Certification Board of Infection Control and Epidemiology (CBIC) 2025 – 400 Free Practice Questions to Pass the Exam

The Safe Medical Devices Act of 1990 mandates that healthcare facilities report adverse events related to medical devices that are associated with serious patient outcomes. This includes any significant incidents or complications arising from the use of these devices, which allows for ongoing monitoring of device safety and efficacy.

Specifically, the act requires facilities to submit reports on a semiannual and annual basis. The semiannual reporting is particularly crucial for serious events, as it allows the FDA to quickly track and respond to potential safety concerns with medical devices. The annual reports summarize the data collected throughout the year, helping to provide a comprehensive overview of device-related events.

This requirement underscores the importance of vigilance in monitoring device performance and safety, which is vital for protecting patient health and ensuring that medical devices on the market meet rigorous safety standards. The emphasis on both semiannual and annual reporting reflects the need for timely communication of safety information in the healthcare setting.