Health Care Reform Must Include a National Surgical Device Registry to Protect Patients

As our country ignites with its furious debate surrounding Health Care Reform, the discussion centers largely around financing - public versus private, etc. There is a danger that smaller but critical portions of this bill which substantially improve patient safety and save lives are going largely unreported and overlooked. For example, Section V of HR 3200 will change patient safety requirements on surgical device manufacturers by expressly calling for a national registry of devices. This would have enormous positive implications.

Consider the case of Richard Stone, a 49 year old married father of two working as an attorney in West Palm Beach Florida who was a candidate for hip replacement surgery at 47 stemming from childhood injuries that deteriorated his bones.

He scheduled surgery at Cornell Weill Hospital for Special Surgery in NYC, the national leader in hip replacement surgery and after his operation went home in severe pain. Unbeknownst to Richard and his surgeon, the prosthetic manufacturer had recalled an entire batch of hip about two weeks after his surgery. His serial number wasn't included since the device had already been implanted. A notice went on the FDA web site, but no information made its way to Richard. Meanwhile, the metal rods that make up the components of his replacement had broken and were rubbing together in his femur - creating excruciating pain. Eventually the metal rods began to protrude from his scar and as his primary care physician. I referred him for the revision surgery. That involved deeply drilling in to his bone and gouging out the prosthesis and installing a new one. Another 6 months of excruciating convalescence followed.

Patients are given information at the time of their surgery, but in the event of a recall or early problem detection, the manufacturing company only has to notify the physicians that have used the devices and the FDA. Without a registry that collects patient info similar to state automobile registries, this guarantees that some patients will remain uninformed. In my practice in Florida, an enormous portion of retirees - the age bracket that has the most surgically implanted devices - have relocated here from other colder parts of the country. There exists huge obstacles in reaching these patients in the event their device has trouble, as they have moved away from their surgeons and physicians.

Consumers have multiple means of gathering automotive information and car manufacturers are quite adept at alerting the public regarding defects, recalls, etc. This has been a law since 1949, overseen by the National Transportation Safety Authority and well accepted and enforced in the name of public safety. Even the manufacturers of your coffee grinder or stereo can notify you if there is a problem with the machine (assuming you filled out that little card). But conversely, the average person walking around with an implanted device has no idea who makes it and manufacturers have no idea who is using their products.

A database already exists which offers exactly this type of service to alert patients of recalls and problems with hips, stents, knees, defibrillators, etc. It was compiled by a non-profit research group at University of Pennsylvania, in conjunction with researchers at the Cleveland Clinic, Columbia Presbyterian Hospital in NYC, Georgetown Medical School and University of Rochester. It can be found here.

In essence, the Health Care Reform Bill being debated, (HR 3200), expressly calls for a registry for surgically implanted devices in Section V, which would be used by patients who have implantable devices to alert them in the event of a recall, act as an early warning system or used by the manufacturers as a tool to alert patients. Think of it like a "Carfax" for stents, defibrilators, orthopedic devices, etc.

The reason this provision of the bill is so crucial are the real life examples of patients who suffered catastrophic complications because of a lack of information about their device like Richard Stone.

If Richard Stone had the Medical Device Registry available to him, he could have looked up his device BEFORE the surgery and discovered any complications. Afterwards he could have registered his implant and been notified IMMEDIATELY of any problems in the field before his condition reached the severity that it did. I have seen several patients like Richard Stone over my career which led to my involvement as an architect of this non-profit registry.

As Congress and the White House are arguing over what a health reform package should include, its important that we recognize comprehensive reform must attempt to fix the problem of patient notification and create a national system to insure patient safety for implanted devices. The Medical Device Registry that has emerged from these academic institutions is effective way to reach patients in the event of ANY problem with ANY device. That is exactly the scenario that HR3200 can now cement into law. Also, when looked at through a financial lens, it will alleviate much of the liability and burden on manufacturers because it provides a communications vehicle direct to patients.

Perhaps calling attention to these lesser understood portions of the Health Care Reform Bill will take the temperature down in some of the town hall meetings and remind people of the much needed measures that will ultimately protect their health.