Healthcare Technology and Regulations Flashcards
7 cards from real CABT practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Healthcare Technology and Regulations flashcards as text
What does the term 'intended use' mean in the context of FDA medical device regulation?
Answer: The objective intent of the manufacturer as indicated in labeling and promotional materials
Intended use refers to the objective intent of the manufacturer as reflected in labeling, advertising, and promotional materials, which determines regulatory classification.
ISO 13485 is a quality management standard specifically designed for:
Answer: Organizations in the medical device supply chain
ISO 13485 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services.
A hospital's biomedical department receives a Class II medical device recall notice. The FIRST action should be to:
Answer: Check the device serial numbers against the recall notice
The first step is to identify which devices on-site are affected by comparing serial/lot numbers against the recall notice before taking further action.
Under the Safe Medical Devices Act (SMDA), which facilities are required to report device-related adverse events to the FDA?
Answer: User facilities such as hospitals and nursing homes
The SMDA requires user facilities, including hospitals and nursing homes, to report device-related deaths and serious injuries to the FDA and/or manufacturer.
Which of the following best describes 'design validation' in medical device development under 21 CFR Part 820?
Answer: Confirming the device meets user needs and intended use through testing
Design validation confirms that the device conforms to defined user needs and intended uses, typically through real-world or simulated use testing.
A CBET notices a patient monitor displaying erratic readings after a nearby surgical cautery unit is activated. This interference is best categorized as:
Answer: Radiated susceptibility (immunity failure)
When a device malfunctions due to electromagnetic energy radiated from a nearby source, this is a radiated susceptibility or immunity failure.
Which federal law established the framework for regulating health information technology and incentivizing adoption of electronic health records (EHRs)?
Answer: HITECH Act (2009)
The HITECH Act of 2009 established programs to incentivize meaningful use of EHRs and strengthened HIPAA privacy and security enforcement.