Statistics: Keeping pace with the medical technology revolution

A medical device is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar related article that is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease, or is intended to affect the structure of any part of the body (Food, Drug, and Cosmetic Act 1997, Section 201). That is, a device is any medical item for use in humans that is not a drug nor a biological product. A far from exhaustive list includes MRI machine, breast implants, surgical instruments, artificial hips, pacemakers, hearing aids, multiple dose inhalers, contact lenses, etc. Cardiology, in particular, has made substantial progress in patient care through the use of such devices as prosthetic heart valves, ventricular assist devices, and most notably, coronary-artery stents. Stents are small metallic scaffolds used to enlarge segments of coronary arteries that have narrowed because of plaque. (January 2003)