Question

The Safe Medical Devices Act of 1990 and its amendments require:

a) Mandatory insurance coverage for medical devices
b) Reporting of adverse events related to medical devices
c) Taxation on medical device manufacturers
d) Government takeover of medical device production

Answer 1

The Safe Medical Devices Act of 1990 requires the reporting of adverse events related to medical devices.

Liability issues in the use of medical devices are complex and context-dependent, and economic pressures on the industry, such as excise taxes, can affect profitability and innovation.

Step-by-step explanation:

The Safe Medical Devices Act of 1990 and its amendments primarily require reporting of adverse events related to medical devices. The Act aims to ensure that medical devices are safe and effective and provides a system for monitoring and addressing potential issues.

In terms of liability, the question of whether hospitals or healthcare workers should be held responsible for following flawed procedures, or if manufacturers should be liable for equipment failure, is complex. It involves considerations around product safety, regulatory compliance, and user training. Liability can depend on the specifics of each case and regulations in place.

Furthermore, the medical device industry is subject to various economic pressures, including excise taxes, such as the medical device excise tax implemented in 2013 and repealed in 2019.

The impact of such taxes on profitability and innovation, as well as how the burden divides between industry and patients, depends on market dynamics like elasticity of demand and supply. Oversight for medical device safety and efficacy is handled by the FDA's Center for Devices and Radiological Health (CDRH).