Justpoint

A new patient safety update is now live on our Knowledge Base. The FDA has classified the Omnipod® 5 Pod recall as a Class I recall — its most serious type of medical device recall. Certain affected Pods may under-deliver insulin due to an internal tubing defect, potentially increasing the risk of severe hyperglycemia and diabetic ketoacidosis (DKA). Our latest article explains: • What the recall is about • How to determine whether your Pods are affected • Warning signs to watch for • What steps to take if you suspect a faulty device • Where to verify official recall information If you or someone you know uses the Omnipod 5 system, staying informed is essential. Read the full article here: https://lnkd.in/d_sJbFfG #PatientSafety #MedicalDevices #FDARecall #Diabetes #Type1Diabetes #Omnipod5 #Healthcare #MedicalNews

Medical devices can improve quality of life — but like any implanted technology, they also require ongoing safety monitoring. A recent analysis of FDA MAUDE reports identified 594 medical device reports involving implanted peripheral nerve stimulation (PNS) systems in a single year, with many cases involving complications such as infection, lead migration, unexpected stimulation, and device removal. Understanding these reports doesn't mean every patient will experience complications. It means patients deserve access to transparent information so they can recognize potential warning signs and have informed conversations with their healthcare providers. That's why we've published a new guide covering: • the most commonly reported PNS complications • what FDA safety data tells us • how to identify your implanted device • what symptoms shouldn't be ignored • where patients can report device-related adverse events Read the full article: 🔗 https://lnkd.in/ejj7wcPg #PatientSafety #MedicalDevices #Neuromodulation #Healthcare #MedicalResearch #ChronicPain #Justpoint

How much do we really know about the long-term performance of synthetic vascular grafts? Our latest article explores the published research on the GORE-TEX® Stretch Vascular Graft and the growing body of evidence surrounding long-term ePTFE calcification. Inside, we cover: • What this vascular graft is and where it's used • What current research says about calcification risk • Potential signs and symptoms patients should be aware of • How to confirm which implant you have • Questions to discuss with your healthcare provider At Justpoint, we're committed to making complex medical research more accessible, helping patients better understand the devices they rely on and the evidence behind them. Read the full article here: 🔗 https://lnkd.in/d8yYE2qR #MedicalDevices #PatientSafety #VascularSurgery #Healthcare #MedicalResearch #PatientEducation #Justpoint

Medical devices are transforming diabetes care, but staying informed about safety updates is just as important as adopting new technologies. Our latest article examines recent regulatory findings related to the iLet® ACE Pump (Beta Bionics), including: • FDA Warning Letter issued after a manufacturing inspection • Reported cartridge leaks and severe hypoglycemia incidents • A cybersecurity vulnerability that was addressed through a software update • Practical guidance for patients, caregivers, and healthcare professionals on what to monitor and how to verify whether their device is up to date. The article is based on publicly available FDA documents and peer-reviewed research and is intended to help patients and clinicians better understand the current regulatory landscape and device safety considerations. #MedicalDevices #PatientSafety #DiabetesCare #Type1Diabetes #Healthcare #FDA #MedicalTechnology #DigitalHealth

Many patients assume that once orthopedic surgery is over, the implanted hardware is no longer something they need to think about. But what if complications can emerge years later? Bioabsorbable interference screws made from PLLA or PLGA have been widely used in ACL reconstructions, ankle repairs, and other ligament procedures. Recent published evidence suggests these devices may be associated with higher rates of complications and treatment failure compared to metallic alternatives. One of the challenges is that many patients don't even know which implant was used during their procedure. Our latest article explains: ✔️ What bioabsorbable interference screws are ✔️ The complications reported in the medical literature ✔️ How patients can verify which device was implanted ✔️ What symptoms may warrant medical evaluation Read more here: https://lnkd.in/gHTDWSD9 #MedicalDevices #PatientSafety #Orthopedics #ACLReconstruction #Healthcare #MedTech #PatientAdvocacy