A healthcare or care provider that buys and uses medical devices is responsible for choosing them well, keeping them safe and reporting problems. The manufacturer's duties, such as classification, conformity assessment and registration, are separate. Use the Medicines and Healthcare products Regulatory Agency (MHRA) guidance on managing medical devices as the benchmark for your system.
Buy devices that carry an accepted marking
A device on the Great Britain market has to conform to the Medical Devices Regulations 2002. In practice you check for a UKCA marking or a CE marking that Great Britain still accepts.
When a device arrives, check that it matches the purchase order or tender specification. Record the order, the results of the delivery checks, who did them and the device's identifier, so that you can trace it later for maintenance or a recall. Keep the manufacturer's instructions where staff can find them.
Keep a record for every device
MHRA guidance says each device's record should show a unique identifier, the date it was bought and put into use, where it is deployed, any legal requirements and whether they have been met, the schedule and details of maintenance and repairs, and its end-of-life date. Keep these records in one system where you can, and protect them so that changes do not obscure what was recorded before.
Maintain and examine your equipment
Under the Provision and Use of Work Equipment Regulations 1998 you must keep work equipment in an efficient state, in efficient working order and in good repair, and keep any maintenance log up to date. Follow the manufacturer's instructions for preventive maintenance and calibration.
Lifting equipment such as a patient hoist, and its lifting accessories, must be thoroughly examined under the Lifting Operations and Lifting Equipment Regulations 1998.
Train the people who use devices
Staff need to know how to use each device safely, carry out routine checks and maintenance, and recognise when something is wrong. MHRA guidance says you must keep records showing that users were trained before using a device and have had refresher training.
Report adverse incidents and act on alerts
Report any adverse incident involving a device, including a near miss, a software failure, a user problem or a problem with the instructions for use. In England and Wales you report through the Yellow Card scheme, in line with your own medical device policy. MHRA guidance says healthcare organisations should appoint a Medical Device Safety Officer, and that staff should know who that person is.
The deadlines for reporting serious incidents under the vigilance system bind manufacturers, not users. You should still act on field safety notices and MHRA alerts and record what you did.
If you use X-ray or other ionising radiation
Enforcement and penalties
Medical devices. The MHRA enforces the Medical Devices Regulations 2002 in Great Britain for the Secretary of State, and local weights and measures (Trading Standards) authorities share that duty for devices ordinarily intended for private use. Contravening the Regulations' prohibitions on placing or supplying devices, or their marking and information requirements, is an offence under section 12 of the Consumer Protection Act 1987, which a 2021 saving provision keeps applying to these Regulations. The offence falls on the person who places or supplies the device, such as the manufacturer, a UK Responsible Person or a supplier. It is tried only in a magistrates' court (or a sheriff court in Scotland), and the maximum is 6 months in prison and a fine, or both. The fine is unlimited in England and Wales and up to £5,000 in Scotland. Breaching an MHRA compliance, suspension, safety or information notice is a separate offence under section 28 of the Medicines and Medical Devices Act 2021, with the same maximum.
Ionising radiation. Breaching the Ionising Radiations Regulations 2017 is an offence under section 33(1)(c) of the Health and Safety at Work etc. Act 1974. It can be tried in a magistrates' court or on indictment, and on conviction on indictment the maximum is 2 years in prison, an unlimited fine, or both.
Before you start work with ionising radiation you must notify the Health and Safety Executive and carry out a risk assessment.
For exposures of patients, the Ionising Radiation (Medical Exposure) Regulations 2017 require you as employer to put written procedures in place, appoint a suitable medical physics expert, and keep a quality assurance programme and an inventory of your equipment. If you know or suspect that someone received a significantly greater dose than intended, you must investigate straight away and notify the enforcing authority unless the investigation shows beyond reasonable doubt that it did not happen.
Legal basis
Primary legislation and key regulations