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Ask yourself this question: How many times have I used a non-Food and Drug Administration (FDA)-approved drug or device in the last year? If you're a corneal or retinal specialist, I'll wager that your answer is "too often!" It is unfortunate that the procedure of choice for many acute corneal perforations and repair of complicated retinal detachments includes the use of non-FDA-approved devices and that a major mode of treatment for the recent explosion of amebic keratitis infections is also not FDA approved.
Where does this leave the ophthalmologist who routinely uses these nonapproved drugs or devices?
I'm afraid that where it leaves us, in the legal sense, is uncomfortably exposed! As best as I can determine from talking with officials from the FDA and malpractice attorneys, the burden of proof is totally on the shoulders of physicians were we to get into any complications from these nonapproved drugs or
Olson RJ. How Exposed Are We? Is There a Better Way? Arch Ophthalmol. 1989;107(8):1131. doi:10.1001/archopht.1989.01070020197023
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