with the potential for colliding with other beings or objects, it has no common clinical or behavioral definition.
The committee interprets children’s active lifestyles as having physical, cognitive, emotional, behavioral, and social aspects that are affected by a child’s stage of development. Physical aspects relevant to device safety include the types of activities engaged in by children of different ages, the environments in which they occur, and their frequency, duration, and intensity.
When FDA granted a humanitarian device exemption for use of a deep brain stimulator with dystonia patients who are 7 years of age or older, it noted that children’s active play and sports participation could damage elements of the implant. It went on to say that “[w]hile some degree of rough play may be unavoidable, children should be advised to avoid games, sports and other pastimes where a strain to the lead/connector assembly or a percussive injury to system components may be likely to occur (e.g., soccer, football/rugby)” (H020007, FDA, 2003, p. 3). (Chronic intractable dystonia is a serious neurological condition characterized by involuntary muscle spasms and abnormal postures or movements.)
The developmental control that children can exert over their physical activity is also relevant to device safety. For example, an infant in a crib and a cognitively intact 14-year-old confined to bed due to illness or injury may both be relatively inactive. The adolescent can, however, be expected to have more awareness of and control over movements such as rolling over that might dislodge or otherwise impair the functioning of a medical device such as a catheter or a breathing tube. Likewise, a 5-year-old and a 25-year-old who have had a cardiac pacemaker implanted may each know that they need to protect the device, but developmental differences in the understanding of risk and causation and in the control of impulses increase the probability of risky behavior by the child, for example, jumping off a porch (see, e.g., Giedd, 2004).
Surgeons may modify their procedures to take children’s activity levels into account. For example, surgeons who perform craniofacial surgery that requires a tracheal or breathing tube may secure the tube by placing wire sutures through the gum because of the high risk of having this tube inadvertently dislodged by the movement of a child and the extreme difficulty of replacing the tube when the facial structures are swollen.
Surgeons implanting a pacemaker in a very young child often will place the pacemaker generator in the abdominal wall, where extra tissue provides more protection than is offered by the usual location near the collarbone. With the usual location, the surgeon connects the generator to the inside of the heart by passing the pacemaker’s leads (small wires) through a vein in the chest. With abdominal placement, surgeons tunnel