by Anne Reed
“I shall protect them from all harm.” From the Hippocratic Oath, it is the mandate under which all physicians serve. It dictates that above all else, during the course of any medical intervention, no additional injury shall be inflicted upon one’s patient. It is the very credo that governs every professional decision a doctor makes, however, in spite of all good intentions, and all professional expertise, there are times when a surgeon can unknowingly compromise patient safety.
Thermal burns to peripheral sites during electrosurgery are not uncommon, yet have long been an inherent risk of laparoendoscopic procedures. Incidences are on the rise, in fact, since more minimally invasive surgeries are performed now than ever before, but with conscientious management, such injury can be averted altogether. It is the role of all perioperative support personnel to ensure that, that which is preventable is indeed prevented, and in the case of electrosurgery, we no longer live in the dark ages.
In the past, all responsibility for monitoring the safety of electrosurgery instruments fell on the staff in Central Sterile Processing departments. Today’s technological advances have effectively shifted that duty to the operating room, but, in spite of such progress, some facilities continue to let it remain in the Central Processing unit, a practice that should be highly discouraged.
The problem lies in the nature of endoscopy/ laparoscopy electrosurgical instruments themselves. Electrosurgery, both monopolar and bipolar, involves cutting tissue and controlling bleeding with electric current. Instruments used in laparoscopy and other electrosurgeries must be insulated to ensure that electricity is directed to the operating tip, and shielded from escaping along the instrument shaft. Insulation materials vary, but no matter the source, all of it is degradable. The reality is that an instrument with faulty insulation can conduct electricity through invisible lesions in the insulation, resulting in inadvertent damage to tissue or organs surrounding the targeted surgical site. Because the keyhole of minimally invasive surgery is so small, the surgeon cannot observe such phenomena outside his field of vision. The consequences can be catastrophic. Most injuries caused by insulation failure result in irreversible tissue death.
Accordingly, it is critical to patient safety that insulation be flawless to prevent escaping current. The AORN Board of Directors in its “Recommended Practices for Electrosurgery” advises, “The active electrode should be inspected for damage, including impaired insulation, at the operative field before use.”
Yet, current modalities in many facilities don’t provide for testing in the operating room. In spite of all advice to the contrary, final inspection of instrument insulation is traditionally done in the Central Sterile department, prior to a tray’s final packing and sterilization cycle. The dangers are two-fold. First, most insulation defects are microscopic in size, and so not readily visible to the naked eye. It is these very pinhole-sized imperfections that can cause the most damage, because the energy is so concentrated, it tends to literally explode out of the perforation into the patient, yet these miniscule flaws are usually undetected. Secondly, already thinning insulation is subject to deteriorate completely during that final processing cycle because of the assault of chemicals and high temperatures. The set is then delivered to the operating room, where no one is aware that an instrument may have become compromised and is now unsafe.
During a laparoendoscopic procedure, only about 10% of an insulated instrument is visible on the video monitor at any one time, which means about 90% of that electrode remains outside the surgeon’s field of view, where it can cause the most damage. When a defective instrument is introduced into the patient, electric current can escape to contiguous tissue or organs, but the surgeon is not aware that a thermal burn at a peripheral site has occurred. In fact, it is estimated that 67% of such injuries are not recognized at surgery. Unfortunately, manifestations of these unsuspected injuries don’t appear until several days after the actual surgery and so, when the impaired patient presents, his or her clinical symptoms are already severe. Diagnosis is difficult and often delayed, and the damage can be irreversible. Complications include perforated organs, permanent disfigurement, and in an estimated 28% of fecal peritonitis cases, even death.
Certainly, because of the very biophysics of minimally invasive electrosurgery, there are other operatives that can result in thermal tissue abuse, such as capacitive coupling or direct coupling, but insulation failure is the most alarming because it is highly preventable. Anecdotal evidence suggests that, without proactive intervention, over 30% of laparoscopic instruments in any given facility have defective insulation. Ruptures in insulation are routine, and are even commonly found on single-use, disposable instruments.
In fact, all insulated electrodes should be considered suspicious, unless adequate safety measures are introduced. The traditional system for inspection in the sterile processing department is hardly foolproof, and its weaknesses must be addressed. Because the margin for error is so great, risk managers and physicians alike are insisting on alternatives that will ensure patient safety and reduce liability exposure.
To preclude claims of negligence, medical providers must put into place a series of procedures that can, to the fullest extent possible, effectively protect a patient from the risk of accidental thermal injury caused by damaged insulation. Certainly, instruments must be inspected prior to packing for sterilization, and pulled from the set when defects are discovered. This should be only one step in the process, however, since pinholes in the insulation are virtually impossible to detect under cursory examination.
Precautions should also include routine microscopic inspection by one’s repair vendor, and an electronic scan if they have the proper technological means to do it. It’s important to learn what device they use for scanning because some are outdated and can actually inflict further damage to the insulation. A common testing device, L.I.T., has been recalled by its manufacturer for that reason. A properly equipped repair technician should be able to demonstrate to you any defects he or she identified, and then re-insulate the instruments immediately. Even following re-insulation, they should be scanned to ensure proper application.
Finally, however, the only absolute safeguard is to test for insulation defects in the operating room, after the set has been opened. “Both reusable and single use electrodes should be inspected preoperatively and postoperatively, and the results should be recorded in the surgical record. . . . A significant cause of injuries from active electrode insulation defects is failure to identify existing insulation defects on electrodes before surgery,” advise authors in Health Devices magazine.
This step can significantly reduce the number of accidental electrosurgical burns because it will prevent an otherwise unwitting surgeon from inserting a potentially lethal instrument into the patient. Insulation that degraded during that final sterilization cycle cannot be detected until this point in time, so it is critical that inspection in the operating room itself be made an integral part of hospital protocol. One device on the market, InsulScan™, is notable, in that it is approved for use in the operating room. Using sterile, disposable testing wands, it takes only seconds to scan a set of instruments for invisible insulation defects.
It is advisable to keep a supply of single-use electrodes available to replace any found to be faulty during the preoperative scan. In lieu of stocking such inventory, one can also devise a vigorous and ongoing inspection plan with a qualified repair vendor, to ensure that all reusable electrosurgical tools are scanned and reinsulated as needed. Certainly, a replacement would then be available from another set when problematic instruments are discovered in the operating 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 current escaped into adjacent, but unseen sites, and so if any post-op clinical complications were to arise, he or she could more easily isolate the cause. Conversely, if the postoperative scan revealed that insulation was damaged during the procedure, he or she may elect to take aggressive steps to investigate further. For documentation purposes, the results of both scans can be recorded in the patient record.
The fact is that a defective electrode can instantly and irreversibly imperil a patient. Delegating full responsibility for averting such disaster to the technicians in the Central Sterile Processing department places them in an untenable situation, simply because it is impossible to guarantee intact insulation on instruments that will undergo sterilization following inspection.
Enlightened managers no longer accept that liability and appreciate that responsibility for final inspection is a function best performed by the perioperative staff, in the surgery suite itself.
Surgeons, subject to malpractice claims resulting from accidental thermal burn, are also insisting on enhanced precautions to protect them and their patients, as well. Thirteen percent of members of The Society of Laparoscopic Surgeons surveyed said they had one or more malpractice cases involving a laparoscopic electrosurgical procedure (4).
Hospitals and surgery centers remain accountable even if they don’t know an instrument is defective. “. . . With liability risks for instrument malfunction equal to those for surgeon error, it would be prudent for hospitals to ensure that they have an adequate system in place for maintaining equipment and testing it for insulation degradation.”(5)
Most importantly, there are preventive measures available today that didn’t exist years ago. Consequently, traditional defenses against related lawsuits are no longer viable in the courtroom. Electrosurgical mishaps are common enough to have given rise to a Laparoscopic Surgery subgroup of the Association of Trial Lawyers of America, which consists of over 130 attorneys dedicated to pursuing litigation arising from thermal burning in minimally invasive lap/endo procedures.
There is indeed, a formidable risk. The Central Sterile department continues to be vital in the detection of defective instruments, but with the availability of technological innovations on the market today, it no longer must be the final authority. It remains the role of the C.S. tech to identify those readily visible defects on instruments so they can be sent for routine reinsulation. To have the most profound impact on patient safety, however, cautious and informed facilities recognize that the definitive challenge for uncovering microscopic flaws in insulation lies beyond the realistic capabilities of even the very best Central Sterile team.
Enlisting the support of the perioperative staff is critical. If equipped with the proper tools, all electrosurgery patients and their surgeons can proceed with confidence, that every available step to prevent straying electrical current has been taken. For their peace of mind and that of all instrument processing personnel, it is a welcome clinical breakthrough.
Reprinted with permission of Infection Control Today