FOI release

Freedom of Information request on mandatory reporting of adverse device events (FOI 22/777)

Published 21 December 2023

FOI 22/777

20 July 2022

Dear

Request Mandatory Reporting

Thank you for your request for further information following our response to your questions raised at the patient and public listening session on the 28 April 2022. Thank you also for sharing the BMJ article regarding the factors influencing the reporting of adverse medical device events: qualitative interviews with physicians about higher risk implantable devices. You asked three questions which are followed by our response:

1.Could the MHRA provide the scientific evidence upon which they based their reasoning that mandatory reporting doesn’t work. Also, could they provide us with information on other countries which use mandatory reporting by clinicians

A report1 conducted by the International Coalition of Medical Regulatory Authorities indicated an inconclusive picture regarding mandatory reporting of healthcare professionals to report suspected adverse drug reactions.

67% of the National Competent Authorities (NCAs – these are similar to the MHRA in other countries), responding to the survey2, indicated that mandatory reporting a neutral effect on national reporting and rates at a healthcare professional level.

60% of NCAs also indicated that mandatory reporting had a neutral effect on reporting at healthcare institutions level.

Many have not measured the impact of these effects in any detail. One of the main limiting issues faced by these national medicines regulators was the inability to enforce healthcare professionals as like ours, it is not within their regulatory remit to do so. Instead, all indicated that a collaborative approach is taken to better educate healthcare professionals about the importance of reporting supported by policy underpinned by best practice policy of reporting suspected adverse drug reactions within their professional codes of conduct.

The MHRA has no legal jurisdiction over healthcare professionals conduct or practice and a framework would be needed for compliance to mandatory reporting to be enforced, as well as how non-compliance and intelligence, would be handled and acted upon, which all sit outside the remit of the MHRA. We are working with other partners to make reporting easier and to promote the importance of reporting and educate on reporting. A seamless single reporting system for healthcare professionals to use would help with the implementation of mandatory reporting. Although there is the Yellow Card app, the Yellow Card website and integration of Yellow Card reporting into some clinical IT systems, deeper integrated reporting routes within IT systems used by healthcare professionals should ideally be in place and these should be effectively working. This would enable the right data to be transmitted in the right format required for MHRA assessment of safety signals. Together a fully joined up system will support any call for mandatory reporting to have a positive impact, especially at a time given the pressures under the NHS.

It is envisaged that integration of Yellow Card reporting into LFPSE (see answer to Q.3 below for more information on this) through our strategic application portal interface (API) development work strands of our SafetyConnect project will take us to this point in the future, at which stage mandatory reporting and the reporting landscape should, as necessary, be re-evaluated.

2.Could the MHRA update us on what will happen to mesh after Brexit in terms of raising it up to Class III from Class IIb. We understand this is happening in the EU.

The classification of surgical mesh will be increased to Class III under the future UK medical device regulations.

We kindly refer you to the recently published Government response to the public consultation on the future regulation of medical devices in the United Kingdom, and specifically to Chapter 2 which provides more detail on the proposed changes to classification of general medical devices including surgical mesh:

https://www.gov.uk/government/consultations/consultation-on-the-future-regulation-ofmedical-devices-in-the-united-kingdom

3.Could the MHRA explain how the LFPSE system will tie into the Yellow Card system so there is joined up data from public and healthcare professional Adverse Event reports

The new national NHS Learn from patient safety events (LFPSE) service3 is in its final stages of development as a central one stop service for the recording and analysis of all patient safety events that occur nationally across the healthcare system. LFPSE is replacing the current National Reporting and Learning System (NRLS) and Strategic Executive Information System (StEIS), to offer better support for staff from across all health and care sectors. When fully functional, LFPSE will make it easier for staff across all healthcare settings to record safety events, with automated uploads from local systems to save time and effort, and introducing new tools for non-hospital care where reporting levels have historically been lower. LFPSE plans to work to understand how best to ensure patients, carers and families can contribute to national learning as it develops.

Currently, healthcare professionals report local incidents, including patient safety incidents, that occur within their organisations using their own Local Risk Management Systems (LRMS) operated by various vendors such as Datix and Ulysses etc. There is a requirement for these to be uploaded into NRLS (which will be replaced by the new LFPSE service).

MHRA are considered key partners in the development of LFPSE. MHRA is working closely with the NHSE team that are developing the LFPSE service. Our vision is to embed Yellow Card reporting functionality through an API so that the reporting of medical device adverse incidents and the reporting of suspected side effects to medicines are included to international and MHRA standards within LFPSE. This means Yellow Card data of the appropriate quality should be able to be extracted out of local risk management reporting systems and uploaded to LFPSE and that any MHRA related incidents are automatically transmitted and uploaded into our new MHRA systems being developed through the MHRA’s SafetyConnect project for improved signal detection and assessment.

We will continue to work with partners across the healthcare system to promote and encourage use of the Yellow Card to help detect safety issues, and mandatory reporting can be considered with other partners in the healthcare system when the current pressures on the NHS have alleviated and the new reporting system is in place. A culture change is also needed to encourage people to report through existing routes until these NHS systems are joined up more effectively to the Yellow Card scheme. Such projects should ensure that the appropriate technology and fields are available within local systems across the NHS to facilitate Yellow Card reporting and we see this as an important next step.

Once we have successfully connected Yellow Card reporting into NHS systems fully to join up the healthcare system, we will be in a better position to revisit mandatory reporting. In the meantime, we are committed to educate reporters about the scheme to encourage reporting.

We hope the information provided is helpful.

Yours sincerely,

FOI Team,

Safety & Surveillance