participate in adverse event reporting and other patient safety initiatives beyond its own boundaries.
It is essential, however, that FDA continue efforts to strengthen its own spontaneous reporting program for medical devices and its pilot MedSun program. Chapter 4 offered several recommendations for program improvements. It also expressed concern about the adequacy of resources for postmarket device surveillance.
In the MedSun program, the agency has an opportunity to use the participating children’s hospitals as connecting points for broader efforts to improve device-related surveillance and problem reporting at the 200 or so children’s hospitals and related institutions nationwide. Many of these institutions already cooperate in various safety and quality improvement efforts. Moreover, improved surveillance in these institutions can generate information that may help improve care even in facilities that do not emphasize pediatric services.
FDA and CDRH specifically are uniquely situated to promote attention to events, errors, and design problems related to medical devices. The value-added potential of FDA’s device-specific expertise and programs is worth mentioning in several specific areas.
One area is the promotion of more attention to the safety of complex medical devices used in the home and to resources to support patients, families, and other home caregivers in safely operating and maintaining devices and getting timely assistance in resolving problems. Although FDA has created a home care committee, more needs to be done. With responsibility so dispersed compared to hospital care, it will take considerable creativity and commitment to weave a better supporting structure of device safety and surveillance for adults and children cared for outside of medical facilities.
Another important value-added area for FDA, as recommended in Chapter 6, is further promotion of common standards and approaches to capturing data about medical device safety and effectiveness from large automated patient care databases. One priority here is continued work on a commonly accepted coding system that will allow more precise identification of specific types and models of devices than is possible with existing coding. Improved coding will strengthen multiple facets of postmarket surveillance.
Although its work focuses on device safety in the United States, FDA also participates in international efforts to harmonize regulatory policies, share reports on serious device problems in a timely fashion, and promote effective manufacturing facility inspection and other programs to assure device safety in global markets. One area of concern is confidentiality policies or practices in other countries that may impede the timely sharing of critical public health information.