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Pages 1-16

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From page 1...
... For example, mechanical ventilators, in combination with medications and additional therapies, rescue thousands of fragile newborns each year and allow many children who rely on respiratory support to live at home with their families, attend school, and participate in community life. Children who once would have died from congenital heart conditions today survive with the aid of implanted devices such as pacemakers, mechanical heart valves, and devices that close holes in the heart.
From page 2...
... to assess whether "the system under the Federal Food, Drug, and Cosmetic Act for the postmarket surveillance of medical devices
From page 3...
... This is partly because the market for most medical products is concentrated among adults, especially older adults. Moreover, discussions of medical product regulation and patient safety focus more on pharmaceuticals than on medical devices and more on the assessment of products prior to marketing than on the subsequent surveillance of product performance.
From page 4...
... Patients, families, and others have taken on roles in device operation, maintenance, and troubleshooting that were formerly performed by health care professionals, but postmarket surveillance has not yet adapted to this reality. · Medical device safety is a shared responsibility.
From page 5...
... After devices enter the market, FDA's postmarket surveillance includes requirements or opportunities for manufacturers, health care facilities, and others to report serious problems -- adverse events -- that are caused or potentially caused by any kind of medical device or errors in its use. For certain devices, the agency can also require postmarket studies to evaluate device performance or safety as devices are used for longer periods, in different settings, and with more varied patients than during their initial testing.
From page 6...
... Public Access to Information About Postmarket Studies Monitoring of postmarket study commitments is important but so is greater openness about study methods and findings. Given the limited research on medical devices used with children, FDA should, at a minimum, provide for more open access to information about required pediatric studies.
From page 7...
... Recommendation 6.6: FDA should collaborate with the National Insti tutes of Health, the Agency for Healthcare Research and Quality, and other research funding agencies and interested parties to define a re search agenda and priorities for the evaluation of the short- and long term safety and effectiveness of medical devices used with growing and developing children. The expanding use of electronic patient information systems presents opportunities to strengthen studies of device outcomes and also improve surveil
From page 8...
... Recommendation 4.1: FDA should collaborate with industry, health care professionals and organizations, and parent and patient advocates to · focus more attention on adverse device events, including events in volving children; · promote linkages between adverse event reporting systems, various FDA databases, and other safety programs; · update product labeling, patient information, and other communica tions to promptly reflect safety-related findings from analyses of ad verse event reports; and · issue yearly reports on results from adverse event analyses, including findings involving children. The evaluation plan for the MedSun program (the agency's pilot Medical Product Surveillance Network, which involves more intensive and active interaction with a sample of 300 medical facilities, including more than 20 children's hospitals)
From page 9...
... Adverse event reporting is particularly important for medical devices in pediatric use because pediatric events are often unusual and sometimes extreme, and involve problems in a patient population that frequently has not been studied before marketing. Recommendation 4.7: Children's hospitals and other user facilities should establish a focal point of responsibility for medical device safety.
From page 10...
... The sharing of responsibilities extends throughout the medical device product cycle -- from innovation and development through testing, marketing, clinical use, safety monitoring, and eventual refinement or replacement. This spectrum of shared responsibility for device safety itself operates within a broader system of shared responsibilities for overall patient safety and health care quality.
From page 11...
... Complete List of Recommendations Adverse Event Reporting Recommendation 4.1: FDA should collaborate with industry, health care professionals and organizations, and parent and patient advocates to · focus more attention on adverse device events, including events involving children; · promote linkages between adverse event reporting systems, various FDA databases, and other safety programs; · update product labeling, patient information, and other communications to promptly reflect safety-related findings from analyses of adverse event reports; and · issue yearly reports on results from adverse event analyses, including findings involving children. Recommendation 4.2: FDA should continue educational and communication programs to promote recognition and useful reporting of serious adverse device events and device problems by hospitals and other user facilities.
From page 12...
... Recommendation 4.4: Within the pilot MedSun program, FDA and participating children's hospitals should serve as a resource for the broader involvement of children's hospitals in patient safety programs to identify, evaluate, respond to, or prevent problems with the use and design of medical devices. In addition, FDA should promote efforts to link or otherwise employ event reporting, device recall, safety notification, and other databases within and outside FDA to better assess and report on device safety issues involving children.
From page 13...
... Tasks include reviewing and monitoring the adequacy of institutional programs in areas such as tracking of safety alerts and recalls, responding to safety alerts and recalls, training in adverse event evaluation and reporting, and factoring safety data or evaluations into device purchase decisions. Recommendation 4.8: FDA should continue to improve and expand its medical device safety resources for patients and families and its focus on devices used in the home and community by · working with patient, family, and consumer organizations, providers, and industry to make it easier for patients or their families to report device problems to manufacturers or FDA and to learn about resources to support the safe use of medical devices; · making online reporting and information resources more accessible by using language and directions appropriate for lay users; and · enlisting hospitals, home care agencies and vendors, and other professional and provider groups to promote patient and family understanding of how to use devices safely, when and how to seek help, and when and how to report problems.
From page 14...
... Recommendation 6.2: As part of government and private health informatics initiatives, such as those supporting the electronic medical record, FDA should promote the development and adoption of common device coding and other standards and approaches for capturing and linking use and outcomes data for medical devices. FDA should also work with agencies such as the Agency for Healthcare Research and Quality and university- and industry-based methodologists to strengthen methods and tools for epidemiologic research on medical device safety.
From page 15...
... Responsibilities for Medical Device Safety Recommendation 7.1: FDA should establish a central point of responsibility for pediatric issues within the Center for Devices and Radiological Health to evaluate the adequacy of the Center's use of pediatric expertise and its attention to pediatric issues in all aspects of its work. Recommendation 7.2: All those engaged in improving the quality of health care and protecting patients from harm should evaluate and sharpen as appropriate their attention to medical device safety, including safety issues that particularly affect children.


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