Pediatric Heart Devices Often Approved By FDA Without Clinical Trials Involving Children: Study

Manufacturers often use data from adults to determine the safety and efficiency of pediatric heart devices, researchers found.

Most pediatric heart devices were originally designed and tested for use on adults, and never undergo clinical trials involving children, resulting in a lack of evidence to establish they are safe and effective for the unique anatomy and physiology of pediatric patients, according to the findings of a new study.

In a report published this month in the Journal of the American Medical Association (JAMA), researchers warn that the U.S. Food and Drug Administration (FDA) often approves heart devices for children without actually examining the effects on these young patients, leaving unanswered questions about their safety and effectiveness.

Researchers from Harvard Medical School examined high-risk cardiovascular devices approved by the FDA for use in children and teens, including data was taken from the premarket approval and humanitarian device exemption databases from the years 1977 to 2021.

According to the findings, many cardiovascular medical devices were not given proper testing for pediatric use. Many of the high-risk cardiovascular devices used on adults were simply repurposed for use among children and teens without any clinical trials or premarket testing.

In fact, of the devices approved for pediatric use, less than half were tested in a clinical trial involving children. These included defibrillators, stents, and prosthetic valves.

Roughly 50% of the devices approved for use in children were implantable and 40% were considered lifesaving.

“Such off-label use of medical devices does not account for the unique anatomy and physiology of pediatric patients, and clinical evidence on the effectiveness and safety of such interventions is often lacking,” wrote study authors.

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The researchers found that most clinical trials did not require researchers to enroll children and teens. For those studies which focused on device use among children and teens, there was often low completion rates for children and adolescents in these studies.

Children and teens have a unique anatomy compared to adults. They require specialized clinical trials and research to ensure that devices and medications are used appropriately with the fewest possible side effects. Many health experts say using data from adults is not sufficient to keep children and teens safe when dealing with complex medical devices or medications which could cause serious harm or side effects to young bodies.

Researchers said more studies are needed to collect evidence on the effectiveness and safety of pediatric cardiovascular devices. Additionally, more regulatory processes, industry assessments, and government regulation would be necessary for these devices to be properly evaluated for use among children and teens.


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