Recently Dr. Stuart Mitchell gave a talk at www.bio2devicegroup.org zoom meeting on “Making Electrically Stimulated Surgical Devices Safer”. Electrically stimulated surgical devices are now ubiquitous, said Dr. Mitchell. Some of the large players in the electrically stimulated surgical device space are Ethicon holding the largest market share, followed by Medronic, Olympus, Hologic, and Conmed. There are many such devices in use but two of the most dominant types are RF devices and Harmonic devices. Radio Frequency or High Frequency devices are the most common type of surgical units on the market. They transform mains current into HF current. One such device Bovie is used to incise tissue, destroy tissue through desiccation, and to control bleeding by causing the coagulation of blood. The harmonic device is used to simultaneously cut and cauterize tissue by using ultrasonic vibration to generate mechanical friction at the active blade site.
Sharing the history of electrically stimulated surgical devices, Dr. Mitchell began with the fact that despite many hazards in the usage, surgical devices though not perfect, often make surgeries easier, faster and lead to lesser post surgical complications. It is an accepted truism in surgery that the time a patient spends under anesthesia, the better the outcome and electrically stimulated devices vastly lessen the time spent in the OR.
However, 33% of surgeries result in complications. In the USA alone 16M patients experience surgical complications and 49% or nearly half of those are avoidable complications of which 77% were due to technical errors. Nearly 1 out of every 200 uses of RF devices result in severe burns or fires and that number is as high as 80,000 patients per year. And sometimes this impact goes beyond the patients and affects medical personnel as well.
Of great concern, among the complications caused with these devices, are fires, burns, and smoke.
One out of 200 uses of RF devices result in severe burns or fires. That affects 80K patients per year. Sometimes the fires affect medical personnel. Sometimes smoke causes the images to get blurred and impairs the ability of the surgeons to see clearly. Smoke can also create other health hazards post surgery, including toxic gas buildup, viruses, bacteria etc. There are now smoke evacuators available. However, that becomes one more equipment to be used in OR and the compliance can be low.
Some surgeons simply refuse to use electric surgical devices for certain procedures, due to these complications.
Dr. Mitchell then shared about their company, Novuson’s range of surgical devices. Novuson’s Direct Therapeutic Ultrasound technology potentially can vastly improve surgical outcomes. DTU offers a range of next gen advanced emergency electrosurgical devices. These are electrically neutral, and they are effective in blood or liquid, cause no burning or charring, do not create smoke, and lead to considerably less thermal damage. Dr. Mitchell played a couple of videos showing how the device works. These devices can be used for all surgical procedures including for open, robotic, minimally invasive surgeries and lead to smaller scars, improve precision, speed and control and are far safer.
This exciting talk was followed by Q&A around the regulatory pathway ahead for various Novuson devices.