Hi! This is Jessica Spellman. We’re going to be
reviewing the safe use of medical equipment.
After taking this course, you will be able
to define medical equipment and be able to
give examples. Understand what constitutes
a medical device and adverse reaction event.
Explain barriers nurses encounter when it
comes to using medical devices correctly.
And review several professional nursing organization
statements regarding the use of medical equipment.
You’ll also be able to incorporate suggestions
in the clinical practice for their prevention
of adverse events related to medical device
adverse events. Medical equipment is defined
as a piece of equipment used to prevent, diagnose,
or treat a medical condition, disease, or injury.
It cannot contain a medication, a biologic
agent or food. And in the U.S., medical
equipment must meet the regulations set forth
by the Food and Drug Administration.
Let’s go over a few examples. We have some simple
medical devices; tongue depressors, gloves,
thermometers, syringes, gauze, bandaids, and
durable medical equipment such as walkers,
hearing aids, diabetic blood glucose monitoring
supplies. We also have very complex medical
devices, such as life supporting devices, ventilators,
heart and lung and dialysis machines.
Monitoring equipment such as ECGs, EEGs, and
pulse oximetry. And diagnostic equipment such
as X-rays, CT scans and MRI machines, as well
as infusion pumps to administer medications.
So I mentioned the FDA is responsible for
maintaining the safety of devices. So, let’s
review how they do that. They require that
medical equipment be safe, effective, and
follow the guidelines set forth by the FDA.
They also register manufacturer devices and
assure that the equipment is labelled according
to regulations before being available for
purchase. They also perform surveillance on
equipment on the market to ensure the product
functions as expected. And when it doesn’t, they
review reports of problems or poor patient
outcomes that result from using medical equipment.
So the FDA is really taking a responsible role
in trying to maintain the safety of medical
devices. But when the device is not safe or
something happens, it’s called a medical
device adverse event. And that’s when the
device is or is suspected of causing or contributing
to the death or serious injury of a patient.
The incidents of medical device adverse events
had risen significantly from 2000 to 2009.
The causes of those adverse events can be
things like device factors such as there’s
incorrect device in the package, inadequate
labeling or instructions, or inaccurate interactions
between the device and health information
technology systems. There's human factors
that could be the cause of the adverse events,
such as inadequate education on the device,
failure of alarm or failure of staff to respond
to a critical alarm or the device design is
not intuitive or easy to use and it was used
inappropriately. Specifically, nurses worry
most about ventilators not functioning properly.
That’s one of the items or pieces of equipment
that they worry about the most. Nurses report
the most frequent means of learning for them
is trial and error and not formal education.
Nurses hear alarms but they have many devices
with many alarms and they do not always respond.
Some perceive alarms as falls or non-urgent
or they’re just overwhelmed with the amount
of alarms. Users are not always familiar with
equipment and have not checked the alarm status.
So it’s another way that the equipment can
fail. Most professional nursing organizations
are listening to nurses’ concerns and developing
position statements related to the safe use
of medical equipment. A position statement
identifies the policies, issues, and standards
important for the nursing profession. Position
statements are important to enhance the entire
nursing profession and enhance outcomes for
patients. A few examples of these organizational
statements, position statements. The Association
of Women’s Health Obstetrics and Neonatal
Nurses discussed with the FDA the increase
in fetal deaths associated with electronic
fetal heart monitoring in order to improve
outcomes for neonates that are hooked up to
fetal heart monitors. Another example is the
Association of Operating Room Nurses who developed
a statement on caring for patients in the
OR and trying to prevent fires in the OR, which
is a significant problem in the operating
room. Education is key to preventing medical
device adverse events. Education for nurses
needs to focus on the following things. Know
the intended use of the device and the desired
outcome. Understand the instructions for use
and contraindications for the device.
Nurses need to be able to recognize the importance
of complying with manufacturer expiration
dates. Device sterility may be guaranteed
only until the expiration date. And insight
into the differences in devices that appear
similar so that you’re using the correct
device. In summary, nurses are the point of
care users for most medical equipment.
Examples of medical devices range from a simple band-aid
to a complex ventilator. And if nurses are
not aware of the safe use of medical equipment,
patient safety is at risk. The FDA is the
agency that compiles most of the reports of
medical device adverse events. And the proper
education of nurses in using medical devices
is the best way to prevent errors and promote
patient safety. This has been safe use of
medical equipment, and I’m Jessica Spellman.