XX Electrosurgical Units Surgical diathermy TRAINING SEMINAR ON

XX. Electrosurgical Units (Surgical diathermy) TRAINING SEMINAR ON MEDICAL DEVICE ACCIDENT INVESTIGATION for Kingdom of Saudi Arabia Saudi Food & Drug Authority Riyadh 11 -14 February, 2007 Presenter: Mark E. Bruley Vice President, Accident and Forensic Investigation ECRI 5200 Butler Pike, Plymouth Meeting, PA, 19642 USA Tel: +1 610 -825 -6000, ext. 5223 E-mail: mbruley@ecri. org Web Sites: www. ecri. org www. mdsr. ecri. org ©ECRI 2007 1

X. Electrosurgical Units • Electrosurgical Basics • Electrosurgical Burns • Laparoscopic Accidents • Injuries to Medical Staff • Fires ©ECRI 2007 2

Some Basic Electrosurgery Facts • Used in about 80% of all surgical procedures • Very effective surgical tool – Cutting – Coagulation – Fulguration • Not well understood by clinicians • Commonly seen in FDA and ECRI problem reporting databases ©ECRI 2007 3

A Primer on Electrosurgery Arrows indicate flow of electrical current in a complete circuit. M 005 XN 9 B-01 ©ECRI 2007 4

Monopolar Electrosurgical Current Flow Current is concentrated at the active electrode to produce cutting or coagulation; it is dispersed at the return electrode to prevent patient burns. M 005 XN 9 B-02 ©ECRI 2007 5

Bipolar Electrosurgery Electrosurgical Unit Current Flow Tissue between tips of forceps ©ECRI 2007 6

Electrosurgery Safety Features • Continuity Monitor – Verifies that a return electrode is connected to electrosurgical unit – Cannot detect if return electrode is disconnected from or in poor contact with the patient – Single- or dual-foil dispersive electrode may be used ©ECRI 2007 7

Electrosurgery Safety Features … • Return Electrode Contact Quality Monitor (RECQM) – Offers better level of protection than continuity monitor – Assures that good contact exists between the dispersive electrode and patient – Uses interrogation current through patient tissues to verify acceptable impedance level – Dual-foil dispersive electrode must be used – ECRI strongly recommends using electrosurgical units with RECQM ©ECRI 2007 8

Dual Plate Return Electrodes Interrogation current flows between each plate of the electrode and the patient. If one side is partially detached from the patient, an alarm will sound. ©ECRI 2007 9

Electrosurgical Accidents • Skin Burns • Fires, Explosions – Fuels/Gases/Oxygen Enriched Atmospheres • Power Delivered – Too much (Eyelid; Testicle) – Too little (Fallopian tube) • Organ Perforations ©ECRI 2007 10

Spermatic Cord Damage from Electrosurgery (old technology, new procedure, bad outcome) ©ECRI 2007 11

Misconnection Problem Figure 1. Flexible bipolar electrode cables can allow misconnection of bipolar leads into the monopolar jacks, resulting in serious patient injury. M 005 XN 9 B-04 ©ECRI 2007 12

Electrosurgical Accidents • Argon Beam Coagulators – Gas Embolism • Interference (EMI) – ESU as “Source” of EMI versus being a “Sink” • User Injuries – Hand sensation – Alternate pathways ©ECRI 2007 13

Electrosurgical Injuries • Return Electrode Issues – Poor electrode placement – Lack of skin prep – Complete or partial removal of return electrodes – Skin reactions to adhesives – Edge effects – Patients with limited viable skin surface area – High electrosurgical currents and long activation times ©ECRI 2007 14

Electrosurgical Injuries … • Active Electrode Issues – Insulation surrounding conductive shaft • Breakdown – Repeated Sterilization – Cuts, Nicks, Abrasions • Capacitive Coupling – Electrical current induced by means of capacitance to other instruments or tissues • Tip “flare-ups” • Inadvertent activation! ©ECRI 2007 15

Electrosurgical Injuries • Active Electrode – Organ Perforations – Alternate Site Burns (Use an Holster!) – Laparoscopic Active Electrodes – Laparoscopic Cannula Burns – Spermatic Cord – Fallopian Tube – Failure to use activation tone ©ECRI 2007 16

Active Electrode Accidents • Inadvertent activation of the ESU due to unintentional switch activation – User places active electrode on the patient or the surgical drape between intended activations – Safety holster not used – Audible activation tone volume is set too low • Insulation failure along shaft during procedures, such as tonsillectomy causing burn to tissue inside mouth or to lip • User makes direct contact with nontarget tissue ©ECRI 2007 17

Electrosurgical Injuries • Return Electrode – Poor Site Preparation – Poor Application technique – Non-uniform Conductivity – Repositioning • Patient • Electrode ©ECRI 2007 18

Return Electrode Accidents • Burns – Use of electrolytic (conductive) distention/irrigation media during TURP – Conductive solution may render electrosurgery less effective – Disperses current away from intended surgical site – Lower surgical effect may lead user to increase power output of ESU – Conductive solution lowers impedance at active electrode, elevating current – Increased power and lower impedance increases current through dispersive return electrode ©ECRI 2007 19

Laparoscopic Electrosurgery • • Monopolar vs. Bipolar Current leakage though cannula Insulation breakage Fire ©ECRI 2007 20

Laparoscopic Injuries • • • Inadvertent tip to tissue contact Insulation failures Capacitive coupling Trocar insertion sites Device interference Resulting in bowel perforations, excess bleeding, damage to nontarget tissue, etc. ©ECRI 2007 21

Figure 2. Inadvertent energizing of a conductive instrument (in this case, a laparoscope introduced through a nonconductive cannula) from contact with active electrode tip during ESU activation. M 005 XN 9 B-05 ©ECRI 2007 22

Figure 3. Insulation failure within a conductive trocar cannula. M 005 XN 9 B-06 ©ECRI 2007 23

Figure 4. Insulation failure within a conductive trocar cannula that has been insulated from the insertion site. M 005 XN 9 B-07 ©ECRI 2007 24

Figure 4. Insulation failure outside the trocar cannula. M 005 XN 9 B-08 ©ECRI 2007 25

ESU-caused Fires • • See surgical fires Heat, sparks, flaming gases Not a device problem Micro-environment of use ©ECRI 2007 26

XX. Electrosurgical Units (Surgical diathermy) QUESTIONS? ©ECRI 2007 27