Should Device Makers Provide Free Training to Doctors
The New York Times investigates the rising number of doctors performing defibrillator implantations. Implantable Cardioverter Defibrillators (ICDs) used to be implanted by specialists. Since last year however, more generous reimbursement from the government has increased demand and more physicians are answering it, with widely different levels of training and experience. Two years ago the Heart Rhythm Society, a trade group of professionals in the field of cardiac pacing and electrophysiology, adopted “fast-track” training guidelines (pdf) for newcomers to these specific implant operations. The society describes an electrophysiologist, or heart rhythm specialist, as “a cardiologist who has devoted an additional year of training to ICD and CRT device implants and to the diagnosis and treatment of abnormal heart rhythms.”
These guidelines ask doctors to attend classroom sessions, pass a daylong written test, and perform several implantations with an expert at their side. Federal authorities started a post-operation database to track whether the rate of complication varied depending on the specialization of the performing surgeon. Death during implantations are very rare. From that small sample, an analysis by the NYT of 45,000 implants shows a 50% increase in deaths for operations performed by non-electrophysiologists vs. those done by specialists. This look at the raw data does not take into account other important factors such as the patient’s condition so it is not statistically conclusive.
Meanwhile, ICD manufacturer Biotronik is offering free training to physicians. Though both the company and doctors taking the training deny this buys the doctors’ business, this still raises a potential conflict of interest. St. Jude Medical and Medtronic also have programs to facilitate training. These corporate-sponsored programs do not necessarily adhere to the Heart Rhythm Society’s recommendations. The NYT also cites a controversy between Medtronic and a cardiologist whom the vendor claimed tied his business to training being brought to him. The cardiologist eventually got training from Biotronik.
Another issue is whether electrophysiologists are presenting ICD implantation as more complex than it is to protect their income. Surgeons used to worry about cardiologists implanting pacemakers, but today the later perform most of these operations. Ultimately, hospitals decide which standards they want doctors to meet.
August 1, 2006 Related topics: Ethics & Scandals, Medical Devices & Products, Surgery, Cardiology