WIREDGOV

The National Institute for Health and Clinical Excellence (NICE) yesterday (10 February) opened a consultation on a new medical technology device to promote wound healing. The medical technology guidance draft was produced by the Medical Technologies Advisory Committee (MTAC), which is part of the Medical Technologies Evaluation Programme at NICE.

The MIST Therapy system claims to promote wound healing in chronic, 'hard to heal' and acute wounds by delivering low-energy, low-intensity ultrasound to the base of the wound through a continuous saltwater mist. The saline mist generated acts as a channel for transmitting ultrasonic energy to the base of the wound, which aims to reduce the amount of bacteria in the wound and stimulate tissue regeneration. The non-contact MIST Therapy treatment lasts between five and seven minutes and is carried out three times a week, at the same time as wound dressings are changed. It is claimed by the device manufacturer that it can improve healing rates, thus reducing treatment time and associated costs, and so offers advantages to both patients and the NHS.

The Committee's view is that the device shows promise, and its use is supported by expert opinion. However, there is not yet enough evidence of sufficient quality to enable the Committee to make a positive recommendation on its use. The Committee recognised that there is a general lack of good quality evidence in the area of wound care, possibly because there are so many different types of chronic wounds, which makes it difficult to collect comparable data. The Committee is therefore strongly encouraging further research on the use of the MIST Therapy system in chronic wounds comparing it with standard care.

NICE medical technology guidance aims to help new medical technologies, or innovative modifications to existing ones, to be used more quickly and consistently in the NHS across England. In particular, MTAC looks at whether a device offers benefits to the patient and the NHS at a lower cost compared with similar products, or increased benefits for equal cost.

Dr Carole Longson, Director of the NICE Centre for Health Technology Evaluation, said: "The Medical Technologies Advisory Committee thought that the MIST Therapy system shows promise, so they have recommended that further research is carried out which will potentially allow definitive recommendations for clinical use to be made in the future. The case for adopting the device couldn't be supported at this point as the evidence provided was unfortunately not of good enough quality, but it is very important to note that this draft outcome doesn't mean that the device should not be used.

"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 for the MIST Therapy system is available on the MIST webpage. The consultation closes on 10 March 2011.

Download PDF version

Notes to Editors

About the draft guidance

1. The MIST Therapy system is manufactured by Celleration.

2. Final guidance on this topic is expected to be published in June 2011.

About the Medical Technologies Evaluation Programme

3. Established by NICE in 2009, the focus of this new 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 http://www.nice.org.uk/MT.

About NICE

4. The National Institute for Health and Clinical 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.

5. 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.

6. 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

7. 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.