Review of literature

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The academic literature was evaluated using the search phrase ' "medical device*'' AND "epidemiology" ' , adjusted to the research dataset's specific requirements - different datasets use truncation symbols other than '*'. Research datasets included PubMed [with and without Medical Subject Heading (MeSH) terminology], Current Contents, Web of Science, International Pharmaceutical Abstracts, and Lexis-Nexis Academic Universe

Table 12.1 Literature dataset descriptions

Dataset title Uniform resource Description locator (URL) (Free/fee-based) information generally copied from dataset vendor

PubMed Free

Current Contents

Fee-based Web of Science


International Pharmaceutical



Lexis Nexis Academic Universe Fee-based

PubMed is a service of the US National Library of Medicine that includes over 16 million citations from MEDLINE and other life science journals for biomedical articles back to the 1950s.

Medical Subject Headings (MeSH) is the controlled vocabulary used for indexing articles for MEDLINE/ PubMed. MeSH terminology provides a consistent way to retrieve information that may use different terminology for the same concepts

Current Contents Connect is a multidisciplinary current awareness Web resource providing access to complete bibliographic information from over 8000 of the world's leading scholarly journals and more than 2000 books

Web of Science provides access to current and retrospective multidisciplinary information from approximately 8700 of the most prestigious, high-impact research journals in the world

Produced in cooperation with the American Society of Health-System Pharmacists, IPA includes 30 years of in-depth indexed reference to the world pharmacy (in the broadest sense) literature. Also includes related health, medical, cosmetic, and state pharmacy journals, and abstracts of presentations at major pharmacy meetings

This service provides full-text documents from over 5600 news, business, legal, medical, and reference publications with a variety of flexible search options

(Medical Academic Search Forms, Medical Journals). The Uniform Resource Locators (URLs) for the websites and the descriptions of the datasets are provided in Table 12.1.

The findings, summarized in Table 12.2, were sparse. In contrast to results for the term 'pharmacoepidemiology', where PubMed yielded 582 hits using MeSH terminology and 743 hits as a text search, the, ''medical device*'' AND ' "epidemiology" ' phrase yielded 47 and 29 hits, respectively. The other research datasets similarly yielded few hits, with a very high proportion of identified articles authored by personnel from the Centers for Devices and Radiological Health, Food and Drug Administration.

Of the device epidemiology articles identified above, relatively few met the definition articulated by Torrence: 'Medical device epidemiology is the study of the prevalence and incidence of use, effectiveness, and adverse events associated with medical devices in a

CONTRASTS WITH PHARMACOPEIDEMIOLOGY Table 12.2 Results of literature searches

Research dataset

Research citations Citations (English language) retrieved (FDA)


PubMed using MeSH headings PubMed using phrase Current Contents Web of Science

International Pharmaceutical Abstracts Lexis Nexis Academic Universe

1992-2006 1990-2004 1997-2005

1993-2005 1993-2005 1984-2005

population. Identification of data sources is needed for medical device epidemiology [1]'. Many focused on nosocomial infection issues, where the device's use contributed to the episode. The remainder involved laparoscopic entry access injuries [2,3], atrial defibrillation devices [4], IUDs [5], and silicone breast implants [6-12].

Searching for a specified device produces similar results. Using the MeSH headings ' "Defibrillators, Implantable" [MeSH] AND "Epidemiology"[MeSH]' yielded no hits, while the headings ' "Epidemiology"[MeSH] AND ("Breast Implantation''[MeSH] OR "Breast Implants"MeSH])' yielded three hits. Note, however, that the MeSH lexicon must be used carefully. Substituting 'epidemiology'[subheading] for the MeSH term yields 163 hits for breast implants, although many of the hits were less precise.

It appears that at the present time, classification systems in use in the major research databases do not accommodate the breadth of the term 'medical device'. Indeed, there is no MeSH term for 'medical device' per se, and the MeSH Browser maps the term to 'Equipment and Supplies'.

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