What does the Safe Medical Device Act (SMDA) of 1990 require from medical device user facilities?

The Safe Medical Device Act (SMDA) of 1990 was established to enhance the reporting and monitoring of medical device safety. A primary requirement of the SMDA for medical device user facilities is to report any incidents where a device has caused or contributed to injury or death. This reporting is crucial because it allows the Food and Drug Administration (FDA) to track problems with specific devices, prompt further investigation, and implement necessary actions to safeguard public health.

By requiring user facilities to report such incidents, the SMDA aims to create a system that helps identify and mitigate risks associated with medical devices. Additionally, this law empowers the FDA and other stakeholders to improve device safety through collected data.

The other options do not capture the essence of the SMDA. While financial losses and in-house testing may be important operational aspects, they are not mandated by the SMDA. Furthermore, although certain dangerous devices can be prohibited, the act itself is focused on improving safety through a robust reporting mechanism rather than outright bans on device usage.