Biomed Instrum Technol. 2026;60(2):9-18. doi: 10.2345/0899-8205-60.2.9. Epub 2026 Apr 7.
ABSTRACT
Objectives: Electrical leakage from laparoscopic instruments with defective insulation places patients, surgeons, and perioperative personnel at risk of shocks or burns. The primary objectives of this multisite study were to determine the prevalence of insulation defects, characterize the location and nature of defects, and compare the effectiveness of visual inspection and an insulation integrity tester (IIT) for detecting nonintact insulation. Methods: Researchers assessed laparoscopic instruments in a tertiary care center, pediatric hospital, and ambulatory surgery center. Assessments included visually inspecting shafts and handles using the facility’s normal methods and testing with an IIT. Defects were inspected and photographed at high magnification with a microscope. Results: A total of 259 instruments contained in 29 trays were evaluated. Defects were found on 13.1% (34 of 259) of instruments, and 58.6% (17 of 29) of trays contained at least one defective instrument. Of the 34 instruments with defective insulation, 9 (26.5%) had defects detected by both methods, 13 (38.2%) had defects found exclusively by visual inspection, and 12 (35.3%) had defects identified exclusively by testing. Defect prevalence varied by location on the instrument, with defects identified on 31.3% (15 of 48) of handles and 8.3% (20 of 240) of shafts. Visual inspection and testing required 11 seconds and 36 seconds (mean) per instrument, respectively. Conclusion: Given the high incidence of defective instruments found in laparoscopic trays and the potential risk for patient or personnel injury, healthcare facilities should consider implementing standardized quality assurance protocols that incorporate both systematic visual inspection and routine insulation integrity testing of all insulated instruments during sterile processing cycles. These protocols will require additional time and resources.
PMID:41945795 | DOI:10.2345/0899-8205-60.2.9
