The Safe Medical Device Act became effective in 1990. What are hospitals required to do as a result?

The Safe Medical Device Act mandates that hospitals have specific responsibilities concerning the tracking and reporting of medical devices. One of the critical requirements is that hospitals must participate in tracking medical devices, particularly when a failure of the device could lead to serious adverse outcomes for patients. This focus on tracking is essential to ensure patient safety, facilitate timely identification of issues related to medical devices, and implement corrective actions when necessary.

The emphasis on tracking devices stems from the need for comprehensive data to evaluate the performance and safety of medical technologies after they are in use in clinical settings. Effective tracking can help identify patterns, potential hazards, and areas for improvement, ultimately ensuring better patient care and device management within healthcare facilities. This requirement reinforces a systemic approach to patient safety and accountability concerning medical devices used in hospitals.