News and communications from MHRA
- Transforming the regulation of software and artificial intelligence as a medical device
- MHRA launches public consultation on future of medical device regulation
- Long-term continual use of topical steroids linked to skin withdrawal side effects
- MHRA statement on COVID-19 booster vaccines
- MHRA statement on booster doses of Pfizer and AstraZeneca COVID-19 vaccines
- Four Non-Executive Directors appointed to the Medicines and Healthcare products Regulatory Agency Board
- Batch of metformin oral solution recalled by MHRA due to nitrosamine impurity
- First monoclonal antibody treatment for COVID-19 approved for use in the UK
- Moderna COVID-19 vaccine approved by MHRA in 12-17 year olds
- Combined paracetamol and ibuprofen medicine approved for general sale
- Regulator seeks views on innovative medicines manufacture at point of care
- MHRA recalls contaminated Irbesartan- batches as precautionary measure
- Access Consortium strategy launched
- Regulator warns against purchasing inaccurate infrared thermometers
- MHRA’s new Chief Safety Officer, Dr Alison Cave, starts vital vigilance work today
Alerts and recalls for drugs and medical devices
- Philips sterilizable defibrillator internal paddles (specific models) – may fail to deliver therapy if pre-use checks are not followed (MDA/2020/022)
- Masks: type IIR from Cardinal Health – destroy affected lots (MDA/2020/021)
- Spinal fixation system – risk of implant failure prior to completion of bone healing (MDA/2020/020)
- Abbott Trifecta / Trifecta GT bioprosthetic aortic heart valves: cases of structural valve deterioration (SVD) (MDA/2020/019)
- Philips HeartStart XL Defibrillator/Monitor – therapy selector switch may fail (MDA/2020/018)
- Philips Respironics V60 ventilator – potential unexpected shutdown leading to complete loss of ventilation (MDA/2020/017)
- Philips HeartStart MRx Monitor/Defibrillators - may fail to deliver therapy without alerting the user to a fault in the event of internal damage (MDA/2020/016)
- Results from laboratory-based tests for COVID-19 antibodies using capillary blood sample collection kits may not be reliable (MDA/2020/015)
- Pilling Clear Advantage aortic punch – risk of infection due to packaging failure (MDA/2020/014)
- COVID-19: All haemofiltration systems including machines and accessories – serious risks if users don’t follow manufacturer instructions for set-up (MDA/2020/013)
- Anaesthetic machines: off-label use during the COVID-19 pandemic (MDA/2020/012)
- Spinal implant: All MAGEC Systems – supply suspended to the UK (MDA/2020/011)
- Spinal implant: MAGEC System Model X rods – risk of failure in use (MDA/2020/010)
- Tympanic thermometers – revision of the calibration frequency of Cardinal Health Genius 2 and Genius 3 models
- Various Olympus duodenoscope models: do not use if elevator wires are frayed or damaged as these may cause lacerations to patients and users (MDA/2020/008)
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