HTSP key terms

The discipline of planning, acquiring, maintaining, and retiring medical equipment so it stays safe, available, and cost-effective across its full lifecycle, combining engineering, clinical, regulatory, and business knowledge.

The process of forecasting clinical need, evaluating options, budgeting, and justifying major equipment purchases before acquisition, including total cost of ownership and replacement timing for aging devices.

The full lifetime expense of a device, covering purchase price, installation, consumables, service contracts, training, utilities, downtime, and disposal, used to compare options fairly rather than by sticker price alone.

Software that tracks equipment inventory, work orders, maintenance schedules, parts, and service history, providing the records and reports that support inspection planning, compliance evidence, and performance monitoring.

A maintained record of every device in use, including manufacturer, model, serial number, location, owner, and risk category, forming the basis for scheduling, recall tracking, and regulatory reporting.

Scheduled inspection, testing, and servicing performed at defined intervals to keep equipment within specification, with intervals set by manufacturer instructions, risk, and experience rather than convenience.

A documented request and authorization for maintenance or repair work, recording the problem, actions taken, parts used, labor, and outcome so the service history and compliance record stay complete.

Unscheduled repair performed after a fault or failure is discovered, restoring the device to safe operating condition and typically triggering documentation of the failure mode and any follow-up testing.

A documented program that replaces some manufacturer-recommended maintenance with an evidence-based alternative schedule or procedure, permitted only when risk is assessed and regulatory conditions are met.

A service frequency chosen from the device's harm potential, failure history, use intensity, and manufacturer guidance, so higher-risk equipment receives more frequent attention than low-risk items.

A regulatory ranking of devices by the potential harm of failure, from low-risk items such as tongue depressors to high-risk life-support equipment, which drives controls, review, and oversight requirements.

A regulatory submission demonstrating that a new device is substantially equivalent to a legally marketed predicate, allowing clearance without full clinical trials in many cases.

A globally unique code on device labels and packaging that identifies the model and production unit, enabling precise recall tracking, inventory accuracy, and adverse event reporting.

A manufacturer or regulator action to remove or correct a device that poses a health risk, classified by severity, requiring the organization to identify affected units, act, and document the response.

A manufacturer-initiated action outside the factory to reduce risk from a marketed device, such as software updates, relabeling, or component replacement, communicated through field safety notices.

The documented directions supplied with a device covering intended use, setup, operation, cleaning, maintenance, and warnings, which the organization must follow or formally justify departing from.

A test instrument that measures leakage current, ground continuity, and insulation resistance on medical equipment, verifying the device meets limits before it is returned to patient use.

Small unintended current flowing from a device to ground, the patient, or the chassis through insulation or capacitance, kept below defined limits because it can cause burns or cardiac disruption.

The measured resistance of the protective earth path from the device chassis to the plug, confirming a low-impedance route that lets fault current trip a breaker instead of reaching a person.

The design and testing characteristic that keeps applied-part circuits separated from earth and mains, limiting current through a patient even when a fault or external source is present.

A very small current, on the order of tens of microamperes, that can trigger ventricular fibrillation when it passes directly to the heart through an intracardiac catheter or similar low-resistance path.

Current applied externally through intact skin, where higher thresholds are needed to cause harm but can still produce burns, muscle contraction, or cardiac effects at sufficient magnitude and duration.

The portion of a medical device designed to contact the patient physically, classified by degree of protection, which determines the isolation and leakage limits that apply during testing.

A device in an isolated power system that continuously reports hazard current to ground, alarming before a first fault becomes dangerous in critical care areas such as operating rooms.

An electrical distribution design in which neither conductor is intentionally grounded, so a single fault does not create a complete circuit through a patient or staff member.

The set of safety, security, hazardous materials, fire, and utility management conditions in which care is delivered, monitored through rounds, documentation, and performance measures.

Scheduled verification that backup generators and critical branch circuits start and carry load within required time, documenting results so life-support equipment remains powered during outages.

A prospective team method that lists ways a process or device can fail, scores severity, occurrence, and detectability, and prioritizes actions to reduce the highest-risk failure modes before harm occurs.

An adaptation of FMEA for healthcare processes that maps steps and failure modes, uses hazard scoring rather than a simple product, and targets the most consequential vulnerabilities for redesign.

A score formed by multiplying severity, occurrence, and detection ratings in FMEA, used to rank failure modes for action, though it should not replace clinical judgment about severe harm.

A structured retrospective investigation that reconstructs an event, identifies contributing system factors and latent conditions, and produces corrective actions aimed at preventing recurrence rather than blaming individuals.

An unexpected occurrence involving death or serious physical or psychological harm, or the risk of it, which triggers immediate investigation, notification, and a root cause analysis.

A managed process for fixing an identified problem and preventing its recurrence, including investigation, action plan, implementation, effectiveness check, and closure with documented evidence.

An organizational approach that distinguishes human error from at-risk and reckless behavior, encouraging reporting of mistakes while still holding people accountable for intentional disregard of safe practice.

A non-punitive system through which staff and sometimes patients submit safety concerns or near misses, supplying data for trend analysis that mandatory incident reports alone would not capture.

An event that could have caused harm but did not reach the patient or produced no injury, valuable because it reveals system weaknesses without the consequences of an actual adverse event.

The practice of designing devices, interfaces, and workflows around real human capabilities and limits, reducing use errors by matching equipment to perception, cognition, and physical reach.

A failure in the interaction between user, device, and environment rather than a personal shortcoming, often traced to confusing controls, ambiguous displays, or workflow mismatches that design can correct.

Formative or summative evaluation in which representative users operate a device under realistic conditions while observers record difficulties, revealing design problems before purchase or deployment.

Desensitization caused by excessive alarms, many of them non-actionable, leading staff to delay or ignore responses and increasing the risk that a true critical alarm is missed.

A coordinated program of default settings, parameter customization, escalation policies, and monitoring that keeps alarms meaningful, audible where needed, and matched to patient acuity.

Equipment that exchanges data over wired or wireless networks, creating benefits in integration and remote monitoring along with exposure to cyber threats, misconfiguration, and dependency on IT infrastructure.

The controls and practices protecting medical devices and their data from unauthorized access, tampering, and disruption, spanning inventory, patching, configuration, monitoring, and incident response.

Dividing a network into isolated zones so that compromised or untrusted systems cannot freely reach clinical devices, limiting the spread of attacks and simplifying access control.

A machine-readable inventory of the software components and versions inside a device, letting organizations assess exposure when a third-party library vulnerability is disclosed.

The ongoing cycle of discovering, prioritizing, remediating, and verifying security weaknesses in devices and supporting systems, balancing clinical availability against the risk of exploitation.

The documented structure of policies, procedures, and records by which an organization controls quality, ensuring consistent service, traceable decisions, and readiness for internal and external audit.

An external evaluation against recognized standards in which surveyors review documents, observe practice, and interview staff to confirm that safety and equipment management requirements are met continuously.

A structured cycle of measuring a process, analyzing variation, testing changes, and holding gains, used to raise equipment availability, safety, and satisfaction with measurable targets.

A quantifiable measure chosen to track whether an important objective is being achieved, such as maintenance completion rate or mean time to repair, reported regularly to guide decisions.

The average operating time between consecutive failures for a population of devices, used to judge reliability, compare models, and justify replacement or maintenance changes.

The average elapsed time needed to restore a failed device to service, reflecting parts availability, staffing, and service responsiveness, and useful for planning spares and support contracts.

The proportion of scheduled time that equipment is available and functioning, a practical indicator of clinical readiness that depends on maintenance quality, redundancy, and rapid repair.

Oversight of vendor agreements covering maintenance scope, response times, parts, and reporting, ensuring contracted obligations are delivered and cost is justified against in-house capability.

Structured education given to clinical staff when equipment is introduced or changed, covering correct operation, safety features, cleaning, and reporting of problems, with competency documented.

The specific manner in which a component or system stops performing its intended function, such as drift, open circuit, or software lockup, forming the unit of analysis in reliability studies.

A hidden weakness in design, staffing, procedures, or equipment that lies dormant until combined with other factors to produce an incident, often the real target of corrective action.

A situation in which a technology manager's personal, financial, or vendor relationship could bias a recommendation or acceptance decision, requiring disclosure and recusal to preserve trust.