Cardiology

Hot topics
› Aliskiren: risk of angioedema and renal dysfunction - added 4 June 2009
› Appointments and reappointments to the Commission on Human Medicines, its Expert Advisory Groups and the Herbal Medicines Advisory Committee - added 4 June 2009
› Off-label or unlicensed use of medicines: prescribers’ responsibilities - added 11 May 2009
› Members announced for the Committee on the Safety of Devices
The MHRA and the Appointments Commission are pleased to announce the appointment of two new members to the Committee on the Safety of Devices (CSD). - added 7 May 2009
› Launch of the e-MDA, the web-based UK-wide Medical Device Alert - added 28 April 2009
› Conference - An essential introduction for doctors in training to the MHRA and NICE
What do doctors need to know about the MHRA and NICE? What is MHRA? How does NICE make its choices? Your questions on the controversies and the successes will be answered at the first ever joint MHRA-NICE Conference. - added 2 March 2009

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.
› 29 April 2009 - Bioprosthetic heart valves. All makes and models. This has been issued due to the premature failure of bioprosthetic heart valves. - added 7 May 2009
› 21 April 2009 - Automatic external defibrillator. Welch Allyn AED 10 (previously branded as MRL JumpStart). This alert has been issued due quality and performance problems.  - added 28 April 2009 
› 18 February 2009 - Unomedical Unilect 4831Q and 4841P short term adult and paediatric ECG monitoring electrodes. This alert has been issued due to these electrodes showing a degradation in performance after defibrillation. 
› 19 November 2008 - LIFEPAK CR Plus automatic external defibrillator manufactured by Medtronic Physio-Control 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:
› 1 April 2009 - CP Multiparin/Monoparin products manufactured by CP Pharmaceuticals/Wockhardt UK contain a very low level of over sulphated chondroitin sulphate in the active raw material - added 28 April 2009
› 12 February 2009 - A batch of Clexane 40mg/0.4ml manufactured by Quadrant Pharmaceuticals Limited has been recalled because it is contaminated with a low level of Over Sulphated Chondroitin Sulphate (OSCS). - added 20 March 2009
› 11 December 2008 - Cartons of Tensipine MR 10mg manufactured by Genus Pharmaceuticals Ltd have inadvertantly been packed in 20mg cartons.
› 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.

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

YOU’RE fragMEANT to retrieve it.. - added 20 March 2009
MHRA has become aware of a number of instances where fragments of vascular catheters and guidewires left in the patient’s body have caused death or serious injury.

• Minimise the likelihood of device breakage by not using too much force on insertion or withdrawal or by bending the device. If the device does break, ensure that this is recorded in the patient’s notes and the patient is made aware.

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.

• Always use according to the instructions for use.

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 2009 Aliskiren: risk of angioedema and renal dysfunction
› April 2009 Off-label or unlicensed use of medicines: prescribers’ responsibilities
› February 2009 Non-steroidal anti-inflammatory drugs: cardiovascular risk
› January 2009 Tacrolimus (Advagraf and Prograf): risk of serious medication errors 
› 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?

• 'Stop smoking' treatments

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

Patient information leaflet (PIL) of the month:
PILs (Patient Information Leaflets) are improving in quality as a result of new legal obligations on manufacturers to test the documents on potential patients. To promote this new initiative and share best practice, we are publishing a series of examples to illustrate improvements and to aid learning. All leaflets associated with this scheme are published with the agreement of the marketing authorisation holder responsible for the medicine to which they relate.
› Tanatril tablets

NICE produces guidance in three areas of health:

• Health technologies - guidance on the use of new and existing medicines, treatments and procedures within the NHS. Particularly important are those novel devices and technologies used in interventional procedures; while these may have good short-term safety and efficacy, there may be little long term data. The reporting of adverse events relating to these devices to MHRA can enable a clearer picture of their long-term safety and performance to be formed, with the opportunity for action to be taken if necessary.
• Clinical practice - guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS.
• 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.

› 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.

Adverse Incident Reports 2008
This annual report provides an overview of medical device related adverse incident reports received by the MHRA in 2007, and records recent developments in adverse incident reporting. It also includes an update from the Device Technology and Safety (DTS) division’s three specialist technical units, background information on incident reporting procedures, a summary of the year’s key statistics and a brief analysis of customer survey responses.
› DB 2009(02) Adverse Incident Reports 2008

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.

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