CHFM - Certified Healthcare Facility Manager Medical Equipment and Technology Management Questions and Answers Flashcards

Which organization establishes the standards for medical equipment management programs required by accredited US hospitals?

Answer: The Joint Commission (TJC)

The Joint Commission's Environment of Care (EC) standards require hospitals to have a written medical equipment management program.

What is the primary purpose of a Medical Equipment Management Plan (MEMP) in a healthcare facility?

Answer: To establish criteria for identifying, inspecting, testing, and maintaining medical equipment

The MEMP defines how a facility identifies, evaluates, and maintains medical equipment to ensure safe and effective patient care.

The FDA requires medical device manufacturers to report equipment malfunctions that could cause serious injury through which system?

Answer: MedWatch / MDR (Medical Device Reporting)

The FDA's Medical Device Reporting (MDR) system, accessible via MedWatch, requires manufacturers and importers to report device malfunctions and adverse events.

An equipment Inspection and Preventive Maintenance (IPM) interval is BEST determined by:

Answer: Manufacturer recommendations, risk assessment, and regulatory requirements

IPM intervals should be based on manufacturer guidelines, the equipment's risk level, and applicable regulatory or accreditation requirements.

Which equipment management strategy involves continuous monitoring of equipment condition to predict failures before they occur?

Answer: Predictive maintenance

Predictive maintenance uses real-time data (vibration, temperature, etc.) to forecast equipment failure and schedule service before a breakdown occurs.

When a healthcare facility receives a Medical Device Safety Alert from the FDA or manufacturer, the FIRST action of the facility manager should be:

Answer: Assess the facility's inventory to determine if affected devices are present

The first step is to assess whether the facility owns affected devices, then follow the alert's recommended corrective actions.