Biomedical Engineering Reference
In-Depth Information
that can provide such assurance and if, in addition, the device is life-supporting or
life-sustaining, or for the use of substantial importance for preventing impairment
of human health, or if the device presents a potential unreasonable risk of illness or
injury” [ 93 ]. Class III includes devices which are life-supporting or life-sustaining,
and devices which present a high or potentially unreasonable risk of illness or in-
jury to a patient. Class III includes complex devices like heart valve, breast implants,
implanted cerebral stimulator and cardiac pacemaker.
2.9.2 Regulation Issues
Development in the area of medical devices is rapidly changing. Over the last 25
years, medical devices have evolved from analog to digital systems. In the current
development, microprocessor, software, smart sensor and actuator are the main com-
ponents of medical systems. Most of the medical devices are based-on embedded
real-time system. The functionality of these complex systems is mainly based on
software to provide robustness, safety and effectiveness. An embedded system may
be used for special-purpose computer system to perform any particular task due
to resource limitation. The life of medical devices has decreased due to more rapid
innovation in enabling technology and demand for the more robust systems. Increas-
ing complexity of the medical systems has raised many recalls. Regulating bodies
are used to control the quality of medical devices and to provide safety in use. The
current development techniques and existing tools are not sufficient to provide as-
surance to use any medical device. Due to failure cases and constraints in exiting
approach, the regulating bodies have offered several research challenges in the area
of medical device development. The following challenges provide a framework for
thinking about the main issues of current medical regulations [ 22 , 33 , 110 ]:
A new platform and implementation technologies is required to support science-
and engineering-based design, development, and certification to analysis the qual-
ity of advanced medical devices and new emerging technologies.
Software based on medical devices must be validated according to the state of the
art taking into account the principles of development life-cycle, risk management,
validation and verification.
Simulation based closed-loop modelling is required to evaluate the medical de-
vices.
Use quantitative analysis to evaluate a risk and to identify the safety issues of
medical devices.
Preventing from a malicious malfunction of software of the medical devices, and
handling the emerging issues for information security and privacy.
To provide a protection against emerging infectious diseases and terrorism.
To use a formal methods-based design techniques to develop the medical devices.
Developing a new approach to use clinical data in evaluating medical devices.
Development of the robust, safe and sustainable medical devices with low manu-
facturing cost with increasing quality and performances.
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