How informed are doctors?
Very few doctors actually conduct outcome studies on the techniques they use. Only a small number of doctors participate in wide clinical trials or device registries that track the outcomes of implants they use such as artificial joints, vessel stents, meshes for hernias, etc. In fact, there are no national registries of any orthopaedic surgical implant used in America. Shocking? That means that when a doctor implants a total knee or a hip prosthesis, there is no national registry tracking whether or not those implants fail. There isn’t a state or local registry either. There isn’t even a company registry. The only way most doctors know if a device fails is if the patient comes back to them. If the patient moves away or is angry about their outcome, the doctor may never know.
And it is not just implants. There is no registry or required post market approval (meaning after the FDA gives its initial blessing) for drugs or braces or breathing devices or just about anything doctors place into or on patients. We rely solely on reports to the doctor and then hopefully the doctor reporting to the FDA.
We could start with a new way of approving medical devices. It would go like this: A company completes all the safety testing required and then conducts a phase I clinical trial in a small number of patients required to prove safety, not efficacy. The company is then allowed to release (sell) the product to the public with a strict web reporting program in place so that any complication, no matter how small, is reported by the patient and or the doctor, and each report is public. By crowd-sourcing the entire experience, experts from across the globe can comment on the efficacy of the device and problems can be immediately identified. With this system, companies are freed from the burden of decades of expensive studies to prove efficacy in a relatively small clinical trial, they can sell and create revenue immediately, and importantly, doctors and patients will actually know which devices work and which don’t.
Read the full article: http://www.stoneclinic.com/blog/how-informed-are-doctors?mc_cid=4135721fc7&mc_eid=0e2a202193