Obstetrics and gynaecology: Guidance and publications

Obstetrics and gynaecology-related guidance and publications

• 12 Sep 2011 | Vaginal tapes for stress incontinence
  

  This page provides Information for patients and the public about these devices, including questions for patients to ask prior to surgery.

• 10 Mar 2011 | Reporting Adverse Incidents and Disseminating Medical Device Alerts - DB 2011(01)
  

  This publication provides guidance on the MHRA's system for reporting adverse incidents for medical devices, and information on the dissemination of Medical Device Alerts.

• 11 Feb 2011 | Guidance on the responsibilities of manufacturers, the regulator and clinicians with respect to endometrial ablation
  

  This guidance has been produced by the MHRA, with the support of the Royal College of Obstetricians and Gynaecologists and the British Society of Gynaecological Endoscopy.  It contains the conclusions of a joint workshop with relevant manufacturers to discuss the various types of endometrial ablation devices, the different circumstances for use, the pros and cons of each technique, how to avoid adverse events and how to report these if they occur.

• 08 Feb 2011 | One Liners issue 83 - February 2011: Blood glucose monitoring equipment in paediatrics
  

  The MHRA receives reports of harm or near misses associated with blood glucose monitoring equipment in paediatrics. This edition of One Liners describes some of these problems with advice on preventing further incidents in the future.

• 12 Jan 2011 | One Liners issue 81 – January 2011: Special maternity issue
  

  The MHRA receives a significant number of reports of harm or near misses involving medical devices in obstetrics. This edition of One Liners describes some of these with advice on preventing further incidents in the future.

• 18 Oct 2010 | One Liners issue P1 – October 2010
  

  The annual cost of medical devices in the health service is now almost as great as that for pharmaceutical products. It is therefore vital that within each trust or healthcare organisation there are systems in place for the purchasing and management of medical devices. This special poster edition of One Liners aims to set out some of the main issues that need to be taken into account.

• 24 May 2010 | Report on Devices Adverse Incidents in 2009
  

  This annual report provides an overview of medical device-related adverse incident reports received by the MHRA in 2009.

• 18 Sep 2008 | ORACLE children study: Outcomes after use of antibiotics in preterm labour
  

  ‘The Lancet’ has published findings from the ORACLE Children Study, a 7 year follow-up study of a large randomised controlled trial of the use of erythromycin and/or co-amoxiclav in women presenting in premature labour (with or without ruptured membranes).

• 21 Apr 2008 | Guidance on the safe use of lasers, IPL systems and LEDs - DB 2008(03)
  

  Guidance on devices used in medical, surgical, dental and aesthetic practices.

• 27 Mar 2008 | Report on Devices Adverse Incidents in 2007
  

  This annual report provides an overview of medical device-related adverse incident reports received by the MHRA in 2007.