Building a cloud-based data sharing model for the Saudi national registry for implantable medical devices: Results of a readiness assessment.

BACKGROUND: Implantable medical device registries are used as a medium to conduct post-marketing surveillance. Little information is available on the development and implementation of implantable biomedical device registries in general and specifically in Saudi Arabia and the Middle East. OBJECTIVES: This study presents the experiences of building an implantable medical device registry in the Kingdom of Saudi Arabia. The work specifically addresses the early experiences of the Saudi Food and Drug Authority in the planning and development of a data sharing model for the implementation of a medical device registry at different hospital sites within the country. METHODS: A two-year case study in which 60 health professionals from 5 hospitals in Saudi Arabia participated in a readiness assessment survey. The readiness assessment examined system-level capacity, hospital workflow and operations, clinical staff-level engagement, and technological assessment as they relate to the implementation of the Implantable Medical Device Registry (IMDR). Both subjective and objective data were collected as part of the readiness assessment survey at each hospital site. Data was collected from participants either individually or as part of a group at each hospital site. Using Microsoft Excel, Microsoft Word, flip charts, and back-and-forth discussion, the data was descriptively summarized and synthesized to provide an overview of hospital readiness for IMDR implementation. RESULTS: Results show that there are large differences among Saudi hospitals in terms of their readiness for IMDR implementation due to a variety of factors relating to differences in hospital-wide organizational systems, clinical practice, technological infrastructure, and data sharing capabilities. Each of the hospitals surveyed in this study had differences in how clinical biomedical implantation policies and procedures were utilized. Manual entry into the cloud-based IMDR was recommended as the most optimal data sharing model that would mitigate the differences between hospital readiness for IMDR implementation. CONCLUSION: Registries play a major role in monitoring the effectiveness of implantable biomedical devices. National standardized policies, enforced regulations, and information technology infrastructure are needed to achieve this goal. Furthermore, due to differences in hospital readiness, building a cloud-based registry system through manual data entry into the IMDR was found to be the most appropriate data sharing model that can be implemented at the national level.

Encapsulation of 5-Flurouracil into PLGA Nanofibers and Enhanced Anticancer Effect in Combination with Ajwa-Dates-Extract (Phoenix dactylifera L.).

Side effects connected with chemotherapeutic agents used in cancer treatment has led to alternative modalities of combinatorial therapies in an attempt to reduce the drug dosage and associated risks. In the current study we evaluated the potential use of Ajwa Dates Extract (ADE), reported to have anti-cancer effects, as an adjuvant therapy in combination with 5-flurouracil (5FU) against the human-breast-adenocarcinoma cell line (MFC-7) in vitro. The effects of ADE alone and in combination with 5-FU were evaluated in terms of cell viability and cytotoxicity. For drug delivery purpose, we successfully encapsulated 5FU in both presence and absence of ADE through electrospinning together with poly lactic-co-glycolic acid (PLGA) in different combinations. Physicochemical properties of 5FU and ADE incorporated into PLGA nanofibers remained unaltered as confirmed by Fourier-Transform-Infrared (FTIR), Raman-spectroscopies and X-ray Diffraction (XRD) techniques. The morphological characterization of nanofibers was done using scanning electron microscopy (SEM) and atomic force microscopy (AFM). The surface roughness of PLGA and PLGA + ADE nanofibers increased by incorporation of 5FU. PLGA + ADE nanofibers were in hydrophilic range (<90°) while nanofibers prepared from both PLGA + 5FU and PLGA + 5FU + ADE combinations were in hydrophobic range (∼112°). The percentage inhibition of MCF-7 proliferation at 72 hrs showed an enhanced combinatorial anti-cancer effect of 5FU and ADE on the cells seeded on PLGA + 5FU + ADE mat (47% decrease) while PLGA + 5FU and PLGA + ADE demonstrated only 23% and 16% decrease respectively as compared to controls. The hydrophobicity induced by 5FU can further be investigated to get improved cellular adherence and efficient controlled-drug-release.

Video Voiding Device for Diagnosing Lower Urinary Tract Dysfunction in Men.

We introduce a novel diagnostic Visual Voiding Device (VVD), which has the ability to visually document urinary voiding events and calculate key voiding parameters such as instantaneous flow rate. The observation of the urinary voiding process along with the instantaneous flow rate can be used to diagnose symptoms of Lower Urinary Tract Dysfunction (LUTD) and improve evaluation of LUTD treatments by providing subsequent follow-up documentations of voiding events after treatments. The VVD enables a patient to have a urinary voiding event in privacy while a urologist monitors, processes, and documents the event from a distance. The VVD consists of two orthogonal cameras which are used to visualize urine leakage from the urethral meatus, urine stream trajectory, and its break-up into droplets. A third, lower back camera monitors a funnel topped cylinder where urine accumulates that contains a floater for accurate readings regardless of the urine color. Software then processes the change in level of accumulating urine in the cylinder and the visual flow properties to calculate urological parameters. Video playback allows for reexamination of the voiding process. The proposed device was tested by integrating a mass flowmeter into the setup and simultaneously measuring the instantaneous flow rate of a predetermined voided volume in order to verify the accuracy of VVD compared to the mass flowmeter. The VVD and mass flowmeter were found to have an accuracy of ±2 and ±3% relative to full scale, respectively. A VVD clinical trial was conducted on 16 healthy male volunteers ages 23-65.

A methodology for on-board CBCT imaging dose using optically stimulated luminescence detectors.

Cone-beam computed tomography CBCT systems are used in radiation therapy for patient alignment and positioning. The CBCT imaging procedure for patient setup adds substantial radiation dose to patient's normal tissue. This study pre-sents a complete procedure for the CBCT dosimetry using the InLight optically-stimulated-luminescence (OSL) nanoDots. We report five dose parameters: the mean slice dose (DMSD); the cone beam dose index (CBDIW); the mean volume dose (DMVD); point-dose profile, D(FOV); and the off-field Dose. In addition, CBCT skin doses for seven pelvic tumor patients are reported. CBCT-dose mea-surement was performed on a custom-made cylindrical acrylic body phantom (50cm length, 32cm diameter). We machined 25 circular disks (2 cm thick) with grooves and holes to hold OSL-nanoDots. OSLs that showed similar sensitivities were selected and calibrated against a Farmer-type ionization-chamber (0.6 CT) before being inserted into the grooves and holes. For the phantom scan, a standard CBCT-imaging protocol (pelvic sites: 125 kVp, 80 mA and 25 ms) was used. Five dose parameters were quantified: DMSD, CBDIW, DMVD, D(FOV), and the off-field dose. The DMSD for the central slice was 31.1 ± 0.85 mGy, and CBDIW was 34.5± 0.6 mGy at 16cm FOV. The DMVD was 25.6 ± 1.1 mGy. The off-field dose was 10.5 mGy. For patients, the anterior and lateral skin doses attributable to CBCT imaging were 39.04 ± 4.4 and 27.1 ± 1.3 mGy, respectively.OSL nanoDots were convenient to use in measuring CBCT dose. The method of selecting the nanoDots greatly reduced uncertainty in the OSL measurements. Our detailed calibration procedure and CBCT dose measurements and calculations could prove useful in developing OSL routines for CBCT quality assessment, which in turn gives them the property of high spatial resolution, meaning that they have the potential for measurement of dose in regions of severe dose-gradients.