff discomfort. For more information, referto “Should You Evacuate Surgical Smoke?” in the March2001 Health Devices. More detailed discussions can alsobe found in the following articles: “Technology Manage-ment Guide: Clearing the Air—Should Surgical Smoke BeEvacuated?” (Health Devices April 1997) and “Should

Surgical Smoke Be Evacuated? (Revisited)” (HealthDevices September 1999).

7. Is equipment standardization used to minimizeuser error?

Determine your facility’s level of standardization regard-ing ESUs and accessories, and then consider whether yourpurchasing practices need to be altered to increase equip-ment standardization. A lack of standardization increasesthe chance of error during the use of these devices. If yourfacility uses multiple product models for the same proce-dures, provide adequate training to ensure correct use ofeach model.

8. Are policies in place and followed to prevent surgi-cal fires?

Ensure that safe practices are followed and that preventivemeasures are implemented to minimize surgical fires. Al-though surgical fires—fires on or in the surgical patient—are rare, they do occur, and their consequences can bedevastating. ECRI’s investigations and research show thatelectrosurgical equipment is a common ignition source inthese fires.

Key preventive measures include minimizing the risksassociated with oxygen and nitrous oxide enrichment nearthe surgical site, especially in head and neck surgery, andnot draping the patient until all flammable prepping agentshave fully dried. Also, keep a 5 lb carbon dioxide fire ex-tinguisher in every room used for electrosurgery. Refer tothe January 2003 Health Devices for more information onsurgical fire safety. Health Devices will publish updatedguidance on this topic in 2006.

9. Are policies in place and followed to minimize thespecial risks during laparoscopic monopolarelectrosurgery?

Ensure that policies are in place and followed to minimizethe special risks associated with the use of monopolarelectrosurgery during minimally invasive procedures, suchas laparoscopy. Some of the resulting burns may lead tobowel perforations, which can be fatal.

For instance, during such procedures, electrical cur-rent can become concentrated within narrow internalpathways, leading to excessive heating of internal struc-tures. Also, contact between an activated electrode tipand other conductive instruments within the patient cancause those instruments to become energized, possiblyleading to a burn.

Consider whether any technology solutions should beused to minimize the risks of stray electrosurgical energy

For More Information onElectrosurgical Safety

ECRI dedicated the August 2005 issue of HealthDevices to special topics in electrosurgical safety,focusing on the particular hazards associated withlaparoscopic monopolar electrosurgery and proce-dures—such as tissue ablation—that require high-current, long-duration electrosurgical unit activations.

Steps that all hospitals should be following tominimize risks associated with laparoscopic proce-dures are described in the supplementary article“General Risks and Protective Measures during Lap-aroscopic Monopolar Electrosurgery.” In addition toenacting the measures discussed in that article, somefacilities may wish to implement the supplementalprotection that can be offered by active-electrodeshielding and some other technologies. In the Evalu-ation “Safety Technologies for LaparoscopicMonopolar Electrosurgery,” we review four productsdesigned to reduce the risk of leakage-current burnsduring laparoscopic monopolar electrosurgery.

In the Guidance Article “Higher Currents,Greater Risks,” we detail the hazards associated withhigh-current, long-activation-time electrosurgicalprocedures and describe the factors that can increasethe risks of return-electrode-site skin injuries for agiven procedure. We also provide recommendationsto help healthcare facilities and clinicians minimizethose risks. ◆


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(leakage current) from the shaft of the active electrodepassing through gaps in the insulating material or acrossthe intact insulation by means of capacitance to otherinstruments or internal tissues. ECRI discussed this topicin detail in the August 2005 Health Devices. (See the inseton page 416 for more information.)

10. Are policies in place and followed to minimizethe special risks associated with tumor ablation andother high-current ESU procedures?

During high-current, long-duration activations, a singleconventional return electrode may be inadequate to safelydisperse high currents; consequently, a patient may beburned at the site of the return electrode. Ensure that clini-cians are aware of this often unrecognized electrosurgicalhazard—which has developed as a result of newer tech-niques that require the continuous application of high cur-rent for a prolonged period of time—and verify thatappropriate practices are followed to minimize the

associated risks. For example, some generator manufactur-ers recommend that for high-current procedures, facilitiesuse either multiple return electrodes or return electrodesthat are no smaller than a specified size.

A specialty electrosurgical generator may increasethe risk of injury if it does not offer RECQM, return-electrode-fault monitoring, or other measures to minimizethe possibility of return-electrode-site burns. In addition,the likelihood of overwhelming the return electrode canincrease if a conductive solution—such as saline or lactatedRinger’s solution—is used as a distention/irrigationmedium. Such solutions can conduct and disperse electro-surgical current away from the surgical site, causing a lossof surgical effect that can lead an operator to increase thepower settings of the ESU. Conductive solutions also lowerelectrical impedance at the active electrode, which furtherelevates current. ECRI also addressed these topics in theAugust 2005 issue. (See the inset on page 416.)

Developing an Electrosurgical Safety Checklist

The information presented below can be used as a guidefor developing a checklist that clinical staff will employ toensure that safe practices are followed before, during, andafter electrosurgical procedures. This is designed as astarter list; facilities should modify or add to it as appropri-ate to meet their particular needs.

Preoperative Precautions andProcedures

1. ESU condition

1.1 Examine the electrosurgical unit (ESU) and itsaccessories for defects. Do not use cables or ac-cessories with damaged (e.g., cracked, burned,taped) insulation or connectors.

1.2 When the ESU goes through its self-test modeafter being powered on, or when it is first acti-vated during surgery, do the following:

1.2.1 Verify that the audible activation tone isloud enough to be heard over other noisesin the operating room.

1.2.2 Verify that the visual activation indicatorilluminates.

1.3 Before connecting the return electrode, verifythat the unit will not activate and that it soundsan alarm if a user attempts to activate the unitwhile the return electrode is disconnected.

1.4 Verify operation of any additional alarms orsafety features, if applicable.

2. Return-electrode integrity and application*

2.1 Clean, shave (if applicable), and dry the applica-tion site.

2.2 If the ESU incorporates a return-electrodecontact-quality monitor (RECQM), verify thata dual-foil-surface return electrode is being usedto enable contact-quality monitoring. (Notethat an RECQM is unnecessary when large-area

capacitive return electrodes are used instead ofadhesive return electrodes.)

2.3 Confirm that the electrode’s expiration date hasnot passed.

2.4 Before placement, inspect the electrode for anyflaws or damage (e.g., discoloration, areas thatappear dry, lack of tackiness).

2.5 Follow the manufacturer’s recommendations forreturn-electrode application, and ensure that theelectrode is firmly attached to the skin.

2.6 Ensure that the electrode is not applied to aweight-bearing surface (e.g., underneath the pa-tient, on bony prominences).

2.7 Ensure that no sections of the electrode overlap.In particular, verify that no electrode is appliedcircumferentially around a small limb becausethis placement increases the likelihood of anoverlap and might cut off circulation.

2.8 If possible, apply the return electrode so thatone of its long edges (one without the cableconnection) is positioned closest to the surgicalsite.

3. Precautions for patients with a pacemakeror ICD

Take appropriate precautions for patients with pace-makers or implantable cardioverter-defibrillators(ICDs). Follow recommendations from the pace-maker or ICD manufacturer or from your facility’scardiology department. When developing a policy forsuch patients, consider including the following steps:

3.1 Use a safer pacing mode (e.g., fixed-rate single-chamber mode), or deactivate the ICD ifappropriate.

3.2 Ensure that the following are readily available: apacemaker or ICD programmer, external defib-rillator, external pacemaker, and cardiac drugs.

3.3 Ensure that the return electrode is not placednear the pacemaker or ICD.

3.4 Ensure that the return electrode is not placed sothat the pacemaker, ICD, or leads are in the pathof the ESU current.


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* The items in this section apply specifically to the use of adhesive returnelectrodes. Although most of these measures (e.g., the use of an RECQM)are not applicable when large-area capacitive return electrodes are used,appropriate measures, such as checking the position and condition of elec-trodes, should be substituted.


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3.5 Ensure that the return- and active-electrode ca-bles are not placed near the pacemaker, ICD, orleads.

4. Safeguarding against alternate-site injuries

4.1 Eliminate patient contact with grounded objects.

4.2 Ensure that the active electrode is properlyseated in the electrosurgical handpiece. (See thephotos above.)

4.3 If feasible, remove nonvital monitoring elec-trodes (e.g., esophageal probes, rectal probes)from the patient.

4.4 Keep ECG and other monitoring electrodes asfar as possible from the surgical site and fromthe active- and return-electrode cables.

4.5 If possible, do not use needle electrodes formonitoring or other nonelectrosurgical pur-poses. Needle electrodes increase the risk of al-ternate-site burns because stray current can flowthrough the small contact area of the needle,particularly when monopolar delivery is used.The risk cannot always be avoided by discon-necting the monitoring cable at the monitor end.If using needle electrodes is deemed necessary,avoid using monopolar electrosurgery followingneedle placement. Instead, consider using ascalpel, a laser, or bipolar electrosurgery.

5. Drying time for prepping agents

Verify that flammable prepping solutions and tinc-tures (if used) have fully dried before draping the pa-tient or activating the ESU.

6. Use of safety holstersPosition an insulated safety holster (see the photosbelow) for each active electrode; the safety holstersshould be in convenient locations.

7. Sparking the active electrodeEnsure that no one sparks the active electrode toground or to the return electrode to test the ESU. Un-der some circumstances, sparking the active electrodethis way can create a current path that passes througha point where the patient is touching grounded metal;consequently, the patient may be burned at this point.

Intraoperative Precautions andProcedures

8. Minimizing oxygen buildup

8.1 Minimize the buildup of oxygen and nitrous ox-ide beneath drapes and, during oropharyngealsurgery, in the oropharynx.

8.2 Verify that electrosurgery is not used around theopen tracheobronchial tree.

9. Activation and deactivation

9.1 Activate the unit only when ready to deliverelectrosurgical current and only when the activetip is in view. This consideration is especiallyimportant when a surgeon is viewing through amicroscope or endoscope.

9.2 Allow only the user of the active electrode toactivate the device, regardless of the activationmechanism (e.g., footswitch) used.

9.3 Keep the active electrode clean; do not, how-ever, wipe the electrode on drapes.

When active electrodes are not in use, place them insafety holsters. Never rest them on beds or patients.

The picture on the left shows an improperly seatedactive electrode in an electrosurgical handpiece. Thepicture on the right shows proper seating.

9.4 Deactivate the unit before the tip leaves the sur-gical site.

9.5 Place the active electrode in a safety holster whennot in use. (See the photos on the bottom of page419.) When long electrodes (e.g., for endoscopicinstruments) are used, store them at a locationaway from the patient.

10. Power settings

10.1 Use the lowest possible power settings and min-imum activation times necessary to achieve thedesired surgical effect at the target-tissue site.

10.2 When a surgical effect is not evident or is lessthan expected for the surgical circumstance,look for other problems (e.g., confirm adequateplacement of the return electrode, check all ca-ble connections) before increasing the genera-tor’s power setting.

11. Repositioning a patientCheck contact and adherence of the return electrodeeach time the patient is repositioned.

12. Patients with a pacemaker or ICD

12.1 Do not use the active electrode in the immediatevicinity (within approximately 6 in [15 cm]) ofa pacemaker, ICD, or the associated leads.

12.2 When possible, use bipolar electrosurgery or al-ternative methods (scalpel or laser) for patientswith pacemakers or ICDs.

12.3 If monopolar electrosurgery is needed, to theextent possible use short intermittent burstsof activation, which will allow the heart to bepaced between activations in the event of

inhibiting interference; these bursts should be atthe lowest output level needed to achieve thedesired surgical effect.

Documentation andPostoperative Procedures

13. Inspecting the patient

When removing the return electrode, inspect the pa-tient for injuries at the return-electrode site and atother sites (e.g., the sacral area). In virtually all cases,electrosurgical injuries are immediately visiblefollowing a procedure; pressure injuries may notshow up for as long as one or two days following sur-gery, however.

14. Documenting all findings

Ensure that procedure documentation includes:

14.1 The ESU identification number

14.2 The ESU settings used (e.g., monopolar orbipolar, cutting or coagulation)

14.3 The location of the return electrode

14.4 The condition of the skin at the return-electrodesite before and after the procedure

14.5 The use and position of any other equipment(e.g., hypo-/hyperthermia units, temperatureprobes) employed during the procedure, includ-ing identification numbers

15. Saving items associated with an incident

If any problems are noted during or after the proce-dure, save all disposable items and their packages(e.g., so that expiration dates can be confirmed). ◆


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