Reutilization Of Medical Devices Intended Only For One Patient
May 6, 2023 ⚊ 1 Min read ⚊ Views 110 ⚊ BUSINESSIn the late 1970s, people started reusing medical gadgets intended for a single patient. Before this point, the majority of gadgets were thought to be reusable. As a method for reducing expenses, there was a rise in the reuse of devices intended for a single patient. Between 20 and 30 per cent of hospitals in the United States have stated that they reuse at least one kind of gadget intended for single-time usage only. Reusing single-use medical devices raises numerous regulatory, ethical, medical, legal, and economic concerns, and it has been at the centre of a heated debate for almost two decades.
This document outlines the Food and Drug Administration’s intention to enforce premarket submission requirements within the following time frames: six months (February 2001) for class III devices (such as cardiovascular intra-aortic balloon pumps and transluminal coronary angioplasty catheters).