The term 'medical device' covers a huge range of products that have a medical use and are not medicines. This includes anything from walking sticks and hip replacements to glucose monitors, blood pressure machines and pregnancy testing kits. Every day in the UK, millions of people safely use medical devices.
When might I come across medical devices?
Many medical devices are used by doctors, nurses and other healthcare workers to help them make a diagnosis or to treat someone. This can be at your general practice, in your home or at a hospital or clinic. However, the number of medical devices that can be bought directly in a shop or over the internet is increasing. For example, you might want to buy a pregnancy test, surgical dressings or plasters, contact lenses and contact lens cleaning fluids or compression stockings.
How do I know if a medical device is safe?
Manufacturers of medical devices are required, by law, to make sure that any medical devices that they make are safe. The UK and the rest of Europe have the same legal requirements for medical device safety and performance. A medical device that meets those requirements will display a CE mark.
Some dos and don'ts when buying a medical device?
Do
- Make sure that you really do need to use the medical device and that you are choosing something that will help you
- Make sure you are buying from a recognised outlet
- Make sure the medical device is CE marked
- Make sure that you know how to use the medical device properly
- Make sure you know how to maintain the medical devices properly
- Ask your doctor, nurse, therapist or pharmacist for advice if you are not sure
Don’t
- Use a medical device if you have not read and understood the instructions
- Buy a second hand medical device from a friend, a car boot sale or an internet auction site
Be careful
- If you buy a medical device on the internet (is it new? does it meet the UK and European laws?)
- If you buy a second hand medical device
-
- only do so from a recognised outlet
- make sure you get the proper instructions for the medical device
- make sure that the medical device is still safe to use.
What does the MHRA do?
One of our jobs is to investigate reports about medical devices that have caused an injury or a death. The medical device might have gone wrong or broken down. MHRA does these investigations for all medical devices, including those that can be bought directly by the public. Doctors, nurses and pharmacists know how to report things to us when they need to; it is important that you do as well so that we hear about problems with medical devices that are brought over the counter.
What should I do if I find that my medical device does not work properly?
Your first contact should be with the supplier of the medical device or the doctor, nurse, therapist or pharmacist who recommended that you should use it. After you have done this, if you are still worried then please let us know.
How can you report problems with medical devices to MHRA?
- By phone by telephoning 020 3080 7080
- By post or by email by downloading a form from our website and emailing to aic@mhra.gsi.gov.uk or faxing to 020 3118 9814
- By telling someone else such as your pharmacist, therapist, nurse or doctor and asking them to tell MHRA
MHRA will need to know:
- the name of the equipment or device
- the name of the manufacturer – if you know it
- any expiry date or batch number
- where and when you bought it
- what went wrong with the equipment
Where can I go for advice?
You could ask your pharmacist, your family doctor (GP) or your community / practice nurse / therapist if you are unsure how to use a medical device. The MHRA website is another source of information.
