Systematic review of quality standards for medical devices and practice measures for patient safety – Pubrica
                     A SYSTEMATIC  
REVIEW OF 
QUALITY  
STANDARDS FOR  
MEDICAL DEVICES 
AND  PRACTICE 
AnM AcaEdemAicS preUsenRtatEionS by  FOR 
Dr.P NaAncyT AgInEes,N HeTad,  TSechAnical Operations, Pubrica  Group: www.pubrica.coFm ETY
Email: [email protected]
TODAY'S 
OUTLINE
In brief  
Introductio
n
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 
BThRe cIoEnteFnt 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 
dpraotvaide a basic p adtaitean tset aendro lrlempeonrt on 
cthoell egcetionggr,a  phic rneugmiobne, rs,  and data
rceognifistdreyntiality in sSeycsutreimtyatnicd Review 
Wstariffti,ng.
INTRODUCTIO
N
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 
 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.
DEVELOPME
ONTF 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 Writin
g Services.
DESIGNING THE MDR
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).
ETHICAL AND LEGAL 
REQUIREMENTS
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.
FUTURE POSSIBILITIES FOR 
MEDICAL  DEVICE REPORTING 
INThe  RscoEpe Gof IreSgisTtersR isI eEvoSlving, as evidenced by the research 
reviewed. Home  Monitoring transmits to physicians daily systematically, 
such as by email.
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.
LIMITATIONS OF 
ARlthEougGh rIeSgistTrieRs inI EclinSical 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.
CONCLUSIO
NWell-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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