Executive Summary

​Endoscopic linear surgical staplers are devices that are intended to simultaneously staple and cut tissue in open or laparoscopic surgery. These staplers, which may be manual or powered, are typically used for resection, transection, or creation of anastomoses.

Endoscopic linear stapling is well-established, but powered surgical staplers are a more recent development. Modifications continue to be made to the reload cartridge-tissue interface, method of articulation and movement, automatic firing and knife retraction, and firing-speed feedback. The availability and performance of such advanced modes and features play a key role in our ratings of these products.

ECRI Institute has tested linear staplers, including manual and powered models, as well as disposable and reusable ones. All the models we tested provide a means of compressing then sealing and dividing patient tissue for the purposes of resection, transection, or the creation of anastomoses.

For our ratings of the tested models, along with information about our test protocol and a discussion of key endoscopic linear surgical stapler specs, refer to the Full Text tab.

ECRI Institute estimates that the annual cost of ownership for endoscopic linear surgical staplers is approximately $249,000. The annual cost of ownership is determined by calculating the cost of all required disposables—from the stapler itself (in the case of disposable models) to the reloads (stapler cartridges) required to achieve your desired outcome. For models with reusable components, the acquisition costs of those components or accessories must also be factored into the analysis.

Who Should Read This

Here's background for our Evaluations of powered and manual endoscopic linear surgical staplers, outlining the key considerations for making wise purchasing decisions. Learn how the technology is used, which specs are important, and what factors we test for. Also review our latest product ratings.

    

Overview

Endoscopic linear surgical staplers are intended to staple and cut tissue for resection, transection, or creation of anastomoses via manual activation or a battery-powered firing system. The devices incorporate a blade to cut tissue along a designated channel immediately after inserting rows of staples alongside the channel to seal the tissue on either side of the cut. These staplers may be used in open or minimally invasive procedures. Most models are disposable, although one currently available powered model features a reusable handle that incorporates both disposable and reusable components.

In comparison to manual endoscopic staplers, powered staplers use battery power to drive the knife and staples rather than manual force. They are designed to maximize user stability and enable more precise compression and staple formation (Roy et al. 2017). Depending on the manufacturer, the battery-powered firing system may be either rechargeable and reusable or disposable.

Stapling has been used as a method of surgical closure since the early 1900s. Endoscopic linear stapling is well-established, but powered surgical staplers are a more recent development. The first powered surgical stapler received FDA clearance in 2010.

Endoscopic linear surgical staplers (see Figure 1) are characterized by a handle for holding the device, a shaft that allows for device operation through a standard surgical cannula, a mechanism for triggering the placement of staples along the length of the staple line, and a mechanism for transecting stapled tissue. Current devices accomplish the latter using a knife on a sled mechanism. Depending on manufacturer design, the knife may be a part of the stapler itself or part of the reload cartridge. Reload cartridges can vary in length, number of staple rows, and staple height. Additionally, cartridge height and surface design can vary greatly between manufacturers.

Figure 1. A composite image of a manual endoscopic linear stapler.

Specific components of endoscopic linear surgical staplers include the following:

1. Reload. Surgeons select a stapler cartridge, known as the "reload," that is most appropriate for the tissue to be stapled. Proper selection is required to avoid bleeding, leaking, or causing damage to any surrounding tissue.

a) Reloads are designed to place six staggered symmetrical rows of staples into tissue, three rows on either side of the knife channel (see Figure 2). The knife will transect the desired stapled tissue when the device fires.

b) Reloads are available in varying staple line lengths to accommodate different requirements. Available line lengths are 30 mm, 45 mm, and 60 mm.

c) Reloads are available in varying staple heights to accommodate different tissue thicknesses. Whether one cartridge houses staples of a single height or staples of multiple, staggered heights varies by manufacturer.

d) Though disposable staplers are for single-patient use, they may be reloaded with cartridges over the course of a procedure. Note that a reusable powered stapler is available.

e) Before the stapler is fired, reloads have open staples seated in recessed drivers within the cartridge. When the stapler is fired, the drivers are forced upward, pushing the staples up through the tissue and against an anvil. The anvil features an array of wells that match the position of the cartridge's drivers. When the open staples come into contact with the anvil's wells, they close into the desired "B" formation.

f) Together, the anvil and the cartridge form the "jaws" of the stapler.

g) The reload features a safety mechanism that prevents the stapler from being fired twice using the same reload. If a user attempted to fire a reload with no staples in the drivers, the device would lock out and prevent firing, rather than transect tissue that had not previously been sealed, as this would likely result in a bleed.

2. Knife. During firing, a beam inside the cartridge advances, engaging a sled mechanism that contacts the recessed cartridge drivers, pushing them upward. The drivers, in turn, push the staples up through the tissue and against the anvil, forming closed staples in the desired "B" formation. A knife follows the sled, advancing via a designated channel and transecting the tissue after it has been stapled. Note that the knife may be integrated into the stapler itself or replaced with each reload, depending on manufacturer design.

3. Mechanisms to enhance surgical site access (as shown in Figure 1):

a) Shaft rotation control. When the device's jaws are closed, the shaft will fit into an endoscopic trocar to allow access to the surgical site; the shaft rotates via a turning mechanism at its base to allow easier positioning at the site.

b) Articulating joint. A mechanism that allows the end of the stapler, known as the end effector, to articulate left and right of center to maximize surgical site access.

4. Triggering mechanism(s). Endoscopic linear surgical staplers may feature one or two mechanisms for initiating the following actions (as shown in Figure 1):

a) Compression—The user squeezes a trigger that closes the device's jaws to allow for tissue compression.

b) Firing—The stapler may include a separate mechanism that advances the sled mechanism to staple and transect the tissue, or this function may be incorporated into the compression trigger. If the latter, the trigger switches over to a firing state after the intentional removal of a safety mechanism. Some powered staplers feature a button, rather than a trigger, to minimize the applied force and movement required to operate the stapler, and thus potentially minimize trauma to the surgical site. Stapler end effectors are typically marked with millimeter measurements to inform the user how far the knife has advanced along its staple line in the tissue.

5. Safety lock. A mechanism that prevents the stapler from being fired when it is not in the appropriate state (i.e., with the jaws correctly closed on patient tissue).

6. Features unique to battery-powered models. Current battery-powered endoscopic linear surgical staplers may appear similar to manual staplers, but have some unique features, in addition to being battery-operated. Depending on the manufacturer, such models may include:

a) An LCD screen to communicate device and battery end-of-life as well as device readiness (available on Medtronic models)

b) A button or trigger that automates the firing sequence

c) Knife-reverse and anvil-release buttons—These may be integrated into the trigger and automatically retract at the end of the firing sequence. 

Figure 2. An endoscopic linear stapler reload (blue) and anvil (opposing face). Note that the reload has six staggered rows that are symmetrical about the knife channel that runs through the center of the reload. When the stapler is closed to compress the tissue and then fired, a sled mechanism moves toward the distal end of the reload. This pushes the drivers, and the open staples seated on them, upward so that the staples pierce the patient's tissue and hit against the anvil to seal the tissue. A knife follows the sled, transecting the stapled tissue.

 

Stapler and reload designs can vary considerably by manufacturer. Recent changes to the technology include:

1. For endoscopic linear staplers:

a) Gripping cartridge surfaces intended to prevent tissue movement during compression (available with Ethicon GST)

b) Stepped-face cartridge surfaces intended to allow for inherent inconsistences in patient tissue thickness and to encourage tissue compression along the knife channel as the stapler fires (available with Medtronic Tri-Staple)

c) Full rotation of the endoscopic shaft, and a stapler head with a greater articular range of motion—approximately 45 degrees from neutral alignment—to allow improved surgical site access

2. For battery-powered systems only:

a) Handles that can be sterilized and reused across multiple patients (available with Medtronic Signia)

b) "Intelligent" reloads that provide user feedback regarding the force required to transect the subject tissue (available with Medtronic Tri-Staple 2.0). Note that these reloads can also be used in manual staplers, but will not provide any sort of feedback.

c) Reverse firing that reverses the knife's direction in the event of an unanticipated issue. Powered systems may also automatically retract the knife as part of the firing sequence.

d) Manual override that allows the physician full control over the automated functionality of the device. Note that manual staplers should also allow users to easily open the stapler when inserted into a cannula should it become jammed on tissue.

Endoscopic linear surgical staplers may be used by surgeons, surgical residents, and registered nurse first assistants for resection, transection, or creation of anastomosis. The devices are typically used for applications in the following clinical categories: abdominal surgery, gastrointestinal surgery, general surgery, gynecological surgery, hepatic surgery, pediatric surgery, thoracic surgery, and urologic surgery. As such, the devices would be used in the departments where these procedures are performed.

These devices are referred to by a number of names. Common synonyms include: surgical staplers, powered staplers, smart staplers, endoscopic staplers, laparoscopic staplers, staplers, and cutters (if the stapler or associated cartridge has an integrated knife).

 

Ratings: Endoscopic Linear Surgical Staplers

Click the product names below to view our complete findings. Products are listed alphabetically by supplier.​ ​ ​ ​ ​ ​ ​ ​ ​ ​

Model               Date Last Updated Rating Performance Safety Workflow Patient Experience Interoperability Cybersecurity Maintenance User Experience Cost of Ownership
Ethicon Echelon Flex Endopath (Manual)
11/2018 GoodGoodGoodNot evaluatedNot evaluatedNot evaluatedNot evaluatedGood$229,000 (estimated)
Ethicon Echelon Flex GST (Powered)11/2018 GoodGoodExcellentNot evaluatedNot evaluatedNot evaluatedNot evaluatedExcellent$242,000 (estimated)
Medtronic Endo GIA Ultra Universal  (Manual)11/2018 GoodGoodGoodNot evaluatedNot evaluatedNot evaluatedNot evaluatedGood$258,000 (estimated)
Medtronic Signia Stapling System (Powered)11/2018 GoodGoodExcellentNot evaluatedNot evaluatedNot evaluatedGoodExcellent$265,000 (estimated)

 

Other Currently Available Endoscopic Linear Surgical Staplers

The following models compete directly with one another, and with the devices in the table above. Note that as of publication, only Ethicon and Medtronic market a powered endoscopic surgical stapling device.

BJ ZHF Panther Medical Equipment Co. Ltd. [456144]

Endo Linear Cutter

Dextera Surgical Inc. [528204]

MicroCutter 5/80

Ethicon Inc., A Johnson & Johnson Co. [101251]

Echelon Flex Powered Vascular Stapler with Advanced Placement Tip

Intuitive Surgical Inc. [377602]

EndoWrist Stapler (intended for use with the da Vinci Si Surgical System)

JustRight Surgical [464968]

JustRight 5mm Stapler

Medtronic Inc. [101809]

iDrive Ultra Powered Stapling System (formerly Covidien)
 

ECRI Institute's Testing

Our testing looks at what we believe are the important considerations when choosing an endoscopic linear surgical stapler, as described below.

Performance

Our testing of endoscopic linear surgical stapler performance includes measuring maximum burst pressure of porcine intestines after stapling. We use thin stapler reloads in 30 mm anastomoses with longitudinal, side-to-side, and intersecting staple lines, then infuse the intestines with distilled water at a rate of 30 mL/min. We also assess cut line integrity in porcine stomach using reloads for thin, medium/regular, and thick tissue types (see the table below for a comparison of the stapler reloads we use in our testing). Additionally, we assess range of articulation and rotation and end-effector stability. All tested tissue is measured with an adjustable force micrometer under compression comparable to that of a closed stapler jaw so as to match specimens as closely as possible between manufacturers.

 

Reloads and Average Tissue Thicknesses Used in ECRI Institute's Stapler Testing

Note that the stapler reloads listed here do not represent the full portfolio of reloads from either manufacturer.​

Tissue Type Manufacturer (Reload Product Line) Reload Color Open Staple Height Closed Staple Height Average Thickness: Intestine Average Thickness: Stomach
Thin ​Ethicon (GST)White2.6 mm1.0 mm

1.002 mm

1.476 mm ​
Medtronic (Tri-Staple)Tan2 mm, 2.5 mm, 3 mm0.88 mm to 1.5 mm
Medium/ Regular ​Ethicon (GST)Green4.1 mm 2.0 mm

Not applicable

2.291 mm ​
Medtronic (Tri-Staple)Purple3 mm, 3.5 mm, 4 mm1.5 mm to 2.25 mm
Thick ​Ethicon (GST)Black4.2 mm2.3 mmNot applicable 3.169 mm ​
Medtronic (Tri-Staple)Black4 mm, 4.5 mm, 5 mm2.25 mm to 3.0 mm

 

Safety

Our testing of endoscopic linear surgical stapler safety includes measuring the force required to overcome the device's safety mechanism, as well as checking for the presence of a fail-safe jaw release that can be activated if the device becomes jammed while on tissue. We also ensure that the design of the device's articulation joint discourages the entrapment of tissue during movement. Specifically for powered stapling devices, we assess trigger button sensitivity and whether the device adjusts for varying tissue thickness within one firing sequence.

Workflow

Our testing of endoscopic linear surgical stapler workflow includes assessment of one-handed use, stapler cartridge compatibility across a manufacturer's stapling platforms, accessibility and readability of the instructions for use (IFU), and whether or not guidance is provided to aid users in the selection of appropriate staple cartridge height. We also examine the device for knife advancement indicators that let the operator know how far the knife has progressed in the cut. Specifically for powered stapling devices, we assess audible alarms and cues (if applicable), battery life, battery recharge (if applicable), the clarity of the instructions for safe battery disposal, and whether or not the device contains an internal error log. If the device is reusable, we ensure that it indicates how many uses remain before disposal is required.

Patient Experience

Not evaluated—the patient experience is not a factor when selecting this device.

Interoperability

Not evaluated—interoperability is not a factor when selecting this device.

Cybersecurity

Not evaluated—cybersecurity is not a factor when selecting this device.

Maintenance

Our testing of endoscopic linear surgical stapler maintenance includes assessment of disinfection and sterilization requirements for reusable components of applicable powered devices.

User Experience

Our evaluation of endoscopic linear surgical stapler user experience includes ease of use, measurement of grip force required to operate the device, and assessment of training material availability.

Cost of Ownership

We estimate the annual cost of using endoscopic linear surgical staplers, including the cost of the stapler itself as well as the cost of reloads required for operation.
 

Technology Background

Principles of Operation

1. The device's long, narrow shaft allows the surgeon access to the surgical site via a cannula.

2. After articulation and rotation to access the surgical site, the desired tissue is placed in the device jaws and then compressed (if indicated) to achieve a uniform thickness, as well as to push fluid out of the tissue. This is done to minimize tissue movement during stapling and the ensuing transection.

3. After compression, the device is fired, which closes the staples in the desired tissue and advances the knife through its designated channel.

4. The knife is retracted and the jaws opened to remove the device from the tissue. The jaws are then closed (not on tissue), and the stapler removed via the cannula.

5. The clinical team checks the integrity of the staple line for hemostasis or leakage.

Normal Operating Procedure

1. A manual device is unboxed and assembled. A disposable powered device will need to have the battery module attached. In the case of reusable powered devices, the handle is removed from the charging cradle and assembled by placing it in a sterile shell and attaching an adapter shaft. Reusable powered devices then run any necessary self-checks indicating availability for operational use.

2. Operating room personnel confirm correct device assembly, including the attachment of an appropriately sized reload cartridge and adapter, if required by the device design.

3. When the device is needed during the procedure, the shaft of the assembled endoscopic stapler is inserted, with its jaws closed, into the cannula and rotated and articulated as necessary to access the surgical site.

4. The jaws are opened and positioned around the target tissue and then, if applicable, clamped down to compress the tissue for an indicated time period (e.g., 15 seconds). A reusable powered device will indicate its readiness for firing.

5. The operator disengages the safety mechanism and the device is fired, placing the staples and advancing the knife. After the knife is retracted (either manually or automatically, depending on the device), the jaws may be reopened and removed from the transected tissue. A safety mechanism will engage to prevent additional firing of the spent cartridge until an unused reload is installed.

6. The operator closes the device jaws, articulates and rotates the device back into neutral alignment, and removes it via the cannula.

7. The surgical team removes the used cartridge; the device may then be reloaded as necessary to complete the procedure. If the end effector does not need to be replaced with each new reload, it should be rinsed in water and inspected for tissue or staples that might be clinging to the anvil or jaw.

8. A stapler may be fired multiple times within a procedure. The recommended maximum number of uses may vary by manufacturer and may depend on whether the stapler has an integrated knife or whether the knife is replaced with every reloaded cartridge.

9. After the procedure, if the device includes some reusable components, the appropriate components must be disinfected and sterilized per the manufacturer's instructions.

Safety

1. Appropriately sized staples must be matched to the tissue that requires transection (see Figure 3).

2. Any number of factors can contribute to the success of a staple line (Chekan and Whelan 2014), including:

a) Patient age, comorbidities, tissue pathology, and prior medications and therapies

b) Tissue location, accessibility, density, thickness, and viscosity. The tissue type also relates to the ratio of liquid to solid mass. Compressing tissue—as is done by a stapler before and during firing—dispels liquid from the tissue; this can help avoid a bleed.

c) Staple specifications

3. Commonly reported problems include:

a) Misfiring or difficulty in firing—this includes instances in which:

(1) Squeezing the stapler handle requires more force than usual

(2) Staples are not fully deployed after the device is fired

(3) The stapler does not articulate or rotate as intended

b) Use errors (e.g., misapplied staples)—as can occur when:

(1) Staples of the wrong size are used

(2) Staples are applied to the wrong tissue

(3) The stapler is applied at an angle such that it does not fully reach across the structure

(4) The stapler is applied across a harder material (e.g., another previously deployed staple, a clip, a surgical instrument) that results in device damage and inappropriate staple formation

(5) Tissue in the stapler's jaws is distributed unevenly

c) Unusual sounds during firing. This can indicate a damaged or malfunctioning internal mechanism.

d) Failure to release tissue after firing—that is, tissue becoming "jammed" in the mechanism.

4. Such problems can prolong surgery or cause complications that require subsequent medical interventions.

5. Complications related to stapler usage have been known to result in:

a) Severe intraoperative hemorrhage

b) Tissue damage

c) Postoperative complications, such as unexpected bleeding or gastrointestinal leakage from incompletely sealed structures

d) Failed anastomoses

e) Infection

Figure 3. Matching stapler cartridge size to tissue thickness is important for secure closure and hemostasis.

 

PriceGuide Data

The following chart represents ECRI Institute PriceGuide data from October 2017 through October 2018 for all linear surgical staplers. Note that these figures may not be limited to endoscopic staplers; they may also include device cartridges as well as staplers intended for open (i.e., non-endoscopic) procedures. Alternatively, users may have reported their product spend under the more generic term of "staplers," which would not be included in this query.

Total Ethicon spend in this category is approximately $40,778,000. Total Medtronic spend is approximately $11,828,000.


 

Estimating the Annual Cost of Ownership for Endoscopic Linear Surgical Staplers

The annual cost of ownership for endoscopic linear surgical staplers is determined by calculating the cost of all required disposables—from the stapler itself, in the case of disposable models, to the reloads required to achieve your desired outcome. For models with reusable components, the acquisition costs of those components or accessories must also be factored into the analysis. The table below shows the results of a sample analysis conducted using ECRI Institute's PriceGuide data.

A more expansive analysis was conducted by Roy et al. in a 2016 study sponsored by Ethicon. The researchers examined laparoscopic bariatric procedures (i.e., Roux-en-Y gastric bypass and sleeve gastrectomy) performed using powered and manual staplers from both Ethicon and Medtronic for outcomes such as hospital length of stay, total hospital costs, supply costs, room and board costs, OR costs, OR time, and others. That study found that costs were significantly lower for the powered stapler group, with a saving of $288 in OR costs and $587 for supplies. Procedure times for the powered stapling group were shorter, but not statistically significantly so, when compared to the manual group.
 

Estimating the Typical Annual Cost of Ownership for Endoscopic Linear Surgical Staplers

The costs reported in this table represent typical purchase costs reported to ECRI Institute's PriceGuide database for the most commonly purchased devices within these product lines. These figures are provided as a guide only and may vary significantly.  ​

DISPOSABLE STAPLERS—PURCHASE COSTS

Components

Typical Cost

Notes

One 60 mm stapler handle

$260

Associated catalog numbers are typically sold in cases of three.

One 45 mm stapler handle

$240

Associated catalog numbers are typically sold in cases of three.

One 60 mm stapler reload

$200

One 45 mm stapler reload

$170

REUSABLE STAPLERS—PURCHASE COSTS

Components

Typical Cost

Notes

One universal powered stapler handle

$3,000

Reusable for 300 procedures; charge typically lasts at least 17 firings. (See Assumption no. 4, below.)

Accessories

$2,600

Accessories include a linear shaft adapter, handle charger, insertion guide, manual retraction tool, and sterilization tray. (See Assumption no. 5, below.)

One 60 mm stapler reload

$200

One 45 mm stapler reload

$170

ESTIMATED ANNUAL STAPLING EXPENDITURES

For disposable stapling

$243,000

​Calculated using the assumptions outlined below.

For reusable stapling

$265,000

​Calculated using the assumptions outlined below.

ECRI INSTITUTE ASSUMPTIONS USED FOR THIS ANALYSIS

1. Manufacturer estimates indicate that there are approximately 900,000 laparoscopic stapling procedures performed in the United States annually. Dividing by the number of registered U.S. hospitals, ECRI Institute assumes that the average hospital performs 200 procedures per year that require the use of a laparoscopic stapler.

2. The average laparoscopic stapling procedure requires five stapler reloads.

3. Fourteen percent of procedures may require switching from one staple line length to another.

4. A reusable power handle may be used in 300 procedures. However, a hospital would likely need to purchase more than one so that a usable stapler is available at all times. For the purposes of this analysis, we have assumed the cost of two power handles per year. The acquisition cost for these two handles would be $6,000, but as each would last 1.9 years at the assumed number of procedures, we have averaged the cost of one reusable power handle to be $1,500 per year.

5. For each power handle, a hospital would purchase a linear adapter per every 50 procedures, a charger, an insertion guide, a manual retraction tool, and a sterilization tray.

6. A charger, insertion guide, manual retraction tool, and sterilization tray will last three years.​

 

Recall and Hazard Analysis

1. The data represented in the charts below is based on ECRI Institute's Health Devices Alerts records from January 2015 through October 2018 and represents 21 total alerts for all vendors.

2. Manual staplers are associated with more alerts than powered staplers. Most reports involved hardware-related issues, such as missing device components, failure to fire, and failure to release from tissue. Also included are issues of device labeling and training, such as updates to product directions for use.

3. ECRI Institute addressed surgical stapler misuse and malfunctions in its list of the Top 10 Health Technology Hazards for 2017. The following recommendations for safe stapler use are based largely on the information from that report:

a) Clinicians—before use:

(1) Read and follow the stapler manufacturer's IFU before using the device for the first time or for the first time in a while.

(2) Have an appropriate range of stapler cartridge sizes available for use.

(3) Have additional staplers and other means of closure available for immediate use.

(4) Inspect the stapler for damage before using it. (Preferably, this should be done both by the scrub technician/nurse who opens the instrument pouch and by the surgeon who will use the instrument.)

b) Clinicians—during and after use:

(1) Do not use a stapler if you are unable to visually assess (either directly or with an endoscope) secure closure and hemostasis.

(2) Before firing the stapler, pause to ensure that the staples are appropriately sized for the intended tissue. If you have difficulty squeezing the handle of the stapler, you may need to resize.

(3) If the stapler makes unusual sounds or is difficult to use: Visually inspect the stapler; check for excessive tissue, foreign material, or interference from another instrument. If this fixes the sounds/difficulty, proceed with caution; if not, continue with another stapler.

(4) Be prepared to convert from laparoscopic to open surgery when transecting and stapling critical vessels such as the renal artery.

(5) Adhere to the cut lines indicated on the stapler jaws. Staplers will not transect beyond their cut line, and multiple cartridges are commonly required to complete the transection of one area.

(6) Adhere to the practices recommended by Fuller et al. (2014); specifically:

(a) Avoid applying clips near an intended staple line site or stapling over an existing staple line.

(b) If a malfunction is noted when the stapler is closed on the tissue, "clamp or ligate the vessel before releasing the stapler."

(c) If tissue is "jammed" in the stapler, avoid forcefully freeing the tissue; consider dissecting proximal to the stapler closure.

(7) Once tissue has been stapled, check the application site for secure closure and hemostasis.

(8) If you identify a faulty stapler:

(a) In the absence of injury, return the stapler (with packaging if possible) to the suppler for analysis and credit.

(b) If an injury has occurred, retain the device for manufacturer and/or third-party investigation.

(c) Contact ECRI Institute to report the problem.

c) Administrators and other personnel:

(1) Materials management (Fuller et al. 2014): Communicate with clinicians during the device procurement process to ensure that surgeons can work with their preferred devices.

(2) Chief of surgery/OR director (Fuller et al. 2014):

(a) Facilitate focused and systematic training on surgical devices for all members of the surgical team to increase comfort with the device and its approved uses, as well as to raise awareness about known types of misuse and malfunction.

(b) Make provisions to allow clinicians to have effective hands-on practice time with surgical devices.

(3) Institute continuing staff education to address technology updates and changes. Perform adequate audits to verify staff competency.

Glossary

Bibliography

References

Al-Awabdy B, Wilcox CM. Use of anesthesia on the rise in gastrointestinal endoscopy. World J Gastrointest Endosc 2013 Jan 16;5(1):1-5. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3547114/.

Chekan E, Whelan RL. Surgical stapling device-tissue interactions: what surgeons need to know to improve patient outcomes. Med Devices (Auckl) 2014 Sep 12;7:305-18. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4168870/.

ECRI Institute. Surgical stapler misuse and malfunctions. Hazard #9—top 10 health technology hazards for 2017. Health Devices 2016 Nov 4. Available from: https://www.ecri.org/components/HDJournal/Pages/Top_10_hazards_for_2017_no_9_surgical_staplers.aspx?tab=1.

Fuller HJ, Paull DE, Williams LC. Surgical stapler adverse events in the Veterans Health Administration: root causes and lessons learned. Proceedings of the International Symposium on Human Factors and Ergonomics in Health Care: Advancing the Cause. 2014 Jun;3(1):153-6. Abstract available from: https://journals.sagepub.com/doi/pdf/10.1177/2327857914031025.

Roy S, Yoo A, Yadalam S, et al. Comparison of economic and clinical outcomes between patients undergoing laparoscopic bariatric surgery with powered versus manual endoscopic surgical staplers. J Med Econ 2017 Apr;4(20):423-33. Available from: https://www.tandfonline.com/doi/full/10.1080/13696998.2017.1296453.

Topics and Metadata

Topics

Bariatric Medicine; Quality Assurance/Risk Management; Technology Management; Technology Selection

Caresetting

Ambulatory Surgery Center; Hospital Inpatient; Hospital Outpatient

Clinical Specialty

Bariatrics; Gastroenterology; Nursing; Surgery; Urology

Roles

Clinical Practitioner; Materials Manager/Procurement Manager; Nurse; Patient Safety Officer

Information Type

Guidance

Phase of Diffusion

 

Technology Class

 

Clinical Category

 

SourceBase Supplier

Product Catalog

MeSH

ICD9/ICD10

FDA SPN

SNOMED

HCPCS

Disease/Condition

 

Publication History