In my opinion, misusing an FDA approved medical device in a way that is known to be more risky than the clinical trials used for the FDA approval without providing any patient benefit or informed consent is Not the practice of medicine.  Knowingly exposing people to unnecessary risk of permanent injury and Not letting them make their own decision about taking uneccesary risks to save a few dollars is Not the practice of medicine. 

The FDA does Not regulate the practice of medicine, but the FDA does regulate all users and practitioners of these devices.  Not everything that a medical Doctor does is considered the practice of medicine.  Being a licensed medical Doctor does Not allow a person to break Federal or State laws.  An off-label use of a device explicitly for the potential benefit of a patient (where the benefit clearly outweighs the risk) would be considered a legitimate practice of medicine.  However, when there is no patient benefit and/or the risk outweighs any benefit, then Not following the FDA labeling does Not constitute the practice of medicine By definition.  Part of the definition of the practice of medicine is to put the patients’ best interests ahead of those of the Doctor.  Why isn't any practitioner or user of these FDA "regulated" (Class I) medical devices (whether or Not he/she happens to be a Doctor) who uses them in an unnecessarily risky way or who does Not provide informed patient consent under the FDA’s regulatory authority and jurisdiction?

Is a practice of medicine exception (which does Not appear in the laws to my knowledge) a way for the FDA to avoid having to investigate (or admit) that tax payer funds intended to ensure that regulated medical devices CAN be used safely does Not actually protect the public from unscrupulous users who wish to save time or money by using them unsafely?

The FDA knows that unsafely using an FDA approved medical device is Not the practice of medicine.  Several medical Doctors have agreed (click here) that reusing Microkeratome blades on multiple patients is outside the standard of care for the practice of medicine.

Medicine is a learned profession taught in medical schools, Not the unsafe use of a medical device that can be used safely.  If there's any doubt, the FDA can call the medical schools and ask them if the practice of medicine involves Not sterilizing devices properly and Not using them safely. 

"Medicine- 1: the branches of medical science that deal with nonsurgical techniques [syn: medical specialty] 2: (medicine) something that treats or prevents or alleviates the symptoms of disease [syn: medication, medicament, medicinal drug] 3: the learned profession that is mastered by graduate training in a medical school and that is devoted to preventing or alleviating or curing diseases and injuries; "he studied medicine at Harvard" [syn: practice of medicine]"

This information is readily available in the FDA's own Ophthalmic devices panel transcripts.  The Ophthalmic devices panel appears to think that any slight modification to how the device is used- even a change in the algorithm or the training of the users is the "practice of medicine" and Not an FDA regulated use of the device. 


So to summarize, we think that in terms of safety and efficacy that LASIK with the Emory system exceeds available alternatives. Therefore, on the basis of the data that we've presented to you today, and I would like to thank you for your attention, we request FDA approval for the Emory LASIK System. We think that safety has been demonstrated and that probable benefits to improving patients' vision outweigh the probable risk.Informed consent must include information concerning the high frequency of enhancements. The issues of simultaneous versus sequential surgery and monocular versus binocular surgery I don't think we should address, because I think the issues remain practice of medicine issues.As far as sequential versus simultaneous surgery, I believe that's a practice of medicine issue.
DR. BULLIMORE: So if somebody wanted to use a different algorithm but nonetheless use the Chiron microkeratome --
DR. ROSENTHAL: Then it's the practice of medicine that has been well set out by the Office in the October letter to all ophthalmologists.
DR. BULLIMORE: So why doesn't that constitute off-label use of the laser?
DR. BULLIMORE: Why doesn't that constitute off-label use?
DR. ROSENTHAL: That does constitute off-label use. What wouldn't constitute off-label use is using the device which has been put together by this sponsor.
DR. BULLIMORE: And using the sponsor's nomogram?
DR. ROSENTHAL: Algorithm and nomogram.
DR. BULLIMORE: And being trained and certified?
DR. ROSENTHAL: And being trained and certified.

By common law, I believe this case precedent applies to all 50 states because common law (which is not a tort) is the same everywhere.   Under common law (See Ketchup v. Howard, 2000 WL 174538, Ga. Ct. App. Nov. 29, 2000;, patients are required to receive a higher level of informed consent than they are getting, but the Emory Doctors may Not train other Doctors to understand patients rights to informed consent.  For instance, Dr. John Meyer (Emory trained) emailed me:“In all of the surgeries I have been involved with, from my time in general surgery to now, consent forms have not listed each individual problem that can occur. If mention is made of the effect of the problem, then there is informed consent. Argument of this point would best be left to the lawyers.” Patients are Not adequately provided informed consent about the risks or about known problems.  NO rational person WOULD provide informed consent to taking unnecessary  risks with their physical and mental health for life- especially given that the surgery is already highly risky (see and