HISTORICAL DEVELOPMENTS OF MEDICAL DEVICES
Today, in many countries, health care expenditures are among the largest social costs, and over the past three decades they have increased quite rapidly. In 1980, Organization for Economic Cooperation and Development (OECD) countries on average spent 4.2% of their gross domestic product (GDP) on health care, and by 1984 the figure increased to almost 8% of GDP.
In 1958, sales of medical devices in the U.S. totaled less than $1 billion, and
grew to more than $17 billion in 1983.Furthermore, in 1988, the U.S. medical equipment production reached around $22 billion.It means the production of medical devices/equipment is an important sector in the U.S. industry.
The history of the reliability field may be traced back to the 1930s and 1940s, when the probability concepts were applied to electric power generation related problems and Germans applied the basic reliability concepts to improve reliability of their V1 and V2 rockets.
Ever since those days, many new developments have taken place, and the field has branched out into many specialized areas: software reliability, human reliability, mechanical reliability, power system reliability , structural
reliability, etc. Comprehensive lists of publications on almost all of the reliability areas are given in references 11 and 12.
The real beginning of the medical device reliability field may be regarded as the latter part of the 1960s. During this period, several publications on the subject Medical Device Reliability and Associated Areas appeared. An article published in 1980 listed most of the publications on the subject, and in 1983 a text on reliability devoted a chapter to medical device/equipment
reliability. Nowadays, the medical device reliability field has become an
important component of the general field.
This chapter presents some introductory aspects of the medical device reliability field.
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