Shared learning database

Royal Liverpool and Broadgreen University Hospital Trust
Published date:
January 2013

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.

Guidance the shared learning relates to:
Does the example relate to a general implementation of all NICE guidance?
Does the example relate to a specific implementation of a specific piece of NICE guidance?


Aims and objectives

"New medical technologies can bring many benefits to patients, carers and clinicians. They can improve the quality of life of patients through more efficient and effective treatments; enable patients to remain in their homes rather than being admitted to hospitals or care homes; make remote diagnosis and treatment possible; reduce treatment times; and enable clinicians to treat more patients more effectively."1

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

Prior to the introduction of the group devices and techniques were implemented within the Trust without full review of safety, efficiency, and cost implications and staff training/knowledge. It was felt that this lack of overarching assessment meant that there was a potential risk to patients, staff and the Trust. Originally the group consisted of two separate groups the new technique and device group and the medical device group; these two groups were merged to ensure there was oversight from the introduction of the technique/device to the embedding within the Trust and the outcome of its use.

How did you implement the project

A group of the relevant leads was established inc. a medically qualified chair, Risk Management, Finance, Medical Engineering, Supplies, Nursing and therapies, Interventional Radiologist, R&D, Ethics, Medical devices training, Decontamination, Health & Safety, Medicine Management and Infection Control. The terms of reference were established to formalise the remit of the group, followed by the Introducing a new technique or medical device policy and the review of the management and decontamination policy. A formal application process was implemented, the application form requires:
- 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.

Key findings

The system ensures that proper governance is followed for the introduction of all new techniques and medical devices; it ensures patients, staff and the trust are protected. It provides proper evaluation of all new techniques and medical devices including cost effectiveness. It ensures there is a programme of audit attached to devices/techniques to ensure outcomes are as expected and where not remedial process put in place. It gives support to those who wish to introduce new ways of working but are not aware of the proper channels to follow.

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

Ensure all the relevant people are included from the onset originally we did not have a member of the decontamination department; however they are vital in ensuring that devices can be decontaminated correctly. Similarly, last year the library manager was invited to join the group. She now undertakes validation of literature reviews and undertakes an independent review to ensure a comprehensive literature analysis is available to add the group's decision making process. Strong links with the supplies team can identify when goods have been ordered that are new to the trust and can therefore point people in the direction of the group if they are aware of its existence.

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.

Contact details

Sarah Byrne
Effectiveness Lead
Royal Liverpool and Broadgreen University Hospital Trust

Secondary care
Is the example industry-sponsored in any way?