Under the Safe Medical Devices Act, which party must report device-related deaths or injuries?

• A. Device manufacturers only
• B. Healthcare facilities that use the devices
• C. Health insurers
• D. Patients

Answer: (B)

Under the Safe Medical Devices Act, the healthcare facility that uses the device is responsible for reporting device-related deaths or serious injuries. This ensures that adverse events observed in real-world clinical settings are quickly communicated to the FDA and to the device manufacturer for prompt investigation and potential action, such as recalls or safety notices. While manufacturers also have reporting duties to the FDA, the obligation emphasized for this scenario is on the facilities where patients experience issues.