Legislators should assign International Classification of Diseases (ICD) codes to all medical devices, coinvestigators in a recent opinion piece in JAMA urged. The resulting administrative data that would be amassed could help identify device-related adverse events more accurately than is currently possible, they argued.
Andrew Ibrahim, MD, MSc, a researcher at the Institute for Healthcare Policy and Innovation at the University of Michigan in Ann Arbor, and his coinvestigator pointed to gastric band devices as a case study in the potential value of assigning codes for medical devices.
“Although most medical devices currently do not carry a unique device identifier that can be tracked in administrative data, the surgically placed gastric band is a notable exception,” they noted.
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According to the Healthcare Cost and Utilization Project, which used gastric band ICD codes as their data source, an estimated 217,000 gastric band-related procedures were conducted in the United States between 2006 and 2014. During that time, of the $2.1 billion associated expenditures for these procedures, $820 million were related to device-related reoperations, suggesting “concerns about safety and expenditures,” the investigators said. “There is broad consensus now that the use of [the] gastric band device should be significantly restricted, if not eliminated, but why did the medical device monitoring system not identify these concerns sooner?”
The answer to that question lies in the limitations of the US Food and Drug Administration’s (FDA) current device approval and post-marketing monitoring process. Device approvals are based on data from relatively short-term clinical trials that often use limited-size and homogenous populations treated by experienced clinicians. That leads to a snapshot that does not reflect real-world practice, they said, arguing that ICD code-based data could remedy that.
Moreover, although the FDA does require device manufacturers and hospitals to report device-related issues in the post-marketing period, providers and patients do so voluntarily, which means a “significant portion” of adverse events is missed, Dr Ibrahim and his colleague said. Again, ICD codes would provide a more real-world understanding.
A recent US congressional investigation on safety monitoring of medical devices agreed with their assessment and noted some additional limitations to the current post-approval approach.
“[The] FDA currently receives more than 1 million reports annually that are often incomplete and require triage through a limited number of clinical reviewers, resulting in significant delays,” the investigators noted. On the other hand, administrative data using ICD codes could be machine-analyzed using algorithms.
The current post-approval process also does not provide the FDA with a picture of how often a device is used, the congressional investigation found. Having device-specific ICD codes would change that, the researchers assert.
Although a trove of ICD code-based data was available when the FDA expanded the indications for the gastric band device in 2011, they were not used. Instead, the FDA relied on trial data showing device reoperation rates as low as 4% — far lower than what the Health Cost and Utilization Project’s findings indicated.
Overall, they said, requiring that all FDA-approved devices have unique ICD codes — as Congress is recommending be done — “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 investigators concluded.
Reference
Ibrahim, AM, and Dimick, JB. Monitoring medical Devices: missed warning signs within existing data. JAMA. 2017;318:327-328.
