Obstetrics and gynaecology - a one-stop resource for obstetrics and gynaecology practitioners

Latest news:
Public consultation (MLX 371): Proposals to amend medicines legislation to allow student midwives access to the parenteral medicines which can be administered by registered midwives - added 24 August 2010

 
Our monthly electronic newsletter aims to give the latest advice for all medicines users to ensure the safe use of medicines.

Recent obstetrics and gynaecology related updates:
Drug Safety Update: Volume 3, Issue 10, May 2010: SSRIs and SNRIs: risk of persistent pulmonary hypertension in the newborn - added 19 May 2010
Drug Safety Update: Volume 3, Issue 10, May 2010: SSRIs and SNRIs: risk of persistent pulmonary hypertension in the newborn
Drug Safety Update: Volume 2 Issue 11, June 2009: Antipsychotics: risk of venous thromboembolic events
Drug Safety Update: Volume 2 Issue 10, May 2009: ACE inhibitors and angiotensin II receptor antagonists: recommendations on use during breastfeeding
Drug safety Update: Volume 2 Issue 7, February 2009: Tibolone (Livial): increased risk of breast cancer recurrence
Drug Safety Update: Volume 2 Issue 5, December 2008: Nitrous oxide: neurological and haematological toxic effects, especially with prolonged use
Drug Safety Update: Volume 2, Issue 2 September 2008: Immunisation against human papillomvirus
Drug Safety Update: Volume 2, Issue 1 August 2008: Caffeine for apnoea of prematurity: check dose regimen before use
Drug Safety Update: Volume 1, Issue 9, April 2008: Hormonal contraceptives: cervical cancer - latest evidence; Combined hormonal contraceptives: venous thromboembolism - update; Co-cyprindiol: recommended duration of use

Medical Device Alerts
Medical devices and equipment are items used for the diagnosis and/or treatment of disease, for monitoring patients, and as assistive technology. Medical Device Alerts (MDAs) are the MHRA's prime means of communicating safety information to medical device users in health and social care. Each MDA is designated either for Immediate action or Action. MDAs may also be used to provide updated information.

Below are an example of some MDA's we have published that are of particular relevance to obstetrics and gynaecology practitioners. MDAs are removed from the list after between three and six months. To see a complete list of our MDAs, please visit the Medical Device Alert section of our website.

MDA/2010/054 - Fetal monitor/cardiotocograph (CTG) - added 28 June 2010
MDA/2010/030 - Blood glucose meters - 5-second CONTOUR® manufactured by Bayer Diabetes Care - added 5 May 2010
MDA/2010/016 - Pregnancy test for professional use - Clearview hCG Combo manufactured by Unipath Limited  - added 10 March 2010
MDA/2010/006 - Devices used for endometrial ablation. All makes and models - added 20 January 2010
MDA/2010/001 - Medical devices in general and non-medical products

Drug Alerts
Where a defect is considered to be a risk to public health, the marketing authorisation holder withdraws the affected product from use and the MHRA issues a 'drug alert' letter. This alert is classified from 1 to 4 depending upon the risk presented to the public health by the defective product. Class 1 is the most critical, for example serious mislabelling, microbial contamination or incorrect ingredients, and requires immediate recall; Class 4 is the least critical and advises 'caution in use'.

Class 4 Drug Alert (Caution in use): CP Pharmaceuticals/Wockhardt UK - CP Multiparin / Monoparin products (Wockhardt Heparin Sodium products) - EL (09)A/08 Rev 1
Class 2 Drug Alert (action within 48 hours): Quadrant Pharmaceuticals Limited - Clexane 40mg/0.4ml pre-filled syringe (Parallel Import) (Enoxaparin 40mg/0.4ml pre-filled syringe) - EL (09)A/04
Class 3 Drug Alert (Action within 5 days): Enoxaparin sodium ("Clexane") pre-filled syringes - EL(08)A/7
Class 4 Drug Alert (Caution in use): Enoxaparin Sodium (Clexane) pre-filled syringes - Supply update and advice to prescribers on shortage of 150mg syringes and use in pregnancy
Class 4 Drug Alert (Caution in Use): Parallel imports of low molecular weight heparin - Enoxaparin sodium (Clexane) pre-filled syringes

MHRA guidance and publications
ORACLE children study: Outcomes after use of antibiotics in preterm labour
Guidance on the safe use of lasers, IPL systems and LEDs for use in medical, surgical, dental and aesthetic practices
Summary report of incident reports received by MHRA in 2007
Guidance on use of the voluntary adverse incident reporting system
Guidance on the decontamination of Endoscopes
Information on the risks and benefits of hormonal contraceptives
Information on the risks and benefits of hormone replacement therapy (HRT)
Cardiotocograph (CTG) monitoring of fetus during labour - update
Information on the effect in CARDIOTOCOGRAHY of the phenomenon "doubling" of the fetal heart rate in connection with devices (17Kb)

One Liners
One Liners is a short news sheet aimed at all healthcare professionals and care staff, which highlights problems with the use of medical devices. It is often a light hearted review of user issues that have been brought to our attention and are generally reports of continuing user’s misuse of simple medical equipment.

We know that all medical devices can fail but an increasing number of incidents that result in significant morbidity or mortality arise out of user/device interface problems or because of poor practices. The aim of the One Liner is to detail briefly some of these problems in an attempt to make users more aware of what can go wrong - it is all too easy to take equipment for granted.

Many of the One Liner series are generic but we have produced a number of editions that focus on a specific device or a theme, or are of interest to primary care trusts or the care homes sector.

One Liners

Interactive education modules
Every year many patients and staff are injured needlessly by medical devices that are either badly maintained or used incorrectly. These injuries are often due to user error or poor systems of work, not the device function or design. In these education packages we have tried to give a generic overview of some of the devices that have been reported to us as problematic.

To this end we have produced a series of certificated educational packages that are simple to use, informative and should take no more than thirty minutes to work through. All our educational packages have been developed by MHRA staff, some in conjunction with and endorsement by royal colleges and other professional bodies.

The packages are aimed at different levels of healthcare staff and can be either simply reviewed or undertaken with the aim of achieving a certificate at the completion of the training. They provide some valuable dos and don’ts when using and operating medical devices.

Devices in practice
Basic observations
Anaesthetic machines
Electrosurgery
The operating table

Have you thought about?

'Stop smoking' treatments

Professor Ellis Downes has been appointed to the Committee for the Safety of Devices as the external expert for obstetrics and gynaecology. He would be very grateful for any important issues that should be discussed by this Committee to be emailed to him at ellis@ellisd.demon.co.uk

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