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FDA moves to ban medical device for the first time in 33 years

Over the last few years, a considerable number of medical devices have made headlines for all the wrong reasons. Indeed, there have been seemingly innumerable stories discussing everything from contaminated endoscopes to pacemakers susceptible to hacking.

As disconcerting as these stories are, they are perhaps not altogether surprising, as there is a natural inclination to associate surgical devices or otherwise invasive medical instruments with an elevated likelihood of danger given the nature of the procedures in which they are typically utilized and the overall vulnerability of the patient.

In a truly shocking turn of event then, the U.S. Food and Drug Administration announced just a few weeks ago that for the first time in 33 years it was enacting a total ban on a ubiquitous and non-invasive medical instrument that can likely be found not just in operating rooms, but exam rooms, nursing stations and other medical facilities across the U.S.

What is the product the FDA has moved to ban?  

The product the FDA has moved to ban is powdered gloves, including powdered patient examination gloves and powdered surgeon's gloves, as well as the absorbable powder used to lubricate gloves.

The ban will take effect January 19, 2017.

Why did the FDA take such a major step?

The FDA has indicated that powdered gloves present "an unreasonable and substantial health risk" to both patients and providers. Indeed, agency officials have attributed their use to such adverse medical events as allergic reactions, hypersensitivity reactions, severe airway inflammation and post-surgical complications.

Will the ban have a major impact on the healthcare profession?

The FDA has indicated that the ban will have only a minimal impact on the healthcare industry given the widespread availability of non-powdered alternatives that are equal in performance, protection and dexterity.

It also predicted that the mandate will serve to reduce the number adverse medical events and their associated costs, which can reach well over $31 million per year.

When is the last time the FDA took such a dramatic step?

The FDA has not instituted a medical device ban since 1983, when it banned prosthetic hair fibers. Indeed, this dearth of regulatory action is perhaps suggestive of just how serious the danger posed by this product really is.

If you or a loved one has suffered serious injuries that you believe can be attributed to a dangerous or defective device, consider speaking with a skilled legal professional to learn more about your rights and your options.

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