HTM Glossary
Plain-English definitions of the key terms, acronyms, and standards in Healthcare Technology Management, biomedical equipment, and clinical engineering.
52 terms
510(k) — Premarket Notification 510(k)
A 510(k) is the FDA premarket submission a manufacturer files to show a new medical device is substantially equivalent to a legally marketed one before selling it in the U.S.
AAMI — Association for the Advancement of Medical Instrumentation
The Association for the Advancement of Medical Instrumentation (AAMI) is the primary U.S. organization developing standards and training for the HTM and medical device community.
ACCE — American College of Clinical Engineering
The American College of Clinical Engineering (ACCE) is the professional society that advances the practice of clinical engineering and certifies clinical engineers.
AEM — Alternate Equipment Management
An Alternate Equipment Management (AEM) program lets a hospital adjust maintenance activities and frequencies away from the manufacturer's recommendations based on a documented, risk-based assessment.
Asset Tag
An asset tag is the unique identifier label affixed to a medical device so it can be tracked in the CMMS throughout its lifecycle.
Biomed
Biomed is the common shorthand for the biomedical equipment staff and department responsible for servicing a hospital's medical devices.
BMET — Biomedical Equipment Technician
A Biomedical Equipment Technician (BMET) is the frontline HTM professional who installs, inspects, repairs, and maintains medical devices in a healthcare facility.
Calibration
Calibration is the process of comparing and adjusting a medical device's output against a known standard to ensure its measurements are accurate.
Capital Planning
Capital planning is the budgeting process of forecasting when medical equipment must be replaced or newly acquired based on age, condition, and lifecycle.
CBET — Certified Biomedical Equipment Technician
A Certified Biomedical Equipment Technician (CBET) is a BMET who has passed AAMI's national certification exam demonstrating competency in medical equipment servicing.
CE — Clinical Engineer
A clinical engineer (CE) is a degreed engineer who manages medical technology programs, evaluates new devices, and oversees the technical staff who maintain them.
CLES — Certified Laboratory Equipment Specialist
A Certified Laboratory Equipment Specialist (CLES) is a technician certified to service the analyzers and instruments used in clinical laboratories.
Clinical Engineering
Clinical engineering is the branch of HTM in which engineers apply engineering principles to the safe, effective, and cost-efficient use of medical technology in patient care.
CMMS — Computerized Maintenance Management System
A Computerized Maintenance Management System (CMMS) is the software HTM teams use to track medical equipment inventory, schedule maintenance, and log work orders.
CMS — Centers for Medicare & Medicaid Services
The Centers for Medicare & Medicaid Services (CMS) is the federal agency whose Conditions of Participation set the medical equipment maintenance rules hospitals must follow to receive Medicare funding.
Corrective Maintenance
Corrective maintenance is the repair work done to restore a medical device to working order after it has malfunctioned or failed.
CRES — Certified Radiology Equipment Specialist
A Certified Radiology Equipment Specialist (CRES) is a technician certified to service imaging and radiology equipment such as X-ray and CT systems.
Depot Repair
Depot repair is a service model in which a failed medical device or module is shipped to a central facility for repair rather than being fixed on-site.
Electrical Safety Analyzer
An electrical safety analyzer is the test instrument BMETs use to verify a medical device's leakage currents and grounding meet electrical safety limits.
EMR — Electronic Medical Record
An electronic medical record (EMR) is the digital version of a patient's chart, into which integrated medical devices can feed measurements and results.
End-of-Life — EOL
End-of-life (EOL) is the point at which a manufacturer no longer supports a medical device with parts, service, or software, signaling it should be planned for replacement.
Field Service Engineer — FSE
A field service engineer (FSE) is a technician who travels to healthcare sites to install, repair, and maintain medical equipment, often on behalf of a manufacturer or ISO.
HTM — Healthcare Technology Management
Healthcare Technology Management (HTM) is the profession of managing the selection, maintenance, safety, and lifecycle of the medical equipment used to deliver patient care.
Imaging Service Engineer — ISE
An imaging service engineer is a specialized technician who services diagnostic imaging systems such as CT, MRI, X-ray, and ultrasound.
Incoming Inspection
Incoming inspection is the safety and performance check HTM staff perform on new or repaired medical equipment before it is placed into clinical use.
ISO (Independent Service Organization) — Independent Service Organization
An Independent Service Organization (ISO) is a third-party company that services and repairs medical equipment independently of the original manufacturer.
ISO 13485
ISO 13485 is the international quality management system standard specifically for organizations that design, produce, or service medical devices.
Joint Commission — TJC
The Joint Commission (TJC) is the independent U.S. body that accredits healthcare organizations and sets standards, including requirements for medical equipment management.
Loaner
A loaner is a temporary replacement medical device supplied to a facility while its own equipment is being repaired, to preserve patient care continuity.
MAUDE — Manufacturer and User Facility Device Experience
MAUDE (Manufacturer and User Facility Device Experience) is the FDA's public database of adverse-event reports involving medical devices.
MDR — Medical Device Reporting
Medical Device Reporting (MDR) is the FDA system through which manufacturers, importers, and user facilities must report device-related deaths, serious injuries, and malfunctions.
Mean Time Between Failures — MTBF
Mean Time Between Failures (MTBF) is the average operating time a medical device runs before it fails, used to gauge reliability and plan maintenance.
Medical Device Cybersecurity
Medical device cybersecurity is the practice of protecting networked medical equipment from unauthorized access, malware, and data breaches that could compromise patient safety.
Medical Device Integration — MDI
Medical device integration (MDI) is the practice of connecting medical devices to hospital networks and electronic health records so device data flows automatically into the patient record.
NFPA 99 — National Fire Protection Association 99
NFPA 99, the Health Care Facilities Code, sets the minimum requirements for the safe installation, testing, and maintenance of gas, electrical, and mechanical systems in healthcare facilities.
OEM — Original Equipment Manufacturer
An Original Equipment Manufacturer (OEM) is the company that built a medical device and typically provides its parts, service, and maintenance recommendations.
PM — Preventive Maintenance
Preventive maintenance (PM) is scheduled, proactive servicing performed on medical equipment to keep it safe and functional before it fails.
PMI — Planned Maintenance Inspection
A Planned Maintenance Inspection (PMI) is the scheduled inspection portion of a preventive maintenance visit, verifying a device is safe and performing to specification.
Preventable Failure
A preventable failure is a medical equipment breakdown that scheduled maintenance or inspection could reasonably have caught and avoided.
Preventive Maintenance Frequency
Preventive maintenance frequency is how often a given medical device is scheduled for PM, set by manufacturer guidance or a risk-based AEM program.
Recall
A recall is a manufacturer or FDA action to correct or remove a medical device that is defective, unsafe, or in violation of FDA regulations.
Recall Class I
A Class I recall is the FDA's most serious recall category, used when a medical device is likely to cause serious injury or death.
Recall Class II
A Class II recall is an FDA recall for a medical device that may cause temporary or reversible health problems, with only a slight chance of serious harm.
Recall Class III
A Class III recall is the FDA's least serious recall category, used when a medical device violates regulations but is unlikely to cause harm.
Right-to-Repair
Right-to-repair is the movement to give hospitals and independent servicers legal access to the parts, manuals, and software needed to repair medical devices themselves.
Service Contract
A service contract is an agreement in which a manufacturer or ISO provides defined maintenance and repair services for medical equipment over a set term.
SLA — Service Level Agreement
A Service Level Agreement (SLA) is the contract defining the response times, coverage, and performance a service provider guarantees for maintaining medical equipment.
SMDA — Safe Medical Devices Act
The Safe Medical Devices Act (SMDA) of 1990 requires manufacturers and healthcare facilities to report device-related deaths, serious injuries, and malfunctions to the FDA.
Test Equipment
Test equipment is the collection of calibrated instruments HTM technicians use to verify that medical devices perform safely and accurately.
UDI — Unique Device Identifier
A Unique Device Identifier (UDI) is the standardized code the FDA requires on medical devices so each one can be identified and tracked through distribution and use.
Uptime
Uptime is the percentage of time a medical device is fully operational and available for patient care.
Work Order — WO
A work order is the documented request and record for a specific maintenance or repair task on a piece of medical equipment.