Question

What does the Safe Medical Device Act require from a hospital?

a) Annual fundraising events
b) Implementation of electronic health records
c) Reporting adverse events related to medical devices
d) Employee fitness programs

Answer 1

The Safe Medical Device Act requires hospitals to report adverse events related to the use of medical devices, as overseen by the Center for Devices and Radiological Health (CDRH) of the FDA.

Step-by-step explanation:

The Safe Medical Device Act requires that hospitals report adverse events related to medical devices. This is mandated to ensure that any incidents where a medical device may have contributed to death, serious injury, or serious illness are properly documented and communicated to the FDA, particularly through the Center for Devices and Radiological Health (CDRH). This reporting is critical to the postmarket surveillance of medical devices and helps the FDA to monitor product performance and identify potential risks.

Adverse events can lead to further investigations, and if necessary, the implementation of risk management plans or Phase IV trials. The goal is to balance the costs associated with treatments and medical equipment, the quality of life of the patient, and the privacy of health records while ensuring that manufacturers maintain responsibility for the safety of their devices and that health-care facilities are observing appropriate protocols for use and maintenance.