The National implant Registry,™ a nonprofit organization, has been established to quickly identify and locate patients with recalled or defective implants and prosthetics. It will assist hospitals and physicians in meeting this significant obligation to their patients. The announcement comes on the heels of recent malpractice decisions holding physicians and hospitals responsible for notifying patients of implant recalls initiated by medical device manufacturers or the FDA.
The National Implant Registry covers such devices as pacemakers, heart valves, IUDs, artificial joints, and intra-ocular lenses. Following implantation, patient and device data are sent to the Registry. The patient implant database is matched frequently against incoming recalls and problem reports from manufacturers and government agencies, as well as from the medical, bioengineering, and legal literature. Hospitals and physicians are then immediately notified of patients who require attention.
The Registry has been engaged in test operations for the past few months, following an 18-month computer system development effort by its sponsor, ECRI. ECRI is the nonprofit, medical device evaluation laboratory that publishes Health Devices, a Consumer Reportslike publication for hospitals. National Implant Registry kits will be available shortly for hospitals, individual physicians, and group practices.
The Registry, located at ECRI's research campus in suburban Philadelphia, employs a sophisticated IBM Model 4331 computer system. An extensive system of safeguards will insure the privacy and accuracy of data. There are elaborate backup capabilities, including reciprocal arrangements for computer availability and maintenance of several duplicate databases, software, and other critical materials in widely dispersed locations.
Elliot Sloane, the Registry's Data Processing Manager, states, "As the number and variety of implants multiply in the future, the degree of protection afforded to patients, their physicians, and hospitals will be very significant. The cost is so low," he says, "that the Registry may be the least expensive insurance policy a patient, physician, or hospital ever obtains. The lifetime cost for tracking a patient and matching his implant against future recalls will be less than a dollar a year."
Joel J. Nobel, M.D., President of ECRI, points out that"the National Implant Registry benefits from the guidance and support of a distinguished Advisory Board of physicians, attorneys, and hospital administrators, as well as several consumer representatives."
The original concept for the Registry emerged from Dr. Nobel's 1973 testimony in Senate Health Subcommittee Hearings, The FDA, however, never fully implemented such recommendations, limiting its efforts to a pacemaker registry now being abandoned for lack of funding. Dr. Nobel pointed out, in a 1973 report to the FDA, that hospitals, physicians, and patients would naturally be reluctant to make such sensitive information available to a federal agency. To minimize this concern, the National Implant Registry and each participating hospitaland physician sign a confidentiality agreement.
For further information, contact the National Implant Registry, 5200 Butler Pike, Plymouth Meeting, Pennsylvania 19462, (215) 825-6700.