Article Preview
TopMedical Devices
Medical devices are defined in EU legislation as: “any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software 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, 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” (EC, 1993). Medical devices also include in vitro medical devices which are defined as “any device which is a reagent, reagent product, kit, instrument, equipment or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of samples derived from the human body with a view to providing information on the physiological state, state of health or disease, or congenital abnormality thereof” (EC, 1998).
Some familiar examples are anaesthetic machines, CT scanner, dental instruments, dressings, endoscopes, examination gloves, intravenous administration sets and pumps, pacemakers, artificial hearts, surgical instruments, syringes and needles, ultrasound imaging equipment, urinary catheters, defibrillators, patient monitors, blood glucose measuring devices, cholesterol test kits, pregnancy test kits, adjustable beds, patient transfer equipment, hearing aids, prescribable footwear, walking aids, wheelchairs, contact lenses, cholesterol test kits, pregnancy test kits, and thermometers. Indeed, the number of different medical devices presently in clinical use runs into thousands. There is a range of complexity and in general the higher the complexity of the device and the higher the number of user options the steeper the learning curve.