• Defining active implantable medical devices • Literature search • Eligibility criteria and citation screening • Data extraction • Reporting of device or procedure-specific data Continue Reading: https://bit.ly/2UMYAPu For our services: https://pubrica.com/services/research-services/systematic-review/ Why Pubrica: When you order our services, We promise you the following – Plagiarism free | always on Time | 24*7 customer support | Written to international Standard | Unlimited Revisions support | Medical writing Expert | Publication Support | Biostatistical experts | High-quality Subject Matter Experts.   Contact us:      Web: https://pubrica.com/  Blog: https://pubrica.com/academy/  Email: sales@pubrica.com  WhatsApp : +91 9884350006  United Kingdom: +44-1618186353

1. Copyright © 2021 pubrica. All rights reserved 1
Systemic Reviews on Implantable Medical
Devices Provide a Quality of Reporting
Dr. Nancy Agnes, Head, Technical Operations, Pubrica, sales@pubrica.com
In brief
Even though there have been many systematic
reviews of implantable medical devices published,
no empirical evaluation of the reviews has been
done. To understand the methodology utilized,
identify existing strengths, limitations, flaws, and
specific issues, and provide recommendations to
enhance future conduct and reporting, we
undertook a critical appraisal of the quality of
reporting in systematic reviews of implanted medical
devices. These characteristics may have an impact
on the study outcomes (1)
.
I. INTRODUCTION
In medical practice and research, systematic reviews
service have a well-established place. Clinicians
utilize systematic reviews to stay up to date on
current research and compare the efficacy of
competing therapies. Although many systematic
evaluations of medical devices have been published,
no empirical evaluation of the reviews has been
conducted. The findings of an empirical evaluation of
systematic reviews of medical devices could be
utilized to design new reporting rules and improve the
conduct and quality of systematic reviews of medical
devices reporting (2)
.
The Consolidated Standards of Reporting Trials
(CONSORT) Statement was recently updated to
include trials of non-pharmacological treatments;
however, there are still no recommendations for
systematic evaluation of medical devices. Implantable
medical devices are one big group of devices of
interest. According to the Food and Drug
Administration (FDA), these are devices that are
partially or implanted into the body or a natural
orifice via surgical or medical procedures and are
intended to remain in the body or orifice for at least
30 days, according to the Food and Drug
Administration (FDA) (or permanently). Such
devices can only be physically removed or medically
deactivated.Implantable devices can also be utilized
to replace an epithelium or ocular surface. The
market for implantable medical devices in the United
States is expected to expand 8.3% year to $49 billion,
with spinal implants, cardiac implants, and
orthobiologics being the fastest-growing categories
(substances that accelerate healing of injured bones).
Here assumed a critical appraisal of the quality of
reporting in systematic reviews of implanted medical
devices as the Evidence-based Practice Center (EPC)
designated for the crosscutting concentration of
diagnostic testing, imaging technologies, and medical
and assistive devices. The project's objectives were to
assess published systematic reviews and meta-
analyses to understand better the methodologies used
and identify current strengths, limitations,
deficiencies, and unique challenges and make
recommendations for future conduct and reporting.
They chose to focus on five broad categories of
implantable medical devices based on the
recommendations of the Technical Expert Panel
(TEP) and to ensure inclusion of the most commonly
used and expensive devices: cardiac implantable
devices, vascular interventional devices, orthopaedic
implants, skin-replacement grafts, and
neurostimulators(3)
.
II. DEFINING ACTIVE IMPLANTABLE
MEDICAL DEVICES
An active medical device operates by using and
converting a large amount of energy. Except for
gravitational and direct human energies, active
devices can use any energy. Active medical devices,
as defined by the Therapeutic Goods (Medical
Devices) Regulations 2002, can be broadly classified
into two categories:
 The manufacturer intends for active medical
devices for diagnosis to be used on a human
being to provide information for detecting,
diagnosing, monitoring, or treating physiological
conditions, states of health, illnesses, or
congenital deformities, either alone or in
combination with another medical device.
 The manufacturer intends for active medical
devices for therapy to be used on a human being
to maintenance, modify, replace, or restore
biological functions or structures to treat or
alleviate an illness, injury, or handicap, either
alone or in combination with another medical
device(4)
.

2. Copyright © 2021 pubrica. All rights reserved 2
III. LITERATURE SEARCH
Systematic reviews published between January 2009
and December 2010 were found using keywords for
each of the five categories of implantable medical
devices in MEDLINE® and the Cochrane Database
of Systematic Reviews. Articles with abstracts that
described searches or eligibility criteria for study
identification or included terms like "systematic,"
"evidence," "evidence-based," "meta-analysis," or
"pooled analysis" were considered potentially
relevant reviews.
IV. ELIGIBILITY CRITERIA AND CITATION
SCREENING
Many published systematic reviews of implantable
medical devices did not explicitly report all three
fundamental components during full-text screening.
Because the goal was to assess reporting
characteristics, it included reviews of any implantable
device from any of the five categories that looked at a
recent publication. For example, a review of a
pacemaker, a review of a defibrillator, or a review of
both a pacemaker and a defibrillator might be
included in the cardiac implantable device category.
Systematic reviews of any type (randomized trials,
non-randomized comparative studies, or
observational research), as well as synthesis
technique, were considered (qualitative or
quantitative synthesis including meta-analyses of
individual patient data) (5)
.
Table: 1 Reporting items for systematic reviews of
implantable medical devices
V. DATA EXTRACTION
There are currently no defined techniques or
protocols for assessing the quality of systematic
reviews of implantable medical devices reporting.
Here examined the TEP to identify device- and
operator-specific information relevant to these
devices' evaluation. In addition to the 30 systematic
reviews, specific information items described in the
MOOSE and PRISMA recommendations have found
eight device- and operator-specific information items.

3. Copyright © 2021 pubrica. All rights reserved 3
VI. RECOMMENDATIONS OF REPORTING
ITEMS FOR SYSTEMIC REVIEWS OF
IMPLANTABLE MEDICAL DEVICES
Reporting of device or procedure-specific data
PROSPERO—the International Prospective Register
of Systematic Reviews—also offers systematic
review reporting, conduct, scientific writing, and
publication through a formal protocol registration
process. At the time of registration of systematic
review protocols, propose include eight new device-
and operator-specific elements unique to implanted
medical device research. This project would
encourage academics to report systematic reviews of
implantable medical devices more accurately and
transparently. Also, propose adding eight new
device- and operator-specific topics to the extension
guide unique to implantable medical device studies (6)
.
Cardiac defibrillators with or without pacemakers:
 Device type
 Method of implantation
 Position of the electrode
 Description of microprocessor technology
and programmable features
 Alert features that monitor lead impedance
Vascular interventional devices (e.g., stents)
 Type of stent and stenting technique
 Generation of the stent (e.g., first or second
generation)
 Type of antiproliferative drug used
 Delivery system
 Polymer layer

4. Copyright © 2021 pubrica. All rights reserved 4
 Stent frame
Orthopaedic implants
 Type of device
 Surgical technique or approach
 Number and location of devices
 Fixation and supplementary materials such
as plates and screws
 Type of device coating
Skin-replacement grafts
 Type of skin graft required
 Composition of graft
 Graft type: bioabsorbable or requiring
removal
Neurostimulators
 Stimulation parameters
o frequency
o intensity
o pulse width
 Electrode location
VII. CONCLUSION
The lack of reporting of some essential general items
applicable to any systematic review and device- and
operator-specific information is revealed in a review
of systematic reviews on implantable medical
devices. Eight device- or operator-specific items were
also identified as potentially useful in reporting on
systematic reviews of implanted devices and might be
included in reporting recommendations.In recent
years, the number of systematic evaluations of
implantable medical devices has increased
dramatically, with reviews appearing in a wide range
of journals. Failure to include data on procedures and
devices could lead to incorrect synthesis or
interpretation of results because there is no widely
acknowledged standard for reporting information to
implantable medical device research(7)
.
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