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Safe Medical Devices for Children
stent (MedSun, 2004, p. 2). FDA asked cardiac catheterization laboratories in study facilities to complete surveys at the beginning and end of the study and to complete another questionnaire to report any events involving drug-eluting stents. Results have yet to be reported publicly. FDA has planned similar surveys involving other devices.
The committee is not aware of special surveys that have involved only the children’s hospitals in the pilot MedSun program. It has learned that both Child Health Corporation of America (CHCA) and the National Association of Children’s Hospitals and Related Institutions (NACHRI) have been working with MedSun to assist the project in gaining substantial input from pediatric hospitals (personal communication, Cheri Throop, R.N., Chief Quality Adviser, CHCA, April 22, 2005). One of the recommendations at the end of this chapter encourages FDA and MedSun participating children’s hospitals to serve as a resource for the broader involvement of children’s hospitals in device safety.
One recent addition to MedSun is the Medical Device Engineering Network (M-DEN), which provides an interactive query and comment option for participants to share questions, experiences, and advice. The discussions may involve problems or concerns that would not normally be reported to FDA (Crowley et al., no date). Several teleconferences already have been organized on topics of interest to biomedical engineers.
MedSun has only recently approached its recruitment goals, and the program has yet to train representatives from many of the recently recruited facilities. Data collection began in February 2002 (FDA, 2004a). Because the pilot program is still in its early stages, it is not ready for systematic evaluation of its performance in meetings its goals. The committee understands that relatively few reports are being submitted each year, on average, by the MedSun facilities, but no public information is yet available. At some point, a comparison of the reports submitted by participating facilities with those received through the passive reporting system will be needed. The recommendations at the end of this chapter include suggestions for the evaluation plan.
Exploring Computer-Based Surveillance and Improved Device Coding
FDA has been interested in the potential applicability to adverse device events of some strategies being used or tested with adverse drug events. For example, the agency supported a study to compare possible device surveillance strategies and evaluate whether computer-based surveillance could reliably detect device adverse events and hazards, which were defined as “a state of increased risk related to device use” (Samore et al., 2004, p. 333). The study, which was conducted at a large medical center that had experience using computer-based strategies for detecting adverse drug events,