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
According to The Joint Commission Environment of Care (EC) standards, medical equipment management plans must include:
Answer: Criteria for identifying, evaluating, and taking inventory of equipment before use
TJC EC standards require that the equipment management plan define criteria for identifying, evaluating, and inventorying equipment prior to its initial use.
Which risk management standard is specifically applicable to the design and manufacture of medical devices?
Answer: ISO 14971
ISO 14971 specifies a process for manufacturers to identify hazards associated with medical devices and manage associated risks throughout the product lifecycle.
A patient-connected medical device shows a leakage current reading of 600 µA under normal condition (NC). Per NFPA 99 and AAMI standards, this reading is:
Answer: Exceeding the 500 µA limit and the device should be removed from service
AAMI/ANSI ES60601-1 and NFPA 99 limit chassis leakage current for patient-care equipment to 500 µA under normal conditions; 600 µA exceeds this limit.
Under the FDA's Quality System Regulation (21 CFR Part 820), which record documents the complete history of the manufacture of a finished device lot?
Answer: Device History Record (DHR)
The Device History Record (DHR) contains the production records demonstrating that the device was manufactured in accordance with the DMR.
Which of the following best describes 'risk priority number' (RPN) used in Failure Mode and Effects Analysis (FMEA)?
Answer: The product of severity, occurrence, and detectability ratings for a failure mode
RPN is calculated by multiplying severity × occurrence × detectability scores, helping prioritize which failure modes require the most urgent corrective action.
Which CMS Condition of Participation requires hospitals to have an ongoing program for maintaining medical equipment?
Answer: 482.41(c) – Equipment Maintenance
CMS CoP 482.41(c) requires hospitals to maintain and inspect equipment to ensure safety for patients and personnel.
A CBET is asked to evaluate a newly proposed telemedicine cart that includes a tablet, camera, and vital signs monitor. The MOST appropriate regulatory framework to apply is:
Answer: FDA regulations for the vital signs monitor component plus HIPAA for data security
The vital signs monitor is an FDA-regulated medical device, while HIPAA governs the security of any transmitted patient health information, making both frameworks applicable.