Information from adverse event and case reports as well as systematic clinical studies and registry-based research will help provide a stronger evidence base for pediatric practice guidelines and standards of competency. These guidelines and standards should, in turn, reduce the unsafe and unnecessary use of devices.

Hospital and Other Device Safety Programs

Hospital and other patient safety programs that now focus almost exclusively on errors or problems involving other medical products and services can extend their reach. For example, for devices used with children, possible targets for such programs include certain types of common workarounds that have not been assessed adequately to determine the extent to which they constitute reactions to device problems, pose risks of their own, or warrant reconsideration of the way devices are used or designed.

One objective of the MedSun program is to encourage more coherence in user facility device safety programs. Children’s and other hospitals generally lack the kind of obvious focal point for medical device safety that pharmacists provide for drugs. Clinical engineering units, risk management departments, an array of clinical units, quality assurance programs, materials management divisions, purchasing departments, and other units share a fragmented and incomplete accountability for device safety.

Recommendation 4.7: Children’s hospitals and other user facilities should establish a focal point of responsibility for medical device safety. 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.

FDA should also charge its home health committee with investigating the role of home health agencies and vendors that supply home medical equipment in reporting adverse events and examining what might be done to support these providers. It is important that these organizations focus on identifying and resolving problems, but it is also important that serious problems be reported to manufacturers and FDA. A better understanding of problems with devices used in the home may promote refinements in the design of such devices, changes in the selection and monitoring of devices for home use, and improved information and training for patients and families.



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