EBME / Clinical engineering managers need to be working in partnership with their organisations to develop their internal model for Healthcare Technology Management (HTM). HTM is different to the traditional EBME asset management and maintenance approach. Forward thinking clinical engineering managers must recognise the need to include healthcare technology assessment, specification, and supply of equipment as part of their services provided to the healthcare organisation. Through working with stakeholders from Operations, Finance; Procurement; Nursing and Medical staff, forward thinking managers can create a strategic model for the future. Most of EBME departments still focus on the ‘current state’ – normally comprising of asset management and maintenance (as in Figure 1 below).
Managing Medical Devices: Guidance for healthcare and social services organisations (April 2015).
The purpose of this important guidance from the Medicines & Healthcare products Regulatory Agency (MHRA) is to outline a systematic approach to the acquisition, deployment, maintenance (preventive maintenance and performance assurance), repair and disposal of medical devices. It is intended primarily for people in hospital and community based organisations that are responsible for the management of reusable medical devices, to help them set up and develop systems that promote the use of the medical devices for safe and effective health care.
Medical devices play a key role in healthcare, vital for diagnosis, therapy, monitoring, rehabilitation and care. Effective management of this important resource is required to satisfy high quality patient care, clinical and financial governance, including minimising risks of adverse events. Unless medical devices are managed proactively, the same types of adverse incidents happen repeatedly. Good medical device management will greatly assist in reducing their potential for harm. Healthcare organisations should appoint a director or board member with overall responsibility for medical device management.
There should be systems in place to ensure reporting of device issues including:
• the effectiveness of the medical devices management system
• the condition and performance of medical devices including: device failures and issues; utilisation, performance, maintenance; repair and calibration history
• the execution of investment, replacement and disposal plans.
The MHRA states that:
The management structure for medical devices should have clear lines of accountability up to board level. Healthcare organisations should set out a long term approach and objectives for the management of their medical devices, including strategic replacement and development equipment procurement planning. This should include an overarching ‘medical devices management strategies document’ setting out medium to long term organisational requirements of assets taking account of cost, performance and risk across the entire equipment lifecycle. This strategic approach should also align with the responsible organisations overarching business / strategic plan. (Medicines & Healthcare products Regulatory Agency, 2015 p. 7)
As the MHRA guidance states, it is important to develop a new management model with your organisation that assesses equipment needs and enables staff to become more productive with newer technology (as in Figure 2 below):
The aim of this approach is to implement a best practice management model that will give clinicians up to date equipment, create a better environment for staff and patients, and help hospitals to deliver better services in a sustainable and cost efficient way. Delivering a healthcare technology management model is much more than an asset management and maintenance model. All stakeholders must understand and be working towards the same goal in order to succeed in delivering a sustainable HTM management model.
What will stop EBME / Clinical engineering managers delivering transformational healthcare technology management (HTM) that meets the MHRA guidance?
EBME / Clinical engineering departments are already under severe pressure due to shortfalls in financial and personnel resources. There is also a shortage of EBME / Clinical engineering managers who actually understand how to design and implement new management systems and policies.
The lack of resources / funding may stop the delivery of the ‘Advanced EBME / Clinical engineering model for Healthcare technology management’ shown in Figure 2.
Most NHS Trusts are failing to meet the MHRA guidance. They do not have the resources that enable them to meet the guidance, and until they do, the Department of Health will not be successful in deploying technology as a transformational lever to deliver higher levels of safety and productivity in the NHS.
Until NHS Trust Executives understand that the advice being given by the MHRA and other government agencies is vital to their transformational agenda’s, EBME / Clinical engineering managers will continue to be under resourced to the detriment of the NHS and ultimately their patients.
Medicines & Healthcare products Regulatory Agency. 2015. Managing Medical Devices - Guidance for healthcare and social service organisations. London : MHRA, 2015.