Needed - A US Registry For Medical Devices

A national medical device registry can make the difference between suffering severe pain from a flawed hip implant and getting the right one installed in the first place. It can mean a quick alert about a defective pacemaker, and a chance to replace it before it fails, with potentially fatal results.

The recalls in 2010 of a widely used hip implant highlighted the need for a national registry of all medical implants and devices in the US. In Australia and the UK, where all medical implants are registered by model and serial number, and traceable to individual patients, surgeons and public health officials were able to see an excessively high number of failures in a particular device. When they confronted the manufacturer with hard numbers showing a failure rate far higher than for other implants, it could no longer dismiss surgeons' concerns as anomalies, or blame their surgical technique. It quickly withdrew the device from the market in those countries. In the US, where no registry exists, it continued to sell the same flawed devices for another two years.

If the US maintained a national registry of implants, surgeons could have seen high failure rates much sooner, and could have spared thousands of patients the pain and crippling effects of a failed implant, and the need for a second major surgery to replace it.

A recently published study demonstrates how a device registry can contribute to better outcomes for patients, and money saved for the US healthcare system. Kaiser Permanente maintains an implant registry for all hip and knee replacements done within its system. Researchers using the registry were able to follow the health outcome for 80,000 people who had hip and knee implants. While the study was in progress, device manufacturers issued eight recalls and advisories. The tracking information available through the registry allowed researchers and orthopedic surgeons to quickly identify the patients involved, contact them, and take whatever actions were necessary, including replacement surgery.

The study's lead author, Elizabeth Paxton was very clear: "Our findings demonstrate the critical impact of registries and the important role they play in counseling patients, identifying risk factors, tracking implanted devices during recalls and assessing comparative effectiveness of devices."

This years Health and Human Services budget includes a plan to establish a National Medical Device Registry that will list all implanted devices by model and serial number. The registry was created as part of the health care reform law, also called America's Affordable Health Choices Act. It will enable HHS to track the more than 600,000 knee and hip replacements performed each year,and to study the safety and effectiveness of all implantable devices. For all those Americans who rely on implants, the new national registry will provide an essential first-line alert.

If you or a loved one has suffered pain or disability due to a medical implant such as a hip replacement, cardiac stent, or pacemaker, you may have an actionable case. You should consult with an experienced medical device attorney as soon as possible.