Buying 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 'Do’s 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?

MHRA stands for the Medicines and Healthcare products Regulatory Agency. MHRA is the UK government agency that works with the public, healthcare professionals, medical device manufacturers and lawmakers to make sure that medical devices used in the UK are as safe as possible. Sometimes we need to give safety advice to users of medical devices, and we may need to stop a manufacturer selling a medical device or even prosecute them for breaking the law. We can only do this if we hear about problems first.

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 7084 3080
• By post or by email by downloading a form from our website and e-mailing to aic@mhra.gsi.gov.uk or faxing to 020 7084 3109
• 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 (G.P.) or your community / practice nurse / therapist if you are unsure how to use a medical device. The MHRA website is another source of information.

MHRA has published a leaflet called "With your help we can make medical equipment safe". You should be able to get a copy from your pharmacist. You can also download it from our website.