Washington Defective Medical Device Attorney

FDA Requirements for Classification

The U.S. Food and Drug Administration (FDA) describes a medical device as any item that is used in the treatment, diagnosis or prevention of a medical condition. This can include a range of items used in the field of health care no matter their complexity. For instance, a bedpan is considered a medical device, as is any equipment used to determine lab test results. Any item classified as such must undergo regulation by the FDA before it can be used in a medical capacity.

Devices must also be recognized in The United States Pharmacopeia and The National Formulary. This documentation regulates a number of health care items, including medical devices, drugs, compounded pharmaceutical products (drug preparations created to meet an individual patient need), supplements and fillers used to complement the main ingredient of a medication.

What Makes a Medical Device Defective?

Like all products, medical devices are required to be manufactured and sold in a condition that is neither defective nor unreasonably dangerous. With certain exceptions, the fact that these products have been tested or approved by regulatory agencies does not exempt them from these legal requirements.

If a device maker sells a product that is found to be defective or unreasonably dangerous, it can be held liable to a patient injured by the product. If the medical device has a known risk that comes with its use, those risks must be disclosed to patients and healthcare providers so that an informed decision can made when considering whether to use the device to treat a particular medical condition.

Example of a Claimed Defective Medical Device 

While a medical device can be an effective treatment method, a report indicates significant discrepancies in identifying potential safety issues. According to Bloomberg, defective endoscopes led to numerous patients falling ill via super bugs, or bacteria that has proven resistant to treatment with antibiotics.

While Olympus (the device manufacturer) and the FDA were seemingly aware of these issues, both failed to act in a manner that prevented potentially dangerous devices from being used. A senate report on this issue pointed to a number of failures which led to increased rates of sickness stemming from these devices.

In this particular case, Olympus failed to alert U.S. hospitals and doctors to the difficulty in cleaning endoscopes (thereby trapping bacteria, which would then be spread to patients) though they did caution patients in Europe about possible risks. The report also found fault with the way the FDA monitors instances of device safety issues. Unlike the monitoring of pharmaceutical products, device monitoring relies on what is referred to as a “passive” system. Accordingly, it can be difficult for the FDA to notice patterns in health issues related to defective devices, which causes a delayed reaction.