FDA Flags Inconsistent Hospital Reporting Of Medical Device Problems: Hazy Reporting Rules Beget Confusion

摘要

Concerns about medical devices going awry in hospitals are pushing the Food and Drug Administration (FDA) to create a new adverse effects reporting system, which, as it is developed over the next five years, will produce seismic changes both directly and indirectly in the way hospitals collect and report incident information. "Passive" hard-copy reports, dinosaurs in this electronic day and age, will be out. The establishment of the new National Evaluation System for Health Technology (NEST) will usher in an era of "active" electronic reports that include clinical data (the current hot term is "real-world evidence" or EWE) about patients hurt by medical devices. New software will appear. Although reporting to the NEST will be voluntary, hospitals, medical device manufacturers, disease registries, insurance companies, and others will be forced to understand new industry software standards, such as the suddenly popular "Fast Healthcare Interoperability Resources;" purchase new inventory and claims software; and upgrade device tracking to identify unique device identification (UDI) barcodes. Significant capital expenditures will be involved.