Respond to this dicussion post below in a positive manner in 5
-7 sentences
While antibiotic resistance is an evolving scientific concept, a
lack of understanding doesn’t excuse a medical device manufacturer
from developing a proper risk prevention and mitigation system.
Even though all three manufacturers met the sanitization
requirements for reprocessed units, they also failed to develop a
strong surveillance system to ensure that the sanitization was
effective. Reprocessing is inherently riskier than using a brand
new piece of equipment, and so the additional risks must be
identified and addressed in order to maintain patient safety. I
don’t think design controls necessarily caused this issue on the
manufacturer’s part, as presumably the devices are produced in a
controlled manner. I think it’s more of a potential device design
failure, with poor designs being harder to clean and contributing
to contamination. However, the FDA is responsible for establishing
and mandating device design controls to ensure safety and efficacy,
so the endoscope issue can ultimately be seen as a failure on the
FDA’s part as well.
Respond to this dicussion post below in a positive manner in 5 -7 sentences While antibiotic resistance is an evolving s
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