that its discontinued user facility newsletter had served its purpose, the problems of facility underreporting and poor-quality reporting remain significant.

The committee commends FDA for the oversampling of children’s hospitals in the MedSun program. The MedSun participating children’s hospitals should be considered not only as a particular resource for investigation of safety questions related to children but also as a resource or base for a broader set of device safety activities involving children’s hospitals, CHCA, and NACHRI.

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.

Information generated by MedSun could also prove more broadly useful. For example, it could be shared with academic clinicians and engineers to stimulate studies to identify device redesign or other strategies to prevent identified problems.

This chapter has noted the lack of a practical, precise coding scheme for medical devices that allows identification of specific models and brands of implants and other devices. Chapter 6 includes a recommendation (6.2) for the development and adoption of common device coding and other standards and approaches for capturing and linking use and outcomes data for medical devices.


Sophisticated manufacturers recognize good adverse event reporting as a resource to help them learn about and correct problems with existing devices and identify areas for design refinement or product innovation. If adverse event reporting programs for devices are to improve device safety, manufacturers must receive timely and useful event reports, maintain sound procedures for evaluating these reports, and respond to identified problems on a timely basis. FDA regulations provide detailed direction on manufacturer responsibilities, and site inspections include a review of manufacturer compliance.

In addition to designing and redesigning devices to protect against unsafe use, promoting the safe use of devices is another important responsibility of device manufacturers. For some complex, high-risk implants and other devices, safe and effective use may require professionals to develop

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