ABSTRACT

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 • Products made and marketed by a prot-making industry • Often taken into the body • Associated with demonstrable problems of efcacy and safety

In addition, they are linked to important economic effects in terms of health care expenditures and the strength of national industrial efforts.