The role of the U.S. Food and Drug Administration in device evaluation and monitoring.

The American Society for Gastrointestinal Endoscopy (ASGE) Technology Committee provides reviews of existing, new, or emerging endoscopic technologies that have an impact on the practice of GI endoscopy. Evidence-based methodology is used by performing a MEDLINE literature search to identify pertinent clinical studies on the topic and a MAUDE (U.S. Food and Drug Administration Center for Devices and Radiological Health) database search to identify the reported complications of a given technology. Both are supplemented by accessing the "related articles" feature of PubMed and by scrutinizing pertinent references cited by the identified studies. Technology Status Evaluation Reports are drafted by 1 or 2 members of the ASGE Technology Committee, reviewed and edited by the committee as a whole, and approved by the Governing Board of the ASGE. When financial guidance is indicated, the most recent coding data and list prices at the time of publication are provided. For this review, the MEDLINE database was searched through October 2009 for articles and references related to devices and the U.S. Food and Drug Administration by using the keywords "FDA" and "devices." In addition, the Web was searched using the same keywords. The U.S. Food and Drug Administration website was also thoroughly reviewed. Practitioners should continue to monitor the medical literature for subsequent data about these issues. Technology Status Evaluation Reports are scientific reviews provided solely for educational and informational purposes. Technology Status Evaluation Reports are not rules and should not be construed as establishing a legal standard of care or as encouraging, advocating, requiring, or discouraging any particular treatment or payment for such treatment.

A meta-analysis of the yield of capsule endoscopy compared to other diagnostic modalities in patients with obscure gastrointestinal bleeding.

OBJECTIVES: Due to its superior ability to examine the entire small bowel mucosa, capsule endoscopy (CE) has broadened the diagnostic evaluation of patients with obscure gastrointestinal bleeding (OGIB). Published studies have revealed a numerically superior performance of CE in determining a source of OGIB compared with other modalities, but due to small sample sizes, the overall magnitude of benefit is unknown. Additionally, the types of lesions more likely to be found by CE versus alternate modalities are also unknown. The aim of this study was to evaluate the yield of small bowel findings with CE in patients with OGIB compared to other modalities using meta-analysis. METHODS: We performed a recursive literature search of prospective studies comparing the yield of CE to other modalities in patients with OGIB. Data on yield and types of lesions identified among various modalities were extracted, pooled, and analyzed. Incremental yield (IY) (yield of CE-yield of comparative modality) and 95% confidence intervals (95% CI) of CE over comparative modalities were calculated. RESULTS: A total of 14 studies (n = 396) compared the yield of CE with push enteroscopy for OGIB. The yield for CE and push enteroscopy was 63% and 28%, respectively (IY = 35%, p < 0.00001, 95% CI = 26-43%) and for clinically significant findings (n = 376) was 56% and 26%, respectively (IY = 30%, p < 0.00001, 95% CI = 21-38%). Three studies (n = 88) compared the yield of CE to small bowel barium radiography. The yield for CE and small bowel barium radiography for any finding was 67% and 8%, respectively (IY = 59%, p < 0.00001, 95% CI = 48-70%) and for clinically significant findings was 42% and 6%, respectively (IY = 36%, p < 0.00001, 95% CI = 25-48%). Number needed to test (NNT) to yield one additional clinically significant finding with CE over either modality was 3 (95% CI = 2-4). One study each compared the yield of significant findings on CE to intraoperative enteroscopy (n = 42, IY = 0%, p= 1.0, 95% CI =-16% to 16%), computed tomography enteroclysis (n = 8, IY = 38%, p= 0.08, 95% CI =-4% to 79%), mesenteric angiogram (n = 17, IY =-6%, p= 0.73, 95% CI =-39% to 28%), and small bowel magnetic resonance imaging (n = 14, IY = 36%, p= 0.007, 95% CI = 10-62%). Ten of the 14 trials comparing CE with push enteroscopy classified the types of lesions found on examination. CE had a 36% yield for vascular lesions versus 20% for push enteroscopy, with an IY of 16% (p < 0.00001, 95% CI = 9-23%). Inflammatory lesions were also found more often in CE (11%) than in push enteroscopy (2%), with an IY of 9% (p= 0.0001, 95% CI = 5-13%). There was no significant difference in the yield of tumors or "other" findings between CE and push enteroscopy. CONCLUSIONS: CE is superior to push enteroscopy and small bowel barium radiography for diagnosing clinically significant small bowel pathology in patients with OGIB. In study populations, the IY of CE over push enteroscopy and small bowel barium radiography for clinically significant findings is >or=30% with an NNT of 3, primarily due to visualization of additional vascular and inflammatory lesions by CE.

[Latest progress of minimally-invasive medical systems in the field of alimentary tract diagnosis and treatment].

The capsule-style micro-system is a hot spot of minimally-invasive medical instruments. Progresses of some typical capsule-style micro-systems, such as the wireless endoscope, site specific delivery capsule (SSDC), alimentary tract sampling capsule, PH capsule, etc. are introduced here in detail. The research activities in China and the developing trend of capsule-style micro-systems are discussed too.