Why Electrosurgical Instruments Should be Tested for Insulation Failure

The three causes of electrosurgical injuries from active electrodes are:

  1. Insulation failure ( also called insulation pin holes)
  2. Direct coupling of current and
  3. Capacitive coupling

Hospitals should introduce practices that identify and reduce the risk of injuries and complications from electro surgery.
(Paraphrased from AORN. Recommended Practices for Endoscopic Minimally Invasive Surgery, 1999 Standards, Recommended Practices, and Guidelines)

Journal of Healthcare Risk Management. (Winter 1998; 18(1): 50, 53, 54) stated that:“…hospitals might also be criticized for its failure to employ certain available safety equipment —to mitigate the risk of these (electrosurgical) procedures.” “While the laparoscope provides a detailed view of the tip of the active electrode, up to 90% of the presumably insulated part of the electrode may be beyond the surgeon’s view at any one time.”1

“Insulation failure occurs when the insulated shaft of the electrode—designed to protect against the release of stray electrical current— becomes compromised due to excessive voltage, abuse, wear and tear, poor handling, or mechanical accident. Insulation breakdown can occur cumulatively over time or can take place during a single laparoscopic procedure

Visual inspection will miss many of the small hidden defects along the shaft, which during an operation may cause unintended tissue burns. “Hospital risk managers, hospital insurers, physician insurers, and surgeons have a strong incentive to protect themselves and their institutions from the financial and legal risks associated with such injuries.”3 It is estimated by the Physician Insurers Association of America that electrosurgical burns occur in slightly more than 5% of the laparoscopies performed in America.4 In 2004, there will be an estimated 1.5 million of these surgical operations performed, which means that there will be almost 100,000 unintended electrosurgical burns this year. The number of electrosurgical operations is expected to continue to dramatically increase annually. “Not surprisingly, the increasing number and scope of malpractice claims citing injury during laparoscopic surgery has prompted the formation of a special Laparoscopic Litigation Group within the Association of Trial Lawyers of America.” 5 The position of this group is that operations where unintended tissue burns occur provide a strong case for malpractice suits. “According to one of the group’s founders, surgeons and hospitals may be targeted both for specific surgical errors as well as for simply using electro surgery tools and instruments that allowed stray current to injure a patient.” 5 “The danger of serious or fatal thermal injury during laparoscopic mono polar electro surgery, however, must be minimized in order to protect patients and reduce medical/legal risk to healthcare institutions and healthcare professionals.”3

“Proper maintenance and testing of instruments by biomedical engineers has been proposed as one of the best approaches to reduce the risk of inadvertent tissue burns during laparoscopic mono polar electro surgery due to insulation breakdown.

“Currently, there are no accepted standards or protocols for such maintenance or testing, even though it is widely recognized that laparoscopic instruments—which are generally used until they fail—may possess defects that can lead to insulation failure. The current lack of testing and maintenance probably stems from the fact that most biomedical engineers would appear to be unaware that the stray energy problem exists or that it can produce significant injury.”5 One of the best methods to reliably test for insulation failure in electrosurgical instruments is to utilize a non-destructive method to detect the smallest pinhole or crack along the entire shaft of the instrument including near its handle.
This can be accomplished by using the MicroMed PD-8K Insulation Defect Detector which provides the user with a visual and audible indicator when a defect is located providing the hospital with an added safe guard and a method to reduce the risk of injury by stray electrical current caused by defects in the insulation of electrosurgical instruments.

References

  • Odell RC. Electrosurgery in laparoscopy. Infertility and Reproductive Medicine Clinics of North America. 1993;4:289-304
  • Tucker RD, Voyles CR. Laparoscopic electrosurgical complications and their prevention. AORN Journal. 1995;62:51-78
  • Communicore Communications In Medicine, Avoiding Electrosurgical Injury During Laparoscopy: An Emerging Patient Safety Issue
  • PIAA Laparoscopic Injury Study, August 2000.
  • Lap electrosurgery targeted by malpractice attorneys. Laparoscopic Surgery Update. 1995;3:87
  • Capelouto CC, Kavoussi LR. Complications of laparoscopic surgery. Urology. 1993;42:2-12

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