nearly 150 countries (ISO, 2004). Using committees that include producers, consumers, regulators, and other relevant parties, the organization develops consensus standards on topics such as terminology, testing methods, product characteristics, and manufacturing processes. Some standards are generic, such as ISO 9000, which concerns quality management. Other standards are industry or product specific, such as ISO 13485, which concerns medical devices. The agency currently has more than 14,000 standards and related documents. Individual countries may choose to adopt the standards by regulation.

In the 1990s, the Global Harmonization Task Force (GHTF) was created specifically as a voluntary process to pursue harmonization of national policies on the regulation of medical devices. It includes participants from national regulatory agencies and industry. Of four GHTF study groups, one has focused on postmarket surveillance, including adverse event reporting programs. FDA supports this activity, but the study group findings and recommendations are advisory, not binding.

One issue for the GHTF task force on adverse event reporting is promoting the exchange of event reports among “national competent authorities” (e.g., FDA in the United States) (GHTF, 2002, p. 4). In 2003, authorities in 16 countries exchanged more than 140 “international vigilance reports,” most related to recalled devices (FDA, 2004v).

Other harmonization activities include those of the International Conference on Harmonization (ICH). ICH has, for example, provided guidance for clinical investigators, primarily those involved in drug studies (ICH, 1996). An ISO document has focused on clinical investigators studying medical devices (ISO, 2003a,b; see Giroud, 2004). FDA has not adopted that ISO standard but has said that it might do so after the next revisions (Dickinson, 2004b).

This chapter has focused on description rather than assessment. Thus, it includes no conclusions or recommendations related to the adequacy of existing laws and regulations or their implementation as they relate to children. The next chapter examines FDA’s programs of adverse event reporting and offers recommendations for improvement.



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