Anaesthetics - a one-stop resource for anaesthetists

Latest news:
MDA/2010/052 - Anaesthetic vaporizers - all manufacturers - added 28 June

    
Our monthly newsletter for healthcare professionals, bringing you information and clinical advice on the safe use of medicines.

Recent anaesthetics-related updates:
Jun 2009: Chloral hydrate (Welldorm) and Triclofos: not first-line options for insomnia
Apr 2009: Methylthioninium chloride (methylene blue): update on CNS toxicity with serotonergic drugs 
Dec 2008: Nitrous oxide: neurological and haematological toxic effects, especially with prolonged use 

Medical Device Alerts (MDAs)
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 MDAs we have published that are of particular relevance to anaesthetists. 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/2010/041 - Visionary single-use laryngeal airway device manufactured by Marshall Products Ltd - added 2 June 2010
MDA/2010/046 - Unilect (TM) ECG monitoring electrodes manufactured by Unomedical - added 24 June 2010
MDA/2010/040 - All chest drains when used with high-flow, low-vacuum suction systems (wall mounted) - added 19 May 2010
MDA/2010/039 - All Aquarius haemofiltration machines manufactured by Edwards Lifesciences Ltd and supplied by Baxter Healthcare - added 24 May 2010
MDA/2010/036 - All anaesthetic breathing systems, anaesthetic machines and anaesthetic ventilators - added 19 May 2010
MDA/2010/034 - Alaris GP and Alaris GP Guardrails volumetric pump, manufactured by CareFusion, branded as Cardinal Health - added 10 May 2010
MDA/2010/032 - Shiley cuffed tracheostomy tubes manufactured by Covidien (formerly Tyco Healthcare) 
MDA/2010/030 - Blood glucose meters - 5-second CONTOUR® manufactured by Bayer Diabetes Care
MDA/2010/027 - Endotracheal (ET) tubes, adult and paediatric sizes manufactured by Unomedical
MDA/2010/026 - PediCap carbon dioxide detector manufactured by Covidien
MDA/2010/024 - Endotracheal (ET) tubes, adult and paediatric sizes manufactured by Unomedical 
MDA/2010/021 - Anaesthetic gas scavenging systems (AGSS) – all manufacturers
MDA/2010/017 - Peripheral cannula, Nexiva closed IV catheter system with Q-Syte connector, manufactured by Becton Dickinson


Reporting of adverse incidents or adverse drug reactions
Any actual, suspected, potential or avoided adverse event should be reported. Further examples of cases which should be reported are available in the sections below. If in doubt, please report. You can help us by reporting adverse incidents. These reports enable us to identify medical devices and medicines that are of concern and allow us to take appropriate action.

The UK's Yellow Card Scheme collects information from healthcare professionals and patients on suspected adverse drug reactions. This vital information helps us safeguard public health. Please report if you know or suspect that use of a medical device has resulted, or could have resulted, in an adverse incident for a patient or user.

What should I report if I suspect a medicine is associated with an adverse reaction?.
Please complete a Yellow Card to report suspected adverse reactions to prescription medicines, over-the-counter medicines, or herbal remedies. For further information, please see http://www.yellowcard.gov.uk/ (external link).

We are particularly interested in receiving Yellow Cards that report serious adverse reactions to established medicines, or that report any reaction to a medicine that is new to the market and carries a black triangle. So that we can assess the Yellow Card, please ensure that you report the suspect drug(s), suspect reaction(s), and basic patient details if known (age, sex, weight, patient's initials, and local identification number for your reference).

Please clarify what a medical device is and what I should report?
Please see our section on reporting safety problems.

Guidance and publications
These guidance documents/posters all relate to areas of practice that  anaesthetics care practitioners may be involved in and so may be of help:
DB 2009(02) Adverse Incident Reports 2008
DB 2008(03) Guidance on the safe use of lasers, IPL systems and LEDs
DB 2006(05) Managing Medical Devices
DB 2006(03) Blood Pressure Measurement Devices
DB 2003(02) Infusion Systems
DB 2002(03) Management and Use of IVD Point of Care Test Devices
Devices in practice - a guide for health and social care professionals medical devices play an crucial role in care and treatment.
Oxygen cylinders and their regulators - top tips leaflet
Poster on electrical cables 'Shocking Trips'
Intravascular and epidural devices - top tips leaflet
Transport ventilators - top tips leaflet
Infusion systems study day posters
Tips on domiciliary ventilators

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...?
The possible effects a patient’s herbal medicine may have?
Herbal safety advice

Your input counts
We would be grateful for your comments on the content and usefulness of this page. Please send your feedback to webusability@mhra.gsi.gov.uk