30 Dec 2022

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FDA Warns of Serious Misuse of Surgical Staplers

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Academic level: High School

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Words: 776

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Misuse of surgical staplers has been identified as one of the technology hazards that has led to numerous adverse effects, including mortality. The literature review considers the evaluation of literature in the area of concern (misuse of surgical staplers) to gain knowledge, which can finally be used to make further exploration of minimizing the misuses of surgical staplers. There is a need to figure out the proper solutions to these problems and minimize the number of such hazards. The minimization of these adverse effects related to this issue can best be achieved when suggestions given after carrying out various pieces of research are adhered to and implemented. This literature review considers identifying the best solution that can be put forward to reduce the chances of having these problems. 

Riggs, M. (2018). A novel approach to assess minimally invasive surgical device failure utilizing adverse event outcome severity and design complexity. 

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Due to the intricate nature of the surgical staplers, the manufacturers and the users have a collective responsibility of ensuring that the errors and misuses are prevented. There is a need for the users to know the complexity of the surgical staplers since it offers insight into the specific mechanisms that can result in the failure of these devices. It will also provide an understanding of awareness on the risks as well as those techniques that can be used for the prevention of the misuse of surgical staplers. There is a need to alter the shape of stapling pins to improve the hemostasis ( Riggs, 2018). Furthermore, the staple size should correspond to the size of tissue that is being stapled. 

Goh, B. K. (2020). A multicentre, randomized, controlled trial comparing reinforced staplers with bare staplers during distal pancreatectomy (hisco-07 trial). 

Annals of Surgical Oncology

1 (3), 24-30. 

The anastomosis of the staple depends on the staple line since this is directly related to the compression of the tissues. The tissues' intrinsic biochemical properties have a variation in line with the thickness and types of tissues. The manufacturers need to give the guideline on the kind of tissues that are effective for any and the size of staple pins to be applied ( Goh, 2020). The stabling procedure force should be varied as per the advice from the manufacturer, which should be established after research. There is a need for the guidelines of the optimal compression time required before firing the device. 

Özcan, B. (2018). Efficacy of endoscopic vascular staplers for splenic hilar control during laparoscopic splenectomy. 

Laparoscopic Endoscopic Surgical Science

2 (3), 54-60. 

It is necessary to have the formation of proper shape for the staples; the surgeons should ensure that there is integrity in the staple line as well as the smooth division of the tissue that is targeted ( Özcan, 2018). The other solution to preventing the misuse of surgical staplers is ensuring proper overall mechanical usage through all the stages in which the device is used. The technical advancement, which has contributed to the development of modified and new surgical techniques, has resulted in surgical staplers. Due to the rapid rate at which technological advancement occurs, the surgeons lack the knowledge on the best measures apply when using the surgical staplers, and this what has led to the misuse. The technological devices should only be introduced to the hospital after training the surgeons. 

Attigah, N., & Schäfer, M. (2019). Surgical staplers.  Atlas of Upper Gastrointestinal and Hepato-Pancreato-Biliary Surgery 2 (4), 27-32. 

Training the surgeons on the tissue handling methods and the limitations associated with the surgical stapler would be an effective solution to the misuse ( Attigah & Schäfer, 2019). The misuse of the staplers has been used attributed to the errors from the practitioners. Having the surgeons' continuous education, training, and improving the design of the surgical staplers would be one of the most exceptional solutions to the misuse of surgical staplers. The education should also be offered to the patients to ensure that they are not involved in risky activities. Additionally, there is a need to share challenges with the manufactures for them to improve their devices. 

There are numerous similarities and differences when considering the solutions that have been set forth by different authors as measures to the misuse of surgical staples. According to Attigah & Schäfer (2019) and Riggs (2018), continuous educations are focused on as the major technique that can be used to reduce misuse of the surgical stapler . Riggs, (2018) and Özcan, (2018) indicated that understanding the complexity of the staples and anatomy is the focus to solve the misuse of surgical staples. Goh (2020) stated the provision of guidelines by the manufacturer as the solution to this technological problem. I consider that offering the training to surgeons is the best solution that can be used to prevent the misuse of surgical staples. Such training should be continuous for the surgeons to be in a position of giving their experience to ensure that devices are improved and will ensure quality assurance. 

References 

Attigah, N., & Schäfer, M. (2019). Surgical staplers.  Atlas of Upper Gastrointestinal and Hepato-Pancreato-Biliary Surgery 2 (4), 27-32. 

Goh, B. K. (2020). A multicenter, randomized, controlled trial comparing reinforced staplers with bare staplers during distal pancreatectomy (hisco-07 trial).  Annals of Surgical Oncology 1 (3), 24-30. 

Riggs, M. (2018). A novel approach to assess minimally invasive surgical device failure utilizing adverse event outcome severity and design complexity. 

Özcan, B. (2018). Efficacy of endoscopic vascular staplers for splenic hilar control during laparoscopic splenectomy.  Laparoscopic Endoscopic Surgical Science 2 (3), 54-60. 

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StudyBounty. (2023, September 14). FDA Warns of Serious Misuse of Surgical Staplers.
https://studybounty.com/fda-warns-of-serious-misuse-of-surgical-staplers-essay

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