NEW YORK — Cornell Medical College, Kaiser Permanente, and medical device registries around the world conducted research on the benefits of tracking hip and knee implants once they are implanted. While the research found there are gaps in the process, tracking medical devices’ effectiveness and safety can improve patient choice and safety.
Medical device registries look to improve the availability of evidence on medical implants so that consumers can make more informed decisions. The FDA sponsored a series of articles that analyzed seven registries to examine the performance and safety of implants, specifically knee and hip implants. The registries are in Australia, Spain, Italy, Sweden, Norway, and the United States (Kaiser Permanente Health East). These registries are part of the International Consortium of Orthopedic Registries. Orthopedic medical devices are the easiest to track via registry because they are the most commonly implanted device.
How are the Registries Used?
The registries are used for both long and short term surveillance of the devices. It allows the medical community to observe how the devices actually operate in the real world, beyond clinical trials, and in routine practice over time. All of the devices in a given registry (for example, hip implants by a specific company) are given a Unique Device Identifier. This is similar to a bar code for an individual implant. Once the patient has the device in their body, the device’s performance is tracked any time the patient has implant-related work done. This is accomplished via electronic medical records, billing data, and provider input. The Unique Device Identifier also allows doctors to be alerted whenever a device is recalled or has an FDA alert.
The FDA recognizes the importance of such information in improving public health and safety. Both doctors and patients are able to make well-informed evidence-based decisions through short and long-term longitudinal data. The creation of unique device identification system is a top priority for the agency after the passage of the 2007 federal health care laws.
Considering the growing number of medical device recalls, dangerous device warnings by the FDA (power morcellators), and defective medical device lawsuits (hip replacement implants), these registries may be crucial in protecting patients from dangerous medical products in the future and/or proving their case when trying to recover money for their injuries.
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Our dangerous device attorneys can help if you or someone you care about was harmed by a defective or recalled medical device. Lawsuits have been filed against the device makers by both patients and their families seeking compensation for injuries caused by the dangerous device. You may be entitled to a settlement.
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