The panel ended up asking for “teachability,” or proof that others could learn to use the system as safely and effectively as the applicants. It was the first time such a concept had been attached to an FDA approval, Dr. O’Malley said. The panel eventually found that it takes about 20 cases for an experienced head and neck surgeon to get to the same level as the applicants, and the FDA gave its approval in 2009.
Explore This IssueNovember 2013
—Michael Rutter, MD
Building Relationships with Patients
Michael Rutter, MD, a pediatric otolaryngologist and director of clinical research at Cincinnati Children’s Hospital Medical Center, said that not only can off-label uses mean good medicine, but they are also necessary to advance the field. “Medicine doesn’t move forward without innovation,” he said. “Innovation frequently involves the off-label use of drugs or devices.”
Among other off-label uses, Dr. Rutter introduced the use of angioplasty balloon dilators for dilation in pediatric tracheoplasty cases in 2001. They’ve used the technique 1,900 times, he said. “A lot of the surgical innovation that we’ve developed in Cincinnati arose out of the personal relationship we have between [a doctor] and a family,” he said. “Most families are willing to let you try if you have a relationship with them and they trust you.”
Not only is communication with the family important, but family dissent is essentially the only thing preventing surgeons from using devices in a different way than intended, modifying devices or using drugs in an off-label way. “There are very few checks and balances between you and your relationship with the patient and the family,” he said.