Job responsibilities
Job Title: Medical Devices Safety Officer (MDSO)
Band: 7
Hours: 37.5 p/w (Full-Time, Mon-Fri)
Responsible to: Deputy Head of Clinical Devices
Accountable to: Deputy Head Clinical Devices
Head of Clinical Devices
Main base: University Hospital Lewisham, post holder will be required to work cross-site & work on any site used by the Trust.
Dept: Clinical Engineering
Summary
The Trust has a statutory duty to deliver a service and environment that protects patients, staff and visitors. The Department supports the Trust in this duty by ensuring there are Trust wide systems in place to manage and continuously learn from areas of safety involving medical devices.
The Medical Devices Safety Officer (MDSO) will be involved in medical device incident reporting and learning within the Trust. The post holder will act as the main contact for medical device safety alerts and incidents to statutory agencies and other internal/external bodies and will exchange specialist and sensitive information. The MDSO will identify, interpret and lead implementation of local and national medical devices safety initiatives including MHRA and DoH alerts.
The MDSO will provide expert advice to medical device users, clinical leads and Trust management and leading on investigating and reporting on medical device safety issues. The post holder will coordinate Central Alerting System (CAS) response with the governance and risk facilitation team and will include the retrieval of equipment and medical devices involved in a patient safety incident and subsequent internal and/or external examination of equipment as appropriate to the circumstance.
The MDSO will also support the medical devices Trainer in delivering training and support to staff in the clinical area and classroom, liaising with the clinical leads, subject matter experts and clinical engineers.
MDSO Functions
Monitor
- Medical device incidents for reporting to the MHRA and other internal/external parties
- Safety alerts (national, supplier, manufacturer, local, etc.)
Investigate & Advise
- Investigate and advise on medical device risks and incidents which can be both complex and contentious in nature
Inform
- Senior staff and committees on ongoing incident investigations
- Senior staff and committees of any serious concerns, risks or exceptions
- MHRA and other relevant statutory agencies
Undertake
- Reporting and management through to closure of medical devices related incidents to the MHRA, including liaison with the MHRA and companies and chasing stakeholders as appropriate.
- Interrogation of investigation findings with Clinical Engineering, lead clinicians, medical devices trainer with feedback to manufacturers and the MHRA
- Analysis of complex data / facts & present medical devices / risk management information
- Production of reports and action plans, where indicated, related to investigations and implementation of local / national recommendations through skilful negotiation and empathy.
- Prepare medical devices reports for MHRA/committees/groups
- Preparation of agenda and reports for Trust Medical Devices groups
- Undertake relevant audits pertaining to the MDSO role and other areas as requested by line manager
- Development of policies, protocols and procedures to improve safe practice in the use of medical devices, to enable the Trust to benefit from joint learning and from national initiatives.
- Ensure there are robust mechanisms in place for the distribution of medical devices safety alerts and notices and that these are acted upon and responded to within a reasonable timescale.
- Improve reporting of and learning from medical device incidents including review of themes and trends, implementing the required actions to prevent re-occurrence of the incident
- Evaluate new equipment as required to support the equipment purchasing strategy this will include the preparation of reports.
- Write or contribute to complaint responses as required.
- Periodic review of the Trusts Medical Devices Management Policy, and any other relevant medical devices documents or media.
Medical Device Training Functions
- To support the Medical Device Trainer in the delivery of training on the safety and use of medical devices as part of the Trust training programme and as an element of improvement actions following a patient safety incident involving a medical device.
- The MDSO will be expected to deliver/support training sessions to multidisciplinary staff groups where required.
- To update training database as required.
- To contribute towards policies and write guidelines/protocols in relation to the safe use of medical devices.
- To provide cover for the lead medical devices trainer
Professional Responsibilities
- Network with medical devices teams locally and nationally and work towards the introduction of national frameworks and standards.
- Ensure circulation and response to patient safety alerts related to medical devices is made, and that the response is both timely and accurate.
- Ensure the Trust is compliant with medical devices regulations and standards
- Ensure that equipment involved in a clinical safety incident is isolated, removed from service and sent for examination.
- Investigate serious incidents providing expert input and advice in respect of use of equipment and/or equipment failure resulting in a serious incident.
- Utilise test equipment and fine tools to conduct investigations where trained and competent.
- Ensure due care and attention to biological hazards associated with equipment that has been in the clinical environment and to prevent exposure of self and others to this hazard.
- Provide insight and feedback to the MHRA and NHS England & Improvement that may contribute to national medical devices alerts
- Advise on the new equipment purchases having made an assessment of the intended purpose.
