With years of experience, McGan Technology came into being in 2003 when there were an estimated 2,500,000 surgeries involving electrosurgical instruments and in a number of operations patients suffered electrosurgical burns to non-targetted areas.
The McGan team recognized the need to assist Central Sterile and OR Directors to reduce, and hopefully eliminate these incidents.
A recent study indicated a 57% rate of failure in an evaluated group of reusable ESI’s. Another study showed a 3% failure rate in prepackaged disposable units. Insulation failure was most common in the distal third of the instruments compared to the middle or proximal third. One in five reusable laparoscopic instruments had an insulation failure.
Recommendation XV of AORN‘s 2010 Perioperative Standards and Recommended Practices page 453 states: “Surgical instruments should be inspected for cleanliness and proper working order after decontamination.” (PNDS: I70). “Inspecting instruments for sterilization before the assembly of trays provides an opportunity to identify those instruments that require additional cleaning or repair before use.” Recommendation XVI.f. states: “Instruments in disrepair should be tagged or labeled and removed from service until repaired.”
By only visually inspecting an ESI, an SPD technician will miss the extremely microscopic pinholes in the coatings. Recommendation XV.e of AORN states “Performing a visual inspection and performing any recommended technological evaluation before preparation for sterilization minimizes the risk of using defective instruments that could lead to patient injury. Detecting insulation failures well in advance of a surgical procedure provides time for equipment replacement.”
The March/April 2014 issue of IAHCSMM’ s Communiqué, page 31, specifically states for laparoscopic instruments “Function and insulation testing should be done before each sterilization.” In conclusion, the best area to test an insulated electrosurgical instrument is in the SPD. An insulation integrity tester should be used to ensure the microscopic pinholes and cracks are identified and tagged. When this happens, the instrument should be removed from service which, in both the short and long term, could save the hospital considerable time and money and improve patient care.
It was in response to these problems that the McGan team offered the industry a solution: inexpensive, highly reliable, insulation defect detection test equipment.
A must for every hospital that uses electrosurgical instruments.