the leads through the chest tissue and then stitch them to the outside of the heart. This approach allows the surgeons to avoid placing the leads through young children’s small subclavian veins, where they might cause a thrombosis that would complicate access for pacemaker leads in future years if needed, for example, as the child grows or if problems arise with the original leads.

The social dimensions of children’s lifestyles, especially adolescent lifestyles, are sometimes featured in discussions of medical devices such as insulin pumps and catheters for peritoneal dialysis that require special attention while users are away from home. Websites for children and teens with diabetes provide tips for living with the insulin pump and include discussion of clothing, eating, school physical education activities, and swimming and other sports.

In addition, as the committee heard during its meeting with families, the desire to be or appear “normal” may cause older children and adolescents—with mixed emotions and reactions from their parents—to engage in activities (e.g., playing contact sports while having an implanted pacemaker) that place great stress on implanted or partly implanted devices such as catheters. Some complications associated with pediatric use of medical devices may result from patient activities that have a realistic potential for harm, given the inherent limitations or characteristics of the device. A continuing interest of clinicians, parents, and device manufacturers is strategies for “child-proofing” devices by changing their design or use.

For infants and toddlers, the use of medical devices may also need to take into account another “lifestyle” factor—their lifting, holding, carrying, and other handling by adults. Just as special precautions may be needed to safely secure a device for infant or child activity, so additional precautions may need to be taken with medical devices to accommodate normal child care.

Yet another consideration is that children living at home with complex medical devices often have siblings whose own “active lifestyle” may create safety issues. On the one hand, siblings could endanger an ill brother or sister through play that dislodges or otherwise interferes with a device. On the other hand, playful or curious siblings could encounter electrical and other hazards to themselves. For example, children have electrocuted themselves after inserting partially or completely disconnected electrode wires from a sibling’s cardiorespiratory monitor into wall outlets (Katcher et al., 1986). Family education and parental monitoring are essential safeguards, but thoughtful design or choice of device that considers home environment and other “human factors” also has a role to play in protecting the safety of all members of a family.



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