Suppose that, soon after buying a car, the buyer discovers that the car has a safety problem such as a faulty ignition, bad brakes, poor steering, airbags that don’t deploy, faulty wiring, or sudden acceleration. Most consumers, we hope, would bring that discovery to the attention of the dealership. When that happens, the dealership must then, by law, report the problem to the National Highway Safety Administration.
But what if instead of a car owner, we have a patient who has been implanted with a medical device. The car becomes a medical device. The car dealership becomes the patient’s doctor, and the National Highway Safety Administration becomes the Food and Drug Administration, or FDA.
One would expect that a doctor, like the car dealership, would report the FDA any problems that the doctor discovers have been caused by a medical device he or she has implanted inside a patient. Unfortunately, that is not the case. The doctor may report the problem to the FDA, but, then again, he or she may not. In fact, doctors actually have no legal duty to report to the FDA problems caused by a medical device they have used on a patient. If a doctor believes that the patient’s problem may reflect poorly on his or her surgical skills, then reporting becomes much less likely.
Adverse event reporting is the most effective way for the FDA to track problems caused by medical devices. By identifying and reporting adverse events, those reporting such events may influence labeling or alerts that impact prescribing practices and help protect the public’s health. Assessment of adverse event reports can lead to changes in how potentially dangerous drugs are used or advertised, and even lead to removal of unsafe drugs from the market. Therefore, it is important for patients to take it upon themselves to report to the FDA problems they have experienced due to a medical device, rather than relying upon their doctors to do the reporting.
Patients experiencing problems with a medical device may report adverse events online by logging on to MedWatch, the FDA’s online Safety Information program. The MedWatch Online Voluntary Reporting Form (3500) may be completed and submitted using the following link:
https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home
Adverse events may also be reported by:
Telephone: 1-800-FDA-1088.
Facsimile: 1-800 FDA-0178 (using the online fillable form and printing it out)
Mail: MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
