What are the advantages of Powered Surgical Staplers - Lookmed

What are the advantages of Powered Surgical Staplers?

Whether it's a wound caused by a trauma or a surgical incision, doctors use a variety of methods to close the wound to allow the split skin to heal better and faster later on. What are the advantages of using Powered Surgical Staplers to staunch a wound compared to traditional“Needle and thread” stitches?

Ezisurg supply professional and honest service.

There are many ways to close a wound in common use. Of course, the most classic and standard method is to use“Needle and thread” to close a wound. However, in addition to needle and thread, there are other ways to close a wound in clinical practice, examples include the most common: tissue adhesives (also called skin glues), butterfly tape pastes, and today's Powered Surgical Staplers.

Powered Surgical Staplers Pros:

1. Close wounds quickly

Although in most cases, the surgeon can slowly and carefully close the wound, for some special cases, such as severe trauma, bleeding has been a lot, the operation time is long, anesthesia has been a lot, and patients with the poor general condition need to return to the ward or ICU and so on. It is particularly important to close the wound and end the operation as soon as possible.

After all, faster wound closure means less surgery time, less bleeding, less use of anesthetic, and lower anesthesia and surgical risk. At this point, Powered Surgical Staplers have the advantage of quickly closing the wound, compared to regular stitch-by-stitch sutures.

In addition, surgical Powered Staplers are better suited to handle a large number of patients with acute trauma resulting from public emergencies because they perform wound closure tasks more quickly, given the limited number of doctors available, the wound needs to be closed as soon as possible to treat the next patient.

2. Relatively safe

Ordinary stitching needle is curved, stitching process needs to be down“Pocket” tissue suture, which may hurt or even sew the deep structure. Surgical Powered Staplers pose a lower risk of accidental needle stick injury than stitches.

These are the benefits of Powered Surgical Staplers, so feel free to contact us if you have any other questions.

Reduction in surgical waste via multi-use surgical staplers

Introduction

The environmental threats we currently face are multi-faceted, far-reaching, and severe, with the climate-related consequences arising from healthcare activity increasingly identified as unsustainable and a cause for concern.1–3 One such concern pertains to excess resource consumption and waste production. It is estimated that United States (US) hospitals generate 8.4 kg waste per patient per day, whereas United Kingdom (UK) hospitals produce on average 3.3 kg of waste per patient per day.4 At the national level, US hospitals reportedly produce 5.9 megatons of waste each year,5 whilst the UK National Health Service (NHS), between and , disposed of 538,600 tons of waste, costing £115 million.5 Confronting excess resource consumption and waste, and recognizing the value from raw materials that is lost when manufactured products are used once and then discarded should therefore be prioritized in order to encourage more sustainable resource use practices in the healthcare sector.6

Since the start of the 20th century, the demand for material resources has increased, resulting in a widening disequilibrium between material inflows and outflows; the amount of materials extracted during this period increased 16-fold, whilst the rate of input materials that are (re) cycled almost halved from 43% to 27%.7 After recognizing the unsustainability of this uninhibited utilization of scarce resources, the concept of a circular economy (CE) was established,6 dictating that manufactured products and used materials should remain in circulation for as long as possible before being recycled or finally disposed. This restorative or regenerative circular approach to resource utilization creates an opportunity to minimize unnecessary waste output through improved resource efficiencies, offered by long-lasting medical devices that allow for reuse, repair, remanufacturing, or high quality recycling.8 This CE approach strives to slow, narrow and close socioeconomic material cycles,9 by reducing absolute material flows.3,7,10 It is fundamentally different to a traditional linear economy whereby raw materials are collected, transformed into products, used once, and discarded as waste.

Within the hospital, surgery is recognized as a resource-intensive activity that follows principles of the linear economy, disproportionately generating large volumes of healthcare waste.11–13 Around one-third of waste generated by the healthcare system is estimated to originate from the operating room (OR),14 with US ORs producing an estimated 730,500 tons of waste each year.15 Of the OR waste produced, up to 90% is wrongly classified as biohazardous waste, meaning it cannot be repurposed, reduced, or recycled, but has to be treated in a manner which prevents any future health risks.12 Misclassification also has cost implications, given that treatment and disposal of biohazardous waste can cost up to 20-times more than non-hazardous waste.12 Further, the extensive use and convenience of single-use, disposable medical supplies has contributed substantially the problem of health-sector waste, and more broadly to the problem of scarce resource depletion.12,16 As such, tackling the ORs reliance on single-use disposable medical devices and ensuring that resources are used efficiently represents an “area of highest impact for health-care decarbonization” and resource savings.16,17

Given that there are a large number of OR procedures applying surgical stapling techniques, procedures using these techniques are of interest for assessing the extent to which resource management efficiencies can be achieved. Although stapling techniques are used across a range of procedures, to the best of our knowledge to date, no publication attempts to assess resource consumption and waste-reduction in the context of surgical stapling.

The primary focus of this analysis is therefore to evaluate the waste prevention potential and extended resource use of multi-use versus single-use powered surgical stapling systems. A CE approach is used to understand whether transitioning from a single-use system (SUS) to a multi-use system (MUS) could facilitate a more efficient use of scarce resources and contribute to healthcare providers’ aims of protecting these resources, whilst also reducing total medical waste.

Materials and Methods

Overview of Analysis Methodology

Surgery often involves the separation or removal of tissue, which requires the subsequent approximation of tissue to close the wound. Surgical stapling is one method of closure. This analysis compares two frequently used surgical, laparoscopic stapling systems; Ethicon’s SUS: ECHELON FLEX™, and Medtronic’s MUS: Signia™ Stapling Technology.18 Modern surgical stapling systems come in a variety of forms and functions depending on the surgical application. Generally, each stapler features a power handle (including battery) which is held by the surgeon, an adapter which is fixed to the power handle, and attached to the end of the adapter is a disposable cartridge holder which houses the staples. The key steps of the approach taken in this study are summarized in Table 1.

Product Material Analysis

The first stage of the analysis was the product material analysis. This involved disassembling the SUS and MUS (excluding all product and sales packaging) to their individual raw-material components and calculating the total weight of each component (composed of multiple raw materials). The types of raw materials in each component were then identified by measuring material density as well as through visual inspection. Finally, the total weight of each material was calculated to understand the material composition of each system.

For the SUS, the products PVE35A, VASECR35, ECR45G, PSEE60A, and ECR60W were mechanically deconstructed and assessed. No component of the SUS is reusable. A PSEE45A power adapter and handle was not mechanically deconstructed and assessed given that the product length of the PSEE45A is identical to the PSEE60A. For the MUS, the reusable product components SIGPHANDLE, SIGADAPTSTND, SIGRIG, SIGSBCHGR, and the single-use components SIGPSHELL, EGIA30XXX, EGIA45XXX, and EGIA60XXX were analyzed. Product components ending XXX indicate that different cartridge holder options are available to the surgeon when operating on different tissue thicknesses, but the core component (and therefore the component’s mass) is unchanged. The surgical stapling systems included in this analysis and their corresponding components and component product codes are summarized.

Waste Generation

Based on the results of the product material analysis, the second stage of the study was to understand how much waste would be generated when SUSs or MUSs are used in clinical practice. The power handle and adapter of the SUS can be used multiple times per procedure but must be disposed of after each surgery, and the SUS cartridge holders must be disposed of after each firing. For the MUS, the power shell is disposed of after each surgery and the cartridges are disposed of after each firing. However, the device handle, adapter, insertion guide, and charging station are reusable and should only be replaced after a pre-defined number of uses. These device component replacement frequencies, presented as circulation ratios, are shown in Table 3. To estimate the share of waste related to one use circle, the total waste generated was divided by the number of uses possible (the circulation ratio).

Three surgical procedures requiring stapling techniques were selected for this comparative analysis. These procedures are laparoscopic sleeve gastrectomy, laparoscopic gastric bypass, and video-assisted thoracoscopic (VATS) lobectomy. For each of these procedures, the functional unit is defined by the product parts required to perform each procedure. Although cartridge use is likely to vary across surgical practice, clinical expert opinion was sought to estimate the expected number and type of stapling cartridges needed for each surgery of interest. The number and length of cartridges required per procedure differs. These estimates are presented.

With these component-specific circulation ratios, as well as an estimate of the average number and length of cartridges required during each surgical procedure, system waste accumulated per procedure was calculated. Additionally, the waste prevention potential of switching from a SUS to MUS was calculated by comparing the total waste generated per device for each surgical procedure.

TMR

The third stage of the study was to compute the total material requirement (TMR) associated with each component and system. TMR, based on the concept of material input per service, is a metric which reflects all abiotic and biotic material as well as the moved soil needed to manufacture a product or a service. The use of air and water in the production process is not taken into consideration in this metric.19,20 For the calculation, the material composition of a product is analyzed. The masses of all used elements are multiplied with specific TMR-coefficients that reflect the primary material use. Therefore, TMR expresses the cumulative mass of primary materials which are extracted for the analyzed product and can be summarized as an indicator for the material intensity of the product.21 In the context of this analysis, calculating the TMR of each system provides an estimate of the natural resource burden linked to each system. This approach differs to a life-cycle assessment (LCA) given that the TMR considers a narrower range of ecological impacts and does not account for end-of-life scenarios.

Based on the material composition and weight of each system, a TMR was calculated for each component (excluding product and sales packaging). The TMR of each system component was then extrapolated to calculate the upstream resource use associated with each surgery (laparoscopic sleeve gastrectomy, laparoscopic gastric bypass, and VATS lobectomy).

Sensitivity Analysis

Finally, sensitivity analyses were conducted to understand how results of this study would be impacted under different input assumptions, to identify dependencies and strengthen conclusions.22 Specifically, varying the level of usage associated with each multi-use component (circulation ratios) was explored to identify the impact this would have on waste prevention potential and extended resource use (TMR) results.

Results

Product Material Analysis

Following mechanical deconstruction, the total weight of each system component was calculated. These results are summarized in Table 5. The material composition of each stapling system (grouped as either circuit boards, motor, glass, metals, plastics, or other) was also calculated. This was calculated for appropriate combinations of cartridge holders (for example, the SUS’s 35 mm cartridge holder [VASSECR35] cannot be used with the 60 mm power handle and adapter [PSEE60A]). The total weight of each surgical stapling system is presented in Table 6.

Mechanically deconstructing and analyzing the make-up of each system (Table 6) revealed that the SUS and MUS are manufactured from a variety of different materials, with the composition of the MUS requiring more materials than the SUS. As shown in Table 6, there is no glass in the SUS, and it is manufactured from fewer thermoplastics than the MUS. The SUS, with either the VASECR35, ECR45, or ECR60 cartridge holders attached, had a total mass of 664.83 g, 694.14 g, and 695.00 g, respectively, with the greatest share of mass attributed to metals (40%, 42%, and 42% of total mass). By comparison, the MUS, with either the EGIA30XXX, EGIA45XXX, or EGIA60XXX cartridge holders attached, had a total mass of .27 g, .14, and .74 g, respectively, with plastics constituting the greatest share of total mass (49% for each surgical procedure considered).

Waste Generation

Based on the device component weights determined by the material composition analysis (Table 5) and the expected circulation ratio of each component per procedure (Table 4), total waste for each system was determined. Total waste accumulated using the SUS versus MUS for different surgical procedures is presented in Table 7 and reveals that compared to the SUS, use of the MUS leads to a reduction in the total amount of system waste accumulated per surgical procedure. For each surgery considered, switching from the SUS to the MUS results in a reduction in the amount of accumulated waste by −0.29 kg, −0.96 kg, and −0.86 kg for sleeve gastrectomy, gastric bypass, and VATS lobectomy, respectively. This reduction in system waste translates to a waste prevention potential of 40% for laparoscopic sleeve gastrectomy, 70% for laparoscopic gastric bypass, and 62% for VATS lobectomy procedures.

TMR

Using total component weights and the material type (TMR-factors) identified following mechanical deconstruction of each system, TMR was calculated for each component use to evaluate its extended resource use. TMR results are presented in Table 8 for each system component. These results show that the TMR of the SUS 60 mm power handle and adapter (PSEE60A) is the most resource-intensive component of the SUS, requiring 328 kg of resources for its production. The most resource-intensive component of the MUS was the handle (SIGPHANDLE), requiring 560 kg of resources. The TMR of all cartridge holders (EGIA30XXX, EGIA45XXX, and EGIA60XXX) required for the MUS were substantially greater than the TMR for cartridge holders required for the SUS.

After factoring in component reuse during surgery, the TMRs associated with each product component were calculated and the results are presented in Table 9. Table 9 shows that the reduction in TMR for surgical procedures when switching from a SUS to a MUS is substantial. The TMR drops from 329 kg to 27 kg for laparoscopic sleeve gastrectomy, 633 kg to 25 kg for laparoscopic gastric bypass, and 633 kg to 34 kg for VATS lobectomy. In all three procedures, the per-procedure TMR is reduced by over 90%, suggesting that over 90% of total raw material inputs utilized in the production of the SUS can be saved by switching to use of the MUS.

Sensitivity Analysis

To examine the importance of reusing product components where possible, a sensitivity analysis was conducted calculating total waste generated and TMR for each surgical procedure where MUS components were used sub-optimally before being disposed of. The results of these sensitivity analyses are presented in Table 10.

These results show that if the MUS were disposed of after a single use for these surgeries, waste generation and resource use of the MUS would exceed that of the SUS. In the single-use MUS scenario, waste generation increases by 1.13 kg for laparoscopic sleeve gastrectomy, 0.46 kg for laparoscopic gastric bypass, and 0.57 kg for VATS lobectomy when compared to SUS. TMR rises by 574 kg, 269 kg, and 277 kg across these respective surgical procedures. If each MUS multi-use component were utilized half of the number of times that they should maximally be used for, total waste accumulated and TMR per surgery for MUSs would still be lower than with the SUS.

Figure 1 presents sensitivity results where total waste and TMR are calculated for each surgery type considered whilst varying the number of times that each multi-use component is reused between one and ten. For laparoscopic sleeve gastrectomy, multi-use components must be reused at least five times for the total waste generated during the procedure with the MUS to be lower than with the SUS. Figure 1 also shows that to achieve a lower TMR with the MUS than the SUS, the multi-use MUS components must be used at least three times. The required number of reuses for other surgery types are also shown in Figure 1. These results highlight the importance of reusing MUS components where possible and indicate that results are highly (or even totally) independent to lower circulation rates.

Abbreviations: kg, kilogram; MUS, multi-use system; SUS, single-use system; TMR, total material requirement; VATS, video-assisted thoracoscopic.

Discussion

By implementing CE principles in the OR through switching to MUSs as opposed to SUS, this analysis suggests that total volumes of operating room waste accumulated during different procedures can be reduced substantially. Little published evidence exists which evaluates high volume products, such as single-use surgical stapling devices. With this study we fill an important evidence gap and thus support hospital decision makers in transitioning from a linear to a CE resource consumption model.

Based on the results of this analysis, in clinical practice the potential to reduce operating room waste by applying CE principles is considerable. For example, UK NHS Reference Costs – report that sleeve gastrectomy for obesity procedures (FF12Z) were undertaken across all NHS trusts and NHS foundation trusts.23 If all these procedures were performed by surgeons using SUSs, the total waste generated and TMR for these procedures would amount to kg and 701,219 kg, respectively. However, if a multi-use system were instead used, the total accumulated waste and TMR these sleeve gastrectomy for obesity procedures would have amounted to 916 kg and 56,649 kg, respectively. Switching from a SUS to MUS for these procedures therefore equates to a 620 kg (40%) reduction in total waste accumulated, and a 644,571 kg (92%) reduction in TMR. Given that the NHS have also pledged to reduce reliance on disposable plastics, with a short-term aim to reduce clinical single-use plastics by 10%, evaluating the typical use of single-use systems in clinical practice presents an opportunity to realize this target.24

In terms of costs, a Royal College of Nursing report found that the median cost per ton of infectious (yellow-bagged) waste was £475, amounting to £0.48 per kg.25 Applied to the NHS example of sleeve gastrectomy (for obesity procedures), the cost of disposing of the waste produced by SUSs ( kg) would equate to £729, versus £435 for the cost of disposing of waste produced by MUSs (916 kg). This simplified calculation reveals a cost saving of £294 for these procedures, suggesting that the environmental benefits of CE may also yield monetary benefits. After signing up to the NHS Plastics Reduction Pledge in /20, the Yorkshire Ambulance Service NHS Trust recorded a four-ton reduction in total annual waste which led to a £12,000 saving in packaging, delivery, and disposal costs,24 confirming that CE principles can lead to economic benefits.

Although the results of this analysis are promising, this study contains limitations. Firstly, this analysis only considers one brand of SUS and one brand of MUS, but it is unlikely that in clinical practice these are the only stapling devices used by hospitals. The material composition of alternative SUSs or MUSs used in clinical practice may also differ to that of the devices analyzed here, and this may lead to different results and conclusions. For example, only the “standard” shaft length SUS staplers were considered in this analysis. The “compact” and “long” models were not analyzed, but if they were used in lieu of the “standard” SUS for some procedures, then results would be expected to differ slightly given that the overall material composition of these devices differs. As such, the results presented in this analysis should only be considered within the context of this study, and further analyses should be conducted at the hospital level for alternative devices of interest.

An additional study limitation is that system costs were excluded from this analysis. Within the recent past, both the widespread adoption of single-use, low-cost technologies, which allowed manufacturers of complex medical devices to manufacturer devices using low-cost plastics, and the rapid uptake of minimally invasive surgical techniques, have led to an influx of complex, high-frequency use medical devices (such as surgical stapling devices) in the market.6 Paired with highly limited hospital budgets, these low-cost technologies have helped to keep the per device hospital spend on some medical devices low, arguably at the expense of the environment. Moving forward, cost will remain a key driver of decisions at the hospital payer level, and the expected higher upfront purchase cost of MUSs, as well as other reusable medical technologies, may hinder uptake. It is therefore important that more detailed analyses, exploring the cost implications of reusable stapling device uptake at the hospital level, are conducted, to fully understand the budgetary implications of doing so.

Additionally, tackling the notion that single-use disposable technologies are safer than reusable technologies is a challenge which must be overcome to implement lasting change. Patient safety should always remain the priority for providers and device users, and the approach taken in this research assumes that the SUS and MUS are comparable devices in terms of safety profiles. However, it is known that the introduction of single-use medical devices has contributed to a reduction in infection rates, and so using devices which are “single-use” appear to provide device users and purchasers with a safety net by ensuring device sterility.6 The US Food and Drug Administration indicated that single-use devices are classified as non-sterile only when the packaging is removed.26 This has contributed to the perceived risk to patient health associated with use of reusable devices. The additional steps which would be required to be implemented to ensure the proper use of multi-use devices at the hospital level may be reinforcing a reluctance to deviate from the use of single-use devices. Additional research into appropriate protocols, and the feasibility of implementing these measures, to mitigate this risk of infection, for example for device collection, sterilization decontamination, and storage of items for reuse, needs to be explored. In the context of surgical stapling, the MUS device assessed includes disposable parts, like the power shell to cover the power handle, to potentially overcome some of these concerns around contamination.

Finally, analysis of the ecological impacts caused by the production, usage, and disposal of single- versus multi-use devices, in the form of a LCA, was not the within the scope of this analysis. For example, product and sales packaging were excluded from this waste prevention assessment. Furthermore, Leiden and colleagues note that the sterilization process is essential for ensuring low infection rates, and the process itself has a notable environmental impact.27 However, this was also excluded from this analysis. Analyzing the complete product life cycle of each stapling system in clinical practice would therefore be essential to fully understand the relevant processes in the product life cycle as well as the ecological impact of both systems.

Conclusion

We present evidence which supports the switch from a linear to CE approach to waste prevention and resource consumption within the OR. We examined how replacing a SUS with a MUS can lead to a reduction in the total amount of waste accumulated as well as extended resource use (TMR) for laparoscopic sleeve gastrectomy, laparoscopic gastric bypass, and VATS lobectomy procedures. We showed that if the multi-use components of the MUS are used more than once, the reduction in waste and TMR associated with a switch from SUSs to MUSs is maintained for a range of reuses.

Evaluating the Environmental Impact of Single-Use and Multi-Use Surgical Staplers with Staple Line Buttressing in Laparoscopic Bariatric Surgery

This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License ( http://creativecommons.org/licenses/by-nc/3.0/ ). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms ( https://www.dovepress.com/terms.php ).

60 mm cartridges were most frequently used in bariatric surgery, and 67% of surveyed surgeons applied staple line reinforcement. MUS with pre-attached buttressing resulted in a reduction of waste, material consumption, and greenhouse gas emissions compared to SUS with separate buttressing: they reduced product waste by 40% (SG and RYBG), packaging waste by 60% (SG) and 57% (RYGB), resource consumption by more than 90%, and greenhouse gas emissions related to the lithium in the batteries by 99.7%. Preloaded buttressing produced less waste than separate buttressing per stapler firing.

A survey of bariatric surgeons was conducted to assess stapler and buttressing use in clinical practice. We deconstructed and analyzed the product and packaging composition of a commonly used SUS with separate staple line reinforcement (Echelon Flex™ with Echelon Endopath™, Ethicon) and MUS (Signia™ with Tri-Staple™ reinforced reloads, Medtronic), where the buttressing material was delivered separately or already incorporated in the reload cartridge, respectively. Both systems were compared regarding total waste generation, resource use (determined as total material requirement), and greenhouse gas emission caused by their lithium content.

Operation rooms have a large environmental impact. Single-use staplers (SUS) are widely used surgical instruments that contribute to resource consumption and waste generation, whereas multi-use staplers (MUS) can greatly reduce the environmental impact of surgery. The staple lines are often reinforced with buttressing material to prevent leaks and bleeding. We explore current clinical practice and environmental concerns regarding stapling and buttressing, as well as the environmental impact of staple line buttressing in sleeve gastrectomy (SG) and Roux-en-Y gastric bypass (RYGB). Furthermore, we extend this analysis by taking packaging material and the lithium in power supplies into consideration.

As surgical stapling and staple line reinforcement are frequently used in laparoscopic bariatric surgery and based on the previous study on the environmental impact of multi-use staplers in bariatric surgery, 14 we reassessed the environmental impact of reusable versus single-use staplers in sleeve gastrectomy (SG) and Roux-en-Y gastric bypass (RYGB) including staple line buttressing. We not only assessed the material composition of the devices but also the impact of packaging on waste generation and the lithium in power supplies contributing to greenhouse gas emissions. The evaluation involved three stages: (1) a survey of bariatric surgeons to understand and quantify stapler and buttressing use in clinical practice; (2) a product deconstruction to assess the material composition of the staplers to determine their environmental impact; and (3) use and product composition data were combined into an environmental impact model.

Staple lines are reinforced in more than 50% of bariatric surgeries to reduce bleeding and leaks. 16 One method of staple line reinforcement with improved clinical outcomes is the use of buttressing: 16 , 17 a thin strip of material that is incorporated into the staple line. The buttress can either be a separate component or it can be pre-attached and therefore already a component of the reload. 18 , 19

Single-use devices contribute to resource consumption and waste generation. 12 Reusing medical devices is a favorable circular economic strategy 13 that can greatly reduce the environmental impact of surgery 14 and can even reduce costs. 15 In bariatric surgery, the use of reusable instead of single-use staplers has been shown to decrease both waste and resource use. 14

The generation of waste and greenhouse gases as well as resource consumption are central to the environmental impact of health care. In developed countries, hospitals generate an average 1% of a nation’s solid waste and 2.1% of its greenhouse gas emissions annually. 1 In the USA, hospitals generate an average tons of waste daily. 7 Operation rooms (ORs) in particular are responsible for a large share of waste, producing approximately 20% of a hospital’s total waste. 7 The ORs of a single hospital can produce over 100 tons of waste per year, with a 30% proportion of plastics. 8 The need for sterility in the OR encourages the use of disposable devices and materials sealed in plastic packaging. 1 , 9–11 Waste disposal costs for an OR were estimated to be USD 45,000 per year. 8

The environmental impact of health care is an increasing cause for concern. 1 Global health care contributes between 1% and 5% of the total global environmental impact, depending on the indicator considered. 2 Hospitals and medical retail of devices and pharmaceuticals together account for 52% of the CO 2eq emissions caused by health care. 3 In , seven European countries committed to strengthening the climate resilience and sustainability of their health systems. 4 Their health carbon footprint amounted to 145.4 Mt CO 2eq , 5 or approximately 58% of all healthcare emissions across the EU. 6 Since then, programs to promote environmentally friendly purchasing decisions have been put in place, and the environmental impact of healthcare decisions is an increasing focus.

Sensitivity analyses were performed in order to understand how different input variables and assumptions affect the end results. 26 The impact of circulation ratios of SUS and MUS was already explored previously. 14 Therefore, we varied the rate of buttressing per procedure to explore the impact on the waste prevention potential and TMR results.

The environmental impact of the stapler’s power supply was estimated by regarding lithium use. The SUS battery is non-rechargeable, whereas the MUS battery is rechargeable. The cells were mechanically separated and deconstructed, and their components dried at 20°C in an extraction hood until their weight remained constant. The dried material underwent an aqua regia digestion and was then analyzed in an Inductively Coupled Plasma Mass Spectrometry screening following EN ISO –2:-01 to determine the lithium content. The greenhouse gas emission per surgery was calculated by multiplying the lithium mass per stapler with the emission factor for lithium 25 and dividing it by the circulation rate of the power supply.

As an indicator for the material intensity of the product, 22 the total material requirement (TMR) was calculated for each component and stapling system. It reflects all biotic and abiotic materials and moved soil that is needed to manufacture a product. 23 , 24 The TMR is calculated based on the material composition and weight of each component: the masses of all used elements are multiplied with TMR coefficients reflecting the primary material use. Here, the TMR of each system component is used to extrapolate the total amount of natural resources used to perform each surgery.

The average number and type of cartridges and reinforcements used per procedure were estimated from survey results. Based on these numbers and the circulation rates per component, the waste associated with each stapler firing and surgical procedure was calculated.

Based on the product material analysis, the amount of waste that is generated per surgery in clinical practice was determined. The stapling systems were compared as described previously. 14 The circulation rates (how many times each component can be used before it has to be replaced) of both stapling systems were determined ( ). The circulation rates of reusable MUS components were pre-defined by the manufacturer based on useful life estimates, 20 and the MUS ensures that it is not possible to exceed the maximum number of uses for the power handle and the adapter. 21 We also analyzed the supplies used for each reinforced staple line firing. The SUS requires one 60 mm staple line reinforcement per firing. The MUS buttressing is preloaded in the stapler cartridge, so no additional components beyond the buttressing material required analysis. For a complete view on waste generation, the analysis of packaging was included.

This study focused on the 60 mm cartridges, which were commonly used in bariatric surgery. For both stapler systems, cartridge options are available for different tissue thicknesses. As their core components remained unchanged, it was considered sufficient to undertake the full analysis only on the 60 mm stapler cartridges. An overview of the surgical stapling system components is provided in .

For the SUS, the components PSEE60A, ECR60W, and ECH60R were disassembled and analyzed. For the MUS, the single-use components SIGPSHELL and SIGTRSB60AMT (with buttressing) or EGIA60AMT (without buttressing) and the reusable components SIGPHANDLE, SIGADAPTSTND, SIGRIG, and SIGSBCHGR were assessed.

Survey responses were analyzed in Microsoft ® Excel ® . Analyses focused on the number of procedures performed, types of stapling systems, size and number of cartridges used, and number of buttressed staple lines per surgery category. The survey also assessed how environmental concerns, if at all, impact decision-making.

The survey took place online on an open-source survey tool provided by LimeSurvey GmbH, Hamburg, Germany ( http://www.limesurvey.org ) between April and June . A total of 46 surgeons who perform bariatric surgery were contacted; 37 surgeons consented to being surveyed and 18 participants from Australia, Canada, France, Italy, New Zealand, the USA, and the UK completed the survey.

For more medical staplersinformation, please contact us. We will provide professional answers.

A survey of bariatric surgeons was done to estimate surgical stapler use and staple line reinforcement in clinical practice including surgeons’ awareness of environmental issues. The survey was reviewed and approved by the Health Media Lab Institutional Review Board (Health Media Lab is registered with the US Department of Health & Human Services, Office of Human Research Protections; HML IRB Review #GSGC22). An independent IRB was approached to review this study as the authors are not affiliated with a research institute and therefore do not have access to an internal IRB. All participants provided informed consent electronically prior to survey participation. A full list of all survey questions and answer options is provided in Supplementary Table 1 .

This study compares two frequently used stapling systems and their respective buttressing material: the single-use Echelon Flex™ stapler (SUS) with the Echelon Endopath™ Staple Line Reinforcement (Ethicon, Cincinnati, OH, USA) and the multi-use Signia™ stapler (MUS) with Tri-Staple™ reinforced reloads that already have buttressing incorporated (Medtronic, Minneapolis, MN, USA). The use of these stapling systems is evaluated in laparoscopic SG and laparoscopic RYGB.

The TMR results of the MUS showed a larger increase than those of the SUS if staple line reinforcement was applied at all stapler firings. This suggests that the resource consumption to create the preloaded buttressing may be higher than that needed to create the separate buttressing. As buttressing is only responsible for a very small part of the total TMR, however, this change does not noticeably affect the overall advantage provided by the MUS.

The sensitivity analysis ( ) shows that MUS generate less waste and have lower TMR than SUS regardless of the rate of buttressing applied. If buttressing is applied to all staple lines, the waste reduction offered by the MUS increases to 1,022.13 g (54.7%) from 649.88 g (45.6%) if no staple line reinforcement is used, as the waste created by the separate buttressing material and its packaging is avoided.

Both surgery types use five 60 mm staple cartridges per surgery on average, the only difference is the number of cartridges that apply buttressing. In the sensitivity analysis, buttressing is either applied to none or all staple firings.

The impact on greenhouse gas emissions per surgical procedure was based on the lithium content of the stapler’s power supplies ( ). The MUS contains less lithium than the SUS, both in terms of relative content of the battery cells (MUS: 4.96%, SUS: 6.72%) and absolute mass (MUS: 0.348 g, SUS: 0.376 g). Due to this lower lithium content and the higher circulation rate of the MUS, its impact on greenhouse gas emissions per surgery at 0.018 g CO 2eq is 324 times smaller than that of the SUS at 5.904 g CO 2eq .

The TMR per surgery of MUS stapler cartridges (with and without preloaded buttressing) was substantially greater than that of the SUS stapler cartridges ( ). Despite the higher TMR, the MUS shows an overall reduction compared to the SUS due to the reusability of the most resource-intensive components. The TMR associated with one SG is reduced from 330 kg (SUS) to 30.9 kg (MUS). For RYGB, the TMR drops from 329 kg to 29.2 kg, respectively. In both procedures, the TMR is reduced by more than 90%, indicating that over 90% of raw material consumption can be saved by switching from SUS to MUS. The resource efficiency is increased by factor 11.

MUS considerably reduce the amount of product and packaging waste per surgery compared to SUS ( ). They reduce the total waste by 813.67 g and 746.47 g for SG and RYGB, respectively. This translates to a total waste prevention potential of 50% for SG and 48% for RYGB. The product waste is reduced by 40% in both types of surgery, and the packaging waste is reduced by 60% per SG and by 57% per RYGB.

The total weight of each stapling system component is provided in . Overall, the MUS is heavier than the SUS by 1,356.08 g, of which 388.34 g are packaging material. The addition of buttressing material slightly increases the total weight of the MUS by 14.22 g; the total weight of the SUS is increased more substantially by 88.67 g ( ).

For each SG, an average 0.6 45 mm cartridges and 5.0 60 mm cartridges were used. No use of 30 mm cartridges was reported. Per RYGB, an average 0.2 30 mm cartridges, 1.0 45 mm cartridges, and 5.0 60 mm cartridges were used. Staple-line buttressing was most frequently used with 60 mm cartridges ( ).

On average, respondents performed 24.9 (range: 4–100) SGs and 9.6 (range: 2–23) RYGBs per month. The majority (88%) of surgeons preferred powered staplers over manual staplers. Staple line reinforcement was frequently applied, with 12 (67%) surgeons using staple line reinforcement, and 7 (39%) of the 12 surgeons applying reinforcement in every procedure.

The majority of survey respondents, 12 (67%) surgeons, stated that they are concerned about the environmental impact of surgery, although only 4 (22%) participants reported that their hospital promoted environmentally friendly purchasing. Half (50%) of the survey participants reported that they never made changes to their work practice based on environmental concerns, with 11 (61%) survey participants prioritizing ease of use and price over environmental impact in purchasing decisions.

Discussion

Laparoscopic surgery can offer many benefits if it is applied in the interest of the patient as well as the operating surgeon.27 A laparoscopic approach to bariatric surgery has been shown to offer benefits compared to an open procedure,28,29 and often relies on stapling for tissue approximation. The use of buttressing to reinforce the staple line has been shown to reduce bleeding and leakage.16,17 However, the single-use staplers produce large amounts of waste, which can be addressed by using multi-use staplers.14,27

The results of our study show that preloaded buttressing reduces the amount of waste created by reinforcement per staple firing compared to separate buttressing. The preloaded buttressing is used with a MUS, whose reuse further reduces the environmental impact, whereas the separate buttressing is paired with the SUS. A previous study already showed that MUS compared to SUS substantially reduce the amount of waste and resource consumption per surgery.14 We confirmed these findings and showed an even larger reduction in OR waste by including packaging materials. Packaging waste has a large impact: more than half of the waste produced by SUS is from packaging. MUS reduced the contribution of packaging waste by approximately 60% and substantially reduced the impact of lithium in the power supply on greenhouse gas emission.

Similar to MUS, the reuse of other medical devices has repeatedly been reported to be more resource efficient, reduce waste, and have a lower environmental footprint than single-use options.14,15,30,31 However, most of these devices require reprocessing, and the efficiency of the reprocessing determines whether reusable devices are actually environmentally more sustainable.31 The handle of the MUS does not require reprocessing for reuse, as it is covered by the disposable power shell component during surgery.

In addition to the environmental benefits, MUS may also offer an economic benefit. A recent review estimated that the cost of waste contributed approximately 25% of healthcare spending in the US, and that interventions to reduce waste could lead to a 25% cost reduction with potential savings between USD 191–282 billion.32 Assuming disposal cost for hazardous medical waste of USD 3.93 per kg,33 the waste disposal for the SUS (55.2 kg per surgeon per month) would cost USD 217, whereas the waste created by the MUS (27.7 kg per surgeon per month) would cost USD 109 to dispose of.

A substantial part of the OR waste that is disposed of as regulated waste is actually general waste1,34 with lower disposal costs.33–35 At disposal costs of USD 1.14 per kg for general waste,33 separating OR waste may increase financial benefits.35 In our study, proper waste separation could reduce the costs of waste disposal per surgeon per month by 36.2% to USD 138 for SUS and by 29.3% to USD 77 for MUS.

During the life-cycle of a lithium-ion battery, the production phase has the highest impact on global warming.36 The greenhouse gas emissions caused by the production of lithium in SUS are 324 times higher than those of MUS. This is in line with the finding that reusable medical devices reduce their carbon footprint between 50% and 97% compared to disposable ones.37 The reuse of rechargeable lithium-ion batteries should be prioritized over recycling of primary batteries, as the recycling process at the end of the battery life still requires harsh chemical- and energy-intensive processes.36

Reducing, reusing, and recycling medical waste is not only beneficial for the environment38 but is also accompanied by a substantial financial incentive. Despite these clear advantages of green policies, our survey showed that they are not widely implemented. The MUS in this study showed a substantially reduced environmental impact regarding waste generation, resource consumption, and greenhouse gas emissions. Waste reduction furthermore decreases waste disposal costs. Finally, the preloaded buttressing does not require additional steps and/or materials to apply it in the OR, which is expected to save time and reduce handling errors during the operation.18

The promising results of this analysis have to be interpreted with its limitations in mind. First, this study only considered buttressing as staple line reinforcement. Oversewing is another commonly used method.16 However, its clinical effectiveness is controversial, with different studies coming to different conclusions.16,39,40 In contrast, buttressing was generally found to be effective in reducing bleeding and leaks in gastrointestinal surgery.16,40 Second, this study only considers one type of separate buttressing material. Other buttressing materials may cause different outcomes in the waste and TMR analyses. Third, we only considered one brand of MUS and SUS each, and only focused on 60 mm cartridges as these were most commonly used in bariatric surgery. Although these systems are used very frequently, we cannot exclude that an analysis of alternative staplers could lead to different results and conclusions. Therefore, the results presented here should be considered within the context of this study, and further investigation is necessary for generalized conclusions.

The costs of the stapling systems were not included in the analysis, even though survey respondents rated the price of the device as more likely to influence their purchasing decision than its environmental impact. Although MUS are likely to reduce the costs of waste disposal, their upfront purchase cost is expected to be higher than those of SUS. To fully explore the financial impact, a more in-depth life-cycle cost analysis is needed.

Finally, an assessment of the ecological impact caused by production, use, and disposal of all components of SUS and MUS in the form of a life-cycle analysis was outside the scope of this study. The present analysis did not consider the environmental impact of the cleaning and sterilization process that is required to safely reuse surgical instruments,15,41 the recycling process of lithium-ion batteries,36 or the reprocessing process that would make single-use items reusable.13 A complete life-cycle analysis of the stapling systems used in clinical practice would be needed to fully understand all relevant processes, environmental impacts, consumed resources, and waste streams. So far, only a life-cycle analysis of SUS but not MUS is available.41

Surgical staplers are generally made of plastic and loaded with a disposable cartridge of surgical staples. The staplers come in both reusable and disposable models. They resemble construction or industrial staplers and are designed to insert and close several staples at once.

The devices may be used internally to seal tissue during surgery. They are useful in minimally invasive surgery because they require only a narrow opening and can quickly cut and seal tissue and blood vessels. Skin staplers are used externally to close skin under high tension, such as on the skull or the trunk of the body.

Surgical staples offer several advantages over sutures.

• They can be inserted quickly.
• They’re strong.
• They are easily removed with a surgical staple remover.
• They reduce the amount of time a patient is in surgery and under anesthesia.

When Are Surgical Staplers Used?

Surgical staplers are frequently used to close incisions in the abdomen and uterus during Cesarean deliveries, or C-sections, since the staples allow women to heal faster and reduce scar tissue. Surgeons may also rely on surgical staplers when removing part of an organ or cutting through organs and tissue inside the body.

They are also used to connect or reconnect internal organs within an organ system. The devices are frequently used for surgeries involving the digestive tract, including the esophagus, stomach and intestines, in which a portion of these tube-like structures have been removed and the remaining portions must be reconnected.

Caring for Surgical Staples

Patients must pay special attention to medical staples in the skin to avoid infection. A study reviewed the surgical site infection rate of wound closure using staples versus sutures in elective knee and hip arthroplasties. The researchers found a significantly higher risk of surgical site infection in patients with staples compared to sutures.

Always follow your doctor’s instructions and do not remove any dressings until it’s safe to do so. Rinse the site twice daily to keep it clean. Your doctor will tell you how and when to dress the wound to prevent infection.

When to Call Your Doctor About Surgical Staple Complications

• Bleeding enough to soak through the bandage
• Brown, green or yellow foul-smelling pus around the incision
• Change in color of the skin around the incision
• Difficulty moving in the area around the incision
• Dryness, darkened skin or other changes around the site
• Fever of 100 degrees or higher for more than 4 hours
• New, severe pain
• Cold, pale or tingling skin near the incision site
• Swelling or redness around the incision

Removing Surgical Staples

Surgical staples usually remain in place for one to two weeks, depending on the type of surgery and the placement of the staples. In some cases, internal staples may not be removed. They are either absorbed or become permanent additions to hold internal tissue together.

Removing surgical staples from the skin is generally not painful. But they should be removed only by a doctor. Never attempt to remove surgical staples on your own.

Removal requires a sterile setting and a specialized surgical staple remover or extractor. The device spreads one staple at a time, allowing the doctor to gently work it out of the skin.

Usually, a doctor will remove every other staple, and a second appointment is scheduled to remove the rest if the wound has not completely healed.

How Surgical Staplers Work

Surgical staplers work by compressing tissue, connecting two pieces of tissue with staggered rows of B- shaped surgical staples and, in some models, cutting away excess tissue to create a clean closure of the surgical wound.

There are various designs for different types of surgeries, with most categorized as either linear or circular.

When using linear staplers, the surgeon uses the handles at one end to close the “jaws” of the stapler at the other end over the tissue. When the surgeon fires the stapler, a row of staples binds the tissue together and a blade cuts the tissue between the staples. The process seals the open wound to prevent bleeding.

Linear staplers are used to connect tissue during minimally invasive surgeries or to remove an organ. Circular staplers are often used for surgeries involving the digestive tract from the throat to the colon.

Circular staplers fire two staggered rows of staples from a circular cartridge. This circular layout allows the stapler to connect two sections of the intestine, or another tube-like structure, after a portion has been removed. The staples cause tissue to pinch up as rings or donuts between the staples. A built-in blade then slices off the overlaying tissue, sealing the new connection.

Surgeons watch the closed wound for about 30 seconds to make sure the tissue has been squeezed together properly and confirm that there is no bleeding.

What Are Surgical Staples Made Of?

Common materials for surgical staples include stainless steel and titanium. These are both strong metals that tend to cause few problems for patients in surgical procedures.

But plastic staples are frequently used for people with metal allergies or to reduce scar tissue.

Staples made from plastic or metals don’t dissolve like many sutures, so extra attention must be paid to prevent infection.

Staples made from polylactide-polyglycolide copolymer are designed to be reabsorbed into the body. They are often used in cosmetic surgery because, like plastic staples, they result in less scaring.

Surgical Stapler Manufacturers

Johnson and Johnson’s Ethicon division and Medtronic are the two largest surgical stapler manufacturers. Together, they produced about 80 percent of the stapler market in , according to an analysis by Future Market Insights. 3M also manufacturers skin staplers sold in the United States.

The devices accounted for close to $2 billion in revenue for manufacturers in , with most sold in North America.

Surgical Stapler Manufacturers and Select Brands

Ethicon

Echelon series, Contour Curved Cutter, Endo-Surgery series, Proximate series

Medtronic

Signia Stapling System, Endo GIA series of staplers, iDrive Ultra Powered Stapling System, DST series, Premium Plus CEEA Staplers, Appose Single Use Skin Stapler, DFS Single Use Fascia Stapler, Roticulator series, DST Single Use series, ILA series, GIA Single Use and Reusable series

Surgical Stapler Recalls and Injuries

Johnson & Johnson subsidiary Ethicon recalled 92,496 surgical staplers in April over concerns that they might not fire with enough force to completely form staples.

The U.S. Food and Drug Administration branded the recall as a Class I recall, the FDA’s most serious type. The agency warned in a statement that the devices could cause serious injuries or death. Some people who have been injured by malfunctioning devices have suffered serious injuries and filed surgical stapler lawsuits.

The recall affected two models of the company’s Endo-Surgery Intraluminal Staplers used in gastrointestinal tract surgeries.

Ethicon reported that two patients had been injured by the devices, according to the FDA. In both cases, the devices misfired, cutting portions of the rectum. Misfires or other malfunctions can prolong operations or require doctors to perform unplanned surgery to correct the damage.

The FDA warned that the misfires could increase complications from surgical staplers, including the risk for bleeding, infection, permanent damage to organs.

In , Ethicon recalled 6,744 Endopath Echelon Flex Powered Vascular Staplers with Advanced Placement Tip and White Reloads. The devices were used in gynecologic, urologic, thoracic, pediatric and general minimally invasive surgeries.

The company reported that an inspection had found the surgical staplers’ cartridges may not insert a complete line of staples when fired.

Medtronic issued two recalls of its Endo GIA staplers and staple cartridges from select production lots, or batches, in and . Both recalls involved possible missing components. The company said the defects could affect staple alignment and lead to serious complications.

At least five people were injured by staplers included in the recall, according to the company. The recall involved defects in staple cartridges that were spotted during the manufacturing process. The company reported “no confirmed complaints” about the devices from doctors or patients.

FDA Actions on Surgical Staplers

The U.S. Food and Drug Administration began tightening restrictions and reporting safety concerns over surgical staplers in . It issued new guidance for using the devices to doctors and hospitals, took steps to reclassify certain surgical staplers from low- to moderate-risk devices and reported tens of thousands of previously unknown cases of stapler malfunctions and injuries.

The new classification would require premarket review and clearance of the devices from the FDA before manufacturers could sell them.

The FDA actions followed a series of surgical stapler problems coming to light earlier in . Kaiser Health News reported that more than half of all surgical stapler malfunctions from through , 56,000 of them, had been reported to a hidden FDA database instead of a database accessible by the public.

The FDA consolidated the two databases so all the reports could be viewed by the public. The total number of reported surgical stapler malfunctions over the eight-year period rose from 41,000 to nearly 110,000.

For more information, please visit endo stapler manufacturer.