NICE Publishes Positive Final Guidance On Device For Use During Electrosurgery

In shortThe National Institute for Health and Clinical Excellence today (22 August) publishes final guidance on a new medical technology device designed to be used during surgery. The guidance advises that the use of the Mega Soft Patient Return Electrode could help reduce the risk of localised burns during monopolar electrosurgery. This so-called “final guidance” has been anticipated since NICE issued its initial findings for consultation in April of this year, here.
BackgroundIn monopolar electrosurgery, the tool used by the surgeon to cut the patient has an electric current running through it which cauterises the cut and so reduces bleeding. A majority of surgical procedures involve some electrosurgery, and the technique is often used for cutting fine vessels in the body. As the tool used to cut the patient carries an electric current, the patient becomes part of an electric circuit, so the current needs to then flow from the patient and back to the monopolar electrosurgery generator to complete the electrical circuit.

In current NHS clinical practice, the electric current leaves the patient via a disposable single-use patient return electrode which is attached directly to the patient’s skin via a ‘sticky surface’. However, the Mega Soft Patient Return Electrode is instead incorporated into a padded layer on which the patient lies during surgery. It is claimed by the manufacturer of the product, Megadyne Medical Products Inc., that as well as reducing burns, which can occur with disposable single-use diathermy pads which are attached directly to the skin, it also relieves pressure.

The NICE guidance advises that the Mega Soft Patient Return Electrode may offer particular advantages for selected patients, such as those who would require shaving for application of disposable electrode pads and those with fragile or damaged skin. In addition, the device may benefit operating theatre staff in terms of increased convenience and reduced setting up time. The economic considerations show that cost/resource requirements are similar to current practice. However, expert advice suggested that the resource consequences of the Mega Soft Patient Return Electrode are greatly influenced by the circumstances in which it is used.

NICE medical technology guidance will help enable new medical technologies, or innovative modifications to existing ones, to be used more quickly and consistently in the NHS across England. The guidance, produced by the independent Medical Technologies Advisory Committee (MTAC), concludes that it is plausible that the Mega Soft Patient Return Electrode reduces the risk of burns related to the diathermy patient return electrode where surgery is carried out in the context of good operating theatre practice.

Professor Carole Longson, Director of the NICE Centre for Health Technology Evaluation, said: “This final guidance for the Mega Soft Patient Return Electrode shows that if used for carefully selected patients, such as those with fragile skin or those whose skin would need shaving first, the device could provide benefits in reducing burns resulting from electrosurgery. There are also possible benefits for theatre staff in terms of convenience and reduced setting up time; which are more likely to be seen for inpatient operating lists than for day case surgery.

“The recommendations also note that clinicians and managers judging the likely benefits of adopting the Mega Soft Patient Return Electrode should take into account current practice in their operating theatres including the proportion of inpatient operations for which it would be used.

“The published clinical evidence comparing the Mega Soft Patient Return Electrode against disposable single-use patient return electrodes for use during monopolar electrosurgery is limited. Rather than advising widespread adoption for all patients, the recommendations have focussed on those patient groups who are likely to gain most benefit. We hope that the guidance will be useful for hospital staff who may be considering how to reduce risk of burns arising from monopolar electrosurgery.”

The guidance “Mega Soft Patient Return Electrode for use during monopolar electrosurgery” is available here.

For more information call Dr Tonya Gillis at the NICE press office on 0845 003 7782 or 07775 583 813 out of hours.

Source: NICE