ABSTRACT
Objectives: Medical devices are increasing by almost 4% per year in France and represent one of the most dynamic growth areas. When applying for reimbursement, manufacturers submit a file and must forecast sales volumes. The aim of this study is to find out whether or not the forecasts are close to what has actually been reimbursed. Method(s): Medical devices with a file for renewal of registration on the LPPR examined by the CEPS between 2018 and 2022 and with a 4-year history were analysed. Sales forecasts from 2014 to 2021 are based on the companies' declarations in the previous file submitted. Reimbursement data from 2014 to 2021 were taken from Health Insurance submitted to the Comite economique des produits de sante (CEPS). The devices general characteristics were taken from the French Health Technology Agency (HAS) assessment. For each device and for each year (n), an index (kn) corresponding to the ratio of the reimbursement data to the sales forecast data and the absolute difference (dn) between these data are calculated. A final index (kf) corresponding to the average of the kn weighted by the dn values is measured. Files with missing or irrelevant data were excluded. Result(s): Of all the files received, 160 could be included in the analysis. It was found that the files forecast higher growth than that actually observed in the reimbursement bases. There was no particular correlation according to the type of product or the presence of a discount mechanism to control expenditure. Conclusion(s): In our sample, sales forecasts tended to be higher than reimbursed data. Contextual factors such as the COVID period, the arrival of competitors or a new version of the product are factors that can impact on the forecasts but which have not been specifically considered in this study. Copyright © 2022
ABSTRACT
Background: Complications following atrial fibrillation (AF) ablation have steadily decreased over the past decade. Following the global COVID-19 pandemic, significant pressure was put on electrophysiology labs to reduce their use of hospital beds. We sought to determine the feasibility as well as safety of same-day discharge following AF ablation procedure. Methods and Results: Between April 2020 and April 2022, 134 patients underwent an AF ablation in our institution and were scheduled to be discharged the same day. Among them, 86.6% (116) went home an average of 8.1 hours after the sheaths were pulled. As for the remaining 18 patients, the majority stayed because the procedure finished too late for the monitoring period to be complete and had no complications requiring an overnight stay. Of the remaining 5 patients, 3 stayed for groin bleed, 1 for minor pericardial effusion and 1 for pulmonary edema. All except the pulmonary edema patient went home the next day. As for the 116 patients who went home the same day, 9.5% (11) came back in the following week to the ER with either pericardial pain (7), shortness of breath (1), recurrent arrhythmia (1) or minor groin discomfort (3). All of them were safely discharged from the ER the same day. Conclusion(s): Our data confirms that same-day discharge following AF ablation procedures is both safe and feasible as confirmed by the absence of any major complications in our single center experience. Some patients came back to the emergency room for expected post ablation discomfort, but none required an overnight stay. Copyright © 2022
ABSTRACT
BACKGROUND: Given the global shortage of N95 filtering facepiece respirators (FFP2 in Europe) during the COVID-19 pandemic, KN95 masks (Chinese equivalent of the N95 and FFP2) were imported and distributed in South Africa (SA). However, there are hardly any published independent safety data on KN95 masks. OBJECTIVES: To evaluate the seal, fit and filtration efficiency of several brands of KN95 masks marketed for widespread use in SA healthcare facilities, using standardised testing protocols. METHODS: The verifiability of manufacturer and technical details was first ascertained, followed by evaluation of the number of layers comprising the mask material. The testing protocol involved a directly observed positive and negative pressure user seal check, which if passed was followed by qualitative fit testing (sodium saccharin) in healthy laboratory or healthcare workers. Quantitative fit testing (3M) was used to validate the qualitative fit testing method. The filtration efficacy and integrity of the mask filter material were evaluated using a particle counter-based testing rig utilising aerosolised saline (expressed as filtration efficacy of 0.3 µm particles). Halyard FLUIDSHIELD 3 N95 and 3M 1860 N95 masks were used as controls. RESULTS: Twelve KN95 mask brands (total of 36 masks) were evaluated in 7 participants. The mask type and manufacturing details were printed on only 2/12 brands (17%) as per National Institute of Occupational Safety and Health and European Union regulatory requirements. There was considerable variability in the number of KN95 mask layers (between 3 and 6 layers in the 12 brands evaluated). The seal check pass rate was significantly lower in KN95 compared with N95 masks (1/36 (3%) v. 12/12 (100%); p<0.0001). Modification of the KN95 ear-loop tension using head straps or staples, or improving the facial seal using Micropore 3M tape, enhanced seal test performance in 15/36 KN95 masks evaluated (42%). However, none of these 15 passed downstream qualitative fit testing compared with the control N95 masks (0/15 v. 12/12; p<0.0001). Only 4/8 (50%) of the KN95 brands tested passed the minimum filtration requirements for an N95 mask (suboptimal KN95 filtration efficacy varied from 12% to 78%, compared with 56% for a surgical mask and >99% for the N95 masks at the 0.3 µm particle size). CONCLUSIONS: The KN95 masks tested failed the stipulated safety thresholds associated with protection of healthcare workers against airborne pathogens such as SARS-CoV-2. These preliminary data have implications for the regulation of masks and their distribution to healthcare workers and facilities in SA.