Medical equipment definition
For the purposes of this policy, the terms medical device and medical equipment are inter-changeable. The UK Medical Devices Regulations 2002 (UK MDR) legally defines a medical device as follows:
“medical device” means an instrument, apparatus, appliance, material or other article, whether used alone or in combination, together with any software necessary for its proper application, which
- is 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, alleviation of or compensation for an injury or handicap,
- investigation, replacement or modification of the anatomy or of a physiological process, or
- control of conception; and
- does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, even if it is assisted in its function by such means, and includes devices intended to administer a medicinal product or which incorporate as an integral part a substance which, if used separately, would be a medicinal product and which is liable to act upon the body with action ancillary to that of the device.
Differentiating between re-usable and single use devices
Medical devices can be broadly split into two main categories:
- re-usable
- single use and limited usage devices
Table 1 provides examples of medical devices in each category and details the associated organisational roles and responsibilities.
|
Description |
Re-usable medical devices/equipment |
Single use and limited use medical devices |
|---|---|---|
|
Examples |
Ventilators |
Syringes |
|
|
Infusion Devices |
Bandages |
|
|
Patient Monitoring |
Gloves |
|
|
|
Walking sticks |
|
Responsible Group |
Medical Equipment Group |
Clinical Users Group |
|
Management |
Medical Physics |
Materials Management |
Table 1
The broad definitions above cover the vast majority of medical devices. However, there are a small range of devices where organisational management responsibility lies with heads of department or specialist service provider groups.
|
Estates/Department Heads |
Theatre tables |
|---|---|
|
|
Beds |
|
|
Wheelchairs |
|
|
Transportation trolleys |
|
|
Patient hoists |
|
|
Pendants and booms |
|
Heads of Department |
Pressure mattresses |
|
Rehabilitation |
Walking aids |
Table 2
Organisational responsibility for managing medical equipment safety (Hazard) alerts and ensuring the appropriate external reporting of equipment related incidents lies with the Equipment Coordinator, regardless of category, ownership or management.
Unless otherwise stated, all references to Medical equipment in this policy relate to the re-usable items managed by Medical Physics as detailed in table 1. Items of equipment managed by other departments or specialist service provider groups are managed under separate systems of work.
