June 7, 2013
Kids’ Medical Devices Sometimes Do More Harm Than Good
Brett Smith for redOrbit.com - Your Universe Online
Medical devices have improved, extended, or saved countless lives, but a new study in the Journal of Hospital Medicine showed that these devices can also be a source of harmful complications in children.
Brady and his colleagues said their research should be used to raise awareness about the need to enhance medical device practices and design with respect to patient safety, especially for young children.
While the widespread use of medical devices has improved care for children with complex medical conditions, there has been relatively little study on how medical devices may expose these children to additional complications, researchers noted. They added that many medical devices are conceived with adults in mind and are later adapted for use in children.
To investigate how these devices may be negatively impacting children, the research team reviewed data from the Pediatric Health Information Systems (PHIS) that included 4.1 million patient admissions at 44 children's hospitals in the United States from 2004 to 2011.
The researchers found that 3.3 percent of patients in the study were involved in at least one adverse medical device event (AMDE) that could be traced back to a medical device, representing 12,000 events for each year of the review.
The researchers added that their methods could be underestimating the prevalence of AMDEs due to data entry factors within the PHIS. The system also prevented researchers from determining if the AMDEs were caused by negative reactions to devices, human error, malfunction, or other factors.
However, PHIS did allow the team to see which kinds of devices were more prone to negative effects. They found that “vascular access devices” and nervous system devices were they most associated with AMDEs, representing 44 percent of the adverse events observed in the study.
The researchers also noted that about 76 percent of AMDEs affected children with complex medical conditions, with the largest age group of those being children 2 years old or younger.
"Although our study cannot answer too much of the 'why' for these events, it does point out that AMDEs are not rare and the burden falls largely on young children with complex chronic conditions," Brady explained. "This is a somewhat early step that will allow our team and other researchers to start asking questions about what causes these events, how to predict them, and how we can design interventions to decrease their frequency."
The study is being released just as the US Food and Drug Administration appears to be enhancing post-market surveillance of medical devices in children, with a focus on improving their use and safety. One of the study's co-authors, Dr. Thomas Gross, is director of the FDA's Office of Surveillance and Biometrics in the Center for Devices and Radiologic Health.