chapter  18
18 Pages

- Hardware Risk Analysis

Issues of balancing risk and benet are familiar in the eld of drugs. Drugs are regulated for efcacy and safety in most countries, and many countries make concerted attempts to in«uence how drugs are prescribed. International organizations, such as Health Action International, continually monitor safety and efcacy with regard to drugs. Devices, however, get much less attention. It seems they are almost ignored despite their similarities to drugs: they are pervasive in medical care, they are products made and marketed by a prot-making industry, they are often taken into the body, and they are associated with demonstrable problems of efcacy and safety. In addition, they are associated with important economic effects in terms of health care expenditures and the strength of national industrial efforts.