Equashield Europe’s Post

Key point: CSTDs protect the healthcare worker (and others) throughout the lifecycle once the HD is manipulated, (compounding, administration, waste) especially during administration. The C-PEC (i.e. BSC) and our PPE protects the compounder. Use of a CSTD decreases contamination in the C-PEC therefore decreasing spread of contamination to the entire facility and employees. The nurse administering the HD has no protection other than PPE unless the CSTD is used.

According to the recent white paper – 'Preventing contamination, exposure and health impacts for workers from hazardous medicinal products (HMPs) at work by the implementation of closed systems in their manufacture and use', published by the European Safety Network, Isolators and BSCs are effective in preventing contamination and occupational exposure in the preparation of hazardous medicinal products HMPs in the pharmacy, whilst CSTDs are effective across the whole life cycle of HMPs and across all therapeutic groups and in particular in the administration of HMPs on the wards. EQUASHIELD Closed System Transfer Device (CSTD) offers safety without compromise! At EQUASHIELD®, we believe that medical devices should be held to the same standards as the drugs they encapsulate. Our products are clinically evaluated and bound by peer-reviewed or independent data on safety and efficacy. https://hubs.ly/Q02s5D8K0 #HealthcareProtection #equashield #CSTD

In accordance with the 𝗘𝗨 𝗱𝗶𝗿𝗲𝗰𝘁𝗶𝘃𝗲 𝗠𝗗𝗥 ("Medical Devices Regulation"), 𝗽𝗿𝗼𝗼𝗳 𝗼𝗳 𝗯𝗶𝗼𝗰𝗼𝗺𝗽𝗮𝘁𝗶𝗯𝗶𝗹𝗶𝘁𝘆 is required for all materials that come into direct or indirect contact with patients. 📋 The primary concern is to determine which materials might be released from the product in practice as well as the extent to which they might cause chemical reactions. This risk must be weighed against the benefits of the product. Materials are considered biocompatible if they have no negative effects on the human body when they come into contact with it. Relevant aspects are… ✅ release of harmful chemicals, ✅ rejection reactions, ✅ allergic reactions, ✅ decomposition by the body and ✅ adhesion. In order to guarantee the biocompatibility of medical devices, 𝗶𝘁 𝗶𝘀 𝗮𝗱𝘃𝗶𝘀𝗮𝗯𝗹𝗲 𝘁𝗼 𝗰𝗼𝗻𝗱𝘂𝗰𝘁 𝘁𝗲𝘀𝘁𝗶𝗻𝗴 𝗮𝘁 𝗮𝗻 𝗲𝗮𝗿𝗹𝘆 𝘀𝘁𝗮𝗴𝗲. This allows manufacturers to make any necessary modifications in a timely manner, thus avoiding potential delays leading up to the launch of the product. TÜV Rheinland now provides such testing and conducts the ‘chemical characterization for medical devices as part of a risk management system’ for manufacturers. Our tests not only fully cover the requirements of 𝗗𝗜𝗡 𝗘𝗡 𝗜𝗦𝗢 𝟭𝟬𝟵𝟵𝟯-𝟭𝟴, but also provide an important advantage regarding 𝗗𝗜𝗡 𝗘𝗡 𝗜𝗦𝗢 𝟭𝟬𝟵𝟵𝟯-𝟭𝟳: With our test report, you get a solid foundation for a toxicological assessment, allowing you to dispense with certain time-consuming and cost-intensive animal tests. For further information, please visit our website. 👇 http://tuv.li/1kHL #health #mdr #medicaldevices #medicine #tuvrheinland

🏥 Unveiling "Basil's Regulatory Roundup: Annual Insights Across Panels" with a focus on the General Hospital clinical review panel from this past year. Amidst a dynamic healthcare landscape, the General Hospital panel reported 284 new 510(k) clearances and 4 De Novo approvals. While no new PMAs were noted, the panel’s commitment to elevating device standards is reflected in the 21 PMA supplements. 📈 At the forefront of product clearances were polymer patient examination gloves with 77 approvals, followed closely by specialty medical gloves with 59, and gloves with chemotherapy indications at 58 approvals. These figures highlight the critical emphasis on safety and protection in patient interactions. Through "Basil's Regulatory Roundup," we bring these essential insights to the forefront, showcasing the significant trends that professionals need to know in the healthcare sector. Join us as we continue to dissect the data from other clinical panels, bringing you comprehensive regulatory intelligence. #GeneralHospital #MedicalDevices #FDAApproval #PatientSafety #HealthcareInnovation #MedTech #RegulatoryAffairs #fdacleared #BasilSystems

🚩 Regulatory Update in Australia! The Therapeutic Goods Administration (TGA) made a big statement on February 8, 2024, announcing the release of Australian Declarations of Conformity templates made especially for in vitro diagnostic equipment. The TGA stressed that the purpose of making these templates available is to help manufacturers create declarations of conformity for their goods. It was made clear, nonetheless, that the maker signing the declaration bears the obligation for guaranteeing its accuracy and compliance. It is expected of manufacturers to confirm that the declaration is accurately written and complies with all legal standards specified by the regulatory body. For more details visit: https://lnkd.in/gb-KZJcu Would you like your products to be registered in Australia? With our state-of-the-art regulatory affairs system, you can have personalized submission files and process management in less than five minutes, and you may begin a device-specific registration in over 140 countries in less than a minute. For more Australia-specific regulatory information visit here: https://lnkd.in/g7W4ZHbw #regulatoryaffairs #medicaldevices #healthcare #omcmedical #australia #regulatorycompliance

The Medicines and Healthcare products Regulatory Agency has just published a new draft Statutory Instrument "𝙏𝙝𝙚 𝙈𝙚𝙙𝙞𝙘𝙖𝙡 𝘿𝙚𝙫𝙞𝙘𝙚𝙨 (𝙋𝙤𝙨𝙩-𝙢𝙖𝙧𝙠𝙚𝙩 𝙎𝙪𝙧𝙫𝙚𝙞𝙡𝙡𝙖𝙣𝙘𝙚 𝙍𝙚𝙦𝙪𝙞𝙧𝙚𝙢𝙚𝙣𝙩𝙨) (𝘼𝙢𝙚𝙣𝙙𝙢𝙚𝙣𝙩) (𝙂𝙧𝙚𝙖𝙩 𝘽𝙧𝙞𝙩𝙖𝙞𝙣) 𝙍𝙚𝙜𝙪𝙡𝙖𝙩𝙞𝙤𝙣𝙨 2024" The Statutory amends the Medical Devices Regulations 2002 with new, more stringent #postmarketsurveillance requirements. Major amendments include: 📌Update of definitions relevant to post-market surveillance. 📌Establishment of a post-market surveillance system based on a #PMS plan. 📌Description of requirements relevant to preventive and corrective actions, including #FSCAs. 📌Introduction of investigation and reporting requirements on manufacturers concerning serious incidents and trends in incidents. 📌Details on retention of the documentation produced by a manufacturer (the longer of the 2: the PMS period for the device model, or 15 years in the case of an implantable device / 10 years in the case of any other device). ⚠️𝘛𝘩𝘦 𝘢𝘮𝘦𝘯𝘥𝘮𝘦𝘯𝘵𝘴 𝘸𝘪𝘭𝘭 𝘢𝘱𝘱𝘭𝘺 𝘵𝘰 𝘥𝘦𝘷𝘪𝘤𝘦𝘴 𝘱𝘭𝘢𝘤𝘦𝘥 𝘰𝘯 𝘵𝘩𝘦 𝘮𝘢𝘳𝘬𝘦𝘵 𝘢𝘧𝘵𝘦𝘳 𝘵𝘩𝘦 𝘳𝘦𝘨𝘶𝘭𝘢𝘵𝘪𝘰𝘯'𝘴 𝘦𝘯𝘧𝘰𝘳𝘤𝘦𝘮𝘦𝘯𝘵 𝘥𝘢𝘵𝘦. #Evnia_UKPR #UKCA #UKRP #medtechnews #medicaldevices #dispositivosmedicos #dispositifsmedicaux #dispositivimedici #medizinprodukte #regulatoryaffairs #brexit #postbrexit

🌍 Empowering #Healthcare Through Quality Assurance. #Counterfeit medicine is a rising threat, especially in low and middle-income countries. Did you know the global counterfeit market is estimated to be worth between US$200-432 billion? 😱   With NCDconnect, an initiative by IDA Foundation and Solvoz, we’re committed to ensuring #transparency and high-quality #procurement of NCD medicines, medical supplies and diagnostics. We sat down with Bart van Osch, IDA’s QA Director, to discuss how we guarantee that our medicines meet international quality, safety, and efficacy standards.   👉 Read more in our latest article: https://lnkd.in/e5Ks7F-e 🤝 And join us in the fight against counterfeit medicines! Together, we can make a difference. 💙   #QualityAssurance #NCDConnect #CounterfeitMedicines

💫 Congress Season Is Here 💫 Today’s S stands for… SYMPOSIA! 💫 💡 There is no such thing as a "medical symposium" under the ABPI Code so you can build compliance confidence by following a simple approach: 🤔 Ask good questions (intent, content, impression etc.?) ⚡ Understand which Code category applies 😎 Adhere to the Code criteria for that category 😉 Simple! #abpicode #clarity #compliance #confidence #pharma #congress

🔌 🏥 𝗕𝗮𝘀𝗶𝗰 𝗦𝗮𝗳𝗲𝘁𝘆 𝗮𝗻𝗱 𝗘𝘀𝘀𝗲𝗻𝘁𝗶𝗮𝗹 𝗣𝗲𝗿𝗳𝗼𝗿𝗺𝗮𝗻𝗰𝗲 𝗼𝗳 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗘𝗹𝗲𝗰𝘁𝗿𝗶𝗰𝗮𝗹 𝗘𝗾𝘂𝗶𝗽𝗺𝗲𝗻𝘁: 𝗔 𝗖𝗿𝘂𝗰𝗶𝗮𝗹 𝗦𝘁𝗮𝗻𝗱𝗮𝗿𝗱 𝗳𝗼𝗿 𝗣𝗮𝘁𝗶𝗲𝗻𝘁 𝗦𝗮𝗳𝗲𝘁𝘆 🔬 Basic safety and essential performance of medical electrical equipment are fundamental for ensuring clinical efficacy and patient protection. Recently, the FDA released detailed guidance on these standards, which are essential to the Accreditation Scheme for Conformity Assessment (ASCA) Program. The document outlines requirements for: 🔹Medical electrical equipment, 🔹Medical electrical systems, 🔹Laboratory medical equipment. These guidelines help standardize the conformity assessment process, enabling a more streamlined and safe review process while fostering technological innovation without compromising safety. 🔗 Learn more through the official FDA link: https://lnkd.in/gcK3Zt83 Compliance with these standards is key to ensuring that new medical devices meet the highest standards of safety and quality. 🚑💡 #MedicalDevices #PatientSafety #HealthcareTechnology #FDA #ASCA #ConformityAssessment #Innovation #MedicalEquipment #MedicalElectricalEquipment Sandra Balseiro Luiz de Pádua Queiroz Júnior Celeste Oliveira Natalia de Souza Lescura

The Medicines and Healthcare products Regulatory Agency has published an infographic of the timelines for placement of #CEmarked #medicaldevices and #invitrodiagnostics on the #GreatBritain market under the Medical Devices (Amendment) (Great Britain) Regulations 2023 Read more: https://lnkd.in/dFU6TeJc #Remember Evnia now offers #UK representation services #UKRP! Our #UKResponsiblePerson operational branch is ready to provide services to manufacturers located outside the #UK, who are looking to place a #medicaldevice or an #invitrodiagnostic on the #GreatBritain market (#England, #Wales, and #Scotland). If you are in the search of qualified #UKrepresentation combined with extensive #TechnicalExperience, do not hesitate to contact us. Read more: https://lnkd.in/dz9j3FXd #UKCA #UKRP #UKPR #Evnia_UKPR #medtechnews #medtech #biotech #dispositivosmedicos #dispositifsmedicaux #dispositivimedici #medizinprodukte #regulatoryaffairs #brexit