Medical Equipment

and Its Life Cycle

[1] Keith Willson, Keith Ison, Slavik Tabakov: Medical Equipment
Management, CRC Press, 2013

Prof. Huynh Quang Linh

Overall
Medical equipment management (MEM) has three essential aims:
- Ensure medical equipment in the clinical environment appropriate to
the needs of the clinical service
- MEM functions effectively and safely
- MEM represents value for money
Overview of medical equipment
management
 What Is Medical Device?
Any instrument, apparatus, appliance, software, material or other article, whether used
alone or in combination, together with any accessories, including the software intended by
its manufacturer for its proper application intended by its manufacturer to be used
specifically for diagnostic and/or therapeutic purposes and necessary for its proper
application, intended by the manufacturer to be used for human beings for the purpose of
• Diagnosis, prevention, monitoring, treatment or alleviation of disease,
• Diagnosis, monitoring, treatment or alleviation of or compensation for an injury or
handicap,
• Investigation, replacement or modification of the anatomy or of a physiological process,
• Control of conception,
and which does not achieve its principal intended action in or on the human body by
pharmacological, immunological or metabolic means, but which may be assisted in its
function by such means.
What Is Medical Device?
Medical equipment life cycle
Equipment Management Processes
Establishing Need
A replacement request often comes from end users who think
equipment is outdated or unreliable or may come from a manufacturer
or clinical engineer facing difficulties in supporting older equipment.
Devices entirely new to the organisation might be needed to set up a
new clinical service or to carry out research. These are usually
requested by clinicians but need support from senior management
where they are part of a strategic clinical initiative. Under leasing or
managed equipment arrangements, equipment renewal is assessed at
agreed intervals.
Funding
Funding for low-cost medical equipment usually comes from a
departmental or service budget. Medium-cost items may require
allocation of funds from the organisation, and very large items often
require funding to be raised externally. Sources of funding include the
following:
- Revenue
- Capital
- Government or other initiatives
- Charitable donations
- Research grants
- Leasing
Specification
A technical specification should be developed for replacement as well
as new equipment, since there may have been a change in factors such
as the functionality of devices, user demands, the type of accessories
and consumable design and cost.
Standardisation is desirable for a number of reasons, including
improvements in safety from user familiarity.
Tendering, Evaluation and
Purchase
Tendering of some kind will be required by any organisation looking for
value for money, and each organisation will have its own procurement
requirements that also incorporate its legal responsibilities.
Evaluation: Technical and clinical.
Once all the information has been obtained, tenders are reviewed
technically to ensure they include financial factors such as purchase,
servicing and lifetime costs and are considered against the outcome of
the technical and clinical evaluations.
Preparatory Work
Preparatory work can be a major part of a large equipping project with
numerous requirements, particularly for imaging or radiotherapy
equipment. Relevant questions include the following: Does the device
fit into the space? Are floor loadings acceptable? Is a controlled zone
around the equipment necessary, as for radiation or magnetic
resonance imaging systems? How can we provide ancillary elements
such as air conditioning and patient access and any special features
such as radiation shielding and water treatment for dialysis? A project
team will be essential to coordinate efforts by estates, contractors, end
users, medical physics, clinical engineering and manufacturers, with
detailed plans put in place well in advance.
Delivery, Installation,
Acceptance and Commissioning
- The delivery process requires active liaison between suppliers, end users and
clinical engineering services.
- Storage: this must be in an environment within acceptable conditions
- Building good relationships with the installation engineer on site will facilitate
the process, especially if the local scientific and technical staff is involved in
acceptance testing and subsequent equipment maintenance and calibration.
- Acceptance and Commissioning: equipment commissioning takes place when
the end user, clinical engineer, or other party acting on behalf of the
receiving organisation tests all functions in the user manual and any
accessories before releasing equipment for clinical use.
- Payment should only be made when the organisation is satisfied that there
has been a satisfactory conclusion of acceptance and commissioning.
User Training
Poor training or even its complete absence is a major source of medical
device risk and accounts for a substantial proportion of device-related
incidents. Users fall into three main groups:
- Non-specialists
- Specialists
- Technical support staff
Training is a necessary part of best practice. It can be provided by the
manufacturer, third-party organisations or in-house trainers.
Deployment
User instructions must go out with new equipment or be easily
available electronically, and operating procedures such as regular daily
checks and arrangements for consumables should be set up and tested
in advance.
Asset Management and
Depreciation
Records of equipment are required for two purposes: corporate
governance, to cover financial and liability issues, and the practical
management of devices in use for location tracking, maintenance
scheduling and product recall.
Comprehensive equipment management database is an excellent tool
for operating an in-house equipment management service.
Management in Use
Storage
Appropriate space and conditions are needed to store both equipment
and consumables. These should be planned for and justified on a risk
management basis.
Decontamination: Cleaning,
Disinfection and Sterilisation
- Cleaning is the removal of dirt and other obvious physical
contaminants like blood and saline from surfaces, and its standard is
judged by appearance.
- Disinfection is the destruction of contaminating organisms such as
bacteria by chemical means.
- Sterilisation is the aggressive destruction of all organisms by
processes such as exposure to steam at elevated temperature
(autoclaving), immersion in noxious gases or exposure to ionising
radiation.
User Maintenance, Spares and
Consumables
Maintenace: Users should be trained in the proper upkeep of their
equipment or delegate it to a local technician or in-house department.
An adequate stock of parts and consumables for user maintenance
should be provided, together with the means to keep stocks updated.
Spares associated with routine maintenance and breakdown repairs
need to be managed in a similar way, although the large number of
possible items means that it is financially and logistically possible to
maintain only the most common or essential of these as stock items.
Expert advice and analysis can help when selecting spares and finding
suitable alternative items.
Planned Preventative
Maintenance and Breakdown
Maintenance
Managing routine maintenance and breakdown repair of medical
equipment is a major undertaking. Every year it typically costs between
5% and 10% of the purchase cost of equipment.
Maintenance is essential to minimise the risk of failure, improve safety,
maximise equipment capability and minimise unplanned downtime.
 Quality Control and
Performance Testing
Regular performance measurement with specialised test equipment may
reveal developing problems or equipment out of adjustment. This is
particularly true for imaging equipment, where image quality is subject to
informal clinical monitoring and frequent quality checks, and more generally
for basic items where visual and inbuilt system checks can pick up developing
or actual faults.
Entry of equipment details onto a medical equipment database is of particular
value. In addition to routine quality testing, records covering frequency of
breakdown, maintenance and training resource costs, consumables
consumption and effective life then support analysis and calculation of costs,
downtime and other relevant performance measures. Clinical engineering is
then in a position to advise when best to replace equipment, identify any
need for further user training and suggest changes to maintenance and
management arrangements, through use of an available evidence base.
Condemning and Disposal
Equipment judged to be beyond its useful working life in a particular
application should be reviewed for condemning or redeployment. Good
financial governance requires that the decision to condemn or dispose
of equipment is made by properly qualified staff, in a transparent way,
with appropriate records kept.
Disposal can be by scrapping, by sale or by donation for reuse after
refurbishment.
What Is Clinical Engineering
Clinical engineering is a professional activity centred on the design,
development, support and management of medical devices. Related
areas of interest include biomechanics, biomaterials and mathematical
modelling of physiological systems, and these are considered by some
groups to fall under a wider definition of medical engineering.
In the broadest sense, a clinical engineer is concerned with application
of the physical sciences to medicine, through engineering.