CHICAGO – Changes in the format of a federal database for mandatory reporting of major and minor complications for medical devices, including cochlear implants, could make it a valuable resource, according to an article in the March issue of Archives of Otolaryngology – Head & Neck Surgery, one of the JAMA/Archives journals.
Although cochlear implants (medical devices that bypass damaged structures in the inner ear and directly stimulate the auditory nerve, allowing some deaf individuals to learn to hear and interpret sounds and speech) are popular and effective therapy, they remain expensive and require an extensive program of accompanying therapy, according to background information in the article. The researchers suggest that to insure the best outcome from the necessary investment of time and money, patients and clinicians need independent, third-party data sources that can go beyond the manufacture-supplied literature on device complications.
Rabindra R. Tambyraja, M.D., Ed.M., of Case Western Reserve University School of Medicine, Cleveland, and colleagues investigated the suitability of the Manufacturer User Facility and Distributor Experience (MAUDE) database, maintained by the Food and Drug Administration (FDA), for systematic analysis of cochlear implant complications and treatments and, in the process, analyze trends in cochlear implant complications for two periods, 2002 and pre-1998. "We believe that the MAUDE database afforded a unique opportunity to use worldwide data collected and organized by an impartial source, with a mandatory reporting requirement," the authors write.
"Confirming other studies, we found device failure to be the most commonly reported complication," the authors report. "We also found a significant decrease in device malfunction from the pre-1998 period to 2002, possibly reflecting increasing quality control and reliability on the part of manufacturers." Infection was significantly more common in 2002, the researchers found, but no other significant differences in events were noted.
The authors suggest that their analysis would have been strengthened by three improvements in the MAUDE database: the development of agreed-upon categories for complications; the development of a place for information needed to assess risk factors and estimation of the useful life of the implant (for example, patient age, any anatomical abnormality and previous implant history); and basic data measuring the patient's hearing and history of hearing loss.
"With the suggested improvements to the MAUDE database, it could become a powerful, sophisticated analytical tool for health care providers and patients alike," the authors conclude. "Used appropriately, it could provide crucial guidance in selecting an expensive but wonderfully life-enhancing therapy."###
(Arch Otolaryngol Head Neck Surg. 2005; 131:245-250. Available post-embargo at www.archoto.com.)
Editorial: The Utility of MAUDE Database in Researching Cochlear Implantation Complications
In an editorial accompanying this study, Yael Raz, M.D., of the University of Pittsburgh School of Medicine, Pittsburgh, points out problems in using the MAUDE database to track cochlear implant complications: "… it seems likely that the MAUDE database is skewed for adverse sequelae related to device failure." Complications like infection that can be managed medically or that arise from problems with the surgery are less likely to be reported to the manufacturer or to the FDA. He also notes that "… the total number of implanted patients from which the MAUDE reports are derived is unknown. Thus, there is no denominator for determining the frequency of various complications."
"Although the conclusions that Tambyraja et al were able to draw from querying the MAUDE database have questionable impact, their efforts are nonetheless significant…" Raz concludes. "The establishment of an exhaustive and uniform national database, which pools the experience of many centers, would certainly be of value. … The authors have initiated a discussion of potential improvements that will enhance MAUDE's utility. However, the database will have limited impact until information regarding the total number of implants from which these complications derive is more accessible, consensus is established regarding the nature of reportable events, and clear guidelines are established regarding the party responsible for initiating the report."
Source: Eurekalert & othersLast reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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