Medical Devices Safety Bulletin (MDSB/2020/01)
This is a new regular bulletin from Medicines and Healthcare products Regulatory Agency (MHRA) to inform health and care professionals of new or ongoing safety issues with medical devices. It is aimed at all parts of the health and care system in the UK.
This bulletin will replace Medical Device Alerts (MDAs) for most serious patient safety issues that do not meet the NaPSAC criteria for a National Patient Safety Alert. We are no longer issuing MDAs.
To help ensure the safety of patients, we recommend you:
- act on any aspects in this bulletin that will affect your practice or the care you provide
- share the safety messages with colleagues who you think need to know this information
- provide feedback on the bulletin via this online survey so we can ensure it is as clear and effective as possible
The MHRA also issues safety communications for medicines, including Drug Safety Updates. Sign up to receive MHRA email alerts here.
Medical devices safety information
HeartStart MRx defibrillators
The Philips HeartStart MRx monitor/defibrillator therapy selector switch may fail, resulting in abnormal device behaviours including:
- the device may not perform the selected function
- the therapy knob may not change to the energy setting selected
- the device may deliver a shock with an energy level different from the setting selected by the user
If one of these behaviours occurs in clinical use, there may be a delay of therapy or a failure to deliver the intended therapy.
Advice for healthcare professionals:
Read the manufacturer’s field safety notice (FSN) – it gives advice on how to prevent this from happening.
Dermal fillers
All models of dermal filler Top-Q® (hyaluronic acid filler manufactured by Qufu Hi-Tech Trading Co Ltd) are being sold with a falsely applied CE Mark.
These devices have been manufactured to unknown standards and their safety as medical devices cannot be verified. Treatment with Top-Q® may lead to unexpected effects or complications in injected patients.
Advice for healthcare professionals:
Do not use any Top-Q® dermal fillers and quarantine them immediately.
Do not buy Top-Q® dermal fillers.
Report suspected or actual adverse events involving these devices.
Contact MHRA Devices Compliance team ([email protected]) about concerns regarding any devices you have or intend to purchase.
Field safety notices
A field safety notice (FSN) is an important communication about the safety of a medical device that a manufacturer, or their representative, sends to customers. For more information, see our flyer.
The MHRA publishes FSNs for information only. If you have affected devices, the manufacturer or distributor should send the FSN directly to your organisation.
If you are a Medical Devices Safety Officer (MDSO) you can ask manufacturers to add you to their FSN distribution lists.
Targeted letters
A targeted letter (TL) is a safety communication about a medical device, which we send only to the healthcare organisations that have the device. We will also send TLs to professional bodies and other organisations to send it on to the relevant target audience.
You can access recent TLs here.
Reporting safety issues
The Yellow Card scheme is vital in helping the MHRA monitor the safety of all healthcare products in the UK to ensure they are acceptably safe for patients and users.
You should report to via our Yellow Card website a suspected problem or incident involving:
- side effect to a medicine, vaccine, herbal or homeopathic remedy
- a medical device including diagnostic tests, software and apps
- defective medicine (not of an acceptable quality)
- falsified or fake medicine or medical device
- side effect or safety concern with an e-cigarette
Alternatively, you can download the Yellow Card app (from iTunes for iOS devices or PlayStore for Android devices).
You can also report side effects for medicines through some clinical IT systems (EMIS/SystmOne/Vision/MiDatabank) for healthcare professionals.
There are different ways for healthcare professionals to report a problem with a medical device if you’re in Scotland or Northern Ireland.
You can use our new dedicated COVID-19 reporting website to report any suspected side effects from medicines, future vaccines or medical devices relating to COVID-19 treatment.
Download the bulletin