MEDICINES & HEALTHCARE REGULATIONS
The Medical Device Directive defines a medical device as: Any instrument, apparatus, appliance,
software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of: l Diagnosis, prevention, monitoring, treatment or alleviation of disease
l Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap
l Investigation, replacement or modification of the anatomy or of a physiological process l Control of conception
and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.
“Although it’s quite a long description,” said Rebecca, “it neatly encompasses how we define a medical device. Within the MDD you have different classes of medical device. Items that are a Class 1 do not require a notified body unless they have a measurement or sterilisation function. Everything above - Class 2a, 2b and 3 - must have a CE mark that has been provided by a notified body. That means the notified body will audit the manufacturers information and will decide whether the device has got the required safety profile to be safe and therefore to be put on the market. MHRA does not give out CE marks, but audits the UK Notified Bodies.”
Yellow Card Scheme The Yellow Card Scheme3
is the reporting
system used by the MHRA to monitor the safety of all healthcare products in the UK to ensure they are acceptably safe for patients and those that use them. Reports can be made for all medicines including vaccines, blood factors and immunoglobulins, herbal medicines and homeopathic remedies, and all medical devices available on the UK market. From 20 May 2016, the MHRA also started collecting reports of safety concerns associated with e-cigarette products through the Yellow Card Scheme. “The Yellow Card Scheme is our reporting
route,” Rebecca stated. “Anyone can report - healthcare professionals; members of the public; patients; patients’ families - it doesn’t matter. The information we want covers problems with medicines, medical devices, defective medicines, fake or counterfeit medicines and devices. “It’s important to fill in as much data as possible because if there are any questions then we can ask for more information. It’s worth bearing in mind that any report that is sent in will be forwarded to the manufacturer. In an ideal world we would like users to
report incidents to the manufacturer and then they report everything to us - although that doesn’t always happen. “If we receive a report and we don’t know which manufacturer or model it is it obviously delays responses. If we receive a report about a device but no information about the manufacturer, we can’t investigate any further.” When a report comes into the MHRA, it is passed to a ‘Responsible Officer’ - a device specialist in that area - and this workflow continues until a resolution is found. “We don’t ever want people to think that when a file comes in we just look at it and leave it at the bottom of the pile,” said Rebecca. “Every incident we receive gets looked at by a person - even though we receive over 18,500 reports per year - and that’s just for devices. For medicines we receive around 400,000 Yellow Card reports. That’s a big number, but we want to reassure people that we look at them. Once it has gone through this workflow, we keep in touch regularly throughout the process to keep everyone in the loop of what’s going on.
“We also get field safety notices sent to us by manufacturers. When a draft arrives, we have two days to comment and say whether we think it’s suitable and whether it’s going to be received well by people in the NHS, or the patients that it’s aimed at. It is the manufacturer’s document. The manufacturer can release one with our comment - and often we will look at it and ask for further information or ask them to edit it and release an updated version. This goes through quite a complicated workflow and requires involvement with the clinical teams as well. So, it has a great deal of internal review before we agree that the risk has been suitably mitigated by the manufacturer. The actions could be anything from providing more information, to the manufacturer initiating a design change or a recall. “We also chase up manufacturers to make sure that they have got suitable reconciliation. When they send out a safety notice we make sure that they’ve had a sensible number of responses back. We do appreciate that, for example, if a manufacturer is trying to reach every single person with a brand of continuous insulin infusion pump that this might be quite difficult. So, we will accept that if they’ve reached as many people as they can, then that can be a case where it’s closed. “We have all of the safety notices on our website so if someone has a device that is the subject of a safety notice, they should receive that field safety notice in their inbox, but it will normally go through the medical device safety officer (MDSO) at their Trust. We facilitate this network of MDSOs and we get them together on teleconferences and discuss issues that are happening across the country with different medical devices. This means that there’s a greater awareness of issues.”
Medical device safety officers
You should always act on a Field Safety Notice. When it comes into your inbox and you realise you have that device, you must act on
it at once. Rebecca Flint, MHRA
18 I
WWW.CLINICALSERVICESJOURNAL.COM
Rebecca highlighted the importance of MDSOs, and concerns that there may not be enough throughout Trusts. “If there is a Field Safety Notice for a device that you will have in your Trust, this should go through your MDSO. If you do not have a MDSO, then it will go to whoever is the nominated person by the manufacturer - it could be someone who’s on maternity leave or is part of procurement. MDSOs are invaluable. If you know who yours is, then get in touch with them - and be friendly! If you don’t know whose yours is, then find out! If you haven’t got one, make your Trust get one! Make a fuss and say that you need one - they are invaluable. You should always act on a Field Safety Notice. When it comes into your inbox and you realise you have that device, you must act on it at once. If you don’t we will pester you until you do! “I must stress again, we don’t own those documents, we just publish them, and all of the other competent authority member states will publish them in their own countries as well. If you’re not sure always go back to the manufacturer and confirm whether you have the device in question. If you don’t get any
JUNE 2018
©magdal3na - Fotolia
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