Medical Device Recall Infographic

 

---

Content Summary for The Medical Device Recall Infographic

In the last 15 years, the most common causes of medical product recalls were due to: Device software malfunction Defective design Nonconforming components or materials The most commonly recalled medical devices are: heart valves, pacemakers, prosthetic knees, hip devices and ventilators. Important facts about Medical Device Safety: The FDA does not monitor healthcare professionals who use products for unapproved uses.https://injurylawyer.com/defective-medical-products/ FDA approval of  devices does not necessarily mean they are safe for human use. Products may not have been tested in real life situations. January - August 2016 24 medical products recalled. Device Defects: 4 Levels Of Reporting Responsibility. 1.  Manufacturers are legally required to notify the FDA of device defects with MDRs (Medical Device Reports) to be published as a notice to the public. 2.  Importers are required to notify the FDA of a device defect in case of death or serious injury. In case of malfunction they need to report to the manufacturer. 3.  Device user facilities - hospitals, nursing homes, outpatient facilities, report to the FDA and the manufacturer in case of death. They can voluntarily report a device malfunction using MedWatch form or MedWatcher mobile app. 4.   Consumers, caregivers, patients and healthcare professionals are encouraged to submit a MedWatch form if they know of or experience a medical product problem. Sources: http://www.fda.gov/downloads/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cdrh/cdrhtransparency/ucm388442.pdf http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm480134.htm http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm https://injurylawyer.com/defective-medical-products/