new procedural and assessment skills. Some manufacturers have established mechanisms to develop and evaluate the competency of professionals to use such devices, and expectations for training and competency may be reflected in the labeling of the device. Training associated with such devices should cover the identification and reporting of adverse events.
Recommendation 4.5: When FDA mandates or agrees to device labeling that requires professionals to be trained in the safe and appropriate use of a medical device, the training should include information on the identification of adverse events, voluntary adverse event reporting under MedWatch, and user facility and manufacturer medical device reporting (MDR) requirements.
In addition, for complex devices that involve monitoring or operation by patients or families, manufacturers should provide directions about when and where to seek help, advice on reporting problems, and instructions, warnings, and troubleshooting guidelines that are understandable to nonprofessionals. Some manufacturers already have strong patient education and assistance programs. For certain home-use devices, FDA should consider requirements that manufacturers of certain devices (e.g., the orthodontic headgear mentioned earlier) affix labels stating that injuries related to the device can be reported to FDA.
FDA inspections of manufacturers should continue to include, as part of quality systems inspections, attention to complaint handling and event investigation and reporting. As discussed in Chapters 3 and 7, such inspections are occurring substantially less frequently than required by law.
For many if not most medical devices, health care professionals who care for children occupy the critical intersection between device manufacturers and children and their families. They are well positioned to understand devices, evaluate their successes and failures with individual children, receive early warning of problems through professional networks, and determine what kinds of education health care workers—and patients or families—need to use devices safely. Significant complications with devices are often first reported at professional meetings without prior reporting to FDA, manufacturers, or other patient safety programs. Child health professionals are thus an essential but underdeveloped resource for identifying and reporting adverse device events. The challenge is how to better employ this resource to protect patients.
One difficulty is that pediatricians and other child health professionals are bombarded with advice, guidance, directives, and educational materials of all sorts. The likelihood that these incoming messages will change behav-