complete solutions
Dress Code - ANSWER- Business Casual Attire or Scrubs/Uniforms
Is it a requirement for BMET's to continue training throughout their career? T/F -
ANSWER- True
Definition of OEM/FSE - ANSWER- Original Equipment Manufacturer/Field Service
Engineer
BMET Core responsibilities - ANSWER- Repair and Maintenance of Medical
Equipment
Define HIPAA - ANSWER- Health Insurance Portability and Accountability Act
Define MEMP - ANSWER- Medical Equipment Maintenance Plan
Device Classes (As defined by the FAA) - ANSWER- 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 - ANSWER- 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 - ANSWER- 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? - ANSWER- 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? - ANSWER- 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? - ANSWER- 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? - ANSWER- 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? - ANSWER- 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) - ANSWER- Planned/Preventative
Maintenance (PM) are scheduled maintenance activities that occur at a defined
frequency (e.g.: annually).
high-risk medical equipment - ANSWER- High-risk medical equipment includes
life-support equipment and would typically require vigorous maintenance
Non-high-risk equipment - ANSWER- 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 - ANSWER- 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.
What equipment can and cannot be included in an AEM implementation?
Organizations cannot deviate from these categories of equipment: - ANSWER-
Any imaging device (x-rays, etc.), Lasers, Anything regulated by state or federal
regulations, and
Devices that are new to the industry, as organizations need relative history in
order to deviate
Should a hospital follow it's own AEM? - ANSWER- The hospital or organization
must follow its own AEM program as it is written to be successful.
What service documents would you need to perform an OEM PM? - ANSWER-
Performing OEM (original equipment manufacturers) preventive maintenance
refers to following the manufacturer's recommended intervals and activities
found in the service documentation or service manual. Companies are not
required to provide the service manual but one could be requested or purchased.
Calling technical support is also an option to acquire service information to
perform the PM.