Biomedical Engineering Reference
In-Depth Information
5.2
Chapter 5.2
Medical device design
and control in the hospital
Joel R. Canlas, Jay W. Hall, and Pam Shuck-Holmes
Clinical engineers (CEs) in the hospital setting use
modern technical, scientific, engineering, and manage-
ment training. Specialization, knowledge, and experience
of CEs serve humankind by contributing significantly to
the provision of safe and effective medical technology.
This view is in harmony with the American College of
Clinical Engineering (ACCE) definition of a CE as ''a
professional who supports and advances patient care by
applying engineering and managerial skills to health care
technology'' (Bauld, 1991). In this chapter, the authors,
reflecting on over 40 years of collective experience as CEs
in a hospital setting, describe their role in designing,
manufacturing, evaluating, and controlling medical de-
vices to ensure their safe and effective application in
health care.
The extent to which a CE is able to perform a re-
sponsible function in the hospital setting depends to
a large degree on the acceptance and understanding of
their roles and capabilities by the hospital administration
and staff. Without the full support of the hospital, from
the lowest to the highest levels, CEs cannot function to
the best of their abilities. Thus, when empowered, CEs
not only follow a course of action specified in good clin-
ical engineering practice guidelines but also go beyond
the call of duty. The CEs clients (i.e., doctors, nurses,
respiratory therapists, imaging specialists, other hospital
staff, patients and their families, health maintenance
organizations [HMOs], and preferred provider organi-
zations [PPOs]), are usually well informed about medical
technologies, which is a result in part, of the Internet and
the accessibility of up-to-date information that once lay
only in the books and journals stored in the deep recesses
of libraries.
As CEs, the authors have striven, consciously and
subconsciously, to change the staff's perception of CEs as
simply repairmen armed with a cell phone and three
pagers dangling from their belts. At William Beaumont
Hospital, CEs have focused on a systems approach to
medical technology management. For example, hospital
beds are not treated as simply a support surface for pa-
tients. The CE considers a hospital bed from the per-
spective of mechanical design, safety features, operating
mechanisms, interfaces with the patient, intelligent
nurse-call and alarm systems, and electrical power re-
quirements. The CE analyzes the risks that the bed or its
accessories pose to a patient, a nurse, or other equip-
ment. Similarly, a robotic system includes the control
device, all of the system components, the maintainers,
the users, the storage environment, the physical-facility
requirements, the specialized test equipment, and the
training requirements. If all devices and systems were so
perfect as to be predictable with no possibility of causing
injury to the patient and user, then the need for CEs
would diminish. As this is not the case, the CE must
identify and utilize available resources, examples of
which include the purchasing department, which can
provide financial analyses and assess the manufacturers'
financial health, test equipment, education and training
in the scientific and engineering method, the manufac-
turers' engineers and technical staff, the Internet, and
device-user experiences.
As in the health care industry at large, in the hospital
there are reactive and proactive elements in managing
medical technology. The proactive, or preventive, com-
ponent in medicine staves off the possibilities that can
cause disease in a patient; e.g., preventing obesity can
prevent the various diseases known to be associated with it
such as diabetes. The reactive, or treatment, component
addresses the patient who is already afflictedwith a disease
and the means for making them well again. This similar
approach works well with the hospital's overall goal of
providing world-class customer service.
