The past
- In the 1950’s there were no Electronic and Biomedical engineering departments (EBME) in the National Health Service (NHS).
- In the 1960’s, the Department of Health and Social Security published Hospital Technical Memorandum number 8 called “safety code for electro-medical apparatus”. The purpose of the document was to establish adequate standards for the design and construction of electro-medical apparatus since no other relevant national standard existed at the time.
- By the 70’s some NHS hospitals had started thinking about maintenance and management of medical equipment. The NHS produced guidance in 1977 that was not implemented in the NHS but did raise the profile of medical engineering. In 1979, HTM 8 was superseded by the British Standard BS 5724 part 1. This document is a comprehensive specification for safety of medical electrical equipment.
- In the 80’s the DHSS issued HEI 95 entitled “Code of practice for acceptance testing of medical electrical equipment”. BS 5724 part 1 was also revised, making it identical to the International Electro-technical Commission standard IEC 601-1: 1988. The standard was subsequently re-numbered as IEC 60601-1.
- In the 90’sThe HEI 95 document was officially withdrawn on the publication by the Medical Devices Agency of MDA DB9801 – Medical device and equipment management for hospital and community based organisations. This document described a more strategic management approach to delivering EBME services.
- In November 2006, the MHRA published Device Bulletin DB2006(05) – “Managing Medical Devices – Guidance for healthcare and social services organisations“.
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:
This guidance aims to:
provide balanced information for groups developing local policy
identify relevant legislation
address the strategies for ownership and use of medical devices
help healthcare organisations meet the Healthcare Commission’s core standards for the safe use of medical devices
identify sources of additional guidance.
The main topics covered are:
monitoring/audit
reporting adverse incidents
acquiring the most appropriate device
acceptance procedures for newly delivered devices
maintenance and repair
training
adequacy of manufacturer instructions
prescribing the best device
decontamination
decommissioning
disposal
transfer of ownership
legal liabilities
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:
decontamination
equipment life cycle
procurement
records
adverse incident reporting
actions required on MHRA’s Medical Device Alerts and manufacturers’ corrective notices
training
technical specifications
regulatory compliance and related issues
rationalisation to single models, where possible
risk management
equipment inventory
manufacturer’s instructions
disposal.
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: https://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:
Patients may die
Longer bed stays / bed management problems
Higher costs for capital purchase
Higher costs for revenue purchases
Higher costs for externally contracted maintenance
Higher legal fees
Higher NHSLA (CNST) costs
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:
Keep up with the latest innovations
Advise on all aspects of medical devices management in line with National Audit office and MHRA recommendations.
Understand clinical interactions between device users, and patients.
Manage larger multi disciplinary teams
Advise Trust executives / attend boardroom meetings.
Liaise with other senior managers in procurement, governance, finance, infection control, etc.
An EBME manager in the 21st century is expected to be able understand and deliver:
Planned equipment replacement programmes
Tender advice to head of procurement
MHRA liaison (Incident investigation)
Advising medical and nursing directors on serious untoward incidents (SUI’s)
NHSLA advice for medical devices governance
Policy production
Evaluating devices
https://www.biomed.exalogics.com/arts/mdeval/
Commissioning devices
https://www.biomed.exalogics.com/arts/accept/
Planned maintenance
https://www.biomed.exalogics.com/arts/planmain/index.htm
https://www.biomed.exalogics.com/arts/rcm/index.htm
Remedial Maintenance
https://www.biomed.exalogics.com/arts/links/index.php?CID=5
User training
Technical training
Database reporting and management
Income generation through service level agreements with other Hospitals.
https://www.biomed.exalogics.com/arts/sla/index.htm
Service contract assessment and control
https://www.biomed.exalogics.com/arts/contract/
Cost saving improvements
https://www.biomed.exalogics.com/arts/money/index.htm
Equipment library set up and management
https://www.biomed.exalogics.com/arts/library/index.htm
Gas safety
https://www.biomed.exalogics.com/arts/links/index.php?CID=6
Electrical safety
https://www.biomed.exalogics.com/arts/links/index.php?CID=4
Technician training
https://www.biomed.exalogics.com/arts/links/index.php?CID=2
Manufacturers and in-house training
Disposal
WEE regulations
Quality management systems
https://www.biomed.exalogics.com/arts/managem/
https://www.biomed.exalogics.com/arts/links/index.php?CID=7
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.