Description: Purpose/Literature Review: Reprocessing of single-use medical devices is appealing from economic and sustainability perspectives; however, many single-use devices are not designed to facilitate thorough cleaning prior to sterilization. There is a lack of research evaluating the safety and efficacy of reprocessing single-use devices, so much so that the Society of Gastroenterology Nurses and Associates issued a position statement saying that critical devices marked as single-use should not be re-used. Hypothesis: It is hypothesized that vessel sealing devices cannot be adequately cleaned during the reprocessing process due to design features such as over-molding and press fits that can only be disassembled destructively.
Methods: This hypothesis was tested experimentally. Specifically, 84 new and 84 reprocessed vessel sealing devices were disassembled, visually inspected and analyzed using scanning electron, laser confocal and optical microscopy along with energy dispersive X-ray spectroscopy. Devices were tested for the presence of hemoglobin, protein and DNA using commercially available assays. Additionally, 125 samples were sent to an external lab for bacterial culture. Care was taken to create a common frame of reference for comparing devices, blinding test conductors to device group, and preventing cross-contamination. Due to the destructive nature of the testing, devices were divided into smaller groups for subsequent testing after visual inspection.
Results: In total, 44/84 reprocessed and 0/84 new devices failed visual inspection due to the presence of residual, presumably organic, material seen on the device. Of the devices further assessed using optical microscopy 6/6 reprocessed and 0/6 new devices were found to have remnant material that is presumably human tissue judging by the reddish-brown or yellow color. Hemoglobin was identified on 19/36 reprocessed and 0/36 new devices. Reprocessed large jaw devices were found to have more than 6 times (p=0.007) as much protein and 3 times (p=0.005) as much DNA present when compared to new devices. One reprocessed device produced a bacterial culture positive for Bacillus thuringiensis. Conclusions/
Discussion: Reprocessed, single-use vessel sealing devices have been found to contain material deposited during previous use. It is well known that the first step in the sterilization process is thorough cleaning, without which sterilization procedures can be ineffective. Given the findings of this study, and regulatory guidelines on proper sterilization procedures, reprocessing devices designed for single-use could pose infection risks to patients. Perioperative Nursing Implications: This study may serve to influence device sourcing, vendor selection, surgical-site infection tracking and monitoring as well as reprocessing procedures and protocols. Disclosure: This work was funded by a medical device manufacturer. Normal 0
Co-Authors: Swathi Ramesh Chivukula, Steven Lammers | Disclosure(s): Jennifer Wagner - Medtronic - Grant/Research Support; Steven Lammers - Medtronic - Grant/Research Support; Swathi Ramesh Chivukula - Medtronic - Grant/Research Support