Policy paper

Factsheet: medical devices information system

Updated 25 January 2021

Top lines

It is vital that medical devices are safe, and that any issues with devices are rapidly identified and prevented to avoid harm to patients.

Regulations made under the MMD bill will facilitate the tracking of higher-risk implanted medical devices across the UK so that their performance and outcomes can be monitored. It will also enable issues to be identified earlier so that clinicians can rapidly intervene, if needed, and mitigate risks faced by patients.

All organisations and individuals who provide, collect or use this information must comply with the UK’s comprehensive data protection legislation and common law duties which establish the critical safeguards on the safe and appropriate use of information.

Work to design and implement the information system is in progress, with input from all home nations.

Current system

The current system of how medical devices are purchased, used and monitored, whilst still being focussed on safety, does not provide for the systematic linking of devices with the patients they are used on.

There is a need for more information to be collected and shared to identify risks of specific devices early. This will allow patients and clinicians to discuss any necessary interventions, prevent harm and keep patients safe.

Expected improvements with the information system

The system will create a joined-up, transparent and integrated approach to the use of data, improving outcomes and product safety.

The information collected by the information system would support the work of clinical registries to aid the monitoring of the performance of devices and ensure patient outcomes can also be tracked.

The Medicines and Medical Devices Bill

The bill:

• provides a power to make regulations setting out how an information system will operate and how information will be collected from healthcare providers and other relevant private healthcare providers across the UK

• provides for full public consultation prior to the regulations being laid, including consultation with the devolved administrations

• through regulations, will allow medical devices to be linked by their unique identifier to a patient’s individual record, and patient and procedure data on devices to be collected and used to improve patient safety

Register, registry and information system

An information system is the collection, linkage and analysis of data, including information from patients, registers or registries as required, to create speciality databases for dissemination.

A registry is a combination of patient information, supplementary clinical information and information about a device or procedure, generated by the information system, to improve the quality of patient care.

The bill separately allows for registers of medical devices to hold the detail of manufacturers and available devices, but registers would not contain patient details.

Keeping data safe

Keeping data safe is of upmost importance and will be a priority throughout the development and use of the information system and the system of registries it will support.

The information system will be operated by NHS Digital which analyses, publishes and disseminates data to the highest information governance standards to protect the personal information of patients.

NHS Digital will comply with the UK’s data protection legislation and common law duties on safe and appropriate use of information.

Information collected and analysed under the system could be used, with safeguards, to ensure the effective use of within the healthcare system via audits and access-controlled analysis.