Currently the American Hospital Association (AHA) has approximately 5000 institutional, 600 associate, and 40,000 personal members. 19 The institutional members include hospitals, headquarters of the health care Introduction 3 systems, hospital-affiliated educational programs, etc. The associate members include commercial companies, suppliers, and consultants. The personal members include individuals working in the health care field, health care executive assistants, and students.
In 1997, there were 10,420 registered manufacturers involved in the manufacture of medical devices in the U.S.
In 1974, the total assets of the AHA-registered hospitals were valued at around $52 billion.
A study conducted around the middle of 1990s discovered that 93% of medical devices in the U.S. had markets worth below $150 million.
During the early 1980s, the U.S. exported more than $2 billion worth of medical devices annually.
In 1969, the U.S. Department of Health, Education, and Welfare special committee reported that over ten years, 10,000 injuries were associated with medical devices and 731 resulted in death.
In 1988, the world medical equipment(cheap medical equipment) production was valued at $36.1 billion,and in 1997, the world market for medical devices was estimated to be about $120 billion.
Faulty instrumentation accounts for 1200 deaths per year in the U.S. ? More than 50% of all technical medical equipment problems are due to operator errors.
The top ten orthopedic companies in the U.S. increased their regulatory affairs staff by 39% during the early years of the 1990s.
In 1990, a study conducted by the FDA reported that approximately 44% of the quality-related problems that led to the voluntary recall of medical devices from October 1983 to September 1989 were due to deficiencies/ errors that could have been prevented through effective design controls.
Emergency Care Research Institute (ECRI) tested a sample of 15,000 various hospital products and found that 4% to 6% of them were sufficiently dangerous to warrant immediate correction.
In 1990, the U.S. Congress passed the Safe Medical Device Act (SMDA), which helped strengthen the FDA to implement the Preproduction Quality Assurance Program. This program encourages and requires manufacturers of medical devices to address deficiencies in product design that contribute to malfunctions.