Question

Death from a medical device or death from a malfunctioning piece of equipment must be reported to __________.

Answer 1

Deaths from medical devices or equipment malfunctions must be reported to the FDA's CDRH. The MedWatch program allows for this reporting. Liability depends on adherence to protocols, device safety, and government regulations.

Step-by-step explanation:

Death from a medical device or death from a malfunctioning piece of equipment must be reported to the U.S. Food and Drug Administration (FDA), specifically to the Center for Devices and Radiological Health (CDRH). The CDRH is responsible for overseeing the safety and effectiveness of medical devices and equipment. Manufacturers, healthcare providers, and other entities are required to report serious adverse events, including deaths, to the FDA. This reporting can be done through the FDA's MedWatch program. However, determining liability in such situations can be complex, as healthcare providers must follow established protocols, manufacturers must ensure the safety of their devices, and the government oversees and enforces regulations and procedures for safe use and maintenance.