OSB is responsible for ensuring the continued safety and effectiveness of medical devices after they have reached the marketplace. OSB also provides statistical and epidemiologic expertise in market approval decisions made by the Center.
To accomplish these tasks, OSB conducts statistical analyses, designs and performs targeted epidemiological studies, directs a nation-wide surveillance system designed to monitor the performance of marketed medical devices, and facilitates cross-Center response when a problem is identified. Statistical analyses of premarket clinical studies are a critical part of the Center’s premarket approval process and provide the empirical basis for expected postmarket device performance.
For high risk devices, epidemiologists help design and oversee manufacturer-required observational studies in the postmarket period. In addition, OSB monitors adverse event reports for all devices looking for and responding to signals indicating potential device problems. OSB’s MedSun program, a dynamic network of hospitals and other user facilities, plays an important role in this process.
When complex device problems are uncovered, OSB frequently assembles teams of experts from across the Center to analyze the problem and develop solution strategies. One key solution strategy involves notifying the user community about the problem and suggesting remedies via a Public Health Notification. These notifications are developed by expert teams and OSB staff and issued by the FDA. They are intended for specific audiences (e.g., clinicians, risk managers, device users) to provide recommendations to aid clinical decision making to mitigate risks associated with the device problem.
Other solutions are to write educational articles for professional journals, working with professional societies to create outreach educational efforts to constituents, and working with device manufacturers to understand device problems. When a regulatory solution is required, OSB works closely with ODE and OC to solve the problem.