mal” (albeit unwanted). Others describe unusual situations that especially challenge those attempting to understand the event and prevent it from occurring again. Most of the stories point to the importance of considering human factors (human behavior and human systems and their interaction with devices) in the design of devices and the interconnection of devices and their accessories.

Although this report has tended to focus on more complex, high-risk medical devices (mainly Class III devices) that undergo clinical testing, several of the vignettes underscore that serious adverse events often involve less complex but very widely used devices such as catheters, accessory tubing, and syringes. Other vignettes describe problems associated with long-term use of an implanted or partly implanted device, that is, problems that cannot be expected to be evident in the relatively short-term clinical studies that are usually submitted as part of the FDA approval or clearance process for medical devices. Absent systematic long-term studies of medical device safety and effectiveness, such adverse events—as well as rare short-term events—may only slowly reveal themselves in usual clinical care. The importance of long-term studies of medical devices used with children is discussed further in Chapter 6.

Each vignette is synthesized from a variety of sources, including case reports in the medical literature, reports in FDA’s adverse event database (MAUDE), training materials for the MedSun program, experiences of committee members, presentations or discussions during public committee meetings, webpages for clinicians and patients and their families, news reports, and similar sources. No example depicts specific child and family circumstances exactly, although each story draws from real experiences. The fictional names, personal situations, and institutional details have been created to add a human dimension to the abstraction of adverse event or case reports and also to underscore points emphasized in this report.

Vignette A: Close call with aspirated syringe cap. This vignette involves a close call with a simple medical device, a syringe with a cap. Other children who have aspirated syringe caps have died. The example highlights the importance of careful communication with parents about the safe use of simple but potentially dangerous devices.

The father of 9-month-old Julia brought her to the primary care clinic because she was clearly uncomfortable and seemed to be running a fever. The doctor diagnosed an infection and prescribed an oral antibiotic to be administered with a syringe. He gave Julia’s father illustrated instructions and also demonstrated



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