Recent Safety Alerts

The College has been asked to notify its Fellowship about the following Medical Device Alerts (MDAs) issued by the Medicines and Healthcare Products Regulatory Agency (MHRA).

MDAs were introduced on 1 January 2003, to replace the previous types of safety warnings (Hazard Notice, Safety Notice, Device Alert, Advice Notice, Safety Notices and Pacemaker Technical Notes). MDAs are distributed to the NHS in England via the Department of Health's Central Alerting System (CAS).  They remain valid unless they are updated or withdrawn and are reviewed once they are five years old (and subsequently every year).  You can view all MDAs via the MHRA website here.

Device Bulletin: Managing Medical Devices
The revised Device Bulletin (Managing Medical Devices) is available on the MHRA website. It was published in April 2014. 

Alert Title Date of Issue
Alaris® syringe pumps (all models) – risk of uncontrolled bolus of medicine with non-recommended syringes 22 December 2016
Heater-cooler devices used in cardiac surgery – risk of infection with Mycobacterium species update 13 December 2016
Total intravenous anaesthesia sets (TIVA) – risk of leakage during use 31 October 2016
AIRVO™2 and myAIRVO™2 humidifier – risk of undetected auditory alarm 2 September 2016
Siemens ADVIA Chemistry and Dimension/Dimension Vista products – risk of false low results due to interference with N-acetylcysteine 22 June 2016
CADD® administration sets with Flow Stop free-flow protection manufactured by Smiths Medical ASD – risk of under-infusion 27 May 2016
Estradiol immunoassays – interference from the drug fulvestrant (Faslodex®) may cause falsely elevated estradiol results (MDA/2016/004) 24 March 2016
Ambulatory syringe pumps (T34 and T60) and syringe extension sets used with the T34 pump, manufactured by Caesarea Medical Electronics (CME) 2 March 2016
Various nebulizers and nebulization kits – risk of nebulizer not delivering therapy to the patient 26 January 2016
Cardiac Resynchronization Therapy Pacing (CRT-P) - risk of loss of pacing therapy (MDA/2015/038) 9 December 2015

The MHRA website where you can search their entire index
Essential reading for all healthcare professionals from the MHRA
NHS England’s system for issuing alerts, important public health messages and safety critical information and guidance.
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