A cursory review indicates that CSF shunts have many different serious complications, including death, which may result from unrecognized or untreated malfunction and infection as well as a host of less common situations.

Issues of Growth and Active Lifestyle

Three specific issues related to growth and lifestyle has been overtly addressed by shunt investigators. The first is the need to revise atrial catheters placed in young children, discussed above. The second is the development of a strategy to avoid revision of peritoneal catheters because of growth. The third is the fracture of catheters under the skin as they cross from the neck to the chest.

Early in the experience with peritoneal catheters, some were concerned that excessive catheter length might be problematic (perhaps wrapping around the bowel and leading to bowel obstruction or causing discomfort because of amount of foreign material) and used catheters just long enough to enter the peritoneal cavity at the time of placement. Children could outgrow these catheters, requiring surgical revision to lengthen the peritoneal end. A catheter that would expand with growth was reported in 1975, but did not achieve widespread acceptance (53). Another theory suggested that a specific, optimal length of catheter could be determined for each patient, avoiding a presumed problem related to excessive catheter length (54). This approach likewise failed to achieve currency. A number of reports have suggested ways to add length to existing catheters (55), (56), (57). Over time, it became common practice to insert catheters long enough to allow for growth through maturity and to avoid elective operations that lengthened the tubing. Recently, this practice has been validated in the published literature (58). Because of the content and nature of the FDA reporting process, these problems are not identified in the formal postmarket surveillance process.

Finally, the issue of fractures of the distal catheter in the neck has been investigated (59), (60), (61). Although it has not been possible to definitively prove that these fractures are related to activity, this is hypothesized to be an important factor because of the consistent location of the fractures.

THE PERIOD OF REGULATION

Regulation Prior to Marketing

In 1976, amendments to the Federal Food, Drug, and Cosmetic Act gave the FDA its first real authority to regulate medical devices. Devices were placed in three classes. Class I devices “present minimal potential for harm to the user” and are the subject of the least regulatory control. Class II



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