HTSP flashcards

32 cards. Read the term and the definition here. The deck at the top of this page is optional.

Total cost of ownership

Purchase price plus installation, training, consumables, service contracts, downtime cost, and disposal cost, discounted over the expected service life of the equipment.

Work order lifecycle

The sequence from request through triage and priority assignment, diagnosis, repair, verification testing, documentation, and authorized return to clinical service.

Equipment uptime

Scheduled available hours minus downtime hours, divided by scheduled available hours, multiplied by 100; tracked by device class rather than fleet-wide only.

Risk control hierarchy

Apply inherently safe design first, then protective measures in the device or process, and rely on information for safety such as labeling or training only as a last resort.

FMEA risk priority number

RPN equals severity multiplied by occurrence multiplied by detection. Act on the highest RPN values and on any failure mode with high severity regardless of RPN.

Residual risk acceptance

After controls are applied, evaluate remaining risk against defined criteria, document the rationale, and monitor through post-production surveillance for new hazards.

Chassis leakage current limit

For Class I patient-care equipment, chassis or earth leakage is typically limited to 500 microamps, while patient-lead leakage limits are substantially lower.

Line isolation monitor

Monitors cumulative hazard current in isolated power systems, commonly alarming near 5 mA, and signals insulation degradation without interrupting power to the load.

Class I versus Class II

Class I devices depend on protective earth plus basic insulation; Class II devices use double or reinforced insulation and do not rely on a protective earth connection.

Electrical safety analyzer tests

Measure protective earth resistance, chassis leakage, patient-lead leakage in AC and DC, and insulation resistance under normal and single-fault conditions such as open ground.

Substantial equivalence

The 510(k) standard requiring a new device to have the same intended use and comparable safety and effectiveness as a legally marketed predicate device.

Unique Device Identification

A globally unique identifier assigned to a device model and often to lot or serial level, recorded in a public database to support traceability and recall management.

Medical device reporting

Manufacturers and importers must report device-related deaths, serious injuries, and certain malfunctions to the FDA within mandated timeframes after becoming aware.

IEC 62304

The medical device software lifecycle standard defining software safety classes and required development, verification, risk management, and maintenance processes.

PM interval basis

Interval set from manufacturer recommendation, device risk score, historical failure rate, and accreditation expectations, with the rationale documented in the maintenance record.

Performance verification versus safety test

Electrical safety testing confirms leakage and grounding limits; performance verification confirms measured output, calibration, and alarm function against manufacturer tolerances.

Return to service authorization

Documented verification that repair and testing are complete and the device meets specifications, signed by qualified personnel before removal of the out-of-service tag.

Evidence preservation

Sequester the device, accessories, settings, and logs immediately after an incident; document state before cleaning, altering, or clearing memory.

Root cause analysis

A structured team method using tools such as fishbone diagrams, five whys, or fault trees to separate immediate causes from contributing system causes.

Non-reproducible failure

Failure not recreated on the bench does not prove the device is fault-free; investigate reported conditions, logs, and environmental factors before concluding.

Software bill of materials

A machine-readable inventory of software components and dependencies in a device, used to assess vulnerability exposure and support coordinated patch management.

Network segmentation

Isolating clinical device networks from enterprise and guest networks using separate VLANs and allow-listing only required ports and protocols.

Default credential risk

Factory default usernames and passwords on networked devices must be changed at commissioning; shared administrator accounts should be eliminated or tightly controlled.

Summative usability evaluation

Validation testing with representative users and use environments to confirm that use-related hazards are adequately controlled by the user interface design.

Alarm fatigue

Desensitization caused by excessive non-actionable alarms; mitigated through appropriate limits, delays, hysteresis, and clear alarm prioritization.

Use error

An action or omission during device use that differs from intended or expected behavior; it is a design and workflow concern, not automatically user negligence.

PDSA cycle

Plan a change and measure, Do a small test, Study the results, then Act to adopt, adapt, or abandon before wider implementation.

Special-cause variation

Variation in a process that signals an assignable, non-random change and warrants investigation, as distinguished from inherent common-cause variation.

Just culture

A framework that consoles human error, coaches at-risk behavior, and sanctions reckless behavior, supporting reporting without punishing honest mistakes.

SBAR communication

A structured handoff format covering Situation, Background, Assessment, and Recommendation, used to convey device or patient safety concerns clearly and promptly.

Scope of practice

The boundary of tasks a technician is trained and authorized to perform; unfamiliar or high-risk work is escalated to qualified personnel rather than attempted.

Contemporaneous documentation

Recording what was done, when, by whom, and with what measurements and results, at the time of the activity, objectively and without later reconstruction.