1 For the purpose of this Report LDUs are taken to mean ward or operating theatre or clinic or general medical or dental practice based facilities where only instruments from within that clinical department are decontaminated before use. The items of equipment employed are usually bench top sterilisers or washer disinfectors.
2 A medical device is any instrument, apparatus, appliance, material or other article whether used alone or in combination, intended by the manufacturer to be used for human beings for the purpose of: control of conception; 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 physiological process.