Medical devices generate valuable data, so why aren't providers using it?
Imagine having reams of useful health data generated by healthcare technology and ignoring it, not putting it to work to help improve care and trim costs. That’s what academics at the University of Michigan are saying is routinely happening in a new report published Saturday in the Journal of the American Medical Association.
“Warning signs of unsafe or low-value care are detectable within existing data but often are overlooked,” the scholars wrote. “Rather than duplicate efforts and collect more data, healthcare leaders should renew their focus on making better use of available data. An example in which this is readily apparent involves the monitoring of medical devices.”
As an example, the academics, Andrew Ibrahim, MD, and Justin Dimick, MD, point to the laparoscopic gastric band to treat morbid obesity, approved by the FDA in 2001.
Between 2006 and 2014, about 217,000 gastric band procedures were performed in the U.S., costing $2.1 billion, researchers found. $820 million spent on the medical device during this period was for reoperations. By 2009, this reoperation trend was evident to caregivers, but about half of the reoperation procedures were performed after 2009.
“The advent, increase and decline in the use of the laparoscopic gastric band to treat morbid obesity illustrates how examination of existing data could have changed practice much earlier,” the scholars wrote. “The gastric band device illustrates the limitations of the current medical device monitoring process. When the FDA reassessed indications for the gastric band device in 2011, no current population-level estimates of device-related adverse events had been published.”
Instead, the FDA relied heavily on a single-group trial including 149 patients to state that the data “provide reasonable assurance of the safety and effectiveness” of the gastric band device, they wrote.
“With that evidence, the FDA expanded indications for use of the gastric band,” they added. “Had existing administrative data been used to evaluate the device, however, it is possible that the decision may have been different.”
There is a stumbling block, though, to better use of medical device data today.
“The majority of medical devices used in practice today, however, cannot be identified within existing administrative data because they lack device-specific ICD-9-CM or Current Procedural Terminology codes,” the scholars wrote. “Legislation that would require all FDA-approved devices to be trackable within data that are already collected could be a useful strategy to help ensure that, unlike the gastric band, the warning signs of other widely adopted devices are not missed.”
The example of the gastric band reveals that even crude measures can be a valuable signal within existing data, they said.