The Safe Medical Devices Act requires health care facilities to report to the manufacturers such as Stryker any injuries or illnesses in patients or employees caused by the use of the manufacturers' medical devices such as an IVC filter. If a patient or employee happens to die as a result of the device being used, the FDA should be contacted as well. This ensures that a manufacturer is made aware of the defect.
This Act states that all healthcare employees who have experienced some incident with a device that has or could have resulted in a detrimental consequence to the patient or the employee, such as surgical robots or transvaginal mesh, must report the incident to the manufacturer. These employees can include:
An employee must take the following steps when a medical device has been found to be defective:
If a health care facility knowingly uses a defective medical device, such as a defective duodenoscope or a defective Bair Hugger, without notifying the manufacturer as required by the Safe Medical Devices Act, the facility may be held liable for injuries to its patients.
If you have been injured by a medical device at a health care facility you should consider hiring a personal injury attorney. An experienced personal injury lawyer can determine whether the health care facility violated the Safe Medical Devices Act and, if so, whether the facility is liable for your injuries.
Last Modified: 12-06-2017 02:05 PM PSTLaw Library Disclaimer
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