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.
Download full-text PDF |
Source |
---|
Korean J Ophthalmol
January 2025
Department of Ophthalmology, Seoul National University Bundang Hospital, Seongnam, Korea.
Purpose: To evaluate the accuracy of toric intraocular lens (IOL) axis prediction between two preoperative measurement devices: the optical biometry (IOLMaster 500 or 700) and the dual Scheimpflug topography (Galilei G4).
Methods: Medical records of 64 eyes from 44 patients who underwent phacoemulsification and posterior chamber toric IOL (Zeiss AT TORBI 709M) implantation between July 2017 and January 2022 were reviewed. All patients underwent preoperative evaluation by optical biometry (IOLMaster 500 or IOLMaster 700) and Galilei G4.
J Assoc Res Otolaryngol
January 2025
The Bionics Institute, 384-388 Albert St, East Melbourne, VIC, 3002, Australia.
Purpose: Variations in neural survival along the cochlear implant electrode array leads to off-place listening, resulting in poorer speech understanding outcomes for recipients. Therefore, it is important to develop and compare clinically viable tests to identify these patient-specific intra-cochlear neural differences.
Methods: Nineteen experienced cochlear implant recipients (9 males and 10 females) were recruited for this study.
Int J Implant Dent
January 2025
School of Stomatology, Zhejiang Chinese Medical University, Hangzhou, 310053, People's Republic of China.
Purpose: SLM 3D printing technology is one of the most widely used implant-making technologies. However, the surfaces of the implants are relatively rough, and bacteria can easily adhere to them; increasing the risk of postoperative infection. Therefore, we prepared a near-infrared photoresponsive nano-TiO coating on the surface of an SLM 3D-printed titanium alloy sheet (Ti6Al4V) via a hydrothermal method to evaluate its antibacterial properties and biocompatibility.
View Article and Find Full Text PDFACS Appl Bio Mater
January 2025
State Key Laboratory of Cardiovascular Disease, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences & Peking Union Medical College, Fuwai Hospital, 167 Beilishi Road, Xicheng District, Beijing 100037, China.
Left atrial appendage occlusion (LAAO) is a well-established alternative to anticoagulation therapy for patients with atrial fibrillation who have a high bleeding risk. After occluder implantation, anticoagulation therapy is still required for at least 45 days until complete LAAO is achieved by neoendocardial coverage of the device. We applied a polylactic acid-resveratrol coating to the LAAO membrane to enhance endothelialization with the goal of shortening the anticoagulation therapy duration.
View Article and Find Full Text PDFEnter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!