medical device safety News
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EC and SCENIHR Begin Public Consultation on Preliminary Opinion on Guidance on the Determination of Potential Health Effects of Nanomaterials Used in Medical Devices
The European Commission (EC) and the Scientific Committee on Emerging Newly Identified Health Risks (SCENIHR) have begun a public consultation on the preliminary opinion concerning “Guidance on the Determination of Potential Health Effects of Nanomaterials Used in Medical Devices.” The aim of the opinion is to address the use of nanomaterials in medical devices and to provide ...
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Winner at the 2020 Med-Tech Awards - Numedico
It is with pleasure that we can announce that Numedico Technologies has been nominated as a winner in the 2020 Global Med-Tech Awards. Announced this week, Global Health and Pharma Magazine published the results of the 3rd annual MedTech Awards. This year the GHP News Medtech Awards 2020, celebrated those who have demonstrated an ability to innovate in this industry. Shining in this dynamic ...
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Neonatal Incubator Developed By MOm And Eg Technology Achieves First Clinical Use In The UK
Created by mOm Founder & CEO, James Roberts, and developed by mOm & the engineering team at eg technology, this innovative, lightweight incubator helped to sustain a premature baby’s life at St Peter’s Hospital, Chertsey. The mOm incubator was originally conceived to save the lives of premature babies in challenging, low/middle-income settings; as well as provide more options ...
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BioQ Pharma Receives CE Mark for Third Infusion System
BioQ Pharma Incorporated (“the Company”), a specialty pharmaceutical company, today announced receipt of CE mark approval in the European Union for its OneDose ReadyfusOR Gen2, single-use medication dispenser. The OneDose ReadyfusOR Gen2 is the second generation of the Company’s original OneDose ReadyfusOR infusion system and was developed to further improve patient convenience. ...
By BioQ Pharma
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Liberate Medical Announces CE Marking for its VentFree Respiratory Muscle Stimulator
Liberate Medical, a medical device company developing novel non-invasive electrical muscle stimulation devices to help patients with pulmonary conditions, today announced that it has received CE marking for its VentFree™ Respiratory Muscle Stimulator and ISO 13485 certification for its quality management system. The VentFree stimulator applies proprietary non-invasive electrical ...
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Sterigenics International and Noxilizer announce partnership to provide NO2 sterilization for pharmaceutical, biotech and medical device products
October 3, 2017 (Baltimore, MD and Broadview Heights, OH) Noxilizer, Inc. and Sterigenics International LLC announce the signing of a global agreement that will make Sterigenics the exclusive worldwide provider of nitrogen dioxide (NO2) contract sterilization services, as well as feasibility and research studies, to the pharmaceutical, biotech and medical device manufacturing industries. ...
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It All Starts With Patient Safety at Medovate
When Medovate was spun out of the National Health Service (NHS) in 2017, one of the key priorities was to ensure that each medical device the company developed added real value to patient safety. The company mission is to “improve patient care and safety by supplying innovative Medtech solutions inspired by clinicians and developed in partnership with the NHS.” Through a unique ...
By Medovate
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BioIntelliSense Launches Patented, FDA-cleared Pulse Oximetry (SpO2) Sensor Technology that Addresses Skin Pigmentation and Motion Monitoring Challenges
Breakthrough pulse oximetry (SpO2 ) optical sensor solution offers medical-grade accuracy of oxygen level measurement across skin tones and while in motion Patented SpO2 sensor chipset, integrated processing and reference design capability to power the next generation of medical and consumer wearable devices BioIntelliSense, a continuous health monitoring and clinical intelligence company, ...
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Safe Label System now integrates with JVM’s automated anesthesia dispensing cabinet
Pharmacy and Hospital Automation Solution provider JVM became an Integrator of Codonics Safe Label System to deliver more complete anesthesia medication management solutions to operating rooms in hospitals worldwide. JVM, a subsidiary of Hanmi Pharmaceuticals and leading global provider of pharmacy and hospital automation solutions including ATDPS and INTIPharm, today announced its integrator ...
By Codonics
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Benefits of using sterilizing bags
Previously, special instruments and consumables were wrapped in green towels and fixed with adhesive tape to indicate whether the items were autoclaved. It is usually proved to be troublesome to just open the tool kit, and there is really no way to ensure that the sterility of even the seemingly complete tool kit is not impaired. Sprinkle a few drops of liquid on a sealed container and you will ...
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Materials and application methods of disinfection and sterilization packaging
Paper or plastic "has a new meaning when it is related to the disinfection of instruments in dental clinics. As a medical device, there are strict standards for the production of sterilization packaging. Disinfection and sterilization bags are usually made of paper and plastic and are a key component of any sterility assurance. The goal of the dental infection control program is to reduce the ...
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Selection of medical packaging materials
Medical packaging materials can be divided into two categories: reusable packaging materials and disposable packaging materials. Packaging begins with the selection of appropriate packaging materials and methods. In addition to the sterilization method, the packaging method should also consider the sterilization items. People have done a lot of research on this, and many kinds of medical ...
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03How to select medical sterilization bags
Some important considerations when purchasing medical sterilization bags: Try to buy items in the same place. If you buy sterilization bags, tooth cleaning cloth, masks, tooth cloth, impression materials and other items in different places, it will take a lot of time. During the economic crisis, if customers lose their jobs, they may also lose their medical insurance, which means that they will ...
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Common problems and countermeasures in the production of medical sterilized paper plastic packaging bags
The medical sterilization paper plastic packaging bag is a disposable medical sterilization packaging material, which has the advantages of good air permeability, good penetration of sterilization medium, high bacteria resistance after sterilization, convenient chemical monitoring during sterilization, simple package sealing, good perspective, long safety period after sterilization, easy opening, ...
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What is the manufacturing process flow of medical sterilization packaging bags?
The manufacturing process of medical sterilization packaging bag includes the upper film and the base paper, which is characterized in that a circle of water-based adhesive is coated on the four frames of the back of the base paper, and the back paper and the upper film are heated at the position where the water-based adhesive is coated on the back of the paper to form a medical sterilization ...
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Analysis of medical sterilization packaging bag
Disinfection and sterilization packaging can be divided into two parts: primary packaging and auxiliary packaging. Generally speaking, the disinfection and sterilization packaging of medical devices refers to the initial packaging of the product, that is, the part that directly contacts the product and forms a microbial barrier. Auxiliary packaging mainly involves the storage and circulation of ...
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Specification and usage of disposable medical sterilization bag
The medical sterilization bag is a medical device approved by the Food and Drug Administration. The appearance of the sterilizing bag must be able to penetrate the sterilizing agent and provide protection during handling and storage. Therefore, a properly used sterilizing bag will provide an effective barrier against contamination before reuse. It is a self sealing paper/transparent plastic ...
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Analysis of the causes of the damage of paper plastic packaging bags in clinical application
The disinfection supply center undertakes the important task of supplying sterile articles and disposable sterile articles in the hospital. The quality of sterile articles is closely related to the quality of medical care. In order to further standardize the implementation of the standard, improve work efficiency, reduce medical costs, and reduce the consumption of human and material resources, ...
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STEMart Launches Pyrogenicity Testing Service for Medical Devices
STEMart, a provider of integrated medical device CRO services dedicated to medical device and diagnostic clinical development, now launches Pyrogenicity Testing service for the medical device industry. This new testing follows the biocompatibility guidelines modified for medical devices. Due to the risks associated with medical devices, comprehensive medical device testing throughout the product ...
By STEMart
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AventaMed selected as Test Case for RWE by NESTcc
The National Evaluation System for health Technology Coordinating Center (NESTcc), an initiative of the Medical Device Innovation Consortium (MDIC), announces twelve new Test-Cases which leverage Real-World Evidence (RWE) and address key priorities for medical device stakeholders. These Test-Cases are intended to accelerate NESTcc’s progress and provide proof of concept for NESTcc’s ...
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