HISTORY I

Mid 1960s-1970s

Clinical engineering’s great impetus for growth occurred in the 1970s. This came about as follows.

Equipment Problems

During the mid-1960s the medical device industry as a whole did not yet have adequate performance or safety standards. Equipment designers were not fully familiar with the require­ments of the hospital environment. Equipment design defects included inadequate energy from defibrillators, ungrounded equipment chassis, and alarms that could be falsely triggered. Quality control was also poor as evidenced by physiological monitors that were grossly out of calibration and equipment
that was cracked, broken, or missing components. New medi­cal equipment that was purchased and delivered in suppos­edly ready-to-use condition was found to have incidence of de­fects ranging from 25% to 50% (9).

At this time the dangers of microshock and leakage cur­rent were starting to be recognized and discussed. Of special concern was the medical equipment used for coronary care and the procedures used to maintain this equipment.

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