1 Provisional recommendations

1.1 The published clinical evidence on the Mega Soft Patient Return Electrode for use during monopolar electrosurgery is very limited and does not demonstrate a change in the incidence of burns as a result of its use. It is technically plausible that the Mega Soft Patient Return Electrode may reduce the risk of burns related to the diathermy patient return electrode when operating theatre practice attains a standard that minimises alternate site burns. The economic evidence and cost modelling demonstrate near equivalent resource use to current practice.

1.2 The Mega Soft Patient Return Electrode may offer advantages for selected patients for example, those who would need shaving before the application of electrode pads and those with fragile or damaged skin.

1.3 There may be system benefits for operating theatre staff using the Mega Soft Patient Return Electrode in terms of increased convenience and reduced setting up time. These benefits are more likely to be realised for inpatient operating lists than day case surgery, and do not appear to lead to a significant reduction in resourceutilisation.

1.4 Clinicians and managers considering adopting the Mega Soft Patient Return Electrode should therefore, in judging the likely benefits, should take into account current practice in their operating theatres with regard to prevention of alternate site burns and the proportion of inpatient operations for which it would be used.

2 The technology

Description of the technology

2.1 The Mega Soft Patient Return Electrode (Megadyne Medical Products) is a reusable dispersive capacitive electrode designed for use during monopolar electrosurgery. The electrode is intended to reduce the risk of burns and to provide pressure relief.

2.2 Electrosurgery uses high frequency current to achieve surgical effects such as cutting and coagulation. It is commonly referred to as diathermy. Monopolar electrosurgery (monopolar diathermy) specifically relies on the patient forming part of the electrical circuit. In addition to the patient’s tissue, the electrical circuit also includes the electrosurgical unit which generates the electrical current, an active electrode and a patient return electrode. High frequency electrical current is conducted from the target tissue to an electrosurgical unit, or generator. When the surgeon touches a selected area of the patient’s tissue with the electrosurgery tool (the active electrode), current passes from the tool, is distributed widely throughout the patient’s body and then returns to the electrosurgical unit via a patient return (dispersive) electrode. In current NHS clinical practice, the electrical circuit is completed by using an adhesive disposable single-use pad with an integral return electrode which is attached directly to the patient’s skin (patient return electrode). These electrodes consist of a conductive foil covered by a polymer. The Mega Soft Patient Return Electrode is incorporated into a large pressure-relieving pad (approximately 117cm x 51cm x 1.25 cm) which is placed on the operating table and on which the patient lies. When using the Mega Soft Patient Return Electrode, the electrical circuit is completed when the patient lies on the pad.

2.3 A standard disposable single-use patient return electrode measures approximately 12 cm x 13 cm. The area is determined by the need to minimise the rise in skin temperature by being large enough to maximise conduction of electrical energy away from the patient (disperse the electrical current). A standard patient return electrode is therefore also known as a dispersive electrode. It may also be called a neutral electrode, and this is the name used in the relevant technical standard specification including the IEC 60601-2-2-2009.  In clinical practice, the standard patient return electrode is commonly referred to as a diathermy pad.

2.4 A standard disposable single-use patient return electrode forms a resistive circuit and the direct electrical connection relies on good contact with the patient. The Mega Soft Patient Return Electrode does not rely on direct contact with the patient and forms a capacitive circuit. The Mega Soft Patient Return Electrode is much larger than a standard disposable single-use patient return electrode, and lies under the whole of the patient’s upper body.    

2.5 The majority of electrosurgical adverse incidents are related to patient burns. During electrosurgery, patients are at risk of two types of burn: return electrode burns and alternate site burns. Return electrode burns can occur when the contact area is reduced (for example, the pad can partially peel during surgery) and the current density increases. Some split disposable single-use patient return electrodes are designed to set off an alarm and cause the electrosurgical unit to cease to function when they start to peel off. Alternate site burns occur when some of the current does not follow the main circuit route, but finds an alternative path to earth rather than back through the generator. If the alternative path leads to a patient then a burn can occur.  Most electrosurgical generators are isolated which means the high frequency circuit is not referenced to earth directly. However, whenever high frequency currents are used, there is some leakage to earth, even in an isolated circuit. If the main circuit becomes harder to complete (for example, because of reduced patient contact with the return electrode), there is an increased possibility of alternate current pathways that can result in alternate site burns. The risk of alternate site burns is generally recognised to be higher with capacitive pads (such as Mega Soft Patient Return Electrode) than with resistive pads (such as standard disposable single-use patient return electrodes).

2.6 During 2009/10 approximately 9.7 million inpatient surgical procedures were performed in the UK. It has been estimated that 2.81 million of these (29% of the total) involved general anaesthesia and lasted for more than 30 minutes. Monopolar electrosurgery is estimated to be used at least half of all surgical procedures; therefore patient return electrodes are used in around 1.4 million procedures per year.

2.7 The cost of the Mega Soft Patient Return Electrode given in the sponsor’s submission is £1900 without VAT. The Mega Soft Patient Return Electrode can be used with all other electrosurgery generators, with the exception of the ERBE generator when that device is used on certain settings. Each pad is recommended for use for a maximum of 24 months.

2.8 The claimed benefits of the Mega Soft Patient Return Electrode presented by the sponsor are:

• reduction in the incidence of burns in patients having monopolar electrosurgery
• avoidance of skin shaving
• reduction in skin irritation because the Mega Soft Patient Return Electrode is not attached directly to the patient’s skin; this may be particularly applicable to patients with burns or other skin conditions as well as to paediatric patients and older patients with fragile skin
• reduction in the risk of pressure-related injury resulting from immobility during surgery
• reduction in staff time because the patient is placed on a resusable electrode and there is no necessity to attach a disposable single-use patient return electrode to the patient in a way that avoids bony prominences, scar tissue and tattoos
• reduction in the incidence of burns with a consequent drop in treatment and litigation costs
• cost saving and improved sustainability compared with current practice because the electrode is reusable and a separate pressure-relieving device may not be needed.

Current management

2.9 Current practice is to apply a disposable single-use patient return electrode to the skin before monopolar electrosurgery. If electrical conduction is impeded at the skin-to-pad surface interface there is a rise in skin temperature and risk of burning. Impedance of the current may occur when the contact area of the standard disposable single-use patient return electrode is reduced by body hair, adipose tissue, bony prominences, fluid invasion, failure of the electrode to adhere to the patient, or scar tissue. To prevent impedance, care must be taken to place patient return electrodes on hair-free areas without bony prominences. This may mean that the skin needs to be shaved before the electrode is applied.

2.10 The patient return electrodes in current practice are single use and disposable: they vary in two main respects. First, they may have split (dual) and non-split (single) electrodes. Second, they may have integral lead wires to attach them to the generator or be supplied without lead wires. If a patient return electrode has integral lead wires then these are discarded with the disposable electrode. Patient return electrodes without attached lead wires are connected to the generator by reusable lead wires. All types of patient return electrode are available in a range of sizes for adults and children. NHS procurement data indicates that the most commonly used type of patient return electrode in the NHS in England is the split adult disposable single-use patient return electrode without a lead wire.

3 Clinical evidence

Summary of clinical evidence

3.1 Full details of all clinical outcomes considered by the Committee are available in the assessment report overview at mtg11

3.2 The key clinical outcomes for the Mega Soft Patient Return Electrode presented in the decision problem were:

• incidence of patient return electrode burns
• incidence of alternate electrosurgical burns
• incidence of post-operative pressure ulcers
• use of the device in certain patient subgroups.

3.3 The clinical evidence for the Mega Soft Patient Return Electrode was based on two published studies and four unpublished documents. The published studies were one technical evaluation (ECRI 2000) and one observational study (Sheridan 2003). Both studies evaluated the earlier version of the Mega Soft Patient Return Electrode, the Mega 2000. The unpublished evidence was one technical evaluation from the sponsor, testimonials from two USA hospitals about the Mega 2000 and the Mega Soft Patient Return Electrode, and one questionnaire from three London hospitals on the Mega Soft Patient Return Electrode.

3.4 ECRI (2000) was a laboratory study that examined the safety, efficacy and cost consequences of the Mega 2000 compared with standard disposable single-use patient return electrodes, in relation to relevant American and international technical standards. The tests were performed on one adult volunteer and on a piece of meat (tests which assessed the occurrence of burns). No statistical tests were reported. Mega 2000 was rated ‘acceptable (with conditions)’. All the test results were rated as good except the test of alternate current pathways, which were rated as fair.

3.5 Sheridan (2003) reported an observational study of 17 children with extensive burns in a tertiary hospital in the USA. The children had only a few areas of the body suitable for placing the electrode and grounding the current. No statistical tests were reported. The results showed that Mega 2000 did not cause any burns, was convenient to use, and enabled effective patient grounding despite the presence of extensive burns.

3.6 A laboratory-based comparative technical study comparing the Mega Soft Patient Return Electrode with a disposable single-use split patient return electrode was submitted by the sponsor. The study has not been peer-reviewed. The tests were carried out on meat. The main outcome was whether or not pad site burns were observed (recorded as, yes or no). No statistical tests were reported. There was a rise in temperature of 9.7°C with the split pad compared with 1.2°C with the Mega Soft Patient Return Electrode. The IEC 60601-2-2-2006 standards for electrosurgery allow a maximum temperature increase of 6°C to minimise the risk of pad site burns.

3.7 The sponsor provided two testimonial reports from Christus St Joseph’s Hospital, USA in 2011. These were not clinical studies and no statistical tests were reported. There were no pre-defined outcomes. These hospitals initially used Mega 2000 and then switched to using Mega 2000 Soft (the US name for the Mega Soft Patient Return Electrode) when it came on to the market. In both reports Mega 2000/Mega 2000 Soft was compared indirectly with standard disposable single-use patient return electrodes for patient comfort and cost savings. Both hospitals issued statements saying that the Mega Soft Patient Return Electrode improved patient comfort and provided cost savings. It was not clear from the testimonial reports whether these benefits are generalisable.

3.8 An evaluation report was based on the use of the Mega Soft Patient Return Electrode at three London hospitals. Over a period of 2 weeks theatre nurses completed a questionnaire after surgery to rate the use of the Mega Soft Patient Return Electrode. The data were incomplete and no analysis was provided about the completeness of responses. Data were obtained after procedures were completed on 18 paediatric patients at one hospital and on 12 and 24 adult patients respectively at the other two. Mean scores were provided, together with raw data submitted for each question. Scores were from 0 to 5, with a higher score indicating a better outcome, and were averaged. Overall a rating of 4.7 was recorded for the Mega Soft Patient Return Electrode. The highest scores were for skin irritation and power settings (4.9) and the lowest score was for positioning (4.2).

Committee considerations

3.9 The Committee noted that patient return electrode burns are rare. It was advised that, on average, 117 burns are reported to the MHRA each year. Of these, approximately one-third are patient return electrode burns and about two-thirds are alternate site burns. In addition, the Expert Advisers stated that patient return electrode burns are very uncommon indeed.  They said that when these burns occur, they are usually not severe and are treated by a topical cream. The Committee was advised that all types of burn can usually be avoided by good operating theatre practice.

3.10 The Committee considered that, the published clinical evidence on Mega Soft Patient Return Electrode was very limited and did not provide evidence of whether or not the device prevented patient return electrode burns in practice. However, it accepted that it is technically plausible that the Mega Soft Patient Return Electrode can reduce the risk of patient return electrode burns, based on technical considerations.  The Committee concluded that technical testing had shown that the Mega Soft Patient Return Electrode was safe in the normal circumstances of UK practice. It noted that no adverse incidents (and specifically no burns of any kind) had been reported from use of the Mega Soft Patient Return Electrode in the UK.  

3.11 With regard to alternate site burns, the Committee noted that the Mega Soft Patient Return Electrode could be associated with an increased risk of alternate site burns compared with standard disposable single-use patient return electrodes if operating theatre practice was not of the highest standard. Balancing the plausible reduction in patient return electrode burns using the Mega Soft Patient Return Electrode against the possible increase in alternate site burns, if operating theatre practice does not attain the highest standards, the Committee judged that there was likely to be a similar overall risk of burns compared with current practice. Any reduction in the overall risk of burns using Mega Soft Patient Return Electrode would depend on the highest standards of operating theatre practice to minimise the incidence of alternate site burns. Therefore, clinicians and managers considering adopting the Mega Soft Patient Return Electrode should take into account current practice in their operating theatres with regard to preventing alternate site burns.

3.12 The Committee accepted it was plausible that the Mega Soft Patient Return Electrode may have advantages in selected patient groups, despite the lack of clinical studies to support these claims. Examples are patients with fragile or damaged skin and patients who would need shaving before application of standard disposable single-use patient return electrodes. The Committee noted estimates from clinical experts that between 20-30% of patients need to be shaved before using standard disposable single-use patient return electrodes.

4 NHS considerations

System impact

4.1 The sponsor claimed that using the Mega Soft Patient Return Electrode can reduce staff time. A patient can be placed on the Mega Soft Patient Return Electrode (which is already on the operating table) and does not need to have a suitable site selected for attaching a standard disposable single-use patient return electrode. The site of the Mega Soft Patient Return Electrode does not need to be checked at the end of the operation. In addition, some patients may need shaving before the use of a standard disposable single-use patient return electrode which involves staff time and the use of a disposable razor.

4.2 The sponsor claimed that the Mega Soft Patient Return Electrode would be cost saving by offering improved sustainability compared with current practice because it is reusable and a separate pressure-relieving device may not be needed.

Committee considerations

4.3 The Expert Advisers stated that any necessary shaving of patients and placement of standard disposable single-use patient return electrodes are normally done at the same time as other tasks and therefore using the Mega Soft Patient Return Electrode would not save time as claimed. The Committee accepted these views and concluded that using the Mega Soft Patient Return Electrode would not normally result in any substantial reduction in time taken to prepare patients in the operating suite.

4.4 The Committee noted comments that, even if operating theatre time was unlikely to be reduced, the use of the Mega Soft Patient Return Electrode might be more convenient and reduce the burden on theatre staff.  This could include removing the need to: shave some patients; select appropriate sites and fix adhesive standard disposable single-use patient return electrodes; adjust or change pads during surgery; or check pad sites at the end of operations.

4.5 The Committee was advised that the possible advantages of the Mega Soft Patient Return Electrode would be significantly influenced by whether it was used for inpatient or for day case surgery. It heard that at least half of operations performed in the NHS are carried out as day cases where a fixed operating table is not generally used. For inpatient operations, the Mega Soft Patient Return Electrode can be placed on the operating table at the start of a day and left in place throughout any operating list. Patients can then be placed on the Mega Soft Patient Return Electrode when they are moved from the trolley on which they are anaesthetised to the operating table. The Mega Soft Patient Return Electrode is left on the operating table and cleaned between patients. By contrast, most day case surgery is performed with the patient on a trolley. Patients are anaesthetised while on the trolley, which is then moved into the operating theatre and then to the recovery area: the patient remains on the same trolley throughout. This means that at least two Mega Soft Patient Return Electrodes would be needed for each day case operating suite. Otherwise, placing each patient on the Mega Soft Patient Return Electrode would involve more time and inconvenience than applying and removing a standard disposable single-use patient return electrode. The Committee concluded the patient, health system and any cost advantages of the Mega Soft Patient Return Electrode were likely to be realised only when it was used for inpatient surgery and not for day case surgery.

4.6 The Committee was advised that no evidence had been submitted to support sustainability and cost impact associated with the reusable nature of the Mega Soft Patient Return Electrode. It noted that waste was likely to be reduced because disposable pads and leads would not need to be discarded after each operation but was unable to reach any conclusions on this because of the lack of data. 

4.7 The Committee noted that the Mega Soft Patient Return Electrode is compatible with all electrosurgical units apart from certain settings on one specific unit (see sections 2.6). It regarded compatibility with existing electrosurgical units as fundamental to any consideration to adopt the Mega Soft Patient Return Electrode.

4.8 The Committee found no evidence to support the claim that the Mega Soft Patient Return Electrode would reduce the need for a separate pressure-relieving device.

5 Cost considerations

Cost evidence

5.1 No published economic evidence on the Mega Soft Patient Return Electrode was identified by the sponsor. The External Assessment Centre found one study (ECRI 2000) that undertook a cost consequences analysis of the Mega 2000 in the USA. The External Assessment Centre noted that ECRI reported that the frequency of use and cost differential meant that with greater use Mega 2000 became more cost-saving; however, the values used in the study were not considered relevant to the decision problem.

5.2 The External Assessment Centre stated that no clinical evidence was presented on which to base the incidence of skin burns from standard disposable single-use patient return electrodes and their associated costs in the sponsor’s model. Evidence was not included on the cost of procuring, storing and disposing of standard disposable single-use patient return electrodes. No independent evidence was supplied on the time saved in theatre by using Mega Soft Patient Return Electrodes rather than standard disposable single-use patient return electrodes.

5.3 The sponsor submitted a de novo economic model that estimated the cost per operation for the Mega Soft Patient Return Electrode compared with a split standard disposable single-use patient return electrode and a non-split standard disposable single-use patient return electrode in adult and paediatric patients undergoing monopolar electrosurgery. The analysis was from the NHS and personal social services perspective. Full details of all cost evidence and modelling considered by the Committee are available in the assessment report overview (mtg11).

5.4 The model used linear formulae that described the relationships between the resource and cost variables. The model did not use any health states. The External Assessment Centre noted that this structure was appropriate to quantify the main cost differences between the technologies given the level of clinical evidence available.

5.5 The sponsor stated that several parameters were not included in the model because a lack of data meant that cost savings were not quantifiable. These included:

• disposal of standard disposable single-use patient return electrodes
• further surgery to treat skin burns from standard disposable single-use patient return electrodes
• litigation because of skin burns from standard disposable single-use patient return electrodes
• treatment of skin irritation from standard disposable single-use patient return electrodes
• ordering and storing boxes of standard disposable single-use patient return electrodes.

5.6 The sponsor’s base-case analysis included several key assumptions:

• The cost of the adult or paediatric Mega Soft Patient Return Electrode (without VAT) is £1900.
• The Mega Soft Patient Return Electrode is used 3 times a day, 5 days a week, and 52 weeks a year (based on Expert Adviser estimates).
• Four types of standard disposable single-use patient return electrode are used in the NHS. The prices given are based on prices from the manufacturers of the different electrodes. (The sponsor did not supply any prices for electrodes without lead wires.)

- Split adult standard disposable single-use patient return electrodes with lead wire: £2.44 per electrode

- Non-split adult standard disposable single-use patient return electrodes with lead wire: £2.60 per electrode

- Split paediatric standard disposable single-use patient return electrodes with lead wire: £1.92 per electrode

- Non-split paediatric standard disposable single-use patient return electrodes with lead wire: £1.74 per electrode

• The price of an operating table pressure-relieving mattress was taken from one manufacturer and is £334.
• The pressure-relieving mattress is used 3 times a day, 5 days a week for 52 weeks a year based on assumptions and estimates.
• Costs of razors to shave patients were from razor manufacturers and are £1.13 for a disposable razor and £2.09 for a clipper head.
• All patients need shaving before using a standard disposable single-use patient return electrode.
• The discount rate of the Mega Soft Patient Return Electrode is 3.5% applied in year 0.
• The lifespan of the Mega Soft Patient Return Electrode is 24 months.
• The resource costs from the Personal Social Services Research Unit (PSSRU) are based on ‘per operation hour’ and are £347 per hour each for a surgeon and an anaesthetist and £41 per nurse.
• The estimated time needed for site preparation when using a standard disposable single-use patient return electrode is 5 minutes.

5.7 The sponsor tested several of the base-case assumptions in deterministic two-way sensitivity analyses. In these analyses the following parameters were increased and decreased by 50% (with no probabilities attached for the likelihood of these events occurring):

• number of operations per week
• cost of standard disposable single-use patient return electrodes
• cost of an operating table pressure-relieving mattress
• life of an operating table pressure-relieving mattress
• cost of razors for shaving
• staff time and hourly staff costs.

5.8 The sponsor’s base-case analysis estimated the cost per operation using the Mega Soft Patient Return Electrode compared with a standard disposable single-use patient return electrode with a lead wire. The findings showed savings of £70.83 per operation for adults and £70.31 for children when using the adult or the paediatric Mega Soft Patient Return Electrode respectively. More than 95% of the savings were from improving efficiency by saving 5 minutes per operation. More than 80% of the savings were from surgeon and anaesthetist time saved. There were greater savings when the Mega Soft Patient Return Electrode was compared with split pad standard disposable single-use patient return electrodes because of the higher cost of the split pads. The largest contribution to the cost saving was from surgeon and anaesthetist time saved (£57.84 per operating hour); Nurse time saved resulted in a further saving of £10.25 per operating hour.

5.9 The External Assessment Centre noted that the sponsor had not justified why its assumptions were the most plausible range of values. Furthermore, the sensitivity analysis did not capture the lower prices for standard disposable single-use patient return electrodes in one NHS trust. The sensitivity analyses demonstrated that the results of the sponsor’s model were sensitive to assumptions about staff time and the cost per hour for surgeons, anaesthetists and nurses.

5.10 The External Assessment Centre expressed particular concerns about a number of parameters in the sponsor’s model and carried out additional analyses to examine the impact of changing the following parameters:

• Inclusion of VAT in the price of the Mega Soft Patient Return Electrode (£2280).
• The most common type of disposable single-use patient return electrode used in the NHS is the split adult disposable single-use patient return electrode with no lead wire (£0.87). This is based on NHS Supply Chain figures.
• The Mega Soft Patient Return Electrode is used 3 times a day, 4 days a week for 50 weeks a year (based on clinician estimates). This equates to 600 operations per year.
• A razor costs £2.09 (disposable razors are no longer used).
• Shaving of 40% of patients (based on clinician estimates that were obtained by the External Assessment Centre as part of its assessment).
• There is no overall delay for site preparation when using a standard disposable single-use patient return electrode based on clinician advice.

5.11 The overall cost per operation when using the parameters described in section 5.10 is £2.16 for the comparator and £1.97 for an adult Mega Soft Patient Return Electrode. Therefore, this analysis demonstrated a cost saving of £0.19 per operation when using an adult Mega Soft Patient Return Electrode compared with a standard disposable single-use patient return electrode.

5.12 The overall cost per operation when using the parameters described in section 5.10 for the paediatric comparator (split paediatric standard disposable single-use patient return electrode with no lead wire) is £2.30 and for the paediatric Mega Soft Patient Return Electrode it is £1.97. This demonstrated a cost saving of £0.33 per operation using a paediatric Mega Soft Patient Return Electrode compared with a standard disposable single-use patient return electrode.

Committee considerations

5.13 The Committee discussed the different assumptions presented to decide which were the most appropriate to use. It judged that:

• VAT should be included for the price of the Mega Soft Patient Return Electrode.
• NHS Supply Chain figures provided the most appropriate comparator (a split disposable single-use patient return electrode with no lead wire).
• The External Assessment Centre’s assumption of use of operating table pressure-relieving mattresses 5 times a day, 4 days a week, 50 weeks a year was reasonable.
• There was unlikely to be any substantial saving of operating theatre time as a result of using the Mega Soft Patient Return Electrode.

5.14 The Committee considered that there was unlikely to be any substantial saving of operating theatre time as a result of using the Mega Soft Patient Return Electrode. Therefore, it did not accept the sponsor’s base-case cost saving of £70.83 and judged that no significant saving would be made.

5.15 The Committee noted that the sponsor’s base-case analysis assumed that 100% of patients are shaved before monopolar electrosurgery with a disposable single-use patient return electrode, but that the External Assessment Centre advised that the percentage is nearer to 40%, based on advice from clinicians. However the Committee was advised by experts and from relevant members’ clinical practice that the percentage of patients who need shaving is more likely to be between 20-30%. The Committee concluded that 30% was a reasonable figure to use for the cost model. If 30% of patients are shaved and all the other parameters in section 5.10 remain the same then the External Assessment Centre advised that the overall cost per operation when using the comparator would be reduced from £2.16 to £1.94. The overall cost per operation when using the Mega Soft Patient Return Electrode remains at £1.97 because patients do not need shaving for this electrode.

5.16 For paediatric patients, the sponsor’s base-case analysis was also based on 100% of patients having monopolar electrosurgery needing to be shaved. The Committee was advised that it is unlikely that any child would need shaving and this figure should be 0%. If no patients are shaved and all the other parameters in section 5.10 remain the same then the Committee noted that the overall cost per operation when using the paediatric comparator is reduced from £2.30 to £1.46. This means that it would cost 51p more per operation to use the Mega Soft Patient Return Electrode because the overall cost per operation when using Mega Soft Patient Return Electrode would remain at £1.97.

5.17 The Committee concluded that the economic evidence and cost modelling demonstrate near equivalent resource use for the Mega Soft Patient Return Electrode to current practice. Expert advice suggested that claims for the Mega Soft Patient Return Electrode’s benefit are greatly influenced by the circumstances in which it is used.

6 Conclusions

6.1 The Committee considered that the published clinical evidence on the Mega Soft Patient Return Electrode is very limited and does not demonstrate that burns are reduced as a result of its use. However, the Committee accepted that it is technically plausible that the Mega Soft Patient Return Electrode can reduce the risk of patient return electrode burns, based on technical considerations.

6.2 Its use might increase the risk of alternate site burns, but if operating theatre practice is of the highest standard, so minimising this risk, then use of the Mega Soft Patient Return Electrode could reduce the overall risk of electrosurgery burns.

6.3 The Mega Soft Patient Return Electrode may have particular advantages for patients who have frail or damaged skin; these include patients with burns, patients with skin conditions, paediatric patients and older patients. It also has the advantage that no patient needs shaving whereas about 30% of patients need to be shaved when disposable single-use patient return electrodes are used.

6.4 The Mega Soft Patient Return Electrode may be more convenient for theatre staff to use than standard disposable single-use patient return electrodes, but it is not likely to provide substantial savings in operating theatre time. The economic evidence and cost modelling demonstrate near equivalent resource use to current practice. Any health system or cost advantages are likely to be influenced significantly by whether the Mega Soft Patient Return Electrode is being considered for use for inpatient operating lists or day case surgery.

7 Implementation

7.1 There are no implementation tools to accompany this guidance.

8 Related NICE guidance

Published

• Suction diathermy adenoidectomy. NICE interventional procedure guidance 328 (2009). Available from www.nice.org.uk/guidance/IPG328
• Electrosurgery (diathermy and coblation) for tonsillectomy. NICE interventional procedure guidance 150 (2005). Available from www.nice.org.uk/guidance/IPG150

Under development

There is no related guidance under development.

Bruce Campbell

Chairman, Medical Technologies Advisory Committee

February 2012

Appendix A. Committee members and NICE lead team

A Medical Technologies Advisory Committee members

The Medical Technologies Advisory Committee is a standing advisory committee of NICE. A list of the Committee members who took part in the discussions for this guidance appears below.

Committee members are asked to declare any interests in the technology to be evaluated. If it is considered there is a conflict of interest, the member is excluded from participating further in that evaluation.

The minutes of each Medical Technologies Advisory Committee meeting, which include the names of the members who attended and their declarations of interests, are posted on the NICE website.

Professor Bruce Campbell (Chair)
Consultant Vascular Surgeon, Exeter

Dr Peter Groves (Vice Chair)
Consultant Cardiologist, Cardiff and Vale NHS Trust

Dr Dilly Anumba
Senior Clinical Lecturer/Honorary Consultant Obstetrician and Gynaecologist, University of Sheffield

Ms Susan Bennett
Lay member

Professor Bipin Bhakta
Charterhouse Professor in Rehabilitation Medicine and NHS Consultant Physician, University of Leeds

Dr Keith Blanshard
Consultant Radiologist, Leicester Royal Infirmary

Dr Martyn Bracewell
Senior Lecturer in Neurology and Neuroscience, Bangor University

Dr Daniel Clark
Head of Clinical Engineering, Nottingham University Hospitals NHS Trust

Professor Karl Claxton
Professor of Economics, University of York

Mrs Gail Coster
Radiography Manager, Strategy, Planning and Governance, Yorkshire NHS Trust

Dr Alex Faulkner
Senior Research Fellow, Centre for Biomedicine & Society, King's College London

Professor Tony Freemont
Professor of Osteoarticular Pathology, University of Manchester

Professor Peter Gaines
Consultant Interventional Radiologist, Sheffield, Vascular Institute and Sheffield Hallam University

Mr Harry Golby
Head of Commissioning, Acute, Access and Diagnostics, Salford NHS

Mr Matthew Hill
Lay member

Dr Paul Knox
Reader in Vision Science, University of Liverpool

Ms Catherine Leonard
Reimbursement Manager, Medtronic UK

Dr Susanne Ludgate
Clinical Director, Devices Medicines and Healthcare Products Regulatory Agency

Mrs Jacqui Nettleton
Programme Director, Long Term Conditions, West Sussex PCT

Professor Sharon Peacock
Professor of Clinical Microbiology, University of Cambridge

Professor Brian J Pollard
Professor of Anaesthesia, University of Manchester. Consultant Anaesthetist, Central Manchester University Hospitals

Dr Allan Swift
Director of Quality and Regulatory Affairs, Gen-Probe Life Sciences

Dr Allan Wailoo
Reader in Health Economics, School of Health and Related Research (ScHARR), University of Sheffield

Professor Stephen Westaby
Consultant Cardiac Surgeon, John Radcliffe Hospital, Oxford

Dr Janelle York
Lecturer and Researcher in Nursing, University of Salford

B NICE lead team

Each medical technology assessment is assigned a lead team of a NICE technical analyst and technical adviser, an expert adviser, a technical expert, a patient expert, a non-expert member of the Medical Technologies Advisory Committee and a representative of the External Assessment Centre.

Jo Burnett
Technical Analyst

Sally Doss
Technical Adviser

Dr Ian Armstrong and Dr Liam Horgan
Lead Expert Advisors

Dr Paul Knox
Non-Expert MTAC Member

Megan Dale – CEDAR
Joyce Craig - NUTH and YHEC
External Assessment Centre Representatives

 Appendix B: Sources of evidence considered by the Committee

A The External Assessment Centre reports for this assessment was prepared by CEDAR and NUTH and YHEC:

Technical Testing Assessment report – Cedar EAC

• Dale M, McCarthy JP. EP141 Technical Testing of Mega Soft Patient Return electrode, January 2012.

Clinical and Economic Assessment report – EAC

• Craig J, YHEC. Reay C, NUTH. Willits I, NUTH. et al. External Assessment report for Mega Soft Patient Return Electrode for use during Monopolar Electrosurgery, January 2012.

B Submissions from the following sponsor:

• Advance Surgical (Sponsor/UK Distributor) and Megadyne (USA Manufacturer)

C The following individuals gave their expert personal view on the Mega Soft Patient Return Electrode by providing their expert comments on the draft scope and assessment report.

• Dr Ian Armstrong, nominated/ratified by the British Association of Day Surgery – clinical expert
• Dr Liam Horgan nominated/ratified by the British Association of Day Surgery – clinical expert

D The following individuals gave their expert personal view on the Mega Soft Patient Return Electrode in writing by completing a patient questionnaire or expert adviser questionnaire provided to the Committee.

• Josef Crutchley, nominated/ratified by the Healthcare Professional Council
• Maureen Theakston, nominated/ratified by the Nursing and Midwifery Council
• Jilly Hale nominated/ratified by the Association for Perioperative Practice
• Kim Wall nominated/ratified by the College of Operating Department Practitioners