This service supports the effective use of a wide range of medical devices by providing professional scientific and technical support and advice.
The service focuses on the medical devices themselves, their characteristics and limitations, and on their application in a clinical environment. Objective advice on the whole life-cycle management of medical devices is provided in the light of advice from the Scottish Executive, Scottish Healthcare Supplies, the MHRA, the Department of Health and other official and private bodies.
The service investigates incidents (adverse incidents and near misses) that may involve medical devices, working with the Division’s risk management teams to help minimise the risk of recurrence. It helps plan teaching strategies for medical devices as well as developing teaching materials and providing training. It develops methods of evaluating and recording the competency of clinical staff in their use of medical devices.
Strategic medical device management advice
The service provides NHS Lothian and others with objective advice on medical device management, based on the recommendations of the Scottish Executive, Scottish Healthcare Supplies, the MHRA and other official and private bodies. This includes:
- Advice to NHS Lothian’s acute and community Divisions, senior management and various groups including Lothian’s Medical Equipment Review Group, Medical Devices Committee, Resuscitation Committee, Consumable User Group and risk management teams.
- Discussion with the MHRA, Scottish Healthcare Supplies and senior medical physicists throughout the UK on medical device use and management.
Example include developing a policy on consumables for use with infusion devices, a policy on the re-use of single-use items and a policy on the use of mobile phones in clinical areas. Further examples include actions/responses to: (i) The Accounts Commission/Audit Scotland reports on medical device management including “Equipped to care”, and (ii) The MHRA recommendations in their “Managing Medical Devices”guidance (formerly DB2006(05) and DB9801).
Objective support for a wide range of medical devices
We provide objective support to the entire Organisation for a wide range of diagnostic and therapeutic medical devices across the entire device lifecycle. This support includes:
- Understanding device characteristics and limitations and how these impact on effective clinical care.
- Developing robust equipment specifications.
- Provision of training to clinical staff (medical and nursing staff) in how to use medical devices safely, examples include:
- Development of training policies for the use of infusion devices within the Hospitals Division and the development of training materials. Advice was also sent to the MHRA to assist them in the compilation of new guidelines on standards for, training in, and the safe use of, infusion devices.
- A recent in depth study investigated the clinical evidence for or against moving to biphasic defibrillators and reviewed the evidence that exists as to the clinical efficacy of the various types of biphasic waveform. The work included a clinical evaluation using an in-house developed questionnaire.
- Reviewing the use of patient monitors, ranging from basic non-invasive blood pressure and oxygen saturation monitors to sophisticated intensive care and theatre monitors. Recent work has included an in depth study of the accuracy of electronic non‑invasive blood pressure monitor; this work has been partly supported by a grant.
Professional, scientific and technical support
We provide continual clinical engineering professional, scientific and technical support for clinicians throughout the organisation. The nature of the support varies considerably, a few examples will highlight the diverse range of work carried out:
- How to avoid burn hazards during endoscopic electrosurgery.
- Problems occurring during infusion therapy, including general safety of infusion therapy, staff training requirements, infusions not running to time, problems with start-up time delays, occlusion alarm hazards, bolus delivery (post occlusion, bolus during low flow rates and height changes on bolus delivery), extension sets, anti-siphon methods and documentation including advice on fluid charting.
- Physiological patient monitoring including strengths and weaknesses of different monitoring methods and resolving problems (e.g. investigating sources of interference [both bio-electrical and external] – and how to prevent and/or minimize). Optimal filter settings that minimize the noise whilst not distorting the signal.
- Radio frequency identification (both active and passive) and its role in supporting medical device management.
- Interface of medical devices to IT networks, computers and other eHealth systems.
- Configuration of medical devices to optimise their performance within specific clinical areas and to reduce risks.
- Critical evaluation and comparison of different technologies.
- Provision of technical support to the project team working on the design and build of the new Royal Hospital For Sick Children and Department of Clinical Neurosciences at the Royal Infirmary site.
- Support for clinicians involved in externally funded research projects.
Risk management
The service help to develop and promote the Division’s risk management strategy, with a particular focus on clinical risk and incidents involving medical devices. The service:
- Acts as a contact focus between the Division and Scottish Healthcare Supplies for incident reporting and investigation.
- Investigates adverse incidents involving medical devices.
- Develops methods of preventing incidents and reducing the likelihood of recurrence, helping to ensure that action is taken in response to safety warnings.
Operational use of medical equipment
The department supports the safe and effective operational use of medical equipment by running an equipment library on one of the Hospitals Division’s main sites. The service is actively working on plans to develop equipment libraries at the other Hospital sites.
