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By Anne Reed
"I shall protect them from all harm." This excerpt from theHippocratic Oath is the mandate under which all physicians serve. It dictatesthat above all else, during the course of any medical intervention, noadditional injury shall be inflicted upon one's patient. It is the very credothat governs every professional decision a doctor makes; however, in spite ofall good intentions and all professional expertise, there are times when asurgeon can unknowingly compromise patient safety.
Thermal burns to peripheral sites during electrosurgery are not uncommon, yetthey have long been an inherent risk of laparoendoscopic procedures. Incidencesare on the rise, since more minimally invasive surgeries are performed now thanever before, but with conscientious management, such injury can be avertedaltogether. It is the role of all perioperative support personnel to ensure thatwhich is preventable is indeed prevented, and in the case of electrosurgery, weno longer live in the dark ages.
In the past, all responsibility for monitoring the safety of electrosurgeryinstruments fell on the staff in Central Sterile (CS) departments. Today'stechnological advances have effectively shifted that duty to the operating room,but, in spite of such progress, some facilities continue to let it remain in thecentral processing unit, a practice that should be highly discouraged.
The problem lies in the nature of endoscopy/laparoscopy electrosurgicalinstruments themselves. Electrosurgery, both monopolar and bipolar, involvescutting tissue and controlling bleeding with electric current. Instruments usedin laparoscopy and other electrosurgeries must be insulated to ensure thatelectricity is directed to the operating tip, and shielded from escaping alongthe instrument shaft. Insulation materials vary, but no matter the source, allof it is degradable. The reality is that an instrument with faulty insulationcan conduct electricity through invisible lesions in the insulation, resultingin inadvertent damage to tissue or organs surrounding the targeted surgicalsite. Because the keyhole of minimally invasive surgery is so small, the surgeoncannot observe such phenomena outside his field of vision, and the consequencescan be catastrophic. Most injuries caused by insulation failure result inirreversible tissue death.
Accordingly, it is critical to patient safety that insulation be flawless toprevent escaping current. In its "Recommended Practices for Electrosurgery,"the AORN board of directors advises, "The active electrode should beinspected for damage, including impaired insulation, at the operative fieldbefore use."1 Yet, current modalities in many facilities don'tprovide for testing in the operating room. In spite of all advice to thecontrary, final inspection of instrument insulation is traditionally done in theCS department, prior to a tray's final packing and sterilization cycle. Thedangers are two-fold. First, most insulation defects are microscopic in size,and not readily visible to the naked eye. It is these very pinhole-sizedimperfections that can cause the most damage because the energy is soconcentrated, it tends to literally explode out of the perforation into thepatient. Unfortunately, these miniscule flaws are usually undetected. Secondly,already thinning insulation is subject to deteriorate completely during thatfinal processing cycle because of the assault of chemicals and hightemperatures. The set is then delivered to the operating room, where no one isaware that an instrument may have become compromised and is now unsafe.
During a laparoendoscopic procedure, only about 10% of an insulatedinstrument is visible on the video monitor at any one time, which means about90% of that electrode remains outside the surgeon's field of view, where it cancause the most damage. When a defective instrument is introduced into thepatient, electric current can escape to contiguous tissue or organs, but thesurgeon is not aware that a thermal burn at a peripheral site has occurred. Infact, it is estimated that 67% of such injuries are not recognized at surgery.2Unfortunately, manifestations of these unsuspected injuries don't appear untilseveral days after the actual surgery and so, when the impaired patientpresents, his or her clinical symptoms are already severe. Diagnosis isdifficult and often delayed, and the damage can be irreversible. Complicationsinclude perforated organs, permanent disfigurement, and in an estimated 28% offecal peritonitis cases, even death.
Certainly, because of the very biophysics of minimally invasiveelectrosurgery, there are other operatives that can result in thermal tissueabuse, such as capacitive coupling or direct coupling, but insulation failure isthe most alarming because it is highly preventable. Anecdotal evidence suggeststhat, without proactive intervention, more than 30% of laparoscopic instrumentsin any given facility have defective insulation. Ruptures in insulation areroutine, and are even commonly found on single-use, disposable instruments.
In fact, all insulated electrodes should be considered suspicious, unlessadequate safety measures are introduced. The traditional system for inspectionin the sterile processing department is hardly foolproof, and its weaknessesmust be addressed. Because the margin for error is so great, risk managers andphysicians alike are insisting on alternatives that will ensure patient safetyand reduce liability exposure.
To preclude claims of negligence, medical providers must use a series ofprocedures that can effectively protect a patient from the risk of accidentalthermal injury caused by damaged insulation. Certainly, instruments must beinspected prior to packing for sterilization, and pulled from the set whendefects are discovered. This should be only one step in the process, however,since pinholes in the insulation are virtually impossible to detect undercursory examination. Precautions also should include routine microscopicinspection by one's repair vendor, and an electronic scan if they have theproper technological means to do it.
Finally, the only absolute safeguard is to test for insulation defects in theoperating room, after the set has been opened. This step can significantlyreduce the number of accidental electrosurgical burns because it will prevent anotherwise unwitting surgeon from inserting a potentially lethal instrument intothe patient. Insulation that degraded during that final sterilization cyclecannot be detected until this point in time, so it is critical that inspectionin the operating room itself be made an integral part of hospital protocol. Itis advisable to keep a supply of single-use electrodes available to replace anyfound to be faulty during the preoperative scan. In lieu of stocking suchinventory, one also can devise a vigorous and ongoing inspection plan with aqualified repair vendor, to ensure that all reusable electrosurgical tools arescanned and reinsulated as needed. Certainly, a replacement would then beavailable from another set when problematic instruments are discovered in theoperating room prior to a case.
If the instruments are re-scanned in the operating room following surgery,the surgeon can be secure in the knowledge that no stray electrical currentescaped into adjacent, but unseen sites, and so if any post-op clinicalcomplications were to arise, he or she could more easily isolate the cause.Conversely, if the postoperative scan revealed that insulation was damagedduring the procedure, he or she may elect to take aggressive steps toinvestigate further. For documentation purposes, the results of both scans canbe recorded in the patient record.
The fact is that a defective electrode can instantly and irreversiblyimperile a patient. Delegating full responsibility for averting such disaster tothe technicians in the CS department places them in an untenable situation,simply because it is impossible to guarantee intact insulation on instrumentsthat will undergo sterilization following inspection. Enlightened managers nolonger accept that liability and appreciate that responsibility for finalinspection is a function best performed by the perioperative staff, in thesurgery suite itself.
The CS department continues to be vital in the detection of defectiveinstruments, but with the availability of technological innovations on themarket today, it no longer must be the final authority. It remains the role ofthe CS tech to identify those readily visible defects on instruments so they canbe sent for routine reinsulation. To have the most profound impact on patientsafety, however, cautious and informed facilities recognize that the definitivechallenge for uncovering microscopic flaws in insulation lies beyond therealistic capabilities of even the very best CS team.
Enlisting the support of the perioperative staff is critical. If equippedwith the proper tools, all electrosurgery patients and their surgeons canproceed with confidence, that every available step to prevent strayingelectrical current has been taken. For their peace of mind and that of allinstrument processing personnel, it is welcome clinical breakthrough.
Anne Reed is vice president of Mobile Instrument Service and Repair,Inc., of Bellefontaine, OH.
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