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. Learn More : https://pubrica.com/services/research-services/systematic-review/ Reference: https://bit.ly/3MCXLOK 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 | Bio statistical 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. 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

2. 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

3. 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),

5. 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.

6. 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.

7. "[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
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.

8. DEVELOPMENT
OF AN MDR
All of the registries in this overview defined and
outlined their objectives, such as collecting valid
data on implant use and related procedures to
assess long-term device safety and efficacy,
screening for complications and adverse events,
measuring failure rates, developing quality
improvement activities, evaluating the patient
Outcome and identifying patients at risk, and
gathering demographic information in Systematic
Review Writing Services.

9. The geographic area covered, the time frame for data collection, the use of national approved
codes – as the Scandinavian registries demonstrate –, the routine link to other databases, the
composition of the registry team, and the time frame for follow-up are all critical factors in the
registry design process.
A clinical or professional review would also benefit from conducting a systematic review. Some
registries capture data at the point of care, whereas others are only virtual.
Data can be gathered through paper-based questionnaires, the Internet, and barcode readers. To
enable long-term longitudinal follow-up, registries must interface with electronic health records
(EHRs).
DESIGNING THE MDR

10. Patients are frequently required to provide formal authorization for the registry to utilize their
information. The Federal Policy for the Protection of Human Subjects outlines the requirements
for obtaining informed consent.
Medical professional secrecy and confidentiality protect the patient's privacy. The essential
components of data security are confidentiality, integrity, and availability.
When registry data is pseudonymized, and therefore a connection from patient to personal data is
feasible, informed consent from patients is usually required to ensure that the register may
transmit information back to patients.
ETHICAL AND LEGAL REQUIREMENTS

11. FUTURE POSSIBILITIES FOR MEDICAL
DEVICE REPORTING IN REGISTRIES
The scope of registers is evolving, as evidenced by the research reviewed. Home
Monitoring transmits to physicians daily systematically, such as by email.

12. The observed events are categorized (medical, system status-related, configuration
monitoring), the rates of occurrences are given, and the follow-up visits to the
patient.
The communicator delivers information from the implanted CRT-D device (cardiac
resynchronization treatment) to the home monitoring equipment in the same way. A
complete integrated medical device interface system is available for outpatient
electronic medical records.
However, this reducing method of documenting is only viable if the equipment is
electronic. This type of home monitoring cannot be used in stents or hip implants.

13. LIMITATIONS OF REGISTRIES
Although registries in clinical trial systematic review services have a high level of external validity,
they can be prone to various biases and systematic mistakes, which must be considered when
developing an MDR.
There is a possibility of selection bias, information bias (validity of detected data), channelling bias
(drugs with comparable therapeutic indications are administered to groups of patients with
prognostic differences, including only previously benefitted users of a drug/device), and loss to
follow-up.
Other biases, such as wandering risk comparisons, confounding by disease severity, depletion of
the susceptible, and the immortal time bias, are summarised in his article. As a result, registries
must analyze the possibility and severity of deception.

14. CONCLUSION
Well-structured registries are an important part of the medical device regulation process and are
useful for decision-makers and management.
Improvements in the comparability of various registers are also achievable in this manner. In this
systematic review, however, only a few studies that outline explicit requirements for the design of
an MDR were found.
The MDRs' outcomes can be significantly improved if detailed suggestions are established. These
ideas for MDR development criteria will serve as a foundation for future efforts to build standards
for medical device registries.
This is a step forward in improving surveillance and expanding the use of well-designed registries
as early warning systems for identifying and informing people at risk of infection.

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