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Hospitals and defective medical devices

When a medical device fails or somehow causes harm to a patient, hospitals are supposed to report the problem to the U.S. Food and Drug Administration. Unfortunately, many hospitals are either unaware of their responsibilities or they are ignoring them. An inspection conducted by the FDA found numerous instances of hospitals failing to report illnesses or injuries tied to defective devices.

The legal requirement

Under federal law, hospitals are considered mandatory reporters when it comes to reporting defective or dangerous devices. Medical Device Reporting, or MDR, requires hospitals as well as device manufacturers and importers to file reports regarding adverse events and product problems tied to medical products. Hospitals must inform the FDA and the device manufacturer if they suspect a death is related to a medical device. They must report serious injuries linked to a device to the manufacturer of the device, or to the FDA if they don't know who manufactured the device. 

Hospitals are not required to tell the FDA about devices that malfunction, if the defect does not harm the patient. They are allowed, or even encouraged, to voluntarily inform the FDA about these problems. Patients are likewise encouraged to voluntarily report injuries or problems with a medical product to the FDA.

Ignorance of the law

At least one hospital cited in the FDA's investigation said it didn't report the issues because it wasn't positive the medical problems were caused by a particular device. The law makes it clear that hospitals must report any injury or death it suspects is related to a medical device. Hospitals are not required to prove that the device caused the injury or death. An FDA official suggested that many hospital members are not familiar with the reporting requirements laid out under federal law.

Defective medical devices can threaten countless patients all across the country. Without adequate reporting from hospitals, discovering which devices are dangerous will take longer. More patients will be injured or killed before the FDA can remove the offending devices from use.

Source: Consumer Advocacy News, "Do Hospitals Know The Defective Medical Device Reporting Requirements," by Andrew Steinberg, 30 November 2016 

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