How Safe Are Adult Medical Devices in Children?
Some medical devices are designed and developed specifically for children. Others are designed for adults but adapted for use in younger, smaller patients. Using devices in this way is probably unavoidable for many clinical conditions, where implantable devices such as pacemakers or defibrillators seem to be the best treatment option. But does this choice exacerbate risk because the devices are not designed, developed, and packaged specifically for children?
A recent Journal of Hospital Medicine article (registration required) suggests that there is an increased risk of adverse medical device events (AMDEs) in children. According to the article, 3.3 percent of children admitted into US tertiary care hospitals between 2004 and 2011 experienced an AMDE, and 44.4 percent of these events were associated with vascular access and nervous system devices.
Though the article didn't offer details about why these events occur, there are several aspects of packaging that could be considered, such as size, product longevity, material exposure, and viability during growth. It is well documented that children respond differently than adults to things such as implantable cardioverter-defibrillators and have a much higher probability of sudden cardiac death. I would suggest that this is not the only area where such differing outcomes could occur.
MDMs and pharma companies invest less in specific device development for children, due to the associated costs, and yet their function can be different from what is required in adults. Should we be allowed to use adult devices off licence in this vulnerable group of patients?
Over 75 percent of the ADMEs cited in the article occurred in children with complex chronic conditions. The FDA says it is keen to support "safe and effective" development of paediatric devices, but the mere fact that it is children who are most at risk (and who are required for the clinical trials) makes this an ethical nightmare.
What does the community think about the specific packaging of medical devices for paediatric patients? Should we continue to adapt adult devices, or is it the responsibility of the industry to invest in specific devices as a fundamental safety consideration?
Adele Graham-King, Blogger