Assessing organic material on single-use vessel sealing devices: a comparative study of reprocessed and new LigaSure™ devices

Area of Science:

• Biomedical Engineering
• Materials Science
• Infectious Disease Prevention

Background:

• Thorough cleaning of reprocessed medical devices is critical for sterilization efficacy.
• Single-use devices, like LigaSure™ vessel sealing devices (VSDs), may present cleaning challenges due to intricate designs.
• Interlocking features in VSDs can trap human tissue, hindering effective cleaning.

Purpose of the Study:

• To compare the presence of organic material in new versus reprocessed LigaSure™ vessel sealing devices.
• To assess the effectiveness of cleaning protocols for reprocessed VSDs.

Main Methods:

• 168 VSDs (84 new, 84 reprocessed) were disassembled and analyzed for organic matter.
• Methods included visual inspection, light microscopy, scanning electron microscopy (SEM), and chemical analysis for hemoglobin.
• Reprocessed devices underwent third-party sterility testing.

Main Results:

• 81/84 reprocessed devices failed inspection for organic material, compared to 0/84 new devices.
• Only 1/12 reprocessed devices tested positive for hemoglobin.
• SEM revealed residues and foreign material on reprocessed devices; sterility testing showed levels <6^-3.

Conclusions:

• Reprocessed VSDs harbor substantial organic material, suggesting inadequate cleaning.
• Remnant materials may indicate bacterial biofilm presence and interfere with sterilization.
• Surface degradation and fiber release were noted, raising concerns about device integrity and safety.