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Mega Soft Patient Return Electrode for use during monopolar electrosurgery

Mega Soft Patient Return Electrode for use during monopolar electrosurgery reduces the risk of electrode burn (The most commonly reported complication during electrosurgery) resulting from improper application of the electrode. The device achieves this by conducting monopolar electrosurgical energy from target tissue of a patient back to an electrosurgical unit (ESU), or generator, safely dissipating heat built and reducing the risk of burns to patients.

Status: History
Expected date of issue: August 2012
Notification date: June 2011
Topic area:
  • Surgical procedures
 

NICE project team

Patient Involvement Lead: Laura Norburn
Analyst: Joanne Burnett
Communications Lead: Tonya Gillis
Project manager: Marlon Hope
Implementation Lead: Katie Worrall
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Provisional schedule

Submission Date: TBC
Topic Selection: 15 July 2011
Draft guidance meeting 16 February 2012
Consultation opens: 09 March 2012
Consultation ends: 05 April 2012
Final guidance meeting: 11 May 2012
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Stakeholders

NICE is developing guidance on this technology. If you would like to become a registered stakeholder in the development of guidance in this technology please complete a stakeholder registration & confidentiality form and return to us at medtech@nice.org.uk.

Registered stakeholders will be informed of key stages in the development of guidance including when documents go out to consultation or comment.

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Project history

Date Update

16 August 2012

 

Additional information

When selecting the Mega Soft Patient Return Electrode for evaluation, the Committee considerations included six questions relating to the technical performance of the Mega Soft Patient Return Electrode.

The specific technical issues raised were:

  • The minimum contact area (with the patient) needed for safe use of the Mega Soft Patient Return Electrode;
  • The impact of the spillage of alcohol-based products on the device or of puncture of the device;
  • The compatibility of the device with other operating theatre equipment including electrosurgery generators;
  • The impact of materials of varying thickness placed between the patient and the Mega Soft Patient Return Electrode;

A technical assessment was commissioned by NICE from the External Assessment Centre, CEDAR, to address these questions. The results of the technical assessment are summarised in the NICE Assessment Report Overview and appear in full, together with the detailed methods, in the External Assessment Centre’s (EAC) Technical Assessment Report.  These documents are available here.

27 July 2012

 

An Initial Scrutiny meeting was held on 23 July 2012, final guidance is expected to be published in August 2012.

12 July 2012

 

As a final quality assurance step, to ensure that NICE acts fairly, those who provided consultation comments are - subject to completing a confidentiality agreement - able to receive a prepublication copy of the final guidance and of the (anonymised) consultation comments.

The Resolution process is to identify errors or breaches of process before publication and respondents must specify which of these two grounds they are requesting resolution on.

One or more resolution requests were received on this technology. An Initial Scrutiny meeting will take place on 23 July to agree if there has been a breach on either grounds (for more information please see section 6 of the programme process guide).

The Programme's Process and Methods Guides are available on the Medical Technologies Evaluation Programme web page.

16 March 2012

The NICE Medical Technologies Evaluation Programme has undertaken an evaluation of Mega Soft Patient Return Electrode for use during monopolar electrosurgery. These consultation documents contain information on the committees draft recommendations and details on how medical technology evaluations are conducted.

Consultation on these documents will open on 21 March 2012 at 9.00am and close on 18 April 2012 at 9.00am. NICE would like to receive comments on these documents from anyone who has an interest in the technology or the disease area in general.

15 March 2012 The medical technology consultation document on Mega Soft Patient Return Electrode for use during monopolar electrosurgery has been delayed. Stakeholders will be updated ahead of the consultation opening.
12 September 2011 The National Institute for Health and Clinical Excellence (NICE) is evaluating this technology.
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Key documents

This page was last updated: 03 September 2013

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Selected, reliable information for health and social care in one place

Accessibility | Cymraeg | Freedom of information | Vision Impaired | Contact Us | Glossary | Data protection | Copyright | Disclaimer | Terms and conditions

Copyright 2014 National Institute for Health and Care Excellence. All rights reserved.