HTSP cheat sheet

HTM scope: technology planning, acquisition support, inventory, maintenance, safety, and disposal of medical equipment across its full lifecycle.

Equipment inventory record minimums: unique ID, manufacturer/model/serial, location, acquisition date, cost, risk score, PM interval, and service history.

Capital planning inputs: clinical need justification, replacement age vs. manufacturer support status, failure/repair cost trend, parts availability, and interoperability requirements.

Total cost of ownership = purchase price + installation + training + consumables + service contracts + downtime cost + disposal cost, discounted over expected life.

Uptime (%) = (scheduled available hours - downtime hours) / scheduled available hours x 100; track by device class, not only fleet-wide.

In-house vs. service contract decision hinges on technician competency, manufacturer training/IP restrictions, parts access, volume, and liability exposure.

Work order lifecycle: request, triage/priority, diagnosis, repair, verification testing, documentation, and return to service authorization.

Priority tiers typically: life-support/immediate (response minutes), urgent clinical (hours), routine (next business day), and scheduled/cosmetic.

Risk = probability of harm x severity of harm; assess both pre- and post-mitigation residual risk and document acceptance rationale.

ISO 14971 sequence: risk analysis, risk evaluation, risk control, evaluation of residual risk, and post-production monitoring.

Risk control hierarchy: inherently safe design, protective measures in device or process, then information for safety (labeling/training) as last resort.

FMEA: list failure modes, rate severity (S), occurrence (O), detection (D), compute RPN = S x O x D, and act on highest RPN and any high-severity mode.

Fault tree analysis works top-down from an undesired event through AND/OR gates to basic causes; FMEA works bottom-up from components.

Use error vs. device failure: distinguish user-action-caused events from malfunctions; the same event may require both human-factors and engineering fixes.

Hazard categories to screen: electrical, mechanical, thermal, radiation, biological, software, alarm, and use-environment hazards.

Recall/field safety corrective action handling: verify affected inventory by serial/UDI, quarantine, correct or replace, document closure, and notify users.

Patient-care categories: critical care (cardiac, ICU, OR) requires the strictest leakage limits; general care and non-patient areas are less restrictive.

Chassis leakage limit for Class I patient-care equipment is typically 500 microamps; patient-lead leakage limits are far lower (about 100 microamps or less).

Ground resistance for receptacles: test with a receptacle tester or milliohmmeter; the equipment grounding conductor path should read well under 1 ohm.

Class I devices rely on protective earth plus basic insulation; Class II (double insulated) devices have no protective earth and must not depend on ground.

Line isolation monitor in critical areas alarms on cumulative hazard current (commonly at 5 mA) and does not interrupt power; it signals insulation degradation.

Electrical safety analyzer tests: protective earth resistance, chassis/earth leakage, patient-lead leakage (AC and DC), and insulation resistance.

Leakage current rises with applied voltage and with the number of connected applied parts; test in normal and single-fault (open ground, reversed polarity) conditions.

Environment of care rounding checks: blocked access to panels, damaged cords/plugs, missing strain relief, liquid near electrical equipment, and expired safety testing labels.

US FDA device classes: Class I low risk (general controls), Class II moderate risk (special controls, often 510(k) with predicate), Class III high risk (PMA).

510(k) requires substantial equivalence to a legally marketed predicate; PMA requires valid scientific evidence of safety and effectiveness.

Quality system regulation (21 CFR 820, now aligned with ISO 13485) governs design controls, purchasing, production, CAPA, and complaint handling.

Unique Device Identification (UDI) enables tracking to the serial/lot level; the Global UDI Database is the public reference for device identifiers.

Medical device reporting: manufacturers and importers must report deaths, serious injuries, and certain malfunctions to FDA within mandated timeframes.

EU MDR classification runs I, IIa, IIb, III with conformity assessment via notified body for higher classes; CE marking follows successful assessment.

Standards map: IEC 60601-1 (basic safety/essential performance), IEC 62304 (medical device software lifecycle), IEC 62366-1 (usability engineering), ISO 14971 (risk).

Accreditation surveys (e.g., Joint Commission) examine equipment maintenance records, testing intervals, and documentation of corrective actions.

PM interval is set by manufacturer recommendation, risk score, historical failure rate, and regulatory/accreditation expectations; document the basis.

Electrical safety testing is a component of PM, not a substitute for performance verification (calibration, output checks, alarm tests).

Performance verification compares measured output against manufacturer tolerance; record the measured value, not just pass/fail.

PM completion should be tracked as a percentage of due items; deferred PM requires documented risk assessment and clinical approval.

Alternate equipment (equivalent device) must be identified for life-support and critical devices to cover downtime and PM windows.

Out-of-service tagging: physically tag, remove from clinical use, log the reason, and require documented verification before return to service.

Test equipment used for calibration must itself be calibrated with traceability to a national standard; record calibration due dates.

Failure trending: analyze work orders by device model and failure mode to adjust PM intervals or justify replacement.

Preserve evidence first: sequester the device, accessories, settings, and logs; do not alter or clean before documentation.

Interview sequence: obtain the account of the event, the device state at the time, environmental conditions, and any alarms or messages observed.

Root cause analysis uses a structured team approach (e.g., fishbone, 5 Whys, fault tree) and distinguishes immediate cause from contributing/system causes.

Device logs (event logs, error codes, therapy history) are primary evidence; export and hash/retain them before clearing memory.

Bench testing should attempt to reproduce the failure under the reported conditions; a non-reproducible failure is not proof of no fault.

Corrective action must address system causes (training, labeling, PM change, design feedback) and be verified for effectiveness, not just closed.

Reportable events may require notification to the manufacturer, FDA (MedWatch), and internal risk management per policy and timeline.

Distinguish device malfunction, use error, and environmental cause; the classification drives the corrective action and reporting path.

Medical device cybersecurity risk assessment covers confidentiality, integrity, and availability, with patient safety impact weighted above data loss.

Pre-market and post-market expectations include a software bill of materials (SBOM), coordinated vulnerability disclosure, and timely security patches.

Network segmentation isolates clinical device VLANs from enterprise/guest networks; allow-list only required ports and protocols.

Default credentials on devices must be changed at commissioning; shared local admin accounts should be eliminated or tightly controlled.

Patch management tension: validate vendor patches before deployment but do not indefinitely defer critical safety-relevant patches; document risk acceptance.

Device inventory must capture network attributes: IP/MAC, OS/firmware version, connected systems, and end-of-support dates.

Wireless medical telemetry requires RF site survey, channel planning, and monitoring for interference and coverage gaps.

Incident response for a compromised device includes isolation, clinical fallback plan, vendor notification, and forensic log preservation.

IEC 62366-1 usability engineering process: identify use-related hazards, characterize use environment and users, and validate the user interface.

Formative evaluation is iterative testing during design; summative evaluation validates that use-related hazards are adequately controlled.

Use error is not the same as user negligence; design should make correct action easy and incorrect action difficult or recoverable.

Alarm fatigue: excessive non-actionable alarms cause desensitization; address via alarm limits, delay/hysteresis settings, and alarm prioritization.

Cognitive load and interruption increase error rates; critical tasks should have confirmation steps and clear state visibility.

Labeling and instructions for use are part of risk control but are weaker than design controls; do not rely on them alone.

Heuristic evaluation and simulated-use testing with representative users reveal interface problems before clinical deployment.

Post-deployment usability issues should feed back to the manufacturer and into local training and workflow redesign.

PDSA cycle: Plan (define change and measure), Do (small test), Study (analyze results), Act (adopt, adapt, or abandon).

Quality measures need a numerator, denominator, data source, and target; run charts and control charts distinguish common from special cause variation.

Common-cause variation is inherent to the process; special-cause variation signals a change requiring investigation.

Sentinel events trigger root cause analysis; near misses should trigger a proactive risk assessment (e.g., FMEA) before harm occurs.

Just culture distinguishes human error (console), at-risk behavior (coach), and reckless behavior (sanction).

Benchmarking: compare device-related adverse events and PM compliance against internal trends and external peer data.

Standardization (equipment models, workflows, labeling) reduces variation and error; too many device models increase training burden.

Close the loop: verify that improvement actions produced measurable change and sustain gains through audits.

Scope of practice: perform only tasks within training and authorization; escalate unfamiliar or high-risk work to qualified personnel.

Documentation standard: record what was done, when, by whom, with what measurements and result; contemporaneous and objective.

Conflict of interest: disclose vendor gifts, sponsored travel, and consulting relationships that could influence equipment decisions.

Confidentiality: patient and device incident data are protected; share only on a need-to-know basis per policy and law.

Communication with clinicians should be clear, timely, and structured (situation, background, assessment, recommendation).

Escalation duty: report unsafe conditions, defective equipment, or near misses through the appropriate chain regardless of hierarchy.

Competency maintenance: track continuing education, certifications, and manufacturer training currency for the equipment you service.

Ethical obligation: prioritize patient safety over schedule pressure, cost savings, or convenience when making release-for-use decisions.