NICE consults on novel medical device

The National Institute for Health and Care Excellence (NICE) today (21 March) opens a consultation on a new medical technology device designed to be used during surgery. The draft guidance considers the use of Mega Soft Patient Return Electrode, a device specifically designed to reduce localised burns during monopolar electrosurgery.

In 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 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.

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 The draft guidance, produced by the independent Medical Technologies Advisory Committee (MTAC), concludes that whilst there may be potential for some benefit with specific groups of patients, the case for routine adoption of Mega Soft Patient Return Electrode in the NHS could not be supported because the evidence available is very limited and doesn't demonstrate that burns linked to electrode use are prevented as claimed.

In particular, MTAC looks at whether a device offers benefits to the patient and NHS at a lower cost compared with similar products, or increased benefits for equal cost. The economic evidence considered and cost modelling demonstrates that the resource use and costs associated with this device are nearly equivalent to current practice.

Mirella Marlow, Programme Director in the NICE Centre for Health Technology Evaluation, said: "The Mega Soft Patient Return Electrode is a promising device but unfortunately the uncertainty about its efficacy is too great for routine adoption in the NHS to be advised in this draft guidance. The very limited published clinical evidence does not demonstrate clearly that burns are reduced as a result of its use, but the Committee thought it possible that if used in operating theatres that already have measures in place to reduce such burns, the Mega Soft Patient Return Electrode could avoid burns to patients in the course of monopolar electrosurgery, which are a rare complication of this type of surgery. However it is very important to note that this draft outcome doesn't mean that the device should not be used since it may offer advantages for selected patients, such as those who would require shaving for application of disposable electrode pads and those with fragile or damaged skin.

"“We look forward to receiving comments on our provisional recommendations from health professionals, industry and patient groups to help inform the development of this guidance."

More information on the medical technology draft guidance consultation is available at . The consultation closes on 18 April 2012.


Notes to Editors

About the guidance

1. Mega Soft Patient Return Electrode is manufactured by Megadyne Medical Products.

2. The cost of the adult or paediatric Mega Soft Patient Return Electrode (without VAT) is £1,900.

3. Final guidance is expected to be published in July 2012.

About the Medical Technologies Evaluation Programme

4. Established by NICE in 2009, the focus of this area of work is specifically on the evaluation of innovative medical technologies, including devices and diagnostics. The types of products which might be included are medical devices that deliver treatment such as those implanted during surgical procedures, technologies that give greater independence to patients, and diagnostic devices or tests used to detect or monitor medical conditions. The independent Medical Technology Advisory Committee has two core remits: selecting medical technologies for evaluation by NICE guidance programmes and also developing medical technologies guidance itself. The guidance applies to the NHS in England, and is not mandatory.

More information is available at /guidance/mtg7/resources/medical-technologies-evaluation-programme.

About NICE

5. The National Institute for Health and Care Excellence (NICE) is the independent organisation responsible for providing national guidance and standards on the promotion of good health and the prevention and treatment of ill health.

6. NICE produces guidance in three areas of health:

  • public health - guidance on the promotion of good health and the prevention of ill health for those working in the NHS, local authorities and the wider public and voluntary sector
  • health technologies - guidance on the use of new and existing medicines, treatments, medical technologies (including devices and diagnostics) and procedures within the NHS
  • clinical practice - guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS.

7. NICE produces standards for patient care:

  • quality standards - these reflect the very best in high quality patient care, to help healthcare practitioners and commissioners of care deliver excellent services
  • Quality and Outcomes Framework - NICE develops the clinical and health improvement indicators in the QOF, the Department of Health scheme which rewards GPs for how well they care for patients

8. NICE provides advice and support on putting NICE guidance and standards into practice through its implementation programme, and it collates and accredits high quality health guidance, research and information to help health professionals deliver the best patient care through NHS Evidence.

This page was last updated: 20 March 2012