Haleyfunder7894

Purpose A medical device may be of any type such as appliance, in vitro usable reagents, apparatus, instrument, machine, implement, material, software or other related articles. Either as a single entity or in combination, these devices are used by the skilled persons as per the manufacturer's instructions to prevent, diagnose, treat, monitor, alleviate the disease, compensate for an injury, investigate, replace, modify or support the anatomy in human beings. Methods Using standards is a voluntary process unless and until it is identified as a mandatory one by the regulatory authority. The manufacturers must demonstrate that the medical devices they manufacture meet the relevant Essential Principles of Safety and Performance and are freely accessible to public. Results Various national and international standards (not recognized by the regulatory authority), industrial standards, manufacturer-developed Standard Operating Procedures (not related to international standards), non-recognized standards, and state-of-the-art techniques are in process in terms of performance, material, design, methods, process or practices. Conclusion The regulatory authority needs to ensure whether the manufacturer has implemented the risk management processes and met the regulatory requirements set. The responsibility towards medical devices safety and performance lies with both manufacturer and the regulatory authority. © 2020 Altayyar.Objective To assess bleeding following transection of the pulmonary artery with powered and manual endoscopic staplers. Methods Cases of video-assisted and open-chest thoracic surgical procedures for non-small cell lung cancer at Ishikawa Prefectural Central Hospital were reviewed between 2012 and 2018. Three stapler groups were assessed Group 1 - Ethicon ECHELON FLEXTM Powered Vascular Stapler (PVS), Group 2 - Medtronic Endo-GIATM iDriveTM powered stapler, Group 3 - Ethicon and Medtronic manual staplers. Results Of 239 patients, 82 cases (34.3%) were Group 1, 94 cases (39.3%) were Group 2 and 63 cases (26.4%) were Group 3. Mean age was 68.3 years (range 36-88 years), and most patients received video-assisted right upper lobectomy (82.8%). Bleeding occurred in 24 cases 17 (70.8%) in Group 2 and 7 (29.2%) cases in Group 3. No bleeding occurred in Group 1. The loaded ECHELON FLEXTM PVS and Endo-GIATM iDriveTM with gray cartridge combinations had the greatest and smallest closed anvil jaw gaps (>0.63 µm and less then 0.15 µm, respectively); Endo-GIATM iDriveTM gray cartridge combinations resulted in ruptures of inner and middle membranes of the pulmonary artery. No ruptures were observed using the ECHELON FLEXTM PVS. Conclusion An excessively narrow gap between cartridge and anvil may damage the blood vessel wall and lead to bleeding following transection. This study provides preliminary evidence that the use of the ECHELON FLEXTM PVS and tan cartridges for pulmonary artery stapling may help to prevent tissue damage and intraoperative bleeding. © 2020 Tsunezuka et al.Background Managing and taking multiple medications as prescribed can be a difficult task for older adults. In-home medication dispensing technologies could help enhance care. The objective of the study was to determine users' perspectives on a medication dispensing system (MDS) in supporting medication adherence of individuals living at home with chronic conditions. Methods This analysis is a part of a randomized controlled trial on an MDS in a Western Canadian province. We interviewed participants who were recruited into the intervention group and started using an MDS. A maximum variation purposive sampling was used to select interview participants based on age, number of medications, and health conditions. Results Thirteen participants were interviewed; most participants were females (n=11) and the average age was 63.7 (SD=8.2) years with an average of 8.9 (SD=3.6) prescribed medications. The most common health conditions were hypertension, diabetes, arthritis, and anxiety and depression. Four main themes emerged from thematic analysis MDS acceptability, MDS patient support, need for the MDS, and areas of technology improvement. Most of the participants found the MDS to be acceptable and convenient, although privacy and security was an issue for some older adults. Audio and visual reminders and pre-organized medication supported participants' medication adherence and independence in daily routines. The perceived necessity of the MDS was split among participants with cost being one of the main concerns. Areas of technology improvement included the hard-to-open plastic medication packets and the sometimes inexact recording of medication adherence by the MDS if medications were dispensed on behalf of the patients. Conclusion The MDS is an acceptable tool for improving medication management and adherence in older adults. Increased medication adherence may lead to patient and system-level benefits. © 2020 Ahmad et al.Purpose To determine the effect of a pleiotropic MMP-inhibitor, a novel chemically-modified curcumin 2.24 (CMC2.24), on the clinical and biological measures of naturally-occurring periodontitis in the beagle dog. Methods Eight adult female dogs with generalized periodontitis were distributed into two groups Placebo and Treatment (n=4/group). After a 1-hr full-mouth scaling and root planing (SRP) at time 0, placebo or CMC2.24 (10mg/kg) capsules were orally administered once/day for 3 months. Various clinical periodontal parameters (e.g., pocket depth, gingival index) were measured at different time periods (0, 1, 2 and 3 months), and gingival crevicular fluid (GCF) samples and gingival tissue biopsies (3-month) were analyzed for cytokines, MMPs and cell-signaling molecules. Standardized radiographs were taken at 0 and 3-month; in addition, peripheral blood monocytes/macrophages from these dogs at 3-month were cultured and analyzed for the pro-, activated-, and total-forms of both MMP-2 and MMP-9. Results CMC2.ential of CMC2.24 as a novel adjunct to SRP in the treatment of chronic periodontitis. © 2020 Deng et al.Purpose The burden of hepatitis C virus infection is particularly high in Asian countries, and new treatments are urgently needed. The purpose of this study was to characterize the pharmacokinetics (PK) and safety of the fixed-dose combination tablet of elbasvir/grazoprevir in healthy Chinese participants. find more Patient and Methods In this Phase I, single-site, open-label, 3-period study in healthy Chinese adults, participants received a single tablet of elbasvir 50 mg/grazoprevir 100 mg, followed by blood sampling for up to 96 hrs (http//www.chinadrugtrials.org.cn/ CTR20160034; Protocol PN071). Participants then received 1 tablet daily for 10 days, followed by a minimum 10-day washout, after which participants received a single dose of 2 tablets (elbasvir 100 mg/grazoprevir 200 mg). Elbasvir and grazoprevir PK were assessed following single and multiple doses. Safety and tolerability were also evaluated. Results Twelve participants (50% male) were enrolled in and completed the study. Following single-dose oral administration of elbasvir 50 mg/grazoprevir 100 mg or elbasvir 100 mg/grazoprevir 200 mg, the median Tmax was 3-4 hrs and elimination half-life was 18 hrs (elbasvir) and 30 hrs (grazoprevir).