DOI: 10.1097/SLA.0000000000001256

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PMID: 26057558

Issn Print: 0003-4932

Publication Date: 2015/07/01


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Fundamental Use of Surgical Energy (FUSE): Closing a Gap in Medical Education

Pascal R. Fuchshuber; Thomas N. Robinson; Liane S. Feldman; L. Michael Brunt; Amin Madani; Stephanie B. Jones; Marc A. Rozner; Malcolm G. Munro; Jessica Mishna; Steven D. Schwaitzberg; Daniel B. Jones

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Author Information: Department of General Surgery, Kaiser Permanente Medical Center, Walnut Creek, CA

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Excerpt

The medical community stands in the midst of a transformation in the delivery of health care. At its core lies a technological revolution that has gained great momentum over the last 2 decades and has touched and disrupted virtually every medical specialty. This is particularly true for surgery, gastroenterology, cardiology, and radiology, which have been radically transformed by the developments in energy application, image-guided procedures, robotics, miniaturization, molecular genetics, and wireless control. The availability of advanced instrumentation and specialized facilities allows surgeons, gastroenterologists, radiologists, and cardiologists to share the ability to perform therapeutic procedures that were once the unique domain of one specialty. Examples include endovascular repairs for vascular diseases; minimally invasive, robotic assisted, and natural orifice procedures; cardiac and oncologic percutaneous ablation procedures; endoscopic antireflux procedures; and endoluminal resections. Essential to these new procedures is the availability of a large portfolio of new mechanical and energy-driven devices that has changed the treatment approaches to entire disease entities. For the most part, these developments have advanced our ability to provide medical care with ever-decreasing complication and mortality rates. Yet, the speed, complexity, and number of new devices introduced annually raise safety and training concerns that are not being addressed by the current regulatory framework.
Efforts to regulate and improve safety of medical devices date back to the mid-1970s with the enactment of the Medical Device Amendments of 1976.1 This legislation provided a framework for Food and Drug Administration supervision, premarket application approval, and completed product development protocol. In 1990, the Medical Device Amendments was replaced by the Safe Medical Devices Act, which provided the current legislative framework for the regulation of medical devices. These government regulations and the additional work from voluntary and nonprofit organizations such as the Association of the Advancement of Medical Instrumentation (founded in 1965) and the Emergency Care Research Institute (ECRI, founded in 1968) have been instrumental to our understanding of medical device safety. As a result, a great deal has been learned about medical device safety and how to prevent accidents and fatalities due to inadequate engineering and wiring design. Most importantly, large voluntary and mandatory adverse event–reporting databases provide essential information about medical device–related accidents and injuries.
This regulatory framework typically lacks specific requirements for training before clinical use of new devices, and this lack of knowledge about the functionality, appropriate use, and hazards of a device or technology likely increases the chance of adverse events. For example, the ECRI's top 10 health technology hazards for 2015 include complications due to insufficient training in robotic assisted laparoscopic surgery. Given that modern medicine, and notably interventional medicine, is highly reliant on technology and devices, it is necessary to address their safety through targeted educational activities. This concept is certainly true for energy devices, the distinct subgroup of energy-powered medical devices that are used in procedure-based specialties to dissect, cut, coagulate, seal, and ablate tissues in the operating rooms, endoscopy suites, and in radiologic interventions.
Because a safe device cannot guarantee device safety, adverse events related to energy-based devices seem to occur commonly and with increasing frequency. The extent of harm is concerning, as the vast majority of adverse events due to energy devices are almost all preventable. According to the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE), 178 deaths and 3553 injuries related to radiofrequency electrosurgical devices were reported in the last 20 years (Fig. 1). The most common causes for injury and death were thermal burns (N = 2353; 63%), hemorrhage (N = 642; 17%), mechanical device failure (N = 336; 9%), and fire (N = 294; 8%).
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