Question to the Department of Health and Social Care:

To ask His Majesty's Government what assessment they have made of the implications for policy in England of the US Food and Drug Administration’s announcement that it would be making the reporting of incidences of surgical burns or fires mandatory; and what discussions they have held with the Medicines and Healthcare Products Regulatory Agency and relevant stakeholders about this.

The Medicines and Healthcare products Regulatory Agency (MHRA) has not had any meetings with the US Food and Drug Administration regarding the change to introduce mandatory reporting of incidences of surgical burns or fires to the MHRA, and we do not intend to impose mandatory reporting of these events.

Mandatory reporting of adverse effects from clinicians would require legislative change. It is not within the MHRA’s scope to compel this, and we do not have any jurisdiction over healthcare professionals. There is limited evidence that making reporting mandatory increases the ability to detect safety signals. There are professional guidelines in place for healthcare professionals to report safety issues, and the MHRA is working to proactively encourage reporting of adverse effects through improvements such as those within the new SafetyConnect system and outreach work. Manufacturers of medical devices are also required to report any incidents they receive to the MHRA.

Healthcare professionals and patients are encouraged to report any suspected adverse incidents with medicines or medical devices to the MHRA via the Yellow Card scheme.