CABT Healthcare Technology and Regulations 5

Question 1

According to The Joint Commission Environment of Care (EC) standards, medical equipment management plans must include:

Accepted Answer

Criteria for identifying, evaluating, and taking inventory of equipment before use

Answer

TJC EC standards require that the equipment management plan define criteria for identifying, evaluating, and inventorying equipment prior to its initial use.

Question 2

Which risk management standard is specifically applicable to the design and manufacture of medical devices?

Accepted Answer

ISO 14971

Answer

ISO 14971 specifies a process for manufacturers to identify hazards associated with medical devices and manage associated risks throughout the product lifecycle.

Question 3

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:

Accepted Answer

Exceeding the 500 µA limit and the device should be removed from service

Answer

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.

Question 4

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?

Accepted Answer

Device History Record (DHR)

Answer

The Device History Record (DHR) contains the production records demonstrating that the device was manufactured in accordance with the DMR.

Question 5

Which of the following best describes 'risk priority number' (RPN) used in Failure Mode and Effects Analysis (FMEA)?

Accepted Answer

The product of severity, occurrence, and detectability ratings for a failure mode

Answer

RPN is calculated by multiplying severity × occurrence × detectability scores, helping prioritize which failure modes require the most urgent corrective action.

(CABT) Certified Associate in Biomedical Technology Practice Test

(CABT) Certified Associate in Biomedical Technology Practice Test

CABT Healthcare Technology and Regulations 5