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HEALTHCARE DATABASES AND DECISION-MAKING
Module 10 –
Biomedical and Medical Devices Integration
Biomedical or medical devices are instruments or equipment used for the diagnosis, treatment,
and management of diseases or disorders in diverse medical settings. Such devices range from
large equipment (X-Ray and MRI – Magnetic Resonance Imaging) to micro devices (cardiac
pacemakers) to tiny nano-scale physiological functions monitoring devices (smart pills and
ingestible sensors) residing in internal organs. These medical devices either integrate
(interconnect) with the main organizational data network, with other devices, or with different
parts of themselves to share data. These biomedical devices and their
integration/interconnectivity are the subjects of this module.
Module 10 Objectives:
After completing this module, you should be able to:
1.
2.
3.
4.
Explain various medical devices’ functions.
Compare types of medical/biomedical devices in use with respect to their functions.
Assess the significance of medical/biomedical devices integration with the EHR.
Evaluate the value of biomedical devices for improving healthcare quality.
Module 10 Readings
Biomedical device technology: principles and
design http://ezproxy.umgc.edu/login?url=https://search.ebscohost.com/login.aspx?direct=true
&db=nlebk&AN=1214062&site=eds-live&scope=site&ebv=EB&ppid=pp_C, Chapter 1 –
Overview of Biomedical Instrumentation, pgs. 5-9.
Methods In Research And Development Of Biomedical
Devices http://ezproxy.umgc.edu/login?url=https://search.ebscohost.com/login.aspx?direct=tr
ue&db=nlebk&AN=545485&site=eds-live&scope=site&ebv=EB&ppid=pp_7. Chapter 2 –
Overview of Biomedical Technologies, pgs.7-9.
World Health Organization (WHO) Medical devices (who.int).
What is a biomedical device? What is a Biomedical Device? | Biotech Careers (biotechcareers.org).
Classify Your Medical Device Classify Your Medical Device | FDA.
Four Considerations for Successfully Integrating a Medical Device into the
EMR Considerations for Integrating a Medical Device into the EMR (welchallyn.com).
Medical Device Integration: Store Real-time Patients Data Directly into EHR, EHR, LIS &
HIS Medical Device Integration Solutions | With EMR, EHR, LIS, HIS (syscreations.com).
Module 10 Presentations
•
•
(45513) What Is a Medical Device? (New Medical Device Regulation MDR 2017/745)
– YouTube.
(45513) FDA 101 for Medical Devices – YouTube
Module 10 Resources
•
•
What are Medical Devices? (news-medical.net).
22 Medical Device Industry Trends You Need to Know About – Medical Trends Now.
FDA Medical Device Classification (FDA & EU MDR) – SimplerQMS
Discusssion
There are several devices in the market that are principally classified as medical, cosmetic,
and pharmaceutical. Using the internet resources, search one for each of these three categories
and discuss their functions. Why do you think they fall in that category? Justify your response
with argument(s). In which of the categories do eyeglasses, fitness tracking applications,
prefilled syringes, and arterial stent fall, and why? Which national institution regulates
biomedical/medical devices? In your opinion, do medical devices improve patients’ health
and how?
You may enhance your discussion by reproducing image(s) for each category. Make sure to
cite them following APA 7
Your initial post comprising a minimum of 250 words should be submitted by Saturday
midnight, followed by a minimum of two (2) responses to classmates’ posts comprising at
least 150 words supporting, challenging, clarifying, or adding to the existing information . 2
credible sources should be used to support your ideas. Follow APA 7
Assignment
Medical device integration implies wireless interconnectivity between themselves for
sharing data as well as with the healthcare facility’s EHR system. Medical device integration
allows for data transfer to the EHR data repository eliminating the need for manual data
collection and entry. Assess the pros and cons of medical device integration
(interconnectivity) with the EHR (Hint: do not stop at data security). Offer pathways to
overcome the cons of the process. Analyze how FDA involved in medical device integration
or wireless interconnectivity. Is it restricting or promoting medical device digitalization
development? Why? Offer one area in healthcare (managerial) where such medical device
integration with EHR is important for organizational sustainability. Provide reasoning for
your choice. Support your responses with arguments and examples of medical devices when
responding to the prompt.
Your APA formatted assignment comprising 2-4, double-spaced, typed in 12-point Times
New Roman (or 11- point Calibri) excluding the Cover and Reference pages. 2 credible
sources should be used to support your ideas. Follow APA 7 format.
Copyright © 2013. World Scientific. All rights reserved. May not be reproduced in any form without permission from the publisher, except fair uses permitted under U.S. or
applicable copyright law.
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Overview of Biomedical Technologies
CONTENTS
2.1 Classification of Biomedical Devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.2 Description of Biomedical Devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.2.1 Aneurysmal Stents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.2.2 Endovascular Stents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.2.3 Biomedical MEMS Micropump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.2.4 Drug Delivery Devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.3 Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.4 Questions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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2.1 Classification of Biomedical Devices
As depicted in Fig. 2.1, a biomedical device can be classified into five categories
that serve both diagnostic and therapeutic purposes. Various types of drug delivery
mechanisms such as nasal, gastrointestinal and intravascular drug delivery systems
are available for a variety of applications. Surgical restoration device such as the
stent is mainly used to restore normal blood circulation through implantation of
biomedical device into the affected tissues or organs. The stent can serve to prevent
cardiovascular-related complications such as re-stenosis or occlusion in arteries.
Medical-assisting devices are applied to correct pathological conditions and
applications include cochlear implants, corrective lenses and heart–lung machines.
Diagnostic devices refer to both procedures such as blood pressure and glucose
monitoring to provide measurement and diagnosis of clinical situations. Mechanical
part replacement indicates the use of artificial components to substitute the diseased
anatomical structures or organs which cannot be treated medically.
2.2 Description of Biomedical Devices
In this section, we present the properties or characteristics of the device, which includes the mechanism of operation and evaluation techniques. Each of the following
7
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8
Methods in Research and Development of Biomedical Devices
Biomedical Device
Drug Delivery Mechanism
Respiratory Drug Delivery
Pulmonary Drug Inhaler
Nasal Drug Delivery
Nasal Drug Spray
Gastrointestinal Drug Delivery
Drug-Eluting Pill
Drug Delivery Micropump
Intravascular Drug Delivery
Drug-eluting Stent
Surgical Restoration
(Via catheterisation)
Intravascular Stent
Biodegradable Heart Stent
Balloon Angioplasty
Non-biodegradable Heart Stent
Septal Occluder
Atrial Septal Occluder
Ventricular Septal Occluder
Cochlear Implant
Corrective Lense
Medical-Assisting Device
(External support device)
Infusion Pump
Dialysis Machine
Heart-lung Machine
Dental Implants
Artificial Limbs
Facial Prosthetics
Ocular prosthetics
Joint Replacement
Medical-Assisting Device
(Surgically implanted device)
Mechanical Part Replacement
Artificial Organ
Prosthetic Heart Valve
Ventricular Assist Device
Artificial Pacemaker
Computed Tomography
Medical Imaging
Blood Glucose Monitor
Diagnostic Device
Magnetic Resonance Imaging
Blood Pressure Monitor
Single Photon Emission
Computed Tomography
Pulse Measurement
Positron Emission Tomography
Temperature Measurement
Ultrasound
Angiography
FIGURE 2.1
Characterisation of medical technologies. A biomedical device can be classified into five categories which serve both diagnostic and therapeutic purposes:
(1) drug delivery mechanisms aim to optimise the transport of medicine into the
body; (2) surgical restoration devices are mainly used to restore normal a normal
body function through implantation of biomedical device into the affected tissues
or organs; (3) medical-assisting devices are applied to correct pathological conditions; (4) diagnostic devices refer to both medical imaging and non-medical imaging
procedures to provide measurement and diagnosis of clinical situations; and (5) mechanical part replacement indicates the use of artificial components to substitute the
diseased anatomical structures or organs which cannot be treated medically and need
to be amputated.
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Overview of Biomedical Technologies
9
subsection highlights of the nature of a biomedical flow device and the considerations
related to its testing and evaluation.
2.2.1 Aneurysmal Stents
Aneurysm is defined as the focal dilatation in the arterial wall and is commonly
caused by atherosclerotic disease of blood vessels. With aging, aneurysms increase
in size, which results in the rupture and initiation of bleeding within the body regions, such as the brain. This is responsible for high mortality such as haemorrhagic
stroke. The affected arteries are generally treated with stents through angioplasty
procedures. Medical imaging techniques such as CT and conventional angiography
play an important role in the detection of aneurysms and preoperative planning. To
achieve effective treatment, the type of stents deployed has to be of sufficient porosity
to minimise aneurysmal rupture,24 and yet has to prevent platelet aggregation. A
computational model can be simulated to show stenting inside the diseased artery at
the entrance of the aneurysm, and demonstrate that the interference with blood flow
is different from the situation before stent treatment. Figure 2.2 shows the various
stent porosities that can be configured for an aneurysm.
Non-Stented
Aneurysm
Stented Aneurysm
(2 Stent Struts)
Stented Aneurysm
(3 Stent Struts)
Stented Aneurysm
(4 Stent Struts)
FIGURE 2.2
Configuration of stent porosities. The reason to insert stents inside the aneurysm
is to embolise it or exclude it from systemic blood circulation, so that the aneurysm
will shrink gradually (due to reduced pressure) and eventually become smaller. It is
true that this may induce stagnation and possible thrombosis formation after stenting;
however, as long as the aneurysm does not grow, the chance of being ruptured is low,
so the goal of preventing it from rupture is achieved.
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