A systematic literature search performed in databases (Medline, Cochrane Library, Scopus, Embase, CRD York), selected journals and websites identified articles describing either a general MDR structure or the development process of specific registries.
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A SYSTEMATIC
REVIEW OF QUALITY
STANDARDS FOR
MEDICAL DEVICES AND
PRACTICE MEASURES
FOR PATIENT SAFETY
An Academic presentation by
Dr. Nancy Agnes, Head, Technical Operations, Pubrica
Group: www.pubrica.com
Email: sales@pubrica.com
TODAY'S OUTLINE
In brief
Introduction
Development of an MDR
Designing the MDR
Ethical and legal requirements
Future possibilities for medical device reporting in registries
Limitations of registries
Conclusion
About Pubrica
IN BRIEF
The content and quality determine the
value of medical device registries (MDRs);
MDRs must have a strong and suitable
structure to achieve their goals. MDRs, on
the other hand, have no design or content
restrictions.
This study aims to examine several MDRs
in implants and provide best practice
suggestions for quality standards in the
design and development of these devices
by Niederlaender and Christine Kriza
(2017),
Interdisciplinary C Interdisciplinary Centre for
Health Technology Assessment (HTA) and Public
Health
(IZPH),
Friedrich-Alexander-University
Erlangen-Nürnberg (FAU).
The following recommendations were based on
extracted MDRs: MDRs should provide a basic
data set and report on the geographic region,
data collecting, patient enrollment numbers,
registry
staff,
and
data
security
and
confidentiality in Systematic Review Writing.
INTRODUCTION
Registries serve an important role in many
aspects of the healthcare system. They're known
as prospective observational studies since they
collect ongoing and supportive data on well-
defined outcomes of attention for analysis and
reporting on well-defined effects of interest.
Disease-specific
registries,
country-specific
registries, product-specific (branded) registries,
and community-based / regional or global
registries are all examples of patient registries.
"[Registries] can be used to learn about natural
history, assess or monitor real-world safety and
effectiveness, evaluate care quality and provider
performance, and determine cost-effectiveness."
A systematic literature search performed in