Electronics Canada Case study 2022

Electronics
Case study

1. The Company which has developed this device (Atomic Energy Canada Limited
(AECL) and CGR in this case) should be held responsible for the errors in the
medical device as the software was ineffectively tested and “patches” of the
software were used from the earlier version of the machine. Also, it was
determined that there was derisory record keeping when the software of the device
was designed/tested. The device had two noticeable software errors, a failed micro-
switch, and a reduced number of safety measures, which lead to the faults in the
medical equipment.
2. Creators of the software have overall responsibility for the device as a whole is
completely dependent on the software. Their lack of testing and careless
programming could lead to the flaws in the software and, in turn, lead to
mishappening; similar to the case which had happened with Therac -25 machines,
which involved six accidents due to overdoses of radiation to patients leading to
death (Gotterbarn, 2002).
3. The first and foremost step of the creators of the software is to focus on the
overall design, i.e., proper programming, superior testing of the individual
component of the system, and sufficient safety features. These steps are morally
required by a software creator so as to minimize the risk of failure of a device
leading to an accident. It is wise to have confidence in your product by adequately
working on the design of the software rather than pointing out foolishly that
computers always have problems with their programming after the failure of the
device (Unwrapped, 2020).
4. FDA should have a proper check of the device and approve its roll out only after
proper testing of the product. The medical devices are designed for providing better
medical treatment to the patients. Still, its benefits should not outweigh its harms,
i.e., it should not have any adverse effect on any human being exposed to its usage