National Institute for Health and Clinical Excellence (NICE)
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NICE consults on two new medical technology devices
The National Institute for Health and Clinical Excellence (NICE) last week opened consultations on two new medical technology devices a mattress to prevent inadvertent hypothermia during surgery, and a ´sticking plaster´ used to treat non-melanoma skin cancer. These medical technology guidance drafts were produced by the Medical Technologies Advisory Committee (MTAC), which is part of the Evaluation Pathway Programme for Medical Technologies.
The first of these two pieces of draft guidance from the new NICE medical technologies programme provisionally supports the use of the Inditherm patient warming mattress. The mattress is designed to be used for patients having surgery involving an anaesthetic who may be at risk of inadvertent hypothermia. A common and preventable complication of surgery, possible consequences of inadvertent hypothermia include increased blood loss, increased heart problems, increased risk of wound infection, longer recovery times and longer hospital stay. The evidence submitted on the Inditherm mattress claims that it is a practical, low-cost and effective patient warming device so offers advantages to patients and the NHS.
The second set of draft guidance considers the use of Ambulight PDT, a device similar in appearance to a sticking plaster, but which delivers therapy ‘on the move' to treat non-melanoma skin cancer. Most photodynamic therapy treatment utilises large static light sources, but the Ambulight PDT device can be used in a community setting avoiding the need for a hospital appointment. It is claimed by the manufacturer of the product that the lower irradiance of Ambulight PDT reduces the pain experienced by the patient compared to treatment with conventional light sources. The case for adoption could not be supported at this stage because the Committee received expert advice that the treatment options for non-melanoma skin cancer are complex, practice varies substantially and, overall, the evidence base needed to guide the rational choice of treatments for non-melanoma skin cancer needs to be developed further.
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. 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 estimated average NHS cost saving for the Inditherm mattress is in the region of £9770 per theatre each year. MTAC was unable to arrive at clear conclusions on the cost impact of adopting Ambulight PDT for the reasons highlighted above.
Dr Carole Longson, Director of the NICE Centre for Health Technology Evaluation, said: “The supportive provisional recommendation for the Inditherm mattress advises that it should be considered for use in patients at risk of inadvertent hypothermia. The evidence examined indicates that as well as benefiting patients by reducing a range of serious complications associated with inadvertent hypothermia, it also benefits the NHS by saving money.
“Whilst Ambulight PDT is an exciting and innovative device it is still early days and, given that treatment options in this area are complex, unfortunately there isn't a substantive evidence base overall to determine the place for adoption of this new technology, relative to others. However it is very important to note that this draft outcome doesn't mean that the device should not be used; it remains one of a range of potential options on offer for treating non-melanoma skin cancer.
“We look forward to receiving comments on our provisional recommendations from health professionals, industry and patient groups to help inform the development of both sets of guidance.”
More information on both medical technology draft guidance consultations is available at http://guidance.nice.org.uk/MT/92 for the Inditherm mattress and http://guidance.nice.org.uk/MT/50 for Ambulight PDT. The consultations close on 2 February 2011.
Notes to Editors
About the guidance
1. The cost models used indicated that the estimated average cost saving for Inditherm is £9770 per theatre each year. The Inditherm mattress is manufactured by Inditherm plc.
2. There was insufficient evidence provided to enable MTAC to arrive at any clear conclusions on cost savings for Ambulight. Ambulight PDT is manufactured by Ambicare Health Limited.
3. NICE published a clinical guideline in 2008 on perioperative hypothermia. This guideline recommends that if a patient's temperature is below 36.0°C they should be warmed using a technique called 'forced air warming' where hot air is blown in to a specially designed blanket. At the time of publication, the guideline noted within the research recommendation section that there was emerging evidence to suggest that electric heating mattresses, electric heating pads and heated water garments may be as effective as forced air warming; however, the evidence at that point was insufficient for use of these devices to be recommended. It is important to note that the draft medical technology guidance on Inditherm does not supersede or update recommendations in the clinical guideline. When the final MT guidance is published it should be considered in addition to the existing recommendations in the clinical guideline.
4. Final guidance on both topics is expected to be published in March 2011.
About the Evaluation Pathway Programme for Medical Technologies
5. 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.
6. 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.
7. 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.
8. 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
9. 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.