Commercially available monitoring software could catch problems with implantable devices before patients are harmed by them.
That's the upshot of a new study of implantable cardioverter defibrillator (ICD) leads conducted by researchers from the Minneapolis Health Institute Foundation, Mayo Clinic and other institutions published this month in the American Heart Association's journal Circulation: Cardiovascular Quality and Outcomes.
The researchers theorized that post-market medical device surveillance depends mainly on voluntary reporting of adverse events; as a result, early safety signals may be missed. They used a commercially available automated surveillance tool in a simulated study to trigger an alert if a particular ICD lead, since recalled, was underperforming at a specified level. The software triggered alerts 22 months after the first implant, and more than a year before the lead was recalled.
"Such a tool, when applied to clinical registries and remote monitoring databases, may limit the exposure of large populations to underperforming and potentially hazardous cardiovascular devices," the researchers concluded.
There has been growing concern regarding the safety of medical devices, which have become more vulnerable not only to faulty design and wear out but to third-party manipulation. This is particularly true for implantable ICDs, which easily cost between $16,000 and $19,000 and can cause death if they underperform or malfunction.