Risk Management
The clinical engineering responsibilities for risk management can be categorized as quality-related or litigation-related. Documentation of all repairs and preventive maintenance as well as monitoring the scheduling and completion of these tasks are important roles in clinical engineering risk management. Clinical engineers are responsible for Food and Drug Administration (FDA) requirements relating to the SMDA. The clinical engineer may act as the chief investigator for medical device incidents that cause death, serious injury, or risk thereof, or he may coordinate investigation activities in accordance with SMDA requirements. Clinical engineers also may serve as expert witnesses in litigation involving medical device incidents.
Department Management—Vision and Growth
At the department level, activities are task-oriented. It is important that clinical engineers, as members of the management team, ensure that the focus of all activities reflect the larger picture of the mission and vision statements of the organization. All activities should be accomplished in an environment that fosters the core values of the system. Technology forecasting and an assessment of current and future needs are integral parts of department management. All successful department managers develop a department mission statement that correlates with the organization’s mission and vision statements. An example of proactive technology forecasting and department vision is the role played by clinical engineers who are already anticipating the service opportunities provided by the Internet and telemedicine. The primary role of the clinical engineer in departmental management is providing documentation for regulatory agencies and supervision of personnel. Although management styles vary according to personality and training, all successful CE management will have the qualities of consistency, respect, and ethics. Management of technical personnel requires an approach that differs from that of management of nontechnical personnel. Young, newly graduated clinical engineers will require closer supervision than will seasoned clinical engineers. In general, technical personnel should be allowed some independence in performing their tasks.