Regulatory Challenges in Biomaterials: Focus on Medical Devices - Biomaterials Science: An Integrated Clinical and Engineering Approach - page 256

FIGuRE 10.6
Lateral view of the neck. An endotracheal tube (white arrow) lies directly anterior to a nasogas-
tric tube (black arrow). Note also the dental fillings and overlying connecting wires. A neuro-
stimulator device is present in the posterior aspect of the upper cervical spinal canal. (Courtesy
of Hunter, T.)
the presence of such a pump on portable “chest films.” It is not uncommon to
see partially radiolucent ECG leads that simulate lung nodules.
In 1986, Wheeler and Scott pointed out the lack of standardization and con-
sistency in medical device radiologic visibility. This remains an important
issue today. Hopefully, the radiologic community, along with other physicians
and health care workers, will be able to persuade the CDRH to formulate rea-
sonable guidelines for the radiologic appearance of medical devices [62-68].
Nanotechnology
Nanotechnology could be defined as a group of enabling technologies capa-
ble of developing structures, systems, and devices in the range scale between
1 and 100 nm. In order to have an idea of this scale, the diameter of a hair is
about 80,000 nm and the size of red blood cell is in the order of 7,000 nm. For a
broader definition of nanotechnology, refer to the National Nanotechnology
Initiative website [69].
Although nanotechnology has been around for many years, it was not
until recently that governments and the industry have started to realize
the great potential of small technologies for biomedical sciences, food, and
cosmetics. In the United States, the National Nanotechnology Initiative
(NNI) was launched in 2000. Currently, many federal agencies, private
research and development centers, and universities are including nano-
technology in their agendas. Nanotechnology is a growing market repre-
senting now almost 1,300 products already being commercialized [80]. The