HTSP study guide
HTSP · Work through your exam, one topic at a time.
The Healthcare Technology Safety Professional (HTSP) credential is aimed at people who keep medical equipment safe and effective inside care facilities: biomedical equipment technicians and clinical engineers, but also safety officers, facilities and IT staff who share responsibility for devices on the network. It tests whether you can reason across the whole device lifecycle rather than just repair a box. The HTSP study guide has 10 sections and about 3,343 words.
01Healthcare Technology Management Fundamentals
This domain tests whether you can run a technology lifecycle, not just repair devices: capital planning, inventory integrity, maintenance strategy, service-delivery models, and the metrics that prove the program works. Plan, select, acquire, accept, maintain, then replace or dispose.
337 words, about 2 min02Medical Device Safety and Risk Management
This domain asks you to quantify and control harm from medical devices across the lifecycle, using ISO 14971 logic and hospital-specific risk ranking. A hazard is a potential source of harm; a hazardous situation exists when people, property or environment are exposed; harm is injury or damage to health.
341 words, about 2 min03Electrical Safety and Environment of Care
This domain tests command of the physical care environment: power distribution, grounding, leakage current, NFPA 99 risk categories and the tests that prove a device is electrically safe. NFPA 99 assigns patient care spaces to categories, with the most stringent requirements for critical care.
365 words, about 2 min04Regulatory Compliance and Standards
Regulatory content tests the boundary between FDA device regulation and the accreditation standards that bind a hospital. Devices are Class I, II or III by risk.
349 words, about 2 min05Equipment Inspection, Testing, and Maintenance
Expect procedural detail: what to inspect, how to measure performance, what limits apply, how to document, and when you may deviate from a manufacturer schedule. Build the schedule from the CMMS inventory.
315 words, about 2 min06Incident Investigation and Failure Analysis
This domain tests a defensible method: make the situation safe, preserve evidence, separate device failure from use error, and close the loop with verified corrective action and required reporting. First make the patient and area safe, then preserve the device exactly as found.
352 words, about 2 min07Networked Medical Devices and Cybersecurity
This domain covers risk management of medical devices on IT networks: shared responsibility between clinical engineering and IT, and the controls that keep therapy available when security fails. IEC 80001-1 defines the responsible organization (the hospital), the medical device manufacturer and the IT provider, and requires a risk management file for changes to the medical IT network.
333 words, about 2 min08Human Factors and Usability in Healthcare Technology
This domain covers how device design and the care environment produce use-related hazards, and how those hazards get evaluated under IEC 62366-1. A use error is an action or failure to act by the user that leads to a different result than intended; it is not negligence.
327 words, about 2 min09Quality Improvement and Patient Safety
Expect methods and measurement: how to prove an improvement is real, how to build a safety culture, and how to respond when harm occurs. The Model for Improvement sets an aim, measures and changes, tested in small PDSA cycles.
307 words, about 2 min10Professional Practice, Ethics, and Communication
This domain covers conduct expectations: competence, conflicts of interest, confidentiality, disclosure and how you communicate risk to clinicians and leadership. Practice within your competence and scope, and escalate when a device or situation exceeds it.
317 words, about 2 min