I note this report is from 2019, my officials will discuss this further with colleagues in the Department for Health and Social Care, and the National Fire Chiefs Council.

Any unexpected or unintended incident which could have or did lead to harm to one or more patients can be recorded on the Learn from Patient Safety Events (LFPSE) service, to support local and national learning. This can include surgical fires or burns. We are informed that NHS England does not define the severity of harm related to surgical fires or burns specifically. Grading the severity of harm related to a patient safety incident that is recorded on LFPSE, should be done using NHS England’s guidance on recording patient safety events and levels of harm, which asks that near miss events be graded as no harm. The guidance is available at the following link:

https://www.england.nhs.uk/long-read/policy-guidance-on-recording-patient-safety-events-and-levels-of-harm/

If a surgical fire or burn is assessed locally and constitutes a patient safety event, it would fall under the scope of the Care Quality Commission’s (CQC) Regulations 16 or 18, and must be reported to the CQC. This means that the most serious surgical fires or burns which result in serious harm or the death of a service user, are subject to mandatory reporting. NHS trusts can comply with this requirement by recording patient safety events using the LFPSE service, and NHS England shares all such data with the CQC, who are responsible for regulating compliance with CQC regulations. CQC Regulations 16 and 18 are available respectively, at the following links:

https://www.cqc.org.uk/guidance-providers/regulations/regulation-16-notification-death-service-user

https://www.cqc.org.uk/guidance-providers/regulations-enforcement/regulation-18-notification-other-incidents

Although the recording of wider patient safety events onto LFPSE is a voluntary process, providers are encouraged to record all patient safety incidents, irrespective of the level of harm, to support local and national learning.

The LFPSE service and its predecessor, the National Reporting and Learning System, do not have specific categories for surgical fires or burns. Determining how many patient safety events related to surgical fires or burns were recorded by National Health Service providers in each of the last five years would require a search of the free text of recorded patient safety events, using key words, and a subsequent expert clinical review of all potential records to determine relevance to the question. This could only be provided at disproportionate cost.

Any unexpected or unintended incident which could have or did lead to harm to one or more patients can be recorded on the Learn from Patient Safety Events (LFPSE) service, to support local and national learning. This can include surgical fires or burns. We are informed that NHS England does not define the severity of harm related to surgical fires or burns specifically. Grading the severity of harm related to a patient safety incident that is recorded on LFPSE, should be done using NHS England’s guidance on recording patient safety events and levels of harm, which asks that near miss events be graded as no harm. The guidance is available at the following link:

https://www.england.nhs.uk/long-read/policy-guidance-on-recording-patient-safety-events-and-levels-of-harm/

If a surgical fire or burn is assessed locally and constitutes a patient safety event, it would fall under the scope of the Care Quality Commission’s (CQC) Regulations 16 or 18, and must be reported to the CQC. This means that the most serious surgical fires or burns which result in serious harm or the death of a service user, are subject to mandatory reporting. NHS trusts can comply with this requirement by recording patient safety events using the LFPSE service, and NHS England shares all such data with the CQC, who are responsible for regulating compliance with CQC regulations. CQC Regulations 16 and 18 are available respectively, at the following links:

https://www.cqc.org.uk/guidance-providers/regulations/regulation-16-notification-death-service-user

https://www.cqc.org.uk/guidance-providers/regulations-enforcement/regulation-18-notification-other-incidents

Although the recording of wider patient safety events onto LFPSE is a voluntary process, providers are encouraged to record all patient safety incidents, irrespective of the level of harm, to support local and national learning.

The LFPSE service and its predecessor, the National Reporting and Learning System, do not have specific categories for surgical fires or burns. Determining how many patient safety events related to surgical fires or burns were recorded by National Health Service providers in each of the last five years would require a search of the free text of recorded patient safety events, using key words, and a subsequent expert clinical review of all potential records to determine relevance to the question. This could only be provided at disproportionate cost.

In January 2023, the Centre for Perioperative Care, following consultation, published revised National Safety Standards for Invasive Procedures. These national standards specifically cover all invasive procedures and include a requirement for local fire safety policies to minimise the risk of surgical fires and to contain a management plan in the event of one occurring.

Recording individual patient safety events is a voluntary process, except where reporting to NHS England fulfils duties for other statutory mandatory requirements, such as reporting notifiable incidents to the Care Quality Commission (CQC). NHS England share all data routinely with CQC. The data is also being made available to integrated care boards and regional teams, to facilitate their roles in safety oversight and provider improvement support.

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.

Any unexpected or unintended incident which could have or did lead to harm to one or more patients can be recorded on the Learn from Patient Safety Events (LFPSE) service, to support local and national learning. This would include incidents caused by surgical fires or burns.

Providers are encouraged to foster a positive safety culture among their staff, and ensure an appropriate local focus on incident recognition, recording, and response.

Recording onto LFPSE is a voluntary process, except where reporting to NHS England fulfils duties for other statutory mandatory requirements, such as reporting notifiable incidents to the Care Quality Commission (CQC). NHS England shares all such data with the CQC. Notifiable incidents include events resulting in “serious harm” or the death of a service user, and therefore the most serious surgical fires or burns are subject to mandatory reporting. However, providers are encouraged to record all patient safety incidents, irrespective of the level of harm, to support local and national learning.

Published National Safety Standards for Invasive Procedures include a requirement for a risk assessment and management plan to minimise the risk of surgical fires in the perioperative environment. They require that multidisciplinary team training should involve rehearsal and analysis of typical and emergency scenarios, such as a surgical fire, and that prior to surgery, any fire risk and the management plan are discussed and confirmed.

LFPSE is not designed for performance management. However, it supports certain oversight functions within providers, including the ability to review all records submitted by staff, and to mark them as either meeting certain other requirements, such as notification to the CQC, or not. This supports good governance within the provider, encouraging scrutiny of recorded events, and the fulfilment of other statutory or national policy reporting requirements. LFPSE data is being made available to integrated care boards and regional teams to facilitate their roles in safety oversight and provider improvement support.

NHS England does not hold or collect information on the number of surgical fires which occur. Although incidents where serious harm and death are captured within LFPSE, and trusts may choose to record lower levels of harm, there is no category for surgical fires within the existing reporting system with which they could be counted and therefore any count would not be definitive.

Any unexpected or unintended incident which could have or did lead to harm to one or more patients can be recorded on the Learn from Patient Safety Events (LFPSE) service, to support local and national learning. This would include incidents caused by surgical fires or burns.

Providers are encouraged to foster a positive safety culture among their staff, and ensure an appropriate local focus on incident recognition, recording, and response.

Recording onto LFPSE is a voluntary process, except where reporting to NHS England fulfils duties for other statutory mandatory requirements, such as reporting notifiable incidents to the Care Quality Commission (CQC). NHS England shares all such data with the CQC. Notifiable incidents include events resulting in “serious harm” or the death of a service user, and therefore the most serious surgical fires or burns are subject to mandatory reporting. However, providers are encouraged to record all patient safety incidents, irrespective of the level of harm, to support local and national learning.

Published National Safety Standards for Invasive Procedures include a requirement for a risk assessment and management plan to minimise the risk of surgical fires in the perioperative environment. They require that multidisciplinary team training should involve rehearsal and analysis of typical and emergency scenarios, such as a surgical fire, and that prior to surgery, any fire risk and the management plan are discussed and confirmed.

LFPSE is not designed for performance management. However, it supports certain oversight functions within providers, including the ability to review all records submitted by staff, and to mark them as either meeting certain other requirements, such as notification to the CQC, or not. This supports good governance within the provider, encouraging scrutiny of recorded events, and the fulfilment of other statutory or national policy reporting requirements. LFPSE data is being made available to integrated care boards and regional teams to facilitate their roles in safety oversight and provider improvement support.

NHS England does not hold or collect information on the number of surgical fires which occur. Although incidents where serious harm and death are captured within LFPSE, and trusts may choose to record lower levels of harm, there is no category for surgical fires within the existing reporting system with which they could be counted and therefore any count would not be definitive.

Any unexpected or unintended incident which could have or did lead to harm to one or more patients can be recorded on the Learn from Patient Safety Events (LFPSE) service, to support local and national learning. This would include incidents caused by surgical fires or burns.

Providers are encouraged to foster a positive safety culture among their staff, and ensure an appropriate local focus on incident recognition, recording, and response.

Recording onto LFPSE is a voluntary process, except where reporting to NHS England fulfils duties for other statutory mandatory requirements, such as reporting notifiable incidents to the Care Quality Commission (CQC). NHS England shares all such data with the CQC. Notifiable incidents include events resulting in “serious harm” or the death of a service user, and therefore the most serious surgical fires or burns are subject to mandatory reporting. However, providers are encouraged to record all patient safety incidents, irrespective of the level of harm, to support local and national learning.

Published National Safety Standards for Invasive Procedures include a requirement for a risk assessment and management plan to minimise the risk of surgical fires in the perioperative environment. They require that multidisciplinary team training should involve rehearsal and analysis of typical and emergency scenarios, such as a surgical fire, and that prior to surgery, any fire risk and the management plan are discussed and confirmed.

LFPSE is not designed for performance management. However, it supports certain oversight functions within providers, including the ability to review all records submitted by staff, and to mark them as either meeting certain other requirements, such as notification to the CQC, or not. This supports good governance within the provider, encouraging scrutiny of recorded events, and the fulfilment of other statutory or national policy reporting requirements. LFPSE data is being made available to integrated care boards and regional teams to facilitate their roles in safety oversight and provider improvement support.

NHS England does not hold or collect information on the number of surgical fires which occur. Although incidents where serious harm and death are captured within LFPSE, and trusts may choose to record lower levels of harm, there is no category for surgical fires within the existing reporting system with which they could be counted and therefore any count would not be definitive.

Q12

.

Mrs Anne-Marie Trevelyan (Berwick-upon-Tweed) (Con):

My constituent, Dr Sarah Pape, one of the UK’s leading burns specialist, went out on Monday to Bucharest to help the Romanian medical teams dealing with the nightclub fire disaster. I understand that some 150 patients are in need of critical burns care and that there are only 25 burns beds in Bucharest. Sarah Pape has asked whether the Prime Minister will consider offering practical humanitarian medical assistance to these burns victims by allowing the use of UK burns facilities for their treatment.

My hon. Friend is absolutely right to raise the tragic events that took place in Bucharest last Friday. All our thoughts are with the victims and their families. I am pleased to hear about Dr Pape’s visit and her selfless work to help. It is a good suggestion to consider whether we can offer specialist help and support and I will take that away and see what can be done.