CCE - Certified Clinical Engineer Regulatory Compliance and Standards Questions and Answers

Question 1

A clinical engineering department is implementing an Alternative Equipment Maintenance (AEM) program for a fleet of general-purpose infusion pumps.
According to The Joint Commission (TJC) standards, which of the following is a mandatory exclusion from an AEM program?

Accepted Answer

Medical laser devices

Answer

Equipment with a history of frequent, low-risk failures

Answer

Devices that are more than 10 years old

Answer

Portable diagnostic equipment used in multiple departments

Question 2

A hospital has received a new model of a medical device. What does the FDA's Quality System Regulation (21 CFR 820) require of the manufacturer regarding the servicing of this device?

Accepted Answer

To establish and maintain instructions and procedures for performing and verifying that servicing meets specified requirements.

Answer

To provide free on-site service for the first year of operation.

Answer

To use only replacement parts sourced from the original component suppliers.

Answer

To ensure all service technicians are certified by a third-party organization.

Question 3

A clinical engineer is involved in the design and risk management process for a new piece of medical electrical equipment. Which international standard provides the general requirements for basic safety and essential performance?

Accepted Answer

IEC 60601-1

Answer

NFPA 99

Answer

AAMI EQ56

Answer

ISO 9001

Question 4

During a routine inspection, a clinical engineer discovers that the labeling on several medical gas zone valve boxes does not accurately reflect the rooms they serve. Which standard is primarily concerned with the proper installation, labeling, and maintenance of medical gas and vacuum systems in healthcare facilities?

Accepted Answer

NFPA 99, Health Care Facilities Code

Answer

The Joint Commission's Environment of Care (EC) standards

Answer

FDA 21 CFR Part 820

Answer

IEC 60601-1-8, Alarms

Question 5

A hospital is preparing for a survey by The Joint Commission. A surveyor asks to see the medical equipment inventory. Which of the following is a key requirement for this inventory under the Environment of Care (EC) standards?

Accepted Answer

It must be a current, accurate, and unique listing of all equipment in the management program.

Answer

It must only include equipment that is owned by the hospital.

Answer

It must be updated once every three years, prior to the survey.

Answer

It must only list high-risk and life-support equipment.

Question 6

Which of the following standards specifically addresses the general requirements, tests, and guidance for alarm systems in medical electrical equipment and medical electrical systems?

Accepted Answer

IEC 60601-1-8

Answer

IEC 62304

Answer

ISO 14971

Answer

NFPA 70