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

A requirement that all PMs are performed by OEM-certified technicians only

Answer

Monthly audits by the state health department

Answer

Mandatory replacement of all equipment older than 10 years

Question 2

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

Accepted Answer

ISO 14971

Answer

ISO 31000

Answer

ANSI/ASSE Z690.3

Answer

IEC 31010

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

Acceptable for all patient-connected devices

Answer

Within limits for body surface contact (BF) devices only

Answer

Only acceptable if the device is isolated from ground

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

Design History File (DHF)

Answer

Device Master Record (DMR)

Answer

Corrective Action Report (CAR)

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

The total cost of potential failures over device lifetime

Answer

The number of reported adverse events divided by total devices in service

Answer

A regulatory classification assigned by the FDA

Question 6

Which CMS Condition of Participation requires hospitals to have an ongoing program for maintaining medical equipment?

Accepted Answer

482.41(c) – Equipment Maintenance

Answer

482.13 – Patient Rights

Answer

482.41 – Physical Environment

Answer

482.45 – Organ, Tissue, and Eye Procurement

Question 7

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:

Accepted Answer

FDA regulations for the vital signs monitor component plus HIPAA for data security

Answer

HIPAA Security Rule only, since only data is transmitted

Answer

Only state telemedicine licensure laws

Answer

FCC regulations for wireless transmission exclusively