By Law
The minute one claims to be an engineer, one is bound by fiduciary responsibility for the safety of the public. Webster’s Dictionary defines fiduciary as “a person who stands in a special relation of trust, confidence, or responsibility in his/her obligation for public safety.”
By Education
In any bona fide engineering school, core courses such as statics, dynamics, thermodynamics, mechanics of materials, physics and mathematics (calculus) prepare one to better understand the cause and effect relations of most problems and incidents. Engineers are known for their problem solving abilities. Most CEs hold undergraduate degrees in the calculus-based engineering discipline such as electrical engineering, mechanical engineering, or computer engineering, and a graduate degree in biomedical/clinical engineering. Some also hold a doctoral degrees. In addition, many CEs are certified as certified clinical engineers (CCE).
By Experience
Over the past 30 years, CEs have participated in prospective approaches to ensure patient safety vis-à-vis technology assessment (T/A) projects. They have developed and published consensus standards (as members of AAMI) for almost all critical medical devices and systems, and many are now ANSI standards. Some CEs work as company consultants or collaborate with companies to conduct alpha or beta site testing of medical devices. Some spend enough on devices from one manufacturer to cultivate the influence to provide feedback and/or participate in the design of fault-tolerant medical devices and systems. These activities are possible only if the CEs are also involved in retrospective assessments to ensure patient safety vis-à-vis incident investigations and since 1991 because of the Safe Medical Devices Act of 1990, CEs have been reporting all medical device vulnerabilities to the manufacturer and/or a central database (FDA MAUDE). The knowledge gained from reading investigations of incidents that occurred elsewhere allows CEs to plug back into the prospective risk-assessment process.