Clinical safety case report

This CSCR outlines our approach to clinical safety risk assessment and the mitigations in place to manage identified risks.

As with all software used in clinical practice there are some potential hazards, these have been assessed and documented in our clinical safety hazard log (CSHL), and assigned to a clinical risk category:

Clinical risk category & Number of hazards

• Very high 0

• High 0

• Significant 0

• Moderate 1

• Low 3

All identified risks have been deemed tolerable and do not require further supplier-side mitigations.

All hazards include controls that should be put in place by the healthcare organisation using Melo.

Last updated: 9th November 2023

Approved by: Dr Stephen Mullin, Clinical Safety Officer

As with all software used in clinical practice there are some potential hazards. For the purposes of the use of Melo within the UK we are required to ensure compliance with the NHS Digital safety standard DCB0129.

This clinical safety case report (CSCR) outlines the evidence that the safety and documentation requirements are met and outlines a set of claims regarding the safety of the Melo digital application. It outlines our approach to clinical safety risk assessment and summarises our Clinical Safety Hazard Log (CSHL).

Intended Audience

In the interest of transparency this CSCR is made publicly available, but is written for stakeholders involved in the deployment of Melo into clinical environments, including those involved in ensuring that DCB0160 standards are met by healthcare organisations using Melo.

This section describes what is within the scope of this CSCR, the product’s intended use, functional user flow, system architecture, and device classification.

Scope

This CSCR includes the entire scope of the Melo digital web application.

The scope includes the third party processors used (See Appendix 1.)

As per best practice for Software-as-a-Service (SaaS) web applications Melo undergoes regular releases.

Overview and intended use

Melo is a digital web application that aims to assist healthcare staff working with clients with neurological or mental health related difficulties, to reduce incidents of violence and aggression. Specifically Melo aims to help healthcare staff working with clients who have reduced capacity to manage their own behaviour to better understand and so to better manage and reduce incidents of behaviour that challenges, including incidents of violence and aggression. Melo supports staff to record and assess incidents of behaviour that challenges and to formulate an appropriate individual intervention plan for each client, using the least restrictive ethical interventions likely to reduce incidents of behaviour that challenges, in a particular individual.

User flow

The high-level user flow is as follows:

• A user finds a specific patient from a list of those that the user has access to within Melo. The user will then either input behavioural data in relation to the specific patient, based upon their direct observations, or will review summary data regarding previously inputted descriptions of behaviour, in order to assist with the development of a management plan.

• Behavioural data may be inputted using either the ABC or ABS forms. The ABC and ABS forms provided structured formats for clinical staff to describe an individual’s behaviour, as well as its antecedents, consequences and context.

• Users have the ability to visualise patient data through a dashboard.

System architecture

The technical details and system architecture are outlined in our technical resources (See Appendix 2).

Medical device status

Melo is not classified as a medical device in the UK, as per the MHRA’s Medical device stand-alone software including apps guidance.

This section describes the people involved in clinical safety analysis, the methodology followed, and the evaluated safety profile.

Team and competency

Clinical safety activities relating to Melo are led by Dr Stephen Mullin, a registered clinician and trained Clinical Safety Officer (CSO). In addition to the CSO, clinical safety activities involve a multidisciplinary team (MDT) who all understand the product and how it is used in the clinical setting, including James Chapman, Co-Founder and Product Manager; James Alcock, Chief Technical Officer; Charlie Dowd, Product Designer; and James Burch, Co-Founder and Compliance Manager.

Methodology

Clinical safety hazard analysis is undertaken at least annually by the MDT to identify new hazards and re-evaluate known hazards, consider causes and existing controls, and identify any controls that should be introduced. Any controls that require input from the healthcare organisation using Melo are flagged as such.

The output from the hazard analysis is documented in our CSHL including an evaluation of the clinical safety risk of each hazard based on the hazard’s severity and likelihood of patient harm given the presence of existing controls. The risk matrix used is shown within the ‘Risk Matrix’ tab of the CSHL.

Clinical safety hazard profile

The following is a summary of the detail within the CSHL:

Clinical risk category & Number of hazards

• Very high 0

• High 0

• Significant 0

• Moderate 1

• Low 3

Hazards:

• Melo does not accurately reflect a patient’s (High) risk profile (HAZ01).

• Melo does not accurately reflect a patient's (LOW) risk profile (HAZ02)

• Melo not available to user: user unable to record or review clinical information in a timely manner (HAZ03)

• Inappropriate access to/sharing of patient confidential information (HAZ 04)

• Some historic hazards (e.g HAZ4.10, 4.11, 4.12) may no longer feature within the hazard log as they have been closed, but to avoid potential confusion their hazard ID is not reused.

All hazards are deemed to be acceptable (risk: low) or tolerable (risk: medium) and therefore no further mitigation is required at this time.

All identified possible causes of Haz01, Haz02 and Haz03 are considered to be of low current risk, due to the provision of existing controls currently in place. These controls are detailed in the attached Hazard Log.

The controls include ensuring that users of Melo are trained in how to use it appropriately. Appropriate training information will be supplied to User organisations and it is the responsibility of the User organisation to ensure that all staff using Melo have been provided with this information.

The controls also include the assumption that users have received appropriate standard training in the safe use of IT systems in Clinical Healthcare settings and have appropriate and up to date training in Clinical Governance, covering issues such as working with confidential clinical information. It is the responsibility of the User organisation to ensure that all staff using Melo have received appropriate standard NHS Clinical Governance training, including training in the safe use of IT systems in Clinical Healthcare settings.

Currently one possible cause of Haz03 is considered to be of medium risk. This is in relation to the possibility that the software may contain bugs (errors), not yet identified, which may cause aspects of the software system to fail. This risk is considered to currently be tolerable (risk: medium) and work is underway to enhance the detection of potential bugs in the software prior to release. A system is also in place to enable users to report bugs, which will aid in the rapid identification and elimination of such errors, which is intended to reduce the risk in future releases.

Clinical safety officer activities

A number of activities are performed by the CSO:

• Each deployment to a production environment is approved by the CSO, including ensuring that appropriate testing controls are in place in line with the clinical safety risk.

• All bug and feature request tickets are assessed by the CSO with regard to clinical safety and the ticket priority includes consideration of clinical safety impact.

• The CSO coordinates and leads on clinical safety activities, including the review of the CSHL and CSCR at least annually.

As part of the CSCR we make the following assertions:

• All foreseeable clinical safety hazards are known, have been evaluated and documented by a multidisciplinary team, and are at an acceptable or tolerable level.

• Robust post-market surveillance mechanisms are in place to ensure the clinical safety of the product in the production environment, and to respond to incidents appropriately.

This clinical safety case report outlines the evidence that the Melo digital platform is appropriate for clinical use as per the outlined intended use, and is compliant with the DCB0129 standard.

Clinical safety hazard analysis involving the appropriate people demonstrates that Melo is a low-risk healthcare product which is not considered a medical device, and has a safety profile that is deemed to be tolerable.