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Module 1
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What does HTM stand for?
Healthcare Technology Management
What do HTMs do
They’re responsible for managing the selection, maintenance, and safe and effective use of medical technology and systems in hospitals
What does ISOs stand for?
Independent Service Organizations
What do ISOs do?
Employs various HTM professionals, and hospitals and/or healthcare organizations contract with them to provide their HTM services.
What does OEM stand for?
Original Equipment Manufacturers
What does MEMP stand for?
Medical Equipment Maintenance Plan
What does MEMPs do?
Outlines the policies of the HTM Department for accredited hospitals
What are Class I devices
low-risk devices like bandages, handheld surgical instruments, and nonelectric wheelchairs.
What are Class II devices
intermediate-risk devices like computed tomography (CT) scanners or infusion pumps for intravenous medications.
What are Class III devices
high-risk devices that are very important to health or sustaining life like pacemakers and deep-brain stimulators.
What is an FDA Class I recall?
Recalls for products which could cause serious injury or death
What is an FDA Class II recall?
Recalls for products which might cause serious injury or temporary illness
What is an FDA Class III recall?
Recalls for products which are unlikely to cause injury or illness, but that violate FDA regulations
What does the SMDA stand for?
Safe Medical Device Act
What did the SMDA do?
requires medical device user facilities to report to the Secretary of Health and Human Services, the manufacturer, or both whenever they believe there is a probability that a medical device has caused or contributed to a death, illness, or injury
What is involved in incoming inspections?
Testing on a new device that has just entered the hospital,
ensures the device is working as it was intended to,
passes all safety tests and QA tests
has includes all necessary service documentation such as a service manual or diagnostic software
adding the device to the hospital’s medical equipment inventory.
Steps of inspection and what they are
Safety: ensure the unit is properly grounded and will not cause a shock hazard to the patient or the user
Operational: an “out of the box” examination to ensure the device is not externally damaged and has all of the accessories.
Functional: following the manufacturer's specifications or recommendations, the functions of the device are tested and verified to be functioning
What does PM stand for?
Planned/Preventative Maintenance
What does Planned/Preventative Maintenance do?
scheduled maintenance activities that occur at a defined frequency
verify the device’s performance and provide the device with a “tune-up”
restore a medical device to good condition
include an inspection for safe and effective operation.
What does AEM stand for?
Alternative Equipment Maintenance
What is Alternative Equipment Maintenance
any maintenance procedure that deviates from the manufacturer’s recommendations for process or frequency
What do you need to do an AEM
a formal AEM Plan be documented showing that the HTM Department evaluated the risks involved and the maintenance history of the device
Organizations cannot do an AEM on what equipment?
Any imaging device (x-rays, etc.)
Lasers
Anything regulated by state or federal regulations
Devices that are new to the industry, as organizations need relative history in order to deviate
What does CM stand for?
corrective maintenance (fancy term for repair)
What does PHI stand for?
potential patient health information
What does CMMS stand for?
Computer Maintenance Management System
What does a CMMS do?
facilitate the daily operations of a Healthcare Technology Management (HTM) department
collects and stores essential asset information for all devices within your medical equipment inventory
schedule and document operational, preventive, and planned maintenance activities
When devices are added into the CMMS which of following information (work orders) should always be recoded?
Unique equipment ID number
Manufacturer
Model Number
Serial Number
Equipment Type (device category)
Location in Hospital
Device Owner (customer or department)
Equipment Status
Acquisition Information (including purchase order, acquisition date, and cost)
Warranty Information
Contract info
Purchase info
What does FSM stand for?
Factory service manuals
What do FSMs do?
Provides info for BMETs about information on maintenance procedures and intervals. Covers cover the servicing, maintenance, and repair of their products
What is considered to be one of the most important skills that BMET employers are looking for?
Communication