Medical Device Regulatory | SCIENCE ARENA

Medical Device Regulatory | SCIENCE ARENA

6/21/2025, 5:20:16 AM

https://www.regulatorymedicaldevice.com/2024/08/cardiovascular-valves-heart-valves.html

Medical Device Regulatory | SCIENCE ARENA

6/18/2025, 2:05:46 AM

Our Community Members have grown to 300+ which includes 20% of International members. https://www.regulatorymedicaldevice.com/p/community.html

Medical Device Regulatory | SCIENCE ARENA

6/13/2025, 11:22:35 PM

*Medtronic Announces Voluntary Recall of Select Newport™ HT70 and Newport™ HT70 Plus Ventilators and Certain Related Newport™ Service Parts* Customers are being asked to remove the affected devices from use and replace with an alternate means of ventilation June 11, 2025 — In May 2025, Medtronic issued a voluntary recall notification to global customers related to specific Newport™ HT70 and HT70 Plus ventilators and certain related Newport™ service parts. The FDA recently designated this voluntary action by Medtronic as a Class I recall. With this recall, Medtronic is advising discontinuation of clinical use of the affected devices. Investigation into customer complaints identified two separate capacitors on one of the ventilator’s controller Printed Circuit Board Assembly (PCBA), that, in case of failure, may result in: The ventilator shutting down during use, or The shutdown alert alarm failing to sound effectively. The following table identifies the item name, manufacture date and use by date: No instances of both capacitors failing on the same PCBA board have occurred, nor are they anticipated to occur. If a ventilator fails and does not provide adequate ventilation, the patient may not be able to breathe on their own, leading to low oxygen levels, high carbon dioxide levels, and potentially severe consequences like brain injury or death. There have been 63 medical device reports (MDRs) associated with this issue, including two serious injuries and one death. HT70 and HT70 Plus ventilators are intended for use by home users, as well as for infant and pediatric patients who may be at higher risks of injury or death due to unanticipated ventilator failures. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/medtronic-announces-voluntary-recall-select-newporttm-ht70-and-newporttm-ht70-plus-ventilators-and?utm_medium=email&utm_source=govdelivery

Medical Device Regulatory | SCIENCE ARENA

6/18/2025, 6:03:01 AM

*Blood Products Administration Set Recall: Fresenius Kabi Removes Large Volume Pump Blood Products Administration Sets due to Incorrect Assembly* The FDA is aware that Fresenius Kabi has identified a specific lot of the Ivenix LVP Blood Products Administration Set was incorrectly assembled. Clinical outcomes can vary from asymptomatic to serious adverse events, especially in vulnerable populations such as neonates, critically ill patients, or those undergoing large-volume transfusions. Short-term and long-term complications will vary depending on the patient population, the underlying condition, health status of the patient, and the treatment regimen. At this time, Fresenius Kabi has not reported serious injuries or deaths associated with this issue. https://www.fda.gov/medical-devices/medical-device-recalls/blood-products-administration-set-recall-fresenius-kabi-removes-large-volume-pump-blood-products?utm_medium=email&utm_source=govdelivery

Medical Device Regulatory | SCIENCE ARENA

6/13/2025, 11:27:03 PM

*eIFU news! Amendment in pipeline * June 2025! The committee has exchange views and accepted the vote on the draft Commission Implementing Regulation that will broaden the scope and streamline the requirements for eIFU in the European Union. KEY CHANGES: ♦️ Broader Scope: Now also covers devices without an intended medical purpose. This extension ensures that more devices can benefit from electronic instructions, making the healthcare sector more efficient and eco-friendly. ♦️ Lay Person Safety: For safety reasons, eIFUs are still not permitted for lay persons. If a device is intended for use by both, professionals and lay persons, manufacturers must provide physical instructions for lay persons. ♦️ Streamlined Requirements: Certain redundant requirements are clarified or removed to enhance compliance and reduce administrative burdens. For example, manufacturers will provide the internet address for electronic instructions in the Eudamed’s Unique Device Identifier (UDI) database once registration becomes mandatory.

Medical Device Regulatory | SCIENCE ARENA

6/13/2025, 2:27:51 PM

*Liquid Bicarbonate Concentrate Recall: Nipro Removes MedicaLyte Liquid Bicarbonate Concentrate due to Contamination* The U.S. Food and Drug Administration is aware that Nipro has issued a letter to affected customers recommending all lots of MedicaLyte Liquid Bicarbonate Concentrate be removed from where they are used or sold due to reports of contamination. Nipro received reports of concerning visual irregularities in some product jugs. Returned units were sent to a third-party laboratory where bacterial and fungal particles were identified through analysis. Risks associated with the use of contaminated dialysate includes infections, treatment disruptions, sepsis, and potential death. Potential long-term health consequences include chronic infections which may cause or contribute to organ damage and a weakened immune system. If the contaminated product is used, the hemodialysis machine will need to be disinfected following the dialysis machine manufacturer’s recommendations. https://www.fda.gov/medical-devices/medical-device-recalls/liquid-bicarbonate-concentrate-recall-nipro-removes-medicalyte-liquid-bicarbonate-concentrate-due?utm_medium=email&utm_source=govdelivery

Medical Device Regulatory | SCIENCE ARENA

5/14/2025, 7:02:08 PM

*US FDA Recall data 2012 Onwards till date* - a Detailed Analysis is Ongoing to strengthen the Quality and applicable standard requirements. Soon Will be Published by Regulators and other statuary bodies. * So Far Medical Device Sector faced Lot of Quality Issues due to clarity and negligence. Since these data are managed by Only US, so Other Regulators are being intersted in evaluation to trace in thier jurisdiction. * Since India does not have trace mechanism for such data and issues so any quantiative analysis is not available till date.

Medical Device Regulatory | SCIENCE ARENA

5/16/2025, 10:23:28 AM

First Session by EPCMD with CDSCO for guidance on Medical and IVD devices