=Paper=
{{Paper
|id=Vol-2931/ICBO_2019_paper_59
|storemode=property
|title=Opportunities for Ontologies in Medical Device Total Product Life Cycle (TPLC) Evaluation
|pdfUrl=https://ceur-ws.org/Vol-2931/ICBO_2019_paper_59.pdf
|volume=Vol-2931
|authors=Asiyah Yu Lin
|dblpUrl=https://dblp.org/rec/conf/icbo/Lin19
}}
==Opportunities for Ontologies in Medical Device Total Product Life Cycle (TPLC) Evaluation==
<pdf width="1500px">https://ceur-ws.org/Vol-2931/ICBO_2019_paper_59.pdf</pdf>
<pre>
         Opportunities for Ontologies in Medical Device Total Product Life Cycle (TPLC)
                                           Evaluation

                                                                Asiyah Yu Lin
           a
               Office of Clinical Evidence and Analysis, Center for Devices and Radiological Health, FDA, Silver Spring, MD, USA



Abstract                                                                            3.   Bridging Unmet Medical Device Ecosystem Needs
                                                                                         With Strategically Coordinated Registries Networks.
The mission of the Center for Devices and Radiological Health                            Krucoff MW et al. JAMA. 2015;314(16):1691-1692.
(CDRH) is to protect and promote public health by assuring that                          doi:10.1001/jama.2015.11036
patients and providers have timely and continued access to safe,                    4.   https://www.fda.gov/medical-devices/breast-
effective and high-quality medical devices, and safe radiation-                          implants/breast-implant-associated-anaplastic-large-
emitting products. In 2012, CDRH launched a plan to establish a                          cell-lymphoma-bia-alcl
national system for the evaluation of medical devices; and in
2016, the Medical Devices Innovation Consortium (MDIC) was
selected to establish the National Evaluation System for health
Technology Coordinating Center (NESTcc). NESTcc is working
with stakeholders within the medical device ecosystem to
advance the timely and cost-effective development of real-world
evidence (RWE) to support its use in regulatory and clinical
decision-making. In addition, the Medical Device Epidemiology
Network (MDEpiNet), a global public-private partnership
launched in 2010, is one of the NESTcc data partners that brings
together multiple stakeholders to conduct medical device studies
(and/or surveillance) to better understand how devices perform in
the real-world. Efforts of NESTcc and MDEpiNet focusing on
linking different types of data sources and distributed data
analysis could be enhanced by the science of ontology in several
areas including: (1) mapping medical device specific outcomes to
the International Statistical Classification of Diseases and Related
Health Problems (ICD) and the Current Procedural Terminology
(CPT) and Systematized Nomenclature of Medicine Clinical
Terminology (SNOMED CT) codes; (2) defining device specific
outcomes/adverse events; (3) building clinically meaningful
medical device categories; and (4) mapping or harmonizing
different common data models. The ontologies can potentially
provide a common infrastructure for linking data from diverse
sources, such as registries, electronic health records (EHRs),
claims data and patient reported outcomes. We will describe our
current efforts in RWE, building of NEST and the global
MDEpiNet, challenges faced, and how the science of ontology
relates to these efforts.
Keywords:
Medical devices, ontologies, Real World Evidence

Reference
    1.   Use of Real-World Evidence to Support Regulatory
         Decision-Making for Medical Devices. August 2018
         (https://www.fda.gov/regulatory-information/search-
         fda-guidance-documents/use-real-world-evidence-
         support-regulatory-decision-making-medical-devices)
    2.   https://www.fda.gov/about-fda/cdrh-reports/national-
         evaluation-system-health-technology-nest


  Copyright © 2019 for this paper by its author. Use permitted under Creative Commons License Attribution 4.0 International (CC BY 4.0).

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