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
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.
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