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 and this 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. During consultation, the sponsor submitted 6 sources of information, 1 of which was not relevant to this device. One was a pressure map evaluation of Mega 2000 Soft (the US equivalent of the Mega Soft Patient Return Electrode) from 2007. This showed that the best average pressure of 24.8 mmHg was measured using Mega 2000 Soft. If no pressure-relieving pad was used, the average pressure was 40.3 mmHg. Four studies evaluated pads made of the same visco-elastic polymer that is used in the Mega Soft Patient Return Electrode (including a randomised controlled trial of 446 patients). Overall, pads made of this material were found to reduce pressure and provide support.
4.3 During consultation, the sponsor submitted a simple waste calculator (a Microsoft Excel spreadsheet) to support the claim of improved sustainability. The calculator showed that waste is likely to be reduced if the Mega Soft Patient Return Electrode is used instead of disposable single-use patient return electrodes. The estimate from this waste calculator for 1 operating room, based on 3 operations a day, 4 days a week for 50 weeks of the year, was 9 lb of waste disposed for the Mega Soft Patient Return Electrode compared with 74.06 lb for single-use patient return electrodes. The waste calculator is based on US practice and has not been validated. It was not specified whether the waste figures were based on disposable single-use patient return electrodes with integral lead-wires or without integral lead wires.
4.4 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 as much time as claimed. The Committee accepted these views and concluded that using the Mega Soft Patient Return Electrode would not normally result in a substantial reduction in theatre time and the time taken to prepare patients in the operating suite.
4.5 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 electrodes during surgery; or check electrode sites at the end of operations.
4.6 The Committee was advised that the possible advantages of using 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 and for these 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 2 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 that 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.
4.7 The Committee considered the results from the waste calculator and whether these supported the claim for improved sustainability and the cost impact associated with the reusable nature of the Mega Soft Patient Return Electrode. It accepted that waste was likely to be reduced but was unable to reach any specific conclusions on this because of the lack of validated data.
4.8 The Committee noted that the Mega Soft Patient Return Electrode is compatible with all electrosurgical generators apart from certain settings on 1 specific generator (see section 2.7). It regarded compatibility with existing electrosurgical generators as fundamental to any consideration to adopt the Mega Soft Patient Return Electrode.
4.9 The Committee accepted the submitted evidence to support the claim that the Mega Soft Patient Return Electrode has acceptable pressure-relieving properties making it unnecessary (in most operations) for an additional pressure-relieving device to be used.