Reprocessed single-use devices in laparoscopy: assessment of cost, environmental impact, and patient safety

Renton, David; Denk, Peter M.; Varban, Oliver A.

doi:10.1007/s00464-018-6275-0

Cited by 9 publications

(10 citation statements)

References 17 publications

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“…Electrothermal bipolar vessel sealing device handpieces have the potential to fail because the instrument tips are more subject to abrasion and degradation after multiple use and resterilization, resulting in the inability to form an adequate seal . Any failure to create an appropriate vessel seal may result in life‐threatening hemorrhage, requirement for conversion of an MIS procedure to an open procedure, and/or additional patient‐related complications . This is a critical factor for the use of EBVS because failure of the handpieces to retain their performance after reuse and reprocessing cycles would limit their use …”

Section: Introductionmentioning

confidence: 99%

Evaluation of the performance of an endoscopic 3‐mm electrothermal bipolar vessel sealing device intended for single use after multiple use‐and‐resterilization cycles

et al. 2020

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Objective To evaluate the performance of an endoscopic 3‐mm electrothermal bipolar vessel sealing device (EBVS) intended for single use after multiple use‐and‐resterilization cycles. Study design Ex vivo study. Sample population Eight 3‐mm EBVS handpieces. Methods Handpieces were subjected to a maximum of 15 cycles of testing, including simulated surgery, sealing and burst pressure testing of porcine carotid arteries, reprocessing, and hydrogen peroxide plasma resterilization. Failure was defined as two sequential vascular seal leakage events occurring at <250 mm Hg. Histological evaluation, maximum external temperature of the jaws, sealing time, tissue adherence, jaw surface characterization, and mechanical deterioration were studied. Failure rate was analyzed by using a Kaplan–Meier curve. Linear and ordinal logistic mixed models were used to analyze sealing time, handpiece jaw temperature, and adherence score. Results Mean ± SD diameter of arteries was 3.22 ± 0.35 mm. Failure was observed starting at cycle 10 and going up to cycle 13 in 37.5% (3/8) of the handpieces. Tissue adherence increased after each cycle (P < .001). Maximum external temperature (79.8°C ± 13.9°C) and sealing time (1.8 ± 0.5 seconds) were not significantly different throughout cycles up to failure. A flatter surface and large scratches were observed microscopically throughout the jaw surface after repeated use and resterilization. Conclusion The 3‐mm EBVS handpiece evaluated in this study can be considered safe to use for up to nine reuse‐and‐resterilization cycles. Clinical significance These data provide the basis for establishing preliminary guidelines for the reuse and hydrogen peroxide plasma resterilization of an endoscopic 3‐mm EBVS handpiece.

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Section: Introductionmentioning

confidence: 99%

Evaluation of the performance of an endoscopic 3‐mm electrothermal bipolar vessel sealing device intended for single use after multiple use‐and‐resterilization cycles

et al. 2020

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“…Reprocessed versions of the same product retail for approximately $330 and $450, respectively, for an average cost savings of 30% ($138) per device. Another potential benefit is the environmental impact: collecting, reprocessing, and reusing SUDs can realize significant reductions in waste streams [ 10 ].…”

Section: Discussionmentioning

confidence: 99%

“…Despite lower purchase prices, the reprocessed SUDs may have quality issues that impact surgery, as previously noted [ 8 ], or create potential health risks, such as infection or inflammatory responses [ 4 , 9 ], that could impact quality of life and add cost to procedures in unanticipated ways. Existing functional and safety evidence for reprocessed SUD devices have been reviewed [ 10 ]; however, we are not aware of studies that examined reprocessed bipolar vessel sealing devices.…”

mentioning

confidence: 99%

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

2020

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Background Reprocessed devices must be thoroughly cleaned prior to sterilization to ensure efficacy of sterilization agents. Many single-use devices are not designed to be thoroughly cleaned. Interlocking design features inherent to LigaSure™ vessel sealing devices may prevent thorough cleaning and promote accumulation of human tissue that cannot be removed. Thus, the aim of this study was to compare industry reprocessed and new LigaSure™ vessel sealing devices for organic material. Methods A total of 168, 84 new and 84 reprocessed, vessel sealing devices were disassembled and inspected for the presence of residual organic matter using visual, microscopic, and chemical analysis. Devices were randomized and test conductors blinded to group membership. Devices were aseptically disassembled and sent through visual inspection. Next, devices were either examined using light microscopy, scanning electron microscopy (SEM) or exposed to a solution that luminesces in the presence of hemoglobin. Additionally, 165 reprocessed devices were sent to a 3rd party lab for sterility testing via direct immersion culture for 14 days. Results Significant amounts of remnant organic material (C, N, O, S, Na, P) were observed with 81/84 reprocessed and 0/84 new devices failing inspection protocols. When tested for the presence of hemoglobin, only 1/12 reprocessed devices passed inspection. SEM of reprocessed devices revealed residues with liquid patterns and diffuse soiling with foreign material. Sterility testing of reprocessed devices revealed a sterility level < 6–3. Conclusions The abundance of material resembling human tissue observed on reprocessed VSDs suggests inadequate cleaning prior to sterilization. Atomic and morphological analyses of the remnant materials suggest that bacterial biofilms could also be present. Additionally, surface degradation and release of reinforcing glass fibers from the device were observed. Devices designed for single use can harbor significant amounts of remnant material that likely interfere with the sterilization process.

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“…Several authors have documented a cost reduction of around 50% due to the use of reprocessed SUMDs [12-15]. Because of the strict requirements for a correct reprocessing, many hospitals use certified third-party outside bodies to reprocess their devices [16-19].…”

Section: Discussionmentioning

confidence: 99%

Reprocessing of Single-Use Medical Devices: Clinical and Financial Results

Martins¹,

Melo²,

Monteiro

et al. 2018

Port J Public Health

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Introduction: Excellent results regarding clinical efficacy and cost reduction are achieved by using certified reprocessed single-use medical devices (SUMDs). This explains why this practice is common in most hospitals across the USA and Germany. However, this is not a common practice at a national level and there are no reports regarding its use in Portugal. We present our experience using these methods at Centro Hospitalar de São João (CHSJ) in Porto. Objective: The aim of this study was to compare the clinical results and the financial impact of the use of 2 SUMDs, original and reprocessed, namely the linear suture machine GIA Covidien^TM and Harmonic ACE® scissors. Method: A group of 733 patients operated in 2014 was evaluated. Of these patients, 316 were operated on with reprocessed SUMDs and 417 with original SUMDs. Variables referring to the clinical and financial results were analyzed through clinical and management information provided by Unidade de Gestão Autónoma de Cirurgia. A comparison between groups was performed using the χ² test and the Mann-Whitney test. Results: Indicators related to clinical efficacy show that the use of these SUMDs, professionally reprocessed, did not represent any added risk in comparison to the use of original devices. Regarding costs, there is a very significant difference between the use of a new medical device and that of a reprocessed one. In the case of the Harmonic ACE® scissors and of the linear suture machine GIA Covidien^TM, savings were up to 50% per device. Conclusion: This study, the first in Portugal, confirms the economic advantages of reprocessing these 2 devices. The financial benefit was obtained with maintenance of the same clinical results as the ones achieved using original devices. These results are in line with the published literature, proving the validity of using SUMDs after professionally certified reprocessing.

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Reprocessed single-use devices in laparoscopy: assessment of cost, environmental impact, and patient safety

Cited by 9 publications

References 17 publications

Evaluation of the performance of an endoscopic 3‐mm electrothermal bipolar vessel sealing device intended for single use after multiple use‐and‐resterilization cycles

Evaluation of the performance of an endoscopic 3‐mm electrothermal bipolar vessel sealing device intended for single use after multiple use‐and‐resterilization cycles

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

Reprocessing of Single-Use Medical Devices: Clinical and Financial Results

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