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
Which FDA classification requires the most stringent premarket approval process for medical devices?
Answer: Class III
Class III devices require Premarket Approval (PMA) because they sustain or support life or present a potential unreasonable risk of illness or injury.
Under HIPAA, a Business Associate Agreement (BAA) is required when a third-party vendor does which of the following?
Answer: Creates, receives, maintains, or transmits PHI on behalf of a covered entity
A BAA is required whenever a vendor handles Protected Health Information (PHI) on behalf of a HIPAA-covered entity.
The primary purpose of the 510(k) premarket notification process is to demonstrate that a new device is:
Answer: Substantially equivalent to a legally marketed predicate device
The 510(k) pathway requires demonstrating substantial equivalence to a predicate device in terms of intended use and technological characteristics.
Which standard specifically governs electromagnetic compatibility (EMC) requirements for medical electrical equipment in the US?
Answer: IEC 60601-1-2
IEC 60601-1-2 is the collateral standard addressing electromagnetic disturbances requirements for medical electrical equipment.
A biomedical technician discovers that a ventilator has caused a patient injury. Under FDA MDR regulations, the hospital must report this event within:
Answer: 30 calendar days, or 5 working days if remedial action was taken
FDA MDR regulations require user facilities to report device-related deaths or serious injuries to FDA within 30 days, or 5 working days if remedial action was taken.
Which regulatory body oversees the accreditation of healthcare organizations in the United States and evaluates compliance with safety standards?
Answer: The Joint Commission (TJC)
The Joint Commission accredits and certifies healthcare organizations, evaluating compliance with performance standards to improve patient care quality and safety.
An IFU (Instructions for Use) for a medical device must be provided in which language for devices sold in the United States?
Answer: English only
FDA requires that IFUs for devices marketed in the US be in English, though manufacturers may include additional languages.