report on postmarket surveillance of medical devices used with pediatric populations.

Postmarket surveillance of medical devices used with children is a little-investigated topic. Again, this is partly because the market for most medical products is concentrated among adults, especially older adults, so attention tends to follow clinical and market realities. Moreover, assessments and discussions of medical product regulation and patient safety tend to focus more on pharmaceuticals than on medical devices. Thus, pharmacoepidemiology is a relatively well-established area of epidemiologic inquiry while medical devices epidemiology is not. In the device arena, no readily identified organizations exist in parallel to the International Society for Pharmacoepidemiology, the International Society for Pharmacovigilance, or the Academic Programs in Pharmacoepidemiology. (These organizations devote some attention to device epidemiology, but it is not a major focus.) In addition, discussions of medical product regulation—for drugs and vaccines as well as medical devices—have tended to concentrate on the regulatory requirements and processes related to the approval or clearance of products for marketing rather than on the subsequent evaluation or surveillance of their performance.

It is appropriate to put a high priority on keeping unsafe and ineffective medical devices and other products from entering the market in the first place. It is also reasonable to ask whether the system of postmarket surveillance established under the Federal Food, Drug, and Cosmetic Act provides adequate safeguards for the use of medical devices once the devices have been approved for marketing. This report considers that question as it relates to children specifically.

As the committee that developed this report reviewed the literature, consulted knowledgeable individuals, and considered the questions before it, several themes emerged. They are:

  1. Children and their families benefit from safe, effective medical devices. Timely access to such devices prevents premature deaths and significantly improves the quality of life for children and their families.

  2. Systematic attention to children’s needs and characteristics is important in medical device design, use, and evaluation because children differ from adults in important ways. For devices developed primarily for use with adults but with expected or possible pediatric uses, such attention can encourage the early identification of potential pediatric benefits and harms and the early consideration of modifications in the design or use of a medical device that will minimize risks and safeguard child patients. In addition, long-term studies may be necessary to understand developmental effects and the long-term balance of benefits and harms of pediatric use of long-term implants and certain other devices.

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