Guidelines in Practice: Electrosurgical Safety

Link, Terri

doi:10.1002/aorn.13421

Cited by 6 publications

(2 citation statements)

References 10 publications

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“…However, nowadays it is necessary to continue to reduce the incidence of errors in surgery. The Guideline for Electrosurgical Safety provides guidance to perioperative personnel on the safe use of electrosurgical units [20]. Regarding the case presented, and to adapt and implement a tool based on clinical practice guidelines related to electrosurgical safety, we have developed a specific checklist model to improve safety related to possible adverse effects associated with the use of monopolar diathermy in our podiatry unit (Figure 6).…”

Section: Discussionmentioning

confidence: 99%

Implementation of an Electrosurgical Checklist in a Podiatry Unit in Relation to a Case of Inadvertent Burns during Hallux Valgus Surgery

Córdoba-Fernández,

Jiménez-Cristino,

Mármol-García

et al. 2023

Reports

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Iatrogenic burns are unpleasant and sometimes difficult to explain to patients. Podiatric surgeons routinely use electrosurgical devices to cut and coagulate tissue during surgical procedures. Although advances in technology have made electrosurgery increasingly safer for patients and personnel, its use is still poorly understood by the surgical community, and the hazards associated with its use still exist presently. Human error, direct or indirect transfer of electricity to a conductive device, or device malfunction can cause serious adverse events, including burns, electrical shocks, and or fires. Here, we report a rare case of a 43-year-old man who suffered severe burns during hallux valgus surgery. The surgeon and the nursing staff did not notice any injuries during the surgical intervention. This unusual clinical case serves to highlight the importance of implementing protocols to prevent injuries related to the use of electrosurgery. Based on this report, a specific checklist was implemented to prevent adverse events related to electrosurgery in our podiatric surgery unit to reduce the risk of electrosurgical complications. The implementation of the checklist can be useful to help health professionals improve patient safety during surgery and avoid potential medico–legal liability claims.

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Section: Discussionmentioning

confidence: 99%

Implementation of an Electrosurgical Checklist in a Podiatry Unit in Relation to a Case of Inadvertent Burns during Hallux Valgus Surgery

Córdoba-Fernández,

Jiménez-Cristino,

Mármol-García

et al. 2023

Reports

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“…1 Surgical briefing with the entire perioperative team is necessary so that each individual understands their role in preventing electrosurgical hazards. 2 In addition to this, case reporting of surgical burns to the national database is necessary for implementation of such preventive measures.…”

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confidence: 99%

Hazards of monopolar diathermy plate in Surgery

Zafar

2023

J Pak Med Assoc

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Respected Madam, I would like to draw attention to the hazard of severe skin burns from the using the monopolar diathermy plate electrode during surgical procedures. Diathermy operates in two modes. The monopolar mode where the current enters the patient’s body through an active electrode and exits via a grounding pad attached to the patient.(1) During a recent total abdominal hysterectomy with bilateral salpingo-oophorectomy of a 30-year-old lady with a complex mass, the grounding pad for the electro-cautery had been applied to the left foot, which was found to have third degree burns after completion of the procedure. Similarly, an elderly diabetic lady presented to our outpatient department with the history of a 32 days old non-healing lesion on her left thigh and a Pfannenstiel incision on her abdomen. She had undergone a complete abdominal hysterectomy in another health care centre. During the surgery, the grounding pad was placed on her left thigh which suffered partial thickness burns. According to the patient’s history, the lesion was coin sized at the beginning, but due to poor glycemic control, it continued to involve the surrounding healthy tissue, including the bone. She had previously undergone multiple debridements for the lesion and was advised hip disarticulation after a thorough assessment by the senior management at our department. Even though the procedure was carried out, she, unfortunately, could not survive a few days following the disarticulation. The reason for the burns was a loose application of the grounding pad to the skin of the patient resulting in heat generation and sparking at the site preventing the current to pass safely causing skin burns. To prevent this, the grounding pad should be firmly applied to the skin preferably with crepe bandage. Some other ways to help prevent such complications are adhesive grounding pads and utilization of diathermy machines alarm system.(1)Surgical briefing with the entire perioperative team is necessary so that each individual understands their role in preventing electrosurgical hazards.(2) In addition to this, case reporting of surgical burns to the national database is necessary for implementation of such preventive measures.(3)

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The 510(k) Third Party Review Program: Promise and Potential

Miller,

Blanks,

Yagi

2023

J Med Syst

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Every year, the Food and Drug Administration (FDA) clears approximately 3,000 medical devices for marketing via the 510(k) pathway. These constitute 99% of all devices approved for human use and includes the premarket review of many devices incorporating newer technology such as artificial intelligence (AI), machine learning (ML), and other software. As the complexity of these novel technologies and the number of applications is expected to increase in the coming years, statutory changes such as the 2016 21st Century Cures Act, regulations, and guidance documents have increased both the volume and complexity of device review. Thus, the ability to streamline the review of less complex, low-to-moderate risk devices through the 510(k) pathway will maximize the FDA’s capability to address other important, future-oriented regulatory questions. For over twenty five years, third party review organizations have served a defined function to assist with the review of 510(k) applications for a set of enumerated device classes. This paper reviews the history of FDA device regulation, the evolution of the 510(k) review pathway, and the recent history of the 510(k) third party review program. Finally, the paper addresses policy concerns from all stakeholders – including the FDA – along with policy suggestions to improve the third party review program and FDA device regulation writ large.

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Guidelines in Practice: Electrosurgical Safety

Cited by 6 publications

References 10 publications

Implementation of an Electrosurgical Checklist in a Podiatry Unit in Relation to a Case of Inadvertent Burns during Hallux Valgus Surgery

Implementation of an Electrosurgical Checklist in a Podiatry Unit in Relation to a Case of Inadvertent Burns during Hallux Valgus Surgery

Hazards of monopolar diathermy plate in Surgery

The 510(k) Third Party Review Program: Promise and Potential

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