JAMA Viewpoint: Is Data to Monitor Medical Device Performance Right in front of us, but Overlooked? Yes.

When I travel overseas I often hear, "Your U.S. healthcare system -- it's all about money!" With nearly 20 cents of every dollar in the US being spent on healthcare, it is hard to argue otherwise. But that isn't entirely bad news.

The Good News About Healthcare Costs

Because payments are so tightly regulated in healthcare, billing information carries a lot important and comprehensive information about the care we provide. This unlikely source of information -- the claims that are filed by hospitals and providers to insurance companies -- has helped us make some of our most important discoveries in healthcare such as the patterns of high performing surgeons and who survives after CPR. Could it also tell us something about the safety and value of medical devices?

Using Billing Data to Track Medical Device Performance

In a recent JAMA Viewpoint, we used the gastric band (aka the "Lap-Band") to see if billing data could demonstrate important patterns of performance. Within the insurance claims data, we were able see how often the device was being placed and how often another operation was needed to have the device fixed or removed. We were also able to track the associated costs. Here's what we found:

Over about a decade, we found that ~$2.2 billion was spent on the device, of which $820 million was for reoperations to fix or remove the device. More alarming, the trend was clear as early as 2009 when reoperations totaled more than 30% of payments. In 2011, when the FDA expanded use of the device use citing research that reoperations rates were as low as 4%, insurance claims revealed that >50% of payments were for device reoperations.

In 2011, when the FDA expanded use of the device use citing research that reoperations rates were as low as 4%, insurance claims revealed that >50% of payments were for device reoperations.

Efforts are ongoing by the FDA to create better registries that can track device performance. While these registries are important, we should also make better use of the data we're already collecting (billing data) to look for early warning signs of poor device performance.

Can We Track All Medical Devices in Claims? No. Should We? Yes.

The gastric band, unfortunately, is one of the few medical devices that carry a unique billing code for device placement and removal making it trackable in insurance data. Most devices that we use everyday do not have such codes, and are not trackable. Currently, there is pending legislation in the US Congress which could change that. We owe it to our patients and the pioneers of innovation to comprehensively track the performance of our widely adopted devices. Making devices trackable within data that we already collect everyday would go a long way to help ensure that, unlike the gastric band, warning signs of future devices are not missed.