Systematic review of quality standards for medical devices and practice measures for patient safety – Pubrica

1. A SYSTEMATIC REVIEWOFQUALITY STANDARDSFOR MEDICALDEVICESAND PRACTICEMEASURES FORPATIENTSAFETY AnAcademicpresentationby Dr.NancyAgnes,Head,TechnicalOperations,Pubrica Group:www.pubrica.com Email:sales@pubrica.com

2. TODAY'SOUTLINE Inbrief Introduction DevelopmentofanMDR DesigningtheMDR Ethicalandlegalrequirements Futurepossibilitiesformedicaldevicereportinginregistries Limitationsofregistries Conclusion AboutPubrica

3. INBRIEF Thecontentandqualitydetermine the value of medical device registries (MDRs); MDRsmusthaveastrong andsuitable structure to achieve their goals. MDRs, on the other hand, have no design or content restrictions. This study aims to examine several MDRs inimplantsandprovidebestpractice suggestions for quality standards in the design and development of these devices byNiederlaenderandChristineKriza (2017),

5. InterdisciplinaryCInterdisciplinaryCentrefor Health Technology Assessment (HTA) and Public Health(IZPH),Friedrich-Alexander-University Erlangen-Nürnberg(FAU). The following recommendations were based on extractedMDRs:MDRsshould provide abasic datasetandreportonthegeographicregion, datacollecting, registry staff, patientenrollmentnumbers, anddatasecurityand confidentialityinSystematicReviewWriting.

6. INTRODUCTION Registriesserveanimportantroleinmany aspects of the healthcare system. They're known as prospective observational studies since they collectongoingandsupportivedataonwell- defined outcomes of attention for analysis and reportingonwell-definedeffectsofinterest. Disease-specificregistries,country-specific registries,product-specific(branded)registries, andcommunity-based/regionalorglobal registriesareallexamplesofpatientregistries.

7. "[Registries] can be used to learn about natural history, assess or monitor real-world safety and effectiveness, evaluate care quality and provider performance,anddeterminecost-effectiveness." A systematicliteraturesearchperformedin databases(Medline,Cochrane Library,Scopus, Embase,CRDYork),selectedjournalsand websitesidentifiedarticlesdescribingeithera generalMDRstructureorthedevelopment processofspecificregistries.

8. DEVELOPMENT OFANMDR All of the registries in this overview defined and outlined their objectives, such as collecting valid data on implant use and related procedures to assesslong-termdevicesafetyand efficacy, screening for complications and adverse events, measuringfailurerates,developing quality improvementactivities, evaluatingthepatient Outcomeandidentifyingpatientsatrisk, and gatheringdemographicinformationinSystematic ReviewWritingServices.

9. DESIGNINGTHEMDR 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 registrydesignprocess. A clinical or professional review would also benefit from conducting a systematic review. Some registriescapturedataatthepointofcare,whereasothersareonlyvirtual. 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).

10. ETHICALANDLEGALREQUIREMENTS 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 forobtaininginformedconsent. Medicalprofessionalsecrecyandconfidentiality protectthepatient'sprivacy. Theessential componentsofdatasecurityareconfidentiality,integrity,andavailability. 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 transmitinformationbacktopatients.

11. FUTUREPOSSIBILITIESFORMEDICAL DEVICEREPORTINGINREGISTRIES Thescopeofregistersisevolving,asevidencedbytheresearchreviewed.Home Monitoringtransmitstophysiciansdailysystematically,suchasbyemail.

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 systemis available for outpatient electronicmedicalrecords. However, this reducing method of documenting is only viable if the equipment is electronic.Thistypeofhomemonitoringcannotbeusedinstentsorhipimplants.

13. LIMITATIONSOFREGISTRIES Althoughregistriesinclinicaltrialsystematicreviewserviceshaveahighlevelofexternalvalidity, they can be prone to various biases and systematic mistakes, which must be considered when developinganMDR. Thereisapossibilityofselectionbias,informationbias(validityofdetecteddata),channellingbias (drugswith comparable therapeuticindications areadministeredto groupsof patientswith prognostic differences, including only previously benefitted users of a drug/device), and loss to follow-up. Other biases, such as wanderingriskcomparisons,confounding by disease severity, depletion of the susceptible, and the immortal time bias, are summarised in his article. As a result, registries mustanalyzethepossibilityandseverityofdeception.

14. CONCLUSION Well-structured registries are an important part of the medical device regulation process and are usefulfordecision-makersandmanagement. 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 anMDRwerefound. 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 formedicaldeviceregistries. This is a step forward in improving surveillance and expanding the use of well-designed registries asearlywarningsystemsforidentifyingandinformingpeopleatriskofinfection.

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