Dealing with off-label medical device use in vascular surgery


Off-label device use is common in vascular surgery, but few studies address off-label uses through both surgical and legal perspectives, according to Wei Li, MD, of the University of Maryland School of Medicine, Baltimore. Dr. Li will discuss the medical-legal landscape of off-label device use in her presentation on Friday morning.

She and her colleagues assessed the publicly accessible LexisNexis legal database and Manufacturer and User Facility Device Experience (MAUDE) from January 2012 to December 2017. Jury verdict and case law searches within the LexisNexis were performed in order to identify representative cases and related legal doctrines for entries related to three (off-label) stents deployed in the superficial femoral artery.

They categorized and compared the reported adverse events for all three stents.

Although off-label device use is both legal and unregulated, it can carry potential legal implications on billing practices and subsequent medical malpractice liability, according to the researchers.

They found that off-label device use was more widespread in the pediatric patient population because of an unmet demand that can require Humanitarian Device Exemption. Among 497 total entries of reportable adverse events in MAUDE, for the three stents, they found significant differences, and they also found that the highest malfunction was associated with stent delivery. No deaths were reported with off-label use.

Dr. Li will discuss how vascular specialists need to have more in-depth knowledge about the off-label devices they use to minimize the chance of complications. Their investigation found no evidence reportable adverse events bear a direct relationship with Food and Drug Administration–approved indications related to the three superficial femoral artery stents in question.

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