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Medtronic Recalls Valiant Navion Thoracic Stent Graft System

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Activ Surgical Announces FDA Clearance for ActivSight Intraoperative Imaging Module

Activ Surgical announced the U.S. Food and Drug Administration (FDA) 510(k) clearance of the company’s ActivSight Intraoperative Imaging Module for enhanced surgical visualization.

Altapure’s Technology Achieves High Level Disinfection of N95 Safety Masks

Altapure, LLC, an innovative technology and manufacturing company dedicated to providing high-level disinfection products to medical and long-term care facilities, today announced new data evaluating two of its devices for the disinfection of personal protective equipment (PPE). Two studies demonstrated the effectiveness of the company’s ultrasonic disinfection technology for the rapid decontamination of large numbers of N95 respirators. Both products generate submicron droplets of peracetic acid (PPA) and hydrogen peroxide and have been shown to be highly effective in eliminating microorganisms in patient treatment spaces and on portable equipment.

One study, published in Pathogens and Immunity, found that the high-level disinfection cabinet, a product that will be available later this year pending FDA 510k approval in high-level disinfection, was more effective than ultraviolet-C (UV-C) light and provided greater reductions on both outer and inner surfaces of N95 respirators with a single cycle. Regarding the UV products, the author stated, “However, the levels of reduction did not meet our pre-established criteria for decontamination (i.e., >3 log10 reduction on inoculated respirators), and moreover would not have met a >2 log10 reduction requirement for decontamination. Thus, the level of reduction would not be adequate to allow shared use of respirators by different individuals.”i

“There remains an urgent need for an effective N95 respirator disinfection process that will allow on-site reprocessing with rapid turnaround times, ease of use with existing personnel and expertise, and flexibility and scalability to process large quantities of respirators,” said Carl Ricciardi, President, Altapure. “Given the efficacy of the Altapure’s process, the study findings have important implications for facilities that are considering decontamination of PPE as a strategy to maintain adequate supplies in the current COVID-19-related public health crisis, and also have potential application for broader decontamination needs.”

The study examined the effectiveness of three methods, including UV-C light, a high-level disinfection cabinet that generates aerosolized PPA and hydrogen peroxide, and dry heat at 70°C for 30 minutes. The decontamination of three commercial N95 respirators, inoculated with methicillin-resistant Staphylococcus aureus (MRSA) and several bacteriophages, including an enveloped RNA virus used as a surrogate for coronaviruses, was assessed.

UV-C administered as a one-minute cycle in a UV-C box or a 30-minute cycle by a room decontamination device reduced contamination but did not meet criteria for decontamination of the viruses from all sites on the N95s. The high-level disinfection cabinet was effective for decontamination of the N95s and achieved disinfection with an extended 31-minute cycle. Dry heat at 70°C for 30 minutes was not effective for decontamination of the bacteriophages.

Currently in pre-print publication,ii a separate multi-institutional study was conducted by researchers at University Hospitals Cleveland Medical Center (UHCMC), Case Western Reserve University (CWRU), National Aeronautical and Space Administration (NASA) Glenn Research Center and the Cleveland Veterans Affairs Medical Center (VAMC) to evaluate the technology for whole-room disinfection of a large number of respirators and evaluated the impact of the treatment on mask performance.

“We found that the PAA room disinfection system was easy to set up, operate and was effective for disinfection of N95 respirators with a total cycle time of 1 hour and 16 minutes. Using multiple methods, we did not detect any adverse effects on filtration efficiency, structural integrity, or strap elasticity after 5 treatment cycles,” said author Curtis J. Donskey, M.D., Professor of Medicine, Case Western Reserve University, and Staff Physician, Infectious Diseases Section, Louis Stokes Cleveland VA Medical Center. “These results suggest that the PAA room disinfection system provides a scalable solution for in-hospital decontamination of N95 respirators to meet the needs of healthcare workers during the SARS-CoV-2 pandemic.”

A scalable platform that can be set up in real-world hospital settings, the PAA room disinfection system offers several potential advantages over other technologies being evaluated for PPE decontamination. Approximately 2,000 N95 respirators could be effectively disinfected in a room with the dimensions of the test room (2447 cu. ft), with capacity increasing proportionally to the room dimensions. PAA works at room temperatures and requires a shorter cycle time than many other disinfection methods, including vaporized hydrogen peroxide (VHP). Currently used for terminal disinfection of patient rooms, the system can be readily repurposed for N95 decontamination without significant added costs.

The AP-4™ High Level Disinfection System (HLDS) is an enhanced automated and touchless high-level disinfection sub-micron aerosol system that will consistently kill 100% of pathogens such as: C. difficile spores, VRE, CRE, MRSA, C. auris, & viruses such as the Corona virus COVID-19, in a treated space. The AP-4™ delivers a dense cloud of sub-micron fog droplets for the high-level disinfection of large spaces such as those found in medical facilities, clean rooms, pharmaceutical facilities, biotechnology facilities, hospitals – including patient rooms, ICUs, and operating rooms. The dense sub-micron aerosol delivers gas-like performance that offers three-dimensional coverage in large areas. The process is safe for all electronics and equipment, non-toxic, organic, food safe, leaves no residue and ends green.

i Cadnum JL, Li D, Redmond SN, John AR, Pearlmutter B, Donskey C. Effectiveness of Ultraviolet-C Light and a High-Level Disinfection Cabinet for Decontamination of N95 Respirators. Pathogens and Immunity. 2020;5(1):52-67. doi: 10.20411/pai.v5i1.372.
ii John AR, Donskey C, et al. Scalable In-hospital Decontamination of N95 Filtering Facepiece Respirator with a Peracetic Acid Room Disinfection System. Pre-print.



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