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.
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.