New York City Hazardous medical devices

Hazardous medical devices can lead to personal tragedy if precautions are not taken to make sure they are removed from the market and manufacturers are held responsible for their defective products. As the practice of medicine advances and more sophisticated technology is utilized in treatment, implanted and other medical devices become more common. The Food and Drug Administration (FDA) is responsible for regulating medical devices and defines a device as "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:

recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of it's primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes."

Sometimes a manufacturer or the FDA will decide to recall a hazardous medical device. In either case, the FDA oversees the recall to ensure that all appropriate measures are taken to protect the safety of the people affected. When a recall is issued, it will be assigned a class to signify the risk that is poses to those who use the device. There are three classes--Class I is the most serious and Class III represents a low risk.

The device you use does not have to be involved in an FDA or manufacturer's recall in order for you to experience an injury from a hazardous medical device. Generally, reports of injury or death related to a device have to accumulate before a recall is issued.

Additional Resources - refreshed on 09/04/2010

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