FDA “Safe Use” Initiative Under Fire




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Are FDA safety initiatives always sufficient?

According to Somnia’s own Clifford Gevirtz, MD, the answer is an easy ‘NO’.

According to the FDA website, “The goal of the Safe Use Initiative is to reduce preventable harm by identifying specific, preventable medication risks…”

A Bronx-based anesthesiologist, Dr. Clifford Gevirtz, unwaveringly called-out the FDA, claiming that this initiative “has been turned on its head.” Using epidural steroid administrations (ESA) as his prime example, he noted that particulate steroids used in ESA are “inherently unsafe” and, according to the Safe Use Initiative, 1 in 5000 cases result in an embolism. Considering the frequency of this procedure, Dr. Gevirtz emphasizes the severity of these numbers. However, the Safe Use Initiative did nothing to encourage change, though there are comparable methods such as using dexamethasone that are just as effective.

This critique by Dr. Gevirtz is a leading example of a doctor going outside of the O.R. to ensure that patient’s safety remains paramount amongst the profession’s regulatory bodies, clinicians and practitioners. Actions like this are necessary for the growth of anesthesiology and the continuation of maximum patient safety nationwide.

“At Somnia, we take pride in bringing in the most passionate and committed clinicians to our team,” said Dr. Robert C. Goldstein, Executive VP and Chief Medical Officer of Somnia Anesthesia. “Patient safety is our top priority. When our doctors like Dr. Gevirtz take those extra steps towards broadening their role in anesthesia and enhancing patient safety, we are elated and supportive.”

To read the entire article by Dr. Gevirtz in Anesthesiology News, click here.

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