It is vital that the inauguration of any new technique or medical device takes into consideration not only costs, implication and benefits but also ensures any risks to patients, staff and the Trust are minimised.
The Royal Liverpool and Broadgreen University Hospital Trust (RLBUHT) established the Techniques and Medical Devices group (T&MDg) to formally assess any new technique/medical device and ensure governance arrangements are in place for its introduction.
Aims and objectives
The November 2003 Health Service Circular The Interventional Procedures Programme (Appendix 4) "medical practitioners planning to undertake new interventional procedures should seek approval from their NHS Trust's Clinical Governance Committee before doing so."2 The Techniques and Medical Devices group was established to fulfil this remit.
The aim of the group is to ensure there is a formal but objective process for the introduction and monitoring of all new techniques and medical devices, whilst minimising risks to patients, staff and the Trust and ensuring the true costs, implications and benefits are considered. The group's roll is:-
- To ensure that prior to the introduction and for the life of a new technique or device that training is provided, undertaken and monitored for staff.
- To consider guidance from the National Institute of Clinical Excellence (NICE), National Patient Safety Agenda (NPSA), Medicines and Healthcare Products Regulatory Agency (MHRA) and the National Health Service Litigation Authority (NHSLA) in respect of physical interventions, ensures compliance with relevant standards and health and safety legislation.
- To ensure that technique and medical device issues are reported and dealt with in a timely manner.
- To ensure that the use of any technique or device is audited in an appropriate manner. References:
1 Health Service Circular HSC 2003/011 November 2003: The Interventional Procedures Programme, Working with the National Institute for Clinical Excellence to promote safe clinical innovation.
2 The Use of New Medical Technologies within the NHS, Fifth Report of Session 2004?05 Volume I, House of Commons Health Committee)
Reasons for implementing your project
How did you implement the project
- Detail about the device including advantages and disadvantages
- Current evidence in regards to the technique/device inc. research papers
- Details of any incidents or safety alerts
- A patient information leaflet inc. the risks (with percentages or likelihood of risks occurring) benefits, alternatives and effects of no treatment.
- CE mark/product license
- Details of training
- A declaration of interest
- Applicant must review if there is currently NICE Intervention Procedure Guidance (IPG) for the technique/device and if so provide details and ensure that introduction of it will be as per NICE guidance. A copy of the 'NICE Suggest a topic form' should be completed and submitted to NICE for any that does not have a IPG; the form is available in the Introducing a Technique and Medical device policy. All applications must be signed off by the relevant directorate accountant, and capital costs, impact on revenue costs and a summary of financial impact should be included. The applicant is invited to the TaMDg meeting to give a short presentation on the technique/device. Consideration is given to training needs, the current evidence base and cost implication. Further questions may be asked, the group will discuss the application in private and a decision made. All accepted applications will be given a time period for which they must return to the TaMDg to provide an overview of the current outcomes, some may be requested to do a full clinical audit and where this is the case liaison with the Effectiveness team is carried out to ensure they added to the clinical audit programmes. The main issue with the introduction of the group was staff awareness, therefore posters were distributed across the Trust, the group advertised in the Trust In-Touch e mail bulletin, and the chair did a presentation at the Grand Round and divisional governance meetings.
During 2008/09 6 applications were submitted to the group this has increased with the number remaining as follows 2009/10 - 20, 2010/11 - 21, 2011/12 - 17 2012/13 - 21 to date.
During 2011/2012 41 applicants provided an update on the implementation of their device/technique to complete the loop of introduction and outcome. A highlight of 12/13 was the introduction of the Divinci robot which has demonstrated a significant reduction in length of stay accompanied by good clinical outcomes.
The next step is to introduce a risk matrix for new devices/techniques which will allow directorates to assess their application prior to submission to group. Those identified as a green risk can be discussed within the directorates for agreement rather than going through the approval process, Amber should gain advice from TaMDg and Red would require a full application and discussion by the group.
Key learning points
Have a programme of staff awareness sessions to ensure all know about who and how to submit applications include grand round or the equivalent to ensure that the junior doctors are aware, use your staff magazines and intranet site to advertise the group and the application process. Develop a database or other form of tracking application forms to not only provide governance reports but also demonstrate the impact that the group and its processes are having within the Trust. Embed audit into the directorate audit programmes to ensure there is governance oversight by involving the audit department.
Try to make it a one step process, ensure your policy is a clear and concise as it can be so that applications are completed accurately to prevent them having to be returned for further information as this demotivates the applicant. Don't over complicate the process. If applications are refused ensure constructive feedback is provided so applicants can amend their applications and resubmit with confidence.