Many Medical Devices Are Tested In the Marketplace – Not the Laboratory
Consumer Reports disclosed in its May 2012 issue that many commonly used medical devices, including artificial hips, defibrillators, lap bands and surgical mesh don’t go through a rigorous testing process before being released for use to the public. Other medical devices may be “grandfathered” into approval based on prior trials conducted on “similar” devices that may or may not be similar. This results not only in recalls, but in countless injured individuals.
Information on defective devices can be elusive as the FDA itself relies solely upon voluntary, not mandatory, reporting of device failures from nearly 300 hospitals. The FDA’s “adverse-event” database about devices, deaths and serious injuries is also incomplete as many hospitals don’t consistently report those events.
Certified Legal Nurse Consultants working on cases involving allegedly defective medical devices should search the FDA website for safety warnings and recalls related to a particular medical device. A simple Internet search regarding a particular medical device can also reveal a wealth of knowledge about it.
As more and more medical devices enter the marketplace untested, litigation involving them will be a growth area for your legal nurse consulting business. If you want to get involved, be sure to search the specific device of interest and you will automatically find some of the attorneys handling these cases. Go ahead – get started today.
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*The opinions and statements made by Vickie Milazzo, the founder of Medical-Legal Consulting Institute, Inc. are based on her experiences and expertise, should not be applied beyond the specific context provided, and do not guaranty or project actual results. Vickie Milazzo is no longer involved in the operations or management of the business, but is involved as an independent education consultant.
