Developing an Evidence-Based Clinical Dataset for the Comprehensive Implantable Medical Device Registry (CIMDR).

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.

Designing and Developing a Multi-Center/Multi-Device National Registry for Implantable Medical Devices.

Designing, developing, and establishing the multi-device/multi-center Comprehensive Implantable Medical Device Registry (CIMDR) for Saudi Arabia is a strategic objective of the Saudi Food and Drug Administration (SFDA). The goal of the CIMDR is to capture all related clinical data along with device related information for implantable medical devices and study population-related outcomes. There is an immediate need in Saudi Arabia to establish the CIMDR to carryout device surveillance, gauge the efficiency and efficacy of various implantable medical devices, and track and recall implantable medical devices.In this work, we report on the development of the SFDA's CIMDR. We specifically focus on the project organization, five primary modules of the CIMDR, and development of the CIMDR through dynamic forms. We anticipate that the collected information in the CIMDR will be used by hospitals and the SFDA to improve patient safety relating to implantable medical devices in Saudi Arabia. Future development of the CIMDR will include a wide range of reporting and embedded analytical tools that will help researchers improve clinical standards and contribute to the research and development of implantable medical device technology.

Developing a Policy and Procedure Framework and Manual for a National Comprehensive Implantable Medical Device Registry in Saudi Arabia.

Policy and procedure manuals provide guidance on the operation and governance of medical device registries. In Saudi Arabia, the Saudi Food and Drug Authority (SFDA) has been developing and implementing a comprehensive national registry for implantable medical devices to facilitate the monitoring of device outcomes through post-market surveillance studies. To help guide the operations of this registry, the SFDA developed a policy and procedure manual. This paper reports on the design of the framework used to develop that manual over the course of one year (2015-2016), using a variety of literature sources, and working with medical device registry and health systems experts. The policy and procedure manual included five key principal level categories, which led to the subsequent creation of seven policies and 28 relevant procedures. The five principal categories were: Staff Engagement, Information Governance, Quality and Auditing, Research, and Reporting. The results of this work could be used to guide the development of policies and procedures for other implantable medical device registries.

Primary Immunodeficiency Diseases in Saudi Arabia: a Tertiary Care Hospital Experience over a Period of Three Years (2010-2013).

PURPOSE: Primary immunodeficiencies (PID) are a group of heterogeneous diseases. Epidemiological studies from databases worldwide show geographical variation. In this study the objective is to determine the spectrum of PID in Saudi Arabia by analyzing the database in a referral tertiary hospital. METHODS: This is a prospective data collection by interviews and medical chart review for all PID patients followed at the King Faisal Specialist Hospital & Research Center (KFSH&RC) from May 2010 to April 2013. RESULTS: A total of 502 patients presented (53 % male and 47 % female). Combined immunodeficiencies were the most common (59.7 %), followed by predominantly antibody deficiencies (12.3 %), congenital defects of phagocyte (9.4 %), combined immunodeficiencies with associated or syndromic features (6.2 %), disease of immune dysregulation (6 %), complement deficiencies (5.8), and defects in innate immunity (0.6 %). The most common combined immunodeficiencies phenotype was T-B-SCID (17 %). The patients' ages ranged from less than 1 year old to 78 years, and 394 patients (78.2 %) are in the paediatrics age group (<14 years). The overall mean age of symptoms onset was 17 months and the overall mean delay in diagnosis was 21.6 months. Recurrent infections were the most common occurring clinical presentation (66 %), followed by family history (26 %). Consanguinity was found in 75 % of the patients. A total of 308 (61 %) patients had undergone stem cell transplantation (SCT). CONCLUSION: The study revealed that combined immunodeficiencies are not uncommon and are the most frequent occurring diagnosis in our patient population. This study is a prerequisite to establish a national registry of primary immunodeficiency in Saudi Arabia.