Final answer:
Investigators in clinical investigations are responsible for ensuring that medical devices are safe and effective through inspection, trials, and surveillance, with oversight by the FDA and CDRH.
Step-by-step explanation:
Investigators involved in clinical investigations of medical devices are responsible for ensuring the safety and effectiveness of these devices through rigorous testing and adherence to established protocols. These responsibilities include inspecting production and warehousing facilities, investigating complaints or adverse outcomes, and reviewing documentation. In addition, they are tasked with conducting clinical trials and postmarketing surveillance to monitor the long-term safety and performance of medical devices approved by the Food and Drug Administration (FDA). The oversight roles are further supported by the Office of Regulatory Affairs, Consumer Safety Officers, and the Center for Devices and Radiological Health (CDRH).
When negative outcomes occur due to flawed protocols or faulty equipment, the question of liability arises. Hospitals and healthcare workers might be held liable if they fail to follow proper procedures, while manufacturers could be held responsible for defective devices. Furthermore, government agencies like the FDA establish protocols and are involved in the approval and monitoring processes to ensure fail-safe use and maintenance of medical equipment.