• 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. An Academic presentation by
Dr. Nancy Agnes, Head, Technical Operations, Pubrica
Group: www.pubrica.com
Email: sales@pubrica.com
SYSTEMI
C REVI
EWS ON
I
MPLANTABLE MEDI
CAL
DEVI
CES PROVI
DE A
QUALI
TY OF REPORTI
NG

2. Today's Discussion
In-Brief
Introduction
Defining Active Implantable Medical Devices
Literature Search
Eligibility Criteria and Citation Screening
Data Extraction
Recommendations of Reporting Items for Systemic
Reviews of Implantable Medical Devices
Conclusion
Outline

3. 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.

4. 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.
Contd...

5. 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.
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.
Contd...

6. According to
(FDA), these
the Food and Drug Administration
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.
Contd...

7. 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.
Contd...

8. 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
recommendations of the Technical Expert
the
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.

9. 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:
Contd...

10. 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.

11. 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.

12. 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
characteristics,
goal was to
it included
assess reporting
reviews of any
implantable device from any of the five categories
that looked at a recent publication.
Contd...

13. Contd...

14. 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).

15. 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.
Data
Extraction

16. 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.
Contd...
Recommendations of Reporting Items for Systemic
Reviews of Implantable Medical Devices

17. Device type
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.
Cardiac defibrillators with or without pacemakers
Contd...

18. Contd...

19. 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)
Contd...

20. 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
Contd...

21. 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 Contd...

22. Type of device coating
Skin-replacement grafts
Type of skin graft required
Composition of graft
Graft type: bioabsorbable or requiring removal
Stimulation parameters
frequency
intensity
pulse width
Electrode location
Neurostimulators

23. 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.
Contd...

24. 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.

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