News and communications from MHRA
- Horizon Scanning Case Study: Developing standards for Adeno-associated virus gene therapies
- Anyone with Prenoxad (naloxone) injection kits must check for missing needles
- Second Pfizer/BioNTech bivalent COVID-19 booster vaccine approved by UK medicines regulator
- Every report to MHRA’s Yellow Card scheme helps improve the safety of medicines and medical devices for all
- Patients urged to check packs of Targocid 200mg after two batches found to be contaminated
- London medicines wholesaler sentenced for illegally importing and distributing over £2.9m of medicines
- Unique opportunity for healthcare professionals to influence future MHRA safety communications and safety reporting systems
- Mental health funding of £1.8m welcomed by MHRA and NICE to explore regulation of digital mental health tools
- MHRA response to contaminated paediatric medicines identified in WHO region of Africa
- European Commission Decision Reliance Procedure (EC DRP) extension
- MHRA appoints first new UK Approved Body to certify medical devices since Brexit
- MHRA launches new conflicts of interest code of practice for independent advisors
- No change to MHRA advice on the safety and effectiveness of COVID-19 vaccines for those who are pregnant or breastfeeding
- Pfizer/BioNTech bivalent COVID-19 booster approved by UK medicines regulator
- Novavax COVID-19 vaccine approved for 12 to 17s by MHRA
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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