Devices used in research
What are medical devices?
The term 'medical device' covers all products, except medicines, used in healthcare for the diagnosis, prevention, monitoring or treatment of illness or handicap. The range of products is very wide: it includes contact lenses and condoms; heart valves and hospital beds; resuscitators and radiotherapy machines; surgical instruments and syringes; wheelchairs and walking frames - many thousands of items used each and every day by healthcare providers and patients.
If you are planning a project using a medical device, please seek further information from the devices section of the MHRA http://devices.mhra.gov.uk/.
If a non CE marked device is to be used in research which involves another organisation in addition to BLT/QMUL, then a letter of no objection is required from the MHRA before the study may commence. For information on how to obtain this please visit the MHRA website.
Assessment of equipment used for research in Barts and The London NHS Trust
The Trust Policy “Management of Medical Equipment” requires all medical equipment, intended for use in clinical investigations on Trust patients, to be assessed by Clinical Physics. This includes equipment provided for free and on loan as well as purchased.
Researchers will need to provide Clinical Physics with the equipment, including any accessories, such as power supplies and patient leads. Additionally, adequate documentation should be provided, including a summary of the research protocol for the clinical investigation. Assessments can either be carried out in Clinical Physics or in the researcher’s department, depending on the type of equipment and what is most convenient.
The assessment is normally completed within a few days. However researchers are advised to contact Clinical Physics as soon as they are able, so that the assessment does not hold them up. Depending on workload it may be difficult to carry out assessments at short notice.
Researchers should contact Phil Daly on tel 020 7377 2202 or email phil.daly@bartsandthelondon.nhs.uk for further details.