Question

The Safe Medical Device Act of 1990: A. Was designed to allow the FDA to have knowledge of a potentially faulty medical device within a year of an adverse event B. Requires all organizations that use medical devices in a home care setting to report injuries, illnesses, or deaths caused by or contributed to medical devices C. Is no longer part of the national standard and you no longer have any responsibility to report adverse events. D. Applies only to minor injuries that are non-life-threatening and dont require immediate medical treatment

1) Was designed to allow the FDA to have knowledge of a potentially faulty medical device within a year of an adverse event
2) Requires all organizations that use medical devices in a home care setting to report injuries, illnesses, or deaths caused by or contributed to medical devices
3) Is no longer part of the national standard and you no longer have any responsibility to report adverse events
4) Applies only to minor injuries that are non-life-threatening and dont require immediate medical treatment

Answer 1

The Safe Medical Device Act of 1990: Requires all organizations that use medical devices in a home care setting to report injuries, illnesses, or deaths caused by or contributed to medical devices (Option B).

Step-by-step explanation:

The Safe Medical Device Act of 1990, marked a crucial shift in medical device regulation in the United States. Option A isn't accurate as the act aimed to ensure the FDA received reports within 10 days of discovering a device-related serious injury or death, not necessarily within a year. Option C is incorrect; the act is still a critical component of national standards for medical device safety. Option D is misleading as the Act applies to all injuries, not just minor ones.

Option B correctly highlights the Act's emphasis on reporting obligations for home care settings, ensuring incidents linked to medical devices are documented and reported. Compliance with this Act is essential for maintaining safety standards and improving device quality in healthcare.

Correct Answer: Option B