HealthLawProf Blog

Editor: Katharine Van Tassel
Concordia University School of Law

Sunday, June 26, 2005

Orthopedic Surgeons Pushing For Better Data Reporting On Medical Devices

According to Barry Meier of the New York Times, doctors get less information about products that are implanted in bodies than consumers get on the safety and performance of cars.   A group of orthopedic surgeons has suggested that the government create a database that shows how competing products performed by adding additional information to the claim form. The data base would also serve as an early warning system to show when a device is repeatedly failing.  The government pays hundreds of millions a year on hip and knee replacements for Medicare patients.   The problem is in part a consequence of manufacturers not regularly disclosing why products are failing, no systemic reporting of how many implanted devices break down while in use, and regulators and manufacturers not disclosing the the data they do gather.    The FDA requires makers of defibrillators and pacemakers to report detailed performance annually, but it does not make those reports public.   

Dr. Steve Phurrough, a Medicare official, says that "this would require an overhaul of Medicare forms and computer software. "  Also, because data comparing competing products are not necessary for payment, Congress does not allow CMS to collect them.

Dr. Robert Haralson, a top official of the American Academy of Orthopaedic Surgeons says that they have "little information on which one of these devices perform better than others."   Dr. Robert Hauser, a cardiologist at Abbott Northwestern Hospital in Minneapolis, voluntarily maintains a database in which several hospitals report problems with pacemakers and defibrillators. 

Currently, doctors and hospitals do not routinely include in their records the make or model of a device used in a procedure as they do for drugs.  This makes it almost impossible to track over time how long a product lasts or what kind of flaws develop over time.  Instead doctors rely on product performance reviews issued by manufacturers who report the "survival rate" of a device, which is not an accurate tell of how well the device functions.  Some physicians argue that if manufacturers were required to publicly disclose more collected safety data, the industry would be forced to produce better products and improve safety.  Thanks to Lindly Bain for her assistance in preparing this post.  [tm]

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