Dress-Code---ans-✔✔Business-Casual-Attire-or-Scrubs/Uniforms
Is-it-a-requirement-for-BMET's-to-continue-training-throughout-their-career?-T/F---ans-
✔✔True
Definition-of-OEM/FSE---ans-✔✔Original-Equipment-Manufacturer/Field-Service-
Engineer
BMET-Core-responsibilities---ans-✔✔Repair-and-Maintenance-of-Medical-Equipment
Define-HIPAA---ans-✔✔Health-Insurance-Portability-and-Accountability-Act
Define-MEMP---ans-✔✔Medical-Equipment-Maintenance-Plan
Device-Classes-(As-defined-by-the-FAA)---ans-✔✔Class-I-devices-are-low-risk-devices.-
Examples-include-bandages,-handheld-surgical-instruments,-and-nonelectric-
wheelchairs.
Class-II-devices-are-intermediate-risk-devices.-Examples-include-computed-tomography-
(CT)-scanners-or-infusion-pumps-for-intravenous-medications.
Class-III-devices-are-high-risk-devices-that-are-very-important-to-health-or-sustaining-life.-
Examples-include-pacemakers-and-deep-brain-stimulators.
define-two-levels-of-recall---ans-✔✔Correction---Addresses-a-problem-with-a-medical-
device-in-the-place-where-it-is-used-or-sold.
Removal---Addresses-a-problem-with-a-medical-device-by-removing-it-from-where-it-is-
used-or-sold.
Define-the-Three-Classes-of-Recalls---ans-✔✔Class-I:-Recalls-for-products-which-could-
cause-serious-injury-or-death;
Class-II:-Recalls-for-products-which-might-cause-serious-injury-or-temporary-illness;
Class-III:-Recalls-for-products-which-are-unlikely-to-cause-injury-or-illness,-but-that-violate-
FDA-regulations.
, What-is-the-SDMA-and-how-is-it-used?---ans-✔✔Safe-Medical-Device-Act-(SMDA)-of-1990
Sequester-the-device-and-all-accessories-to-ensure-the-device-is-not-used-on-another-
patient
Ensure-the-device-is-clearly-labeled,-"Do-Not-Use"-to-ensure-another-employee-in-your-
department-does-not-put-it-back-into-service
Report-the-incident-your-supervisor-immediately
Document-the-incident
What-is-a-visual-inspection-that-a-HTM-performs?---ans-✔✔A-visual-inspection-is-a-type-
of-inspection-of-medical-equipment-using-vision,-hearing,-touch,-and/or-smell.-Visually-
inspect-a-medical-device-to-see-if-the-equipment-is-undamaged,-plugged-in,-and-working.
What-is-a-safety-check-that-a-HTM-performs?---ans-✔✔A-safety-check-on-a-device-is-a-
common-test-to-ensure-the-unit-is-properly-grounded-and-will-not-cause-a-shock-hazard-to-
the-patient-or-the-user.-There-is-a-specific-piece-of-test-equipment-(seen-later-in-the-
module)-that-measures-ground-resistance-and-chassis-leakage.-Once-the-unit-passes-
this-test-then-operational-and-function-tests-can-be-performed.
What-is-a-operational-check-that-a-HTM-performs?---ans-✔✔An-operational-check-is-
an-"out-of-the-box"-examination-to-ensure-the-device-is-not-externally-damaged-and-has-
all-of-the-accessories.-The-unit-is-then-set-up-to-be-functionally-tested.
What-is-a-functional-check-that-a-HTM-performs?---ans-✔✔A-functional-check-is-
performed-once-the-electrical-safety-check-(if-applicable)-and-operational-checks-are-
completed.-Following-the-manufacturer's-specifications-or-recommendations,-the-
functions-of-the-device-are-tested-and-verified-to-be-functioning-to-be-used-on-a-patient-or-
in-a-lab.
Planned/Preventative-Maintenance-(PM)---ans-✔✔Planned/Preventative-Maintenance-
(PM)-are-scheduled-maintenance-activities-that-occur-at-a-defined-frequency-(e.g.:-
annually).
high-risk-medical-equipment---ans-✔✔High-risk-medical-equipment-includes-life-support-
equipment-and-would-typically-require-vigorous-maintenance
Non-high-risk-equipment---ans-✔✔Non-high-risk-equipment-are-the-devices-not-included-
in-the-high-risk-category.-In-other-words,-there-are-two-categories:-high-risk-and-
everything-else.-Non-high-risk-may-or-may-not-require-maintenance-depending-on-the-
device-and-hospital-experience.
Alternative-Equipment-Maintenance---ans-✔✔An-Alternative-Equipment-Maintenance-is-
any-maintenance-procedure-that-deviates-from-the-manufacturer's-recommendations-for-
process-or-frequency.-To-execute-an-AEM,-regulatory-agencies-require-that-a-formal-
AEM-Plan-be-documented-showing-that-the-HTM-Department-evaluated-the-risks-
involved-and-the-maintenance-history-of-the-device.