Up until the mid 1980s, The NHS had traditionally focussed on medical equipment maintenance (excluding procurement planning, user training, and quality records). It was during the 80s that staff in the NHS realised that there was a need for better management of maintenance, training, and procurement.
The key to all of this was quality management. In the 1990s The Medical Devices Agency produced a document entitled DB 9801 - Medical Devices and Equipment Management for Hospital and Community-Based Organisations. This document was detailed, giving descriptions of all areas that impacted on medical devices management within an organisation.
Since this document was produced, NHS Hospitals have been writing medical equipment policies that incorporate the guidance from this document. Unfortunately the majority of NHS Hospitals have not been able to implement their policies and do not maintain quality at the levels that their policies aspire to.
The risk of not managing medical equipment correctly has been recognised by the NHS litigation authority (NHSLA), and also by the care quality commission (CQC). As a result of the perceived risks both of these organisations have included audit criteria that NHS Hospitals must abide by if they are to be successful when these audits are carried out.
After being involved with the implementation of these standards across multiple organisations it has become apparent to me that the reason why the NHSLA and CQC are auditing against these criteria is because the perceived risk is real, and patients are dying and being seriously injured because many Hospitals do not successfully implement the requirements of the standards and regulations (usually stated within their policies).
In my experience, many organisations are able to produce reasonable policies by sharing knowledge with other organisations (in other words, they copy the Hospital's policies). Although sharing of documents is a good idea, this in itself does not mean the Hospital will be successful in implementing the standards. To implement the standards the Hospital must take responsibility for producing and managing processes that relates to the policy. Once these processes have been agreed, those processes must then be facilitated by the staff responsible. To enable the facilitation, it is best to set up project leads (usually at least two people for an average acute Hospital) one of these people will be at a senior management grade (medical devices manager), and the other will act as an assistant. There are key stakeholders within an organisation that need to be on the medical equipment steering group-this group will be accountable for the medical equipment policy. The medical devices manager may chair the medical equipment steering group, which will have representation from all clinical and non-clinical directorates.
Procurement is very important to ensuring standardisation, reduction in risk, and cost control (or cost savings). The training and development department are important in ensuring that users are trained and understand the risks involved with the equipment they use. The medical equipment maintenance department are important because they ensure that equipment is kept in an operational and safe condition. The Finance team should have a representative on the steering group to ensure that budgets are adjusted where necessary. This group will usually have at least one senior executive (usually the board level executive responsible for medical devices) that can direct the steering group from a corporate perspective.
DB2006 (05) Managing Medical Devices: Guidance for healthcare and social services organisations
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 medical equipment management services struggling to keep up with the latest NHS executive and Dept of Health initiatives.
This has led to some 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 the Care Quality Commission (CQC) and the National Health Service Litigation Authority. 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.
The report concludes that, although there are examples of good practice, overall more needs to be done by NHS 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. (This inventory information should include diagnostic imaging equipment, pathology equipment, and general biomedical equipment) Procurement of medical equipment needs to be better co-ordinated across Trusts, with more involvement of medical 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 actual financial cost of doing nothing... (i.e. not investing in medical equipment management) is higher than funding the positions needed to have a Hospital that meets the current standards from the CQC and the NHSLA.
Medical equipment managers will hold a senior management post, but will be expected to:
A medical equipment manager in is expected to be able understand and deliver:
Author: John Sandham IEng MIHEEM MIET November 2009