Medical devices muddle with pediatric care

Medical devices muddle with pediatric treatment of complex conditions

Medical devices have weathered well their submergence into the choppy technological depths of a treading industry and are quickly becoming the primary buoyancies of continual care and longer life expectancy. But staying afloat, as researchers from the Division of Hospital Medicine at Cincinnati Children's Hospital Medical Center can attest, requires more than its fair share of sinking.

According to a recent investigation into the influence of medical devices on pediatric care, a significant number of younger patients reported some sort of complication with their health gadget(s), promoting some pause within developer and medical communities regarding the level of safety present in mobilized care.

Lead author of the study and physician at Cincinnati Children's Hospital Medical Center, Patrick Brady, chalks up device hiccups as necessary hazards of the trade that, with diligence, can be amended.

"Medicine and pediatrics have made amazing advances over the last couple of decades that have resulted in children with congenital diseases and prematurity living longer, so this issue is a by-product of that success,” Brady said in a news release.

For children with complex conditions, devices have been life-changing, Brady said, although limited amounts of research have been conducted regarding what new threats and exposures come unto patients with the administering of these technologies (which in truth, are designed predominantly with adults in mind rather than children).

To identify such threats, Brady and colleagues looked to 4.1 million patient admissions reported within the facility PHIS system, then narrower to the 136,465 patients (3.3 percent) who were admitted due to an adverse event involving a medical device.  For each year of the study, approximately 12,000 AMDE events resulted in hospital admission, a figure that may even be underestimated, Brady emphasized.

The two most prevalent devices associated with AMDEs amongst the study pool were “vascular access devices (such as central venous lines) and nervous system devices (often involving shunts designed to drain excess cerebral spinal fluid from the brain).” The two tools together make up 44.4 percent of all AMDEs in the study.

"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 said. "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."

Additional study factoids include:

All information and data courtesy of Cincinnati Children's Hospital Medical Center. Presentation by PhysBizTech.

The study parallels and intersects current efforts put forth by the U.S. Food and Drug Administration to increase and better post-market surveillance of pediatric medical devices.

The study was published in the June 7 issue of the Journal of Hospital Medicine.