Cardiologists' section

Hot topics
› Committee on the Safety of Devices: New members required

Recent cardiology-related 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.

› 19 Nov 2008 - LIFEPAK CR Plus automatic external defibrillator manufactured by Medtronic Physio-Control - updated 21 November 2008
This Medical Device Alert has been issued to highlight a faulty internal cable in defibrillators manufactured between November 2006 and March 2008 which means the defibrillator may fail to power on.

› 22 September 2008 - An Alert has been issued due to a risk of electric shock to clinicians or mortuary personnel while removing implantable cardioverter defibrillators (ICDs).
›16 June 2008 - Medtronic Physio-Control LIFEPAK® 12, LIFEPAK® 20 and LIFEPAK® 20e external defibrillators with certain settings, may start before a warning is given to the user to stand clear of hte patient
›3 June 2008 - Invasive blood pressure monitoring sets: LogiCal, NovaTrans and TranStar models with trigger flush device, which due to a fault in the manufacture of the trigger flush device can lead to over-infusion
›28 February 2008 - SmartCheck INR test systems by Unipath Ltd were recalled due to an increased risk of incorrect results
› 6 December 2007 - External temporary cardiac pacemaker by APC Medical Ltd (Bedside model 4170) demonstrated a potential for rapid pacing to occur when the temporary pacemaker is switched off
› 7 November 2007 - Welch Allyn AED 20 automatic external defibrillators were recalled due to a malfunction that prevents or delays the delivery of therapy
› 19 October 2007 - Medtronic Sprint Fidelis implantable cardioverter defibrillator (ICD) leads were withdrawn from the market due to fracture
› 5 June 2007 - External defibrillator batteries for the Lifepak 20 manufactured by Medtronic were replaced due to a reduction in capacity

Recent cardiology-related Drug Alerts
If a defective medicine is thought to be a risk to public health, the product is withdrawn from the market and information from the MHRA issued:
› 20 August 2008 - Batches of Brevibloc vials (esmolol hydrochloride 10mg/ml) manufactured by Baxter Healthcare Ltd, distributed since the start of 2008, have been distributed with an error in the Technical Leaflet (TL) document supplied in the pack.
› 22 January 2008 - Metwest Pharmaceuticals Ltd Simvastatin Tablets 10mg were recalled because the blister foil was incorrectly labelled as Simvastatin 20mg.
› 19 November 2007 - Suspension of UK licences for Lumiracoxib due to severe hepatotoxicity.
› 1 November 2007 - Chatfield Pharmaceuticals Ltd recalled Atenolol 25, 50 & 100mg Tablets due to multiple Good Manufacturing Practice failures at their contract manufacturer.
› 15 October 2007 - Bristol Laboratories Ltd Warfarin Tablets 1mg tablets were recalled due to certain batches not complying with the voluntary code of practice.

Recent MHRA guidance and publications
› MHRA guidance on management of pacemakers and implantable defibrillators
› MHRA guidance on the cardiovascular risk of COX-2 inhibitors and non-selective NSAIDS
› Keep up-to-date with MHRA guidance on bare metal and drug eluting stents
› MHRA guidance on the adverse incident Vigilance reporting system for CE marked coronary stents (521Kb)
› MHRA guidance on the adverse incident Vigilance reporting system for CE marked artificial heart valves (120Kb)

One Liners
All medical devices can fail, but many incidents that result in significant morbidity or mortality arise out of user/device interface problems or because of poor practices. The aim of One Liners is to outline these problems to make users more aware of what can go wrong - it is all too easy to take equipment for granted.

Keeping up-to-date on everything else that goes wrong in hospital? Then read our One Liners.
› One Liners

Tip Off!
MHRA has received a number of reports of catheter tips breaking on removal, often requiring interventional surgery for retrieval. Always (visually) check tips of intra-vascular devices, including catheters, guide wires, introducers, etc., after removal, to ensure the tip is intact.

Drug Safety Update - the monthly newsletter from the MHRA and Commission on Human Medicines
Our monthly electronic newsletter aims to give the latest advice for all medicines users to ensure the safe use of medicines:

› Drug Safety Update      

Highlights:
› May 2008 Rimonabant: depression and psychiatric adverse reactions
› January 2008 Statins: interactions, and updated advice for atorvastatin
› December 2007 Rosiglitazone and pioglitazone: cardiovascular safety
› October 2007 Botulinum toxin products: rare but serious risk
› September 2007 Corticosteroids: early psychiatric side-effects
› August 2007 Extraneal and products that contain (or are metabolised to) maltose, xylose, or galactose: false glucose reading

Interactive education modules
Do you understand how diathermy works and its associated risks?
› An interactive teaching session on diathermy – highly recommended if you forgot to prepare for your lunchtime teaching session!

This anaesthetic educational package looks briefly at the history of the anaesthetic machine and then covers the basic principles involved in the safe use of anaesthetic machines.

Helping your patients stop smoking?

• Smoking-cessation aids

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

NICE produces guidance in three areas of health:

• Public health - guidance on the promotion of good health and the prevention of ill health for those working in the NHS, local authorities and the wider public and voluntary sector.
• Health technologies - guidance on the use of new and existing medicines, treatments and procedures within the NHS.
• Clinical practice - guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS.

› National Institue of Clinical Excellence (external link)

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.

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 www.yellowcard.gov.uk.  We are particularly interested in receiving Yellow Cards that report serious adverse reactions to established medicines, or that report any reaction for 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?
Follow this link to a small Q&A session on what a faulty medical device is, and when it should be reported.