RESUMO
Medical registries are in a need of a data set that is based on clinical evidence. In 2014, the Saudi Food and Drug Administration (SFDA) launched a plan to develop the national Comprehensive Implantable Medical Device Registry (CIMDR). One of the primary goals of the CIMDR is to develop a clinical -and population- based data set. The aim of this study is to report on the process of developing the data elements for the CIMDR. We used an iterative process of multi-stakeholder consultation over a two year period (2014-2016). The goal of the multi-stakeholder consultations was to build a dataset to address the need for device traceability, effectiveness, safety, and the recall of implantable medical devices. We investigated international and local standards for implantable medical device information capture, conducted a review of the literature, and consulted expert opinions in the development of the CIMDR dataset. The CIMDR data framework includes demographics, patient history, diagnosis, procedure information, and follow-up details for orthopedic and cardiac related implantable medical devices. Most of the dataset elements are logically validated with minimal free text entry to avoid human error and facilitate ease of entry. We use the International Classification for Diseases-Australian Modification as the standardized nomenclature for the CIMDR.
