PDI International ’s Post

Our new article "Unintended Exposure" delves into the complexities of coatings on limited duration devices. It will help device manufacturers understand how coatings impact device functionality and patient safety, and why regulatory bodies are stringent about them. We also included some tips on navigating these challenges and ensuring your device meets the highest safety standards. https://hubs.ly/Q02sVYRg0 #medicaldevice #regulatorycompliance #ISO #10993 #patientsafety

Operating tables ensure safe surgical progress effectively. A new commented version of IEC 60601-2-46 ED4 mandates a safe working load for operating tables. Discover what's new: https://bit.ly/3OSEpJY #IECCommentedStandards #medical #IECblog

Here are some key points worth noting.

International standards relevant to small-bore connectors for liquids and gasses in healthcare applications focus on their ease of use and resistance to leakage or mishandling. ISO 80369 standards cover a set of test methods, which provide a broad matrix of functionality checks recommended for quality assurance in such components. Torque (and force) measurement is critical in meeting these standards and in addition, 21CFR Part 11 regulations play a vital role in the considerations of organisations in the medical and medical devices sector. #casestudy #medicaldevices #medicaldevicemanufacturing #qualityassurance #testing #testingsolutions #forcetesting #torquetesting https://hubs.la/Q02mvW3r0

Choose a truly closed system that provides the necessary protection for healthcare workers handling hazardous drugs. EQUASHIELD® Closed System Transfer Device (CSTD) restricts the escape of hazardous drugs and vapour due to a unique encapsulated syringe unit with an internal sterile air chamber and closed pressure equalizstion system. The following are links to some of the relevant studies: https://bit.ly/3EPAzLh https://bit.ly/3rpBleW #EQUASHIELD #CSTD #closedsystemtransferdevice #safety #hazardousdrugs #vapour

Authorized representative: Any natural or legal person established within the Union who has received and accepted a written mandate from a manufacturer, located outside the Union, to act on the manufacturer’s behalf in relation to specified tasks with regard to the latter’s obligations. Are you going to finalize your EC-REP? Read Article 11 of #eumdr and below guidance from MDCG https://lnkd.in/d6YQdD3z #eurep #medicaldevice #regulation #iso13485

Form For Comment – GLF-MD-11A – Medical Device AE Reporting Form Guideline For Comment – SAHPGL-MD-03 – Guideline Medical Device Adverse Events Reporting

ISO 17665:2024 Publication : 2024-03 Sterilization of health care products Moist heat Requirements for the development, validation and routine control of a sterilization process for medical devices   What is ISO 17665?  ISO 17665 outlines requirements for moist heat sterilization processes, ensuring the transformation of non-sterile medical devices into sterile ones. It addresses the inactivation of microbiological contaminants, emphasizing the need for validated, controlled, and monitored sterilization processes.   This first edition cancels and replaces ISO 17665-1:2006, ISO/TS 17665-2:2009 and ISO/TS 17665-3:2013, which have been technically revised. The main changes compared to the previous editions are as follows: — combined ISO 17665-1, ISO/TS 17665-2 and ISO/TS 17665-3 into a single standard. #wyrobymedyczne #sterylizacja #medicaldevices #sterilization #iso https://lnkd.in/dcNeSaxN

The FDA classified about 1,460 Hamilton Medical ventilators in a Class I recall, part of a voluntary correction, because electrolyte fluid might leak onto the device's control board. A leakage could cause the ventilator to short-circuit and result in serious injury or death, the agency said Oct. 18. Hamilton Medical has not received any reports of adverse events related to the recall. In late July, the company instructed customers to test the device's service software. The affected products include the Hamilton-C1 Portable Intensive Care Ventilator, Hamilton-T1 Intensive Care and Transport Ventilator, Hamilton-MR1 Intensive Care Ventilator, Hamilton C1/T1/MR1 Control Board Spare part and the Hamilton-T1 ESM Shielding Set Spare Part. The recall is not a product removal. #medicaldevices #FDA #regulatoryaffairs #valueanalysis #recalls

🔍 New ISO 18562:2024 Standards Update for Medical Devices: What Manufacturers Need to Know The medical device industry is evolving, and so are the standards that govern it. The recent update to the ISO 18562 series is a game-changer, especially for devices with gas pathways, including medical respiratory PPE such as surgical masks and N95 respirators. 🔬 Key changes include: ▪️ Inclusion of medical respiratory PPE in the scope ▪️ Introduction of new terms like "infrequent use" and "total exposure period," impacting testing requirements ▪️ Expanded patient populations and adjusted default daily breathing volumes ▪️Enhanced testing for volatile organic substances (VOS) and leachables 🌐 Manufacturers face new challenges with heightened testing and understanding of exposure and toxicity nuances. 💡 Leverage NAMSA's expertise for risk assessments and compliance with international standards. 📖 Read our blog post, "Understanding the ISO 18562:2024 Standards Update for Medical Devices," for an in-depth look at these important updates. 🔗 https://lnkd.in/gwYZuGFU #ISO18562 #MedicalDevices #StandardsUpdate #HealthcareInnovation #NAMSAKnows