Hospital Compliance with Defective Medical Device Reporting Requirements
Did you know that hospitals are required to report adverse events related to medical devices to the United States Food and Drug Administration?
No? You’re not alone.
A recent investigation found that even most hospitals were unaware of such requirements.
Over the past year, the FDA investigated claims that alleged some hospitals were not reporting injuries that were caused by medical devices. A total of 17 hospitals were investigated, including UMass Memorial Medical Center. The investigation concluded that UMass Memorial did not report patient infections that were possibly linked to a duodenoscope.
A duodenoscope contains a small camera. The device is inserted through the mouth and travels down the colon, allowing doctors to get a detailed view of the small intestine. However, due to the design of this device, it is difficult to completely sterilize it between uses. UMass apparently did not report 14 cases of infection that were allegedly caused by defective duodenoscopes. Three patients died from their complications, and two others had additional health problems. The hospital stated that it did not realize it had to report the incidents because it was not able to definitively link the devices with the infection.
According to federal law, however, all hospitals must report any information that reasonably suggests that a medical device either caused or contributed to the death or injury of a patient. The report must be made to the FDA and the manufacturer of the medical device.
Without proper reporting from hospitals, manufacturers and the FDA may be unaware of issues with medical devices. Of course, this places patients at increased risk of suffering complications or even dying after undergoing medical treatment. Although the FDA has stated that it will work with hospitals to ensure they understand all reporting requirements, patients must be vigilant during their hospital visits as well.
Failing to comply with FDA requirements may mean trouble for hospitals. They may find themselves liable for injuries that occur due to defective devices. In many cases, if a medical professional knew or had reason to know that a device was defective, and did not provide adequate warning to patients about the device, the medical professional may be liable if that device harms a patient.
In addition to medical professionals and hospitals, the manufacturer, testing laboratory, sales representative, and retail supplier may all be liable when a medical device harms a patient. In any case, several individuals or entities may be liable for the patient’s injuries.
Contact our Freehold NJ injury attorneys today to evaluate your medical device injury claim
If you feel a medical device caused your injuries, you should seek legal counsel as soon as possible. At Lomurro Law, our NJ injury attorneys are experienced in medical device injury claims and work with clients throughout the U.S. To schedule a free consultation, call 732-482-9285 or contact us online.