Conclusions

Several conclusions are evident from an academic perspective of epidemiology and medical devices. The first relates to medical literature classification schemes. As noted, the National Library of Medicine's present MeSH structure does not seem to easily accommodate medical literature searches for medical device-related issues, and other common literature retrieval databases are even less precise. The MeSH and other classification systems should be modified to better accommodate searches on medical devices and epidemiology.

The second relates to discernment issues. In contrast to pharmacoepidemiology, where the enterprise of detecting exposure is facilitated by billing records generated through pharmacies - and hence is available for both institutional settings and community exposure - a parallel structure is not available for medical devices. Bundled billing practices and lack of a unique identifier for medical devices complicates the discernment issue. In consequence, the epidemiology opportunities (bottom row, Figure 12.1) are constrained by the high costs of manual chart review, absence of unique medical product identifiers for most medical devices, and the missed opportunity for exposure information retrieval through data switches [1]. A uniform identification code should be developed and become routinely used in health care records.

As medical device epidemiology emerges from its infancy and some of these issues are resolved, major research opportunities are likely to present themselves.

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