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Food and Drug Administration blamed for ongoing scope use

Despite safeguards that are supposed to prevent defective medical devices and pharmaceutical drugs from ever reaching the general public, dangerous products continue to sneak through quality control. It is not unreasonable to expect the Food and Drug Administration to act in a timely manner once these dangers are discovered, yet it is, apparently, not adhering to its responsibility to Ohio consumers. Inaction by the FDA has reportedly resulted in patients being repeatedly exposed to dangerous bacteria.

The FDA first became aware of a defective scope back in 2012. At the time, it was discovered that the scope’s design was effectively flawed and that it could not be fully sanitized. Keeping tools and other equipment clean and free of harmful bacteria is essential to patient safety, and, yet, the FDA did not take immediate action despite numerous patient deaths. The manufacturer of the scope — Olympus — did not recall the product until early 2016.

Many hospitals and other institutions are still using the recalled scope even though its defective design can harbor dangerous bacteria. The FDA has reported at least eight recent infections and two patient deaths on top of previously recorded outbreaks linked to the scope. In a 2013 outbreak, nearly 40 people were infected, 18 of whom died. Most of the early outbreaks received meager attention from the FDA, as the administration failed to note model numbers and did not disclose exactly where the outbreaks were occurring.

Ohio hospitals are required to obtain informed consent from patients, which simply means that a patient must be informed of all risks before he or she can be asked to agree to a procedure, but many doctors were never told of the recall and, therefore, could not supply their patients with the necessary information. The continued use of dangerous and defective devices is perhaps caused in part by the lack of action from the Food and Drug Administration. Patients who have been wrongfully harmed by a defective design do not have to suffer in silence, and they can indeed achieve just compensation for their injuries by successfully navigating product liability claims to completion.

Source: The New York Post, “The feds dawdle while patients die needlessly“, Betsy McCaughey, April 6, 2016

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