Being an EBME Manager in the 21st Century

The past:

DB2006 (05)
This document updates and replaces previous guidelines published in DB 9801 'Medical device and equipment management for hospital and community-based organisations' (including supplement 1 'Checks and tests for newly-delivered medical devices' and supplement 2 'Guidance on the sale, transfer of ownership and disposal of used medical devices') and also DB 2000(02) 'Medical devices and equipment management: repair and maintenance provision'.

It is intended primarily for people in hospital and community based organisations (including social services) that are responsible for the management of medical devices, to help them set up systems that minimise risks associated with the use of those medical devices.

The purpose of this document is to outline a systematic approach to the purchasing, deployment, maintenance, repair and disposal of medical devices.

This guidance aims to: The main topics covered are:

It also states "Responsible organisations should appoint a director or board member with overall responsibility for medical device management. There should be clear lines of accountability throughout the organisation leading to the board. These lines of accountability should be extended, where appropriate, to include general practitioners, residential and care homes, community based services independent hospitals providing services for NHS patients, managed care providers, PFI organisations and other independent contractors. It is important to establish who is accountable, and where there is a need for joint accountability arrangements".

The board should ensure that policies address:

In the past few decades some NHS Hospitals have been involved in producing these standards, and are therefore up to date, and others have been given documentary advice through the NHS executive, National Audit Office [NAO], Medicines and Healthcare Products Regulatory Agency [MHRA] (previously the Medical Devices Agency - MDA), and asked to implement the recommendations without management training or external assistance.

Many NHS organisations have not funded the increased responsibilities thereby leaving their EBME services struggling to keep up with the latest NHS executive and Dept of Health initiatives.

This has led to some EBME services still operating with the same number of staff that they had in the 80's, but with a much larger inventory of medical equipment to manage and maintain, and increased expectations from top down. Unfortunately, many of the top executives have little or no understanding of the complexity of meeting the standards

The National Audit Office produced a report on The Management of Medical Equipment in NHS Acute Trusts in England.

See: http://www.nao.org.uk/publications/nao_reports/9899475.pdf

The report concludes that, although there are examples of good practice, overall more needs to be done by trusts to allocate clear responsibility for medical equipment at board level. Trusts need to ensure that inventory information is comprehensive and used fully in decision making. Procurement of medical equipment needs to be better co-ordinated across trusts, with more involvement of technical personnel. They can also usefully contribute to non-clinical aspects of user training. We also recommend action that should help to improve the standards of reporting of adverse safety incidents, and to reduce their occurrence.

The risks of a Hospital not investing in its EBME team are:

The actual cost of doing nothing... i.e. not investing in EBME services is higher than the investment need to have a service that meets the needs of the 21st century.

The future for EBME managers:
EBME managers will hold a senior management post, but will be expected to: An EBME manager in the 21st century is expected to be able understand and deliver:

It is a challenge for the EBME manager to keep up with their continuing professional development. It is important for senior executives to understand what the risks are of not supporting the EBME manager (in delivering professional services).

The future innovations in medical device management should be coming from proactive EBME managers, with executive support.



Compiled and Edited by John Sandham IEng MIET MIHEEM
March 2008